− Conference Call Today at 8:00 am ET−
- Advancing pipeline of wholly owned
therapeutic candidates: IMGN853 in initial evaluation of efficacy
in treatment of targeted ovarian and endometrial cancers; new
IMGN529 clinical data to be reported at ASH; dose-finding
evaluation of IMGN289 ongoing; IMGN779 advancing towards IND
submission in 2015.
- Kadcyla® sales exceed $150 million in
Roche’s most recent quarter, with regulatory submissions for two
more indications expected in 2015; eight other novel programs in
clinic through partnerships, with number expected to increase
markedly over the coming year; partner data presentations expected
at ASH.
- Company reiterates previous guidance
for 2015 fiscal year.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops novel anticancer therapeutics using its antibody-drug
conjugate (ADC) technology, today reported financial results for
the three-month period ended September 30, 2014 – the first quarter
of the Company’s 2015 fiscal year. ImmunoGen also provided an
update on product programs and reiterated its guidance for its 2015
fiscal year.
“We are executing on our strategy of employing our ADC
leadership to establish a pipeline of therapies that can make a
meaningful difference for people with cancer,” commented Daniel
Junius, President and CEO. “We are assessing our lead compound,
IMGN853, specifically for the treatment of ovarian and endometrial
cancers while concurrently evaluating a more frequent dosing
schedule, to ensure we take the best schedule forward into more
advanced testing. Dose finding is ongoing with both our IMGN529 for
non-Hodgkin lymphoma and our IMGN289 for EGFR-positive cancers,
with updated IMGN529 clinical findings accepted for presentation at
ASH in December. And we are advancing our next novel agent,
IMGN779, toward IND submission in 2015.”
Mr. Junius continued, “Additionally, we are entering a period
with a marked increase in our anticipated partner events. This
certainly includes the readouts from the next two Kadcyla Phase III
trials – MARIANNE and GATSBY – as projected by Roche and, if
positive, their registration submissions. It also includes several
partner compounds advancing deeper into clinical testing plus a
number of additional novel therapies entering the clinic,
underscoring our leadership position in the field.”
ImmunoGen Wholly Owned Product Candidates
IMGN853 – a potential new treatment for many ovarian and
endometrial cancers.
- IMGN853 is undergoing initial
assessment of activity and safety in the treatment of folate
receptor α (FRα)-positive platinum-resistant ovarian cancer and
relapsed endometrial cancer. In this assessment, it is administered
once every three weeks at its recommended Phase II dose
(RP2D).
- ImmunoGen is also assessing a weekly
dosing schedule, with dose finding ongoing. Company research
indicates dosing IMGN853 on a more frequent basis should increase
total drug exposure – and thus further enhance activity – while
reducing peak exposures – and thus further improve
tolerability.
- The Company intends to report
comprehensive IMGN853 findings at a major medical conference in
mid-2015.
IMGN529 – a potential new treatment for B-cell malignancies,
including non-Hodgkin lymphoma (NHL).
- Dose-finding assessment with this
CD37-targeting ADC is ongoing in NHL.
- Updated clinical findings will be
reported at the American Society of Hematology (ASH) annual meeting
in December 2014.
- The Company expects the RP2D of IMGN529
to be established and its evaluation in disease-specific patient
populations to begin in 2015.
IMGN289 – a potential new treatment for EGFR-positive cancers,
which include many head and neck, lung, breast, stomach and
esophageal cancers.
- Phase I dose finding is ongoing.
- The Company intends to report initial
IMGN289 clinical findings at a major medical conference in
2015.
IMGN779 – a potential new treatment for acute myeloid
leukemia.
- Additional preclinical findings will be
reported at ASH in December 2014.
- ImmunoGen expects to submit the
Investigational New Drug (IND) application for IMGN779 in the
second half of 2015.
Partner Compounds
Roche’s marketed product, Kadcyla (ado-trastuzumab emtansine),
is the lead therapy utilizing ImmunoGen’s ADC technology.
- Sales – Roche reported global Kadcyla
sales of 144 million CHF for its quarter ending September 30, 2014,
comprising 70 million CHF in the US and 74 million CHF
internationally. ImmunoGen receives and recognizes royalties on
Kadcyla sales in the quarter after the quarter in which Roche
records the sales.
- Roche expects the readout from its
MARIANNE Phase III trial by the end of 2014 and results from its
GATSBY Phase III trial in 2015. These assess Kadcyla for the
first-line treatment of HER2-positive metastatic breast cancer and
the second-line treatment of advanced HER2-positive gastric cancer,
respectively. With positive results, Roche intends to submit in
2015 for marketing approval for these uses.
- Roche also has three Phase III trials
underway assessing Kadcyla for early stage HER2-positive breast
cancer – for neoadjuvant use (KRISTINE), adjuvant use (KAITLIN) and
residual invasive disease (KATHERINE).
Over the past five years, the number compounds in the clinic
through ImmunoGen partnerships has increased by over fifty percent;
over the next 12-15 months, it is expected to increase
substantially again.
- Numerous leading healthcare companies
have partnered with ImmunoGen, including Amgen, Lilly, Novartis,
Roche and Sanofi.
- Data presentations on partner compounds
are expected at ASH.
Financial Results
For the Company’s quarter ended September 30, 2014 (1QFY2015),
ImmunoGen reported a net loss of $22.3 million, or $0.26 per basic
and diluted share, compared to a net loss of $11.2 million, or
$0.13 per basic and diluted share, for the same quarter last year
(1QFY2014).
Revenues for 1QFY2015 were $13.2 million, compared to
$17.2 million for 1QFY2014. Revenues in the current period
include $6.2 million of license and milestone fees, compared to
$13.2 million in 1QFY2014. The current year fees include $4.0
million of cash milestone payments from Sanofi earned with the
initiation of a Phase IIb trial for SAR650984 and a Phase I trial
for SAR408701 and $1.8 million of amortization of an upfront
license fee received from Sanofi in FY2014. The prior year fees
include $7.8 million of amortization of an upfront license fee
received from Lilly in FY2012 that was recognized in 1QFY2014 with
Lilly taking a development and commercialization license in that
quarter as well as a $5 million cash milestone payment from
Roche earned in 1QFY2014 with the approval of Kadcyla in Japan.
Revenues in 1QFY2015 also include $4.2 million of royalty
payments received from Roche in September 2014 for sales of Kadcyla
during the three-month period ended June 30, 2014, compared to $2.1
million of royalty payments received in 1QFY2014. Additionally,
1QFY2015 revenues include $0.8 million of research and
development support fees, compared to $2.0 million in such fees for
1QFY2014, and $2.0 million of clinical materials revenue, compared
to minimal revenue for 1QFY2014. The level of research support and
the number of batches of clinical materials produced and released
to partners varies on a quarter-to-quarter basis.
Operating expenses in 1QFY2015 were $35.1 million, compared
to $28.6 million in 1QFY2014. Operating expenses in 1QFY2015
include research and development expenses of $28.0 million,
compared to $22.0 million in 1QFY2014. This change is
primarily due to increased third-party costs related to the
advancement of our internal products, increased costs associated
with manufacturing clinical materials on behalf of our partners and
increased personnel expenses, principally due to recent hiring.
Operating expenses also include general and administrative expenses
of $7.1 million in 1QFY2015, compared to $6.5 million in
1QFY2014. This increase is primarily due to increased personnel and
patent expenses.
ImmunoGen had approximately $121.8 million in cash and cash
equivalents as of September 30, 2014, compared with $142.3 million
as of June 30, 2014, and had no debt outstanding in either
period. Cash used in operations was $18.9 million in the first
three months of FY2015, compared with $23.6 million in the
same period in FY2014. Capital expenditures were $1.7 million and
$0.6 million for the first three months of FY2015 and FY2014,
respectively.
Financial Guidance for Fiscal Year 2015
ImmunoGen’s financial guidance remains unchanged from that
issued in August 2014. ImmunoGen expects: its revenues to be
between $100 million and $105 million; its operating expenses
to be between $160 million and $165 million; its net loss
to be between $60 million and $65 million; its cash used in
operations to be between $55 million and $60 million; and
its capital expenditures to be between $7 million and
$9 million. Cash and marketable securities at June 30, 2015
are anticipated to be between $75 million and
$85 million.
“We are investing in advancing and expanding our portfolio of
novel therapies designed to make a meaningful difference for
patients with cancer,” commented David Johnston, EVP and CFO. “This
includes investment in the research, trials and clinical materials
needed to advance our programs, and also in the human resources and
expertise needed to take them successfully to and through future
stages.”
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 913-312-0384; the conference ID is 9325211. 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 7, 2014.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The
Company’s ADC technology uses tumor-targeting antibodies to deliver
an ImmunoGen cell-killing agent specifically to cancer cells; the
Company has also developed antibodies with anticancer activity of
their own. The first product with ImmunoGen’s ADC technology is
Roche’s Kadcyla. ImmunoGen has three wholly owned product
candidates in clinical testing with additional compounds in
clinical testing through the Company’s partnerships with Amgen,
Bayer HealthCare, Biotest and Sanofi. More information about
ImmunoGen can be found at www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, a member of the
Roche Group.
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 revenues, operating expenses, net loss, cash used in
operations and capital expenditures in its 2015 fiscal year; its
cash and marketable securities as of June 30, 2015; 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, 2014 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)
September 30, June 30, 2014 2014
ASSETS Cash and cash equivalents $ 121,798 $ 142,261 Other
assets 21,308 23,057 Total assets $ 143,106 $
165,318 LIABILITIES AND SHAREHOLDERS' EQUITY Current
liabilities $ 39,774 $ 21,254 Long-term portion of deferred revenue
and other long-term liabilities 44,361 68,365 Shareholders' equity
58,971 75,699 Total liabilities and
shareholders' equity $ 143,106 $ 165,318
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
Three Months Ended September 30,
2014 2013
Revenues: License and milestone fees $ 6,234 $ 13,167 Royalty
revenue 4,166 2,053 Research and development support 776 1,990
Clinical materials revenue 2,027 8
Total revenues 13,203 17,218
Expenses: Research and development 28,018 22,029 General and
administrative 7,095 6,526 Total
operating expenses 35,113 28,555
Loss from operations (21,910 ) (11,337 ) Other (expense)
income, net (372 ) 111 Net loss $
(22,282 ) $ (11,226 )
Net loss per common share, basic
and diluted $ (0.26 ) $
(0.13 ) Weighted average common
shares outstanding, basic and diluted 85,872
85,010
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Pure Communications,
Inc.Dan Budwick, 973-271-6085
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