- Wholly owned product candidates –
advancing, with expanding news flow expected.
- Kadcyla® sales growing – launches in
European Union starting.
- Beyond Kadcyla – encouraging
initial clinical findings now reported with six other compounds in
development through partnerships.
- Company updates guidance – expects to
end fiscal year with greater cash balance than previously
projected.
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 March 31, 2014 – the third quarter of
the Company’s 2014 fiscal year. ImmunoGen also provided an update
on Company and partner product programs.
“The expanding amount of encouraging clinical data being
reported by us and our partners reflects the investments we have
made in our technology and in our product development
capabilities,” commented Daniel Junius, President and CEO. “Earlier
this month, we reported clinical data showing that our change to
the dosing calculation for IMGN853 appears to have had the desired
effect, and we are pleased with the dose levels being achieved.
There continues to be strong investigator interest in our IMGN289
EGFR-targeting ADC, which has enabled dose escalation to already be
reaching potentially therapeutic dose levels. Dose escalation with
IMGN529 has resumed, as noted previously, and this compound for
B-cell malignancies is now being administered at doses above those
where anticancer activity was first seen.”
Mr. Junius continued, “Kadcyla sales are off to a good start,
with the results from its next registration trial – MARIANNE –
expected later this year. Encouraging initial clinical data were
reported with Amgen’s AMG 595 earlier this month, and we expect the
body of clinical data around our compounds and those of our
partners to increase substantially in 2014.”
ImmunoGen Wholly Owned Product Candidates
IMGN853 – This ADC is a potential treatment for folate receptor
α-positive cancers, including many ovarian, endometrial and lung
cancers.
- Initial findings reported at the annual
meeting of the American Association of Cancer Research (AACR)
earlier this month showed the change made in dose calculation –
from use of total body weight (TBW) to adjusted ideal body weight
(AIBW) – appears to have achieved its objective: none of the six
patients treated with IMGN853 at 5 mg/kg AIBW had ocular toxicity
compared with four of ten using TBW. Evidence of activity has been
seen with IMGN853 at doses of 3.3 mg/kg (TBW) and above, as
previously reported.
- Additional IMGN853 clinical data are to
be presented at the upcoming annual meeting of the American Society
of Clinical Oncology (ASCO).
- The Company expects to establish the
maximum tolerated dose of IMGN853 with the current once every 3
weeks dosing schedule this quarter and to begin assessing IMGN853
specifically in patients with platinum-resistant ovarian cancer or
relapsed endometrial cancer. The first disease-specific data are
expected to be reported later this year.
- IMGN853 also is being assessed using a
modified weekly dosing schedule, to enable the best schedule to be
used as it advances.
IMGN529 – This CD37-targeting ADC is a potential new treatment
for B-cell malignancies, including non-Hodgkin lymphoma.
- The first clinical findings with
IMGN529 are scheduled for presentation at ASCO.
IMGN289 – This EGFR-targeting ADC is a potential new treatment
for many epithelial tumors, including squamous cell head/neck and
lung cancers.
- The Company reported preclinical data
at AACR on the activity of IMGN289 against tyrosine kinase
inhibitor (TKI)-resistant EGFR-positive cancers.
- Dose-escalation is ongoing in the
IMGN289 Phase I clinical trial, with updates – initial data and/or
development events – expected in the second half of 2014.
Partner Compounds
Roche’s Kadcyla (ado-trastuzumab emtansine) is the first
marketed product utilizing ImmunoGen’s ADC technology.
- Sales – Roche reported global Kadcyla
sales of 102 million CHF (approximately $115 million) for the
first quarter of 2014 (January-March, 2014). Launch of Kadcyla has
begun in some countries in the EU and is ongoing in the US; launch
in Japan began last week. ImmunoGen receives and recognizes
royalties on Kadcyla sales in the quarter after the quarter in
which Roche records the sales.
- First-line for HER2-positive metastatic
breast cancer – Roche expects results from its MARIANNE Phase III
trial to be reported in the second half of 2014, and – with
positive results – to submit in 2015 for regulatory approval.
- Advanced HER2-positive gastric cancer –
Roche is evaluating Kadcyla for second-line use in this disease in
its GATSBY trial. Regulatory submission – with positive results –
is expected in 2015.
- Early stage HER2-positive breast cancer
– Roche has three Phase III trials with Kadcyla: KAITLIN, for
adjuvant use, which is underway; KATHERINE, for residual invasive
disease, which is underway; and KRISTINE, for neo-adjuvant use,
which is expected to start this quarter.
A number of leading companies in oncology are developing
anticancer compounds through partnerships with ImmunoGen. Recent
updates include:
- The first clinical data with Amgen’s
AMG 595 in glioblastoma were reported at AACR, with evidence of
activity seen at doses that were well tolerated.
- With the presentation of the AMG 595
data at AACR, encouraging initial clinical findings have now been
reported for six partner compounds in addition to Kadcyla: Amgen’s
AMG 595, Bayer HealthCare’s BAY 94-9343 (anetumab ravtansine),
Biotest’s BT-062 (indatuximab ravtansine), Sanofi’s SAR3419
(coltuximab ravtansine), SAR566658, and SAR650984.
- Patient dosing has begun in a clinical
trial assessing CD138-targeting BT-062 for the treatment of triple
negative metastatic breast cancer and metastatic urinary bladder
cancer. BT-062 also is in clinical testing for the treatment of
multiple myeloma. ImmunoGen has a BT-062 opt-in right for
co-development and co-commercialization jointly with Biotest in the
US.
- ImmunoGen expects one or more partner
IND submissions in 2014, plus additional clinical data
presentations.
Financial Results
For the Company’s quarter ended March 31, 2014 (3Q FY2014),
ImmunoGen reported a net loss of $37.5 million, or $0.44 per basic
and diluted share, compared to a net loss of $1.4 million, or
$0.02 per basic and diluted share, for the same quarter last year
(3Q FY2013). Included in the current period is a $12.8 million
($0.15/share) non-cash expense related to the collaboration
recently established with CytomX.
Revenues for 3Q FY2014 were $6.9 million, compared to
$25.0 million for 3Q FY2013. Revenues in the current
period include $0.3 million of license and milestone fees, compared
to $22.0 million in 3Q FY2013. The prior year fees include
$11.1 million of amortization of an upfront license fee received
from Novartis in FY2011 that was recognized in 3Q FY2013 with
Novartis taking a development and commercialization license in that
quarter as well as a $10.5 million milestone payment from
Roche earned in 3Q FY2013 with the approval of Kadcyla in the
US.
Revenues in 3Q FY2014 also include $2.6 million of royalty
payments received from Roche in March 2014 for sales of Kadcyla
during the three-month period ended December 31, 2013; the Company
had no royalty revenue in 3Q FY2013. Additionally, revenues in 3Q
FY2014 include $1.9 million of research and development
support fees, compared to $2.3 million in such fees for
3Q FY2013, and $2.1 million of clinical materials revenue,
compared to $0.7 million for 3Q FY2013. The amount of research
and the number of batches of clinical materials produced and
released to partners varies on a quarter-to-quarter basis.
Operating expenses in 3Q FY2014 were $44.3 million,
compared to $26.3 million in 3Q FY2013. Operating expenses in
3Q FY2014 include research and development expenses of
$38.3 million, compared to $21.3 million in 3Q FY2013. In
3Q 2014, the Company recorded a $12.8 million non-cash charge
to research and development expense for technology rights obtained
under the collaboration agreement executed with CytomX in January
2014. Also driving the change from the prior period are increased
personnel expenses and increased costs associated with
manufacturing clinical materials on behalf of our partners.
Operating expenses also include general and administrative expenses
of $6.0 million in 3Q FY2014, compared to $5.0 million in 3Q
FY2013. This increase is primarily due to increased personnel
expenses and patent expenses.
ImmunoGen had approximately $164.1 million in cash and cash
equivalents as of March 31, 2014, compared with $195.0 million as
of June 30, 2013, and had no debt outstanding in either
period. Cash used in operations was $34.7 million in the first nine
months of FY2014, compared with $48.7 million in the same
period in FY2013. Capital expenditures were $4.7 million and $2.4
million for the first nine months of FY2014 and FY2013,
respectively.
Updated Financial Guidance for Fiscal Year 2014
ImmunoGen is updating its financial guidance for FY2014 from
that issued in January 2014. ImmunoGen now expects:
- Revenues to be between $60 million
and $64 million, compared with previous guidance of between
$71 million and $75 million;
- Operating expenses to be between $133
million and $137 million, compared with previous guidance of
between $140 million and $144 million;
- Net loss to be between $71 million
and $75 million, compared with previous guidance of between
$67 million and $71 million;
- Net cash used in operations to be
between $56 million and $60 million, compared with previous
guidance of between $64 million and $68 million;
- Capital expenditures to between $8
million and $10 million, unchanged from previous guidance; and
- To end its fiscal year on June 30, 2014
with cash and cash equivalents of between $134 million and
$138 million, compared with previous guidance of between
$124 million and $128 million.
“We are investing in advancing and expanding our portfolio of
compounds designed to make a meaningful difference for patients
with cancer,” commented David Johnston, EVP and CFO. “In addition
to using partnerships as an important source of non-dilutive
capital, we also continue to carefully manage our cash expenses, as
reflected in these financial results.”
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 913-312-0376; the passcode is 4427468. 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 May 9,
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 2014 fiscal year; its
cash and marketable securities as of June 30, 2014; 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; and
other factors more fully described in ImmunoGen's Annual Report on
Form 10-K for the fiscal year ended June 30, 2013 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, 2014 2013 ASSETS Cash
and cash equivalents $ 164,076 $ 194,960 Other assets 22,618
18,636 Total assets $ 186,694 $ 213,596
LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities $
21,197 $ 19,173 Long-term portion of deferred revenue and other
long-term liabilities 67,563 72,576 Shareholders' equity
97,934 121,847 Total liabilities and shareholders'
equity $ 186,694 $ 213,596
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
Three Months Ended Nine Months Ended March 31,
March 31, 2014
2013 2014
2013 Revenues: License and milestone fees $ 305 $
22,010 $ 39,150 $ 23,372 Royalty revenue 2,558 - 6,946 - Research
and development support 1,948 2,257 5,860 5,670 Clinical materials
revenue 2,064 734 2,197 2,662 Total revenues
6,875 25,001 54,153 31,704 Expenses: Research
and development 38,280 21,318 81,171 66,674 General and
administrative 6,040 4,995 18,013 16,098 Total
operating expenses 44,320 26,313 99,184 82,772
Loss from operations (37,445) (1,312) (45,031) (51,068)
Other (expense) income, net (7) (39) 166 132
Net loss $ (37,452) $ (1,351) $ (44,865) $ (50,936)
Net
loss per common share, basic and diluted $ (0.44)
$ (0.02) $ (0.53) $
(0.61) Weighted average common shares
outstanding, basic and diluted 85,684
84,279 85,375 83,923
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Pure Communications,
Inc.Dan Budwick, 973-271-6085
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