− Conference Call Today at 8:00 am ET−
- Profit reported for quarter, driven by
partner activity; Company reiterates previous financial guidance
for fiscal year.
- Numerous events expected in 2015 with
ImmunoGen and partner product programs.
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 December 31, 2014 – the second quarter
of the Company’s 2015 fiscal year (2QFY2015). ImmunoGen also
provided an update on product programs and reiterated its financial
guidance.
“We believe the potential of ImmunoGen as a product company will
become more clearly established in 2015, driven by achievements
with our most advanced compounds, IMGN853 and IMGN529,” commented
Daniel Junius, President and CEO. “We are preparing to expand the
IMGN853 clinical program markedly this year based on the
encouraging clinical findings to date, which are being submitted
for presentation at the ASCO annual meeting. We expect to initiate
assessment of IMGN529 specifically in the treatment of diffuse
large B-cell lymphoma – building on the promising data reported at
ASH last month – and in chronic lymphocytic leukemia, and to
present more mature clinical findings later in the year.”
Mr. Junius continued, “In 2015, Roche expects the presentation
of the data from its MARIANNE breast cancer trial as well as the
read out from its GATSBY gastric cancer trial, which should lead to
a better understanding of the potential opportunity for Kadcyla in
the patient populations studied. We expect the potential of several
earlier-stage partner compounds to become better established in
2015, and three-to-four more to enter the clinic. The first of
these, Novartis’ LOP628, started Phase 1 testing earlier this
month.”
ImmunoGen Wholly Owned Product Candidates
IMGN853 – This ADC is currently in initial (Phase 1b)
efficacy testing for the treatment of folate receptor α
(FRα)-positive platinum-resistant ovarian cancer and
relapsed/refractory endometrial cancer. It is being assessed as a
single agent, administered once every three weeks at its
recommended Phase 2 dose (RP2D).
- The Company is targeting the annual
meeting of the American Society of Clinical Oncology (ASCO) in
2Q2015 for presentation of IMGN853 clinical findings to date.
- ImmunoGen expects to initiate Phase 2
testing in FRα-positive ovarian cancer or endometrial cancer, or
both, in 2H2015, pursuing, as appropriate, potential accelerated
registration pathways.
- ImmunoGen plans to initiate in 2015
assessment of IMGN853 in combination regimens for the treatment of
patients with FRα-positive ovarian cancer.
IMGN529 – This CD37-targeting ADC is a potential new treatment
for diffuse large B-cell lymphoma (DLBCL) and other B-cell
malignancies. It is in dose-finding assessment in patients with
non-Hodgkin lymphoma (NHL), with encouraging evidence of activity
in patients with relapsed/refractory DLBCL presented at the
American Society of Hematology (ASH) annual meeting in
December.
- The Company expects the RP2D of IMGN529
to be established in 1H2015 and to begin disease-specific testing
with IMGN529 in mid-2015.
- ImmunoGen intends to assess IMGN529
specifically for the treatment of DLBCL and of chronic lymphocytic
leukemia (CLL).
- The Company plans to report new IMGN529
clinical data at a medical conference in 2H2015.
IMGN289 – This ADC is 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.
IMGN779 – This CD33-targeting ADC is a potential new treatment
for acute myeloid leukemia. It utilizes one of ImmunoGen’s new
DNA-acting payload agents.
- Data showing IMGN779 is highly active
in preclinical models of AML with FLT3-ITD mutations were reported
at ASH.
- ImmunoGen expects to submit the
Investigational New Drug (IND) application for IMGN779 in
2H2015.
Technology innovations – The Company expects to report
information related to the ongoing expansion of its
state-of-the-art technology portfolio at the American Association
of Cancer Research (AACR) annual meeting in April. Numerous
abstracts were submitted to this conference on ImmunoGen and
partner compounds.
Partner Compounds
Roche’s Kadcyla (ado-trastuzumab emtansine), which uses
ImmunoGen’s ADC technology, is the only ADC with full FDA approval
(EMILIA Phase 3 trial).
- Sales – Roche reported global Kadcyla
sales of 165 million CHF for its quarter ending December 31, 2014,
comprising 69 million CHF in the US and 96 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
GATSBY trial in 2015, and – if positive – to apply for marketing
approval of Kadcyla for the second-line treatment of advanced
HER2-positive gastric cancer.
- Roche also expects the data from its
MARIANNE trial to be presented in 2015; it intends to discuss these
data with appropriate regulatory authorities.
- Roche has expanded its Kadcyla clinical
program to include assessment for non-small cell lung cancer
(NSCLC), starting a Phase 2 trial in late 2014 assessing Kadcyla
for second-line/later treatment of advanced HER2-positive
NSCLC.
- Patient enrollment continues in the
three Phase 3 trials assessing Kadcyla for early stage
HER2-positive breast cancer – for neoadjuvant use (KRISTINE),
adjuvant use (KAITLIN) and residual invasive disease
(KATHERINE).
Other leading companies are advancing clinical-stage compounds
that use ImmunoGen technology – Amgen, Bayer HealthCare, Biotest,
Novartis and Sanofi. Recent updates include:
- Encouraging Phase 2 data were reported
at ASH for Sanofi’s CD38-targeting SAR650984 and Biotest’s
indatuximab ravtansine (BT-062). ImmunoGen has an opt-in right with
Biotest for the US.
- In January, Novartis advanced its
cKit-targeting ADC, LOP628, into clinical testing, triggering a
$5 million cash milestone payment to ImmunoGen that will be
reflected in the Company’s 3QFY2015 financial results.
In 2015, ImmunoGen expects:
- 2-3 partner compounds to advance to IND
submission and/or clinical testing in addition to LOP628.
- A number of clinical data presentations
on partner compounds.
Financial Results
For the Company’s quarter ended December 31, 2014 (2QFY2015),
ImmunoGen reported net income of $13.6 million, or $0.16 per basic
and diluted share, compared to net income of $3.8 million, or
$0.04 per basic and diluted share, for the same quarter last year
(2QFY2014).
Revenues for 2QFY2015 were $48.3 million, compared to
$30.1 million for 2QFY2014. Revenues in the current period
include $41.4 million of license and milestone fees, compared to
$25.7 million in 2QFY2014. The current year fees include $41.4
million of amortization of upfront fees, in aggregate, previously
received from Novartis and Lilly that were recognized in 2QFY2015
due to their license activity in the period. The prior year period
includes $18.2 million of amortization of upfront fees previously
received from Novartis that were recognized in 2QFY2014 due to
Novartis license activity and its executing an extension of its
multi-target agreement with the Company. They also include a
$5 million cash milestone payment earned from Roche with the
approval of Kadcyla in the EU and $2.2 million of amortization of
upfront license fees from Amgen.
Revenues in 2QFY2015 include $4.6 million of royalty
payments received from Roche in December 2014 for sales of Kadcyla
during the three-month period ended September 30, 2014, compared to
$2.3 million of royalty payments received in 2QFY2014.
Additionally, 2QFY2015 revenues include $0.8 million of
research and development support fees, compared to $1.9 million in
such fees for 2QFY2014, and $1.4 million of clinical materials
revenue, compared to $0.1 million for 2QFY2014. 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 2QFY2015 were $34.5 million, compared
to $26.3 million in 2QFY2014. Operating expenses in 2QFY2015
include research and development expenses of $27.6 million,
compared to $20.9 million in 2QFY2014. 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 $6.9 million in 2QFY2015, compared to $5.4 million in
2QFY2014. This increase is primarily due to increased personnel and
patent expenses.
ImmunoGen had approximately $106.6 million in cash and cash
equivalents as of December 31, 2014, compared with $142.3 million
as of June 30, 2014, and had no debt outstanding in either
period. Cash used in operations was $34.4 million in the first six
months of FY2015, compared with $21.6 million in the same
period in FY2014. Capital expenditures were $2.6 million and $2.3
million for the first six months of FY2015 and FY2014,
respectively.
Financial Guidance for Fiscal Year 2015
ImmunoGen’s financial guidance remains unchanged from that
issued in October 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.
“Our financial results this quarter reflect our business model
of investing in the development of our own product candidates
designed to make a meaningful difference for patients with cancer,
and utilizing partnerships to help fund these programs,” commented
David Johnston, EVP and CFO.
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 913-312-0977; the conference ID is 8510777. 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 February 13,
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 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, Novartis 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)
December 31, June 30, 2014 2014 ASSETS
Cash and cash equivalents $ 106,604 $ 142,261 Other assets
21,936 23,057 Total assets $ 128,540
$ 165,318 LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 19,643 $ 21,254 Long-term portion of deferred
revenue and other long-term liabilities 31,427 68,365 Shareholders'
equity 77,470 75,699 Total liabilities
and shareholders' equity $ 128,540 $ 165,318
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) Three Months Ended Six Months
Ended December 31, December 31, 2014
2013 2014 2013 Revenues: License and
milestone fees $ 41,417 $ 25,678 $ 47,651 $ 38,845 Royalty revenue
4,625 2,335 8,791 4,388 Research and development support 832 1,922
1,608 3,912 Clinical materials revenue 1,426
125 3,453 133 Total revenues 48,300
30,060 61,503 47,278 Expenses:
Research and development 27,647 20,862 55,665 42,891 General and
administrative 6,872 5,447 13,967
11,973 Total operating expenses 34,519
26,309 69,632 54,864 Income (loss) from
operations 13,781 3,751 (8,129 ) (7,586 ) Other income, net
(146 ) 62 (518 ) 172 Net income (loss)
$ 13,635 $ 3,813 $ (8,647 ) $ (7,414 )
Net income
(loss) per common share, basic and diluted $ 0.16
$ 0.04 $ (0.10 ) $
(0.09 ) Weighted average common shares
outstanding, diluted 86,665
87,276 85,904 85,221
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Pure Communications,
Inc.Dan Budwick, 973-271-6085
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