− Conference Call Today at 8:00 am ET−
- The Company is investing in its wholly
owned product programs, including expanding its mirvetuximab
soravtansine (IMGN853) and IMGN529 clinical programs and developing
plans for recently reacquired coltuximab ravtansine (SAR3419).
Initial clinical data with mirvetuximab soravtansine in the
treatment of platinum-resistant ovarian cancer are to be reported
at ASCO annual meeting.
- ImmunoGen continues to expand its
antibody-drug conjugate (ADC) technology portfolio, had multiple
presentations at the AACR annual meeting, and recently announced
access to its technology has been licensed by Takeda.
- The Company expects to end its fiscal
year on June 30, 2015 with between $265 million and $275
million in cash and cash equivalents, reflecting its recent royalty
transaction.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops novel anticancer therapeutics using its ADC technology,
today reported financial results for the three-month period ended
March 31, 2015 – the third quarter of the Company’s 2015 fiscal
year. ImmunoGen also provided an update on its product pipeline and
financial guidance.
“We are executing against our product development plan and
recently strengthened our financial resources to support these
programs,” commented Daniel Junius, President and CEO. “The
clinical findings with mirvetuximab soravtansine to date are
encouraging, and we look forward to their presentation at ASCO next
month. Based on these data and the medical need, we are expanding
the compound’s clinical program and implementing preparations to
support an accelerated development pathway.”
Mr. Junius continued, “We are also expanding the development
program for our CD37-targeting ADC, IMGN529, to include assessment
in combination with rituximab for non-Hodgkin lymphoma as well as
evaluation as a single agent for diffuse large B-cell lymphoma and
chronic lymphocytic leukemia. Updates on other hematology programs
include that we are developing our plans for the CD19-targeting
ADC, coltuximab ravtansine, for B-cell malignancies that we
recently regained from Sanofi, we remain on track for IND
submission later this year with IMGN779 for acute myeloid leukemia,
and Biotest continues to make important progress with their
CD138-targeting ADC for multiple myeloma and certain solid
tumors.”
Pipeline Updates
Mirvetuximab soravtansine, a potential new therapy for many
cases of ovarian cancer as well as for endometrial cancer and other
solid tumors that highly express folate receptor α (FRα); wholly
owned by ImmunoGen.
- This ADC now has received orphan
designation in ovarian cancer in the EU as well as in the US.
- Initial findings with mirvetuximab
soravtansine – used as a single agent – to treat FRα-positive
platinum-resistant ovarian cancer will be presented at the 2015
ASCO Annual Meeting. The data are from a disease-specific Phase 1
cohort. ImmunoGen plans to initiate a Phase 2 trial in this
indication by the end of 2015 that could potentially support an
accelerated registration pathway.
- ImmunoGen also plans to initiate in
2H2015 assessment of mirvetuximab soravtansine used in combination
regimens for ovarian cancer.
- Assessment of mirvetuximab soravtansine
for the treatment of FRα-positive relapsed/ refractory (R/R)
endometrial cancer is ongoing. ImmunoGen is preparing to also
assess it for FRα-positive R/R non-small cell lung cancer.
- In addition to the every three week
dosing schedule being used in the disease-specific testing
underway, dose-finding with a weekly dosing regimen is advancing.
The findings to date also have been accepted for presentation at
ASCO.
IMGN529, a potential new treatment for B-cell malignancies;
wholly owned by ImmunoGen.
- Once the recommended Phase 2 dose is
established, ImmunoGen plans to evaluate it specifically for the
treatment of R/R diffuse large B-cell lymphomas (DLBCL) and chronic
lymphocytic leukemia.
- Preclinical findings with IMGN529 used
with rituximab (Rituxan®) will be reported at the International
Conference on Malignant Lymphoma in Lugano in June 2015. ImmunoGen
is planning to initiate a clinical trial to assess the
combination.
- The next IMGN529 clinical data
presentation(s) are targeted for the ASH annual meeting in
December.
Indatuximab ravtansine (BT-062), a CD138-targeting ADC for
multiple myeloma and certain solid tumors; wholly owned by Biotest;
ImmunoGen holds rights to opt-in with Biotest on joint US
development and commercialization.
- Phase 2 trial ongoing in multiple
myeloma; Phase 1 trial ongoing in triple-negative breast cancer and
metastatic urinary bladder cancer.
Coltuximab ravtansine (SAR3419), a potential therapy for DLBCL
and other B-cell malignancies; demonstrated encouraging activity in
the treatment of R/R DLBCL in STARLYTE Phase 2 trial presented at
ASCO 2014 and selected for Best of ASCO.
- ImmunoGen recently regained the rights
to this promising ADC from Sanofi.
IMGN779, CD33-targeting ADC utilizing one of ImmunoGen’s
DNA-acting payload agents; a potential treatment for acute myeloid
leukemia and myelodysplastic syndrome; wholly owned by
ImmunoGen.
- Remains on track for IND submission in
2H2015.
IMGN289, EGFR-targeting ADC, wholly owned by ImmunoGen.
- The Company has stopped Phase 1 testing
and returned the program to research.
Genentech/Roche’s ado-trastuzumab emtansine (Kadcyla®), which
uses ImmunoGen’s ADC technology.
- Approved in the US, Europe, and other
geographies based on the results from the EMILIA Phase 3 trial; in
development by Roche for a number of indications, with data from
the MARIANNE Phase 3 trial to be presented at ASCO.
- ImmunoGen recently reported a
monetization transaction pertaining to the royalties earned on
Kadcyla sales.
Financial Results
For the Company’s quarter ended March 31, 2015 (3QFY2015),
ImmunoGen reported a net loss of $21.6 million, or $0.25 per basic
and diluted share, compared to a net loss of $37.5 million, or
$0.44 per basic and diluted share, for the same quarter last year
(3QFY2014).
Revenues for 3QFY2015 were $11.4 million, compared to
$6.9 million for 3QFY2014. They include $5.1 million of
license and milestone fees, principally from a $5 million cash
milestone payment earned from Novartis with the initiation of Phase
1 testing of its product candidate, LOP628. They also include
$5.1 million of royalty payments received from Roche in March
2015 for sales of Kadcyla during the three-month period ended
December 31, 2014. The royalty transaction recently announced
impacts royalties earned on Kadcyla sales starting January 1, 2015.
Revenues for 3QFY2015 also include $0.7 million of clinical
materials revenue and $0.5 million of research and development
support fees. 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 3QFY2015 were $32.7 million, compared
to $44.3 million in 3QFY2014, and consist of research and
development expenses of $25.7 million and general and
administrative expenses of $7.0 million. The prior year period
included a $12.8 million non-cash charge recorded to research
and development expense related to a collaboration agreement
executed with CytomX.
ImmunoGen had approximately $111.8 million in cash and cash
equivalents as of March 31, 2015, – inclusive of a $20 million
upfront payment received from Takeda – compared with $142.3 million
as of June 30, 2014. Cash used in operations was $27.4 million
in the first nine months of FY2015 and capital expenditures were
$4.5 million.
Financial Guidance for Fiscal Year 2015
ImmunoGen has updated its guidance for its fiscal year ending
June 30, 2015. The Company’s guidance for its net loss is
unchanged, and expected to be between $60 million and $65 million.
Expected revenues are now projected to be between $85 million and
$95 million, compared with previous guidance of between
$100 million and $105 million, due to changes in the
expected timing of partner milestone events. Expected operating
expenses are now projected to be between $145 million and
$150 million, compared with previous guidance of between
$160 million and $165 million.
ImmunoGen now projects cash and cash equivalents at June 30,
2015 to be between $265 million and $275 million,
compared to previous guidance of $75 million to
$85 million. This change principally reflects the Kadcyla
royalty monetization transaction announced in March 2015. The
Company’s guidance for cash used in operations and capital
expenditures remains unchanged from that issued on January 2015.
These are projected to be between $55 million and
$60 million and between $7 million and $9 million,
respectively.
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 913-312-0966; the conference ID is 2370723. The call also may
be accessed through the Investors 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 8, 2015.
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 utilizes its ADC technology with its antibodies to create
ImmunoGen product candidates and also out-licenses limited rights
to use its technology to other companies. Roche’s Kadcyla® is the
first marketed product with ImmunoGen’s ADC technology. More
information about the Company can be found at
www.immunogen.com.
Rituxan® and Kadcyla® are registered trademarks of their
respective owners.
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) March 31, June 30,
2015 2014 ASSETS Cash and
cash equivalents $ 111,827 $ 142,261 Other assets 21,975
23,057 Total assets $ 133,802 $
165,318 LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 22,812 $ 21,254 Long-term portion of deferred
revenue and other long-term liabilities 51,320 68,365 Shareholders'
equity 59,670 75,699 Total
liabilities and shareholders' equity $ 133,802 $ 165,318
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended Nine
Months Ended March 31, March 31,
2015 2014
2015 2014
Revenues: License and milestone fees $ 5,078 $ 305 $ 52,729 $
39,150 Royalty revenue 5,099 2,558 13,890 6,946 Research and
development support 532 1,948 2,140 5,860 Clinical materials
revenue 718 2,064 4,171
2,197 Total revenues 11,427
6,875 72,930 54,153
Expenses: Research and development 25,666 38,280 81,331
81,171 General and administrative 7,000 6,040
20,967 18,013 Total
operating expenses 32,666 44,320
102,298 99,184 Loss from operations
(21,239 ) (37,445 ) (29,368 ) (45,031 ) Other (expense)
income, net (379 ) (7 ) (897 ) 166
Net loss $ (21,618 ) $ (37,452 ) $ (30,265 ) $
(44,865 )
Net loss per common share, basic and
diluted $ (0.25 ) $ (0.44
) $ (0.35 ) $ (0.53
) Weighted average common shares
outstanding, diluted 86,080
85,684 85,962
85,375
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Pure Communications,
Inc.Dan Budwick, 973-271-6085
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