−Company Provides Corporate Update and Fiscal
Year 2015 Financial Guidance −
− Conference Call Today at 8:00 am ET−
- Advancing pipeline of wholly owned
therapeutic candidates: IMGN853 beginning evaluation in target
patient populations; initial evidence of IMGN529 activity reported;
IMGN289 being assessed at increasingly higher doses; next IND
candidate disclosed.
- Partner progress includes impressive
clinical data for SAR3419 and SAR650984 presented at recent medical
meeting, advancement of ninth partner compound into clinic, and
expected readout of Kadcyla® MARIANNE trial later this year.
- Company ends fiscal year with solid
cash position.
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 June 30, 2014 – the fourth quarter of
the Company’s 2014 fiscal year. ImmunoGen also provided an update
on product programs and guidance for its 2015 fiscal year.
“We believe the potential value of our wholly owned and partner
compounds will become considerably more established over the next
12 months,” commented Daniel Junius, President and CEO. “For our
wholly owned compounds, a key step in this process is having the
appropriate dosing information to begin initial assessment of
efficacy in target patient populations. IMGN853 has now reached
this stage, and both IMGN529 and IMGN289 are being dosed at levels
where the selected dose for each could be established within the
next six months.”
Mr. Junius continued, “Over the course of the coming year, we
also expect to have markedly greater insight into potential for a
number of partner programs. This certainly includes the expected
disclosure by Roche of the findings from the MARIANNE
phase III trial as well as an increasing body of data on the
adoption of Kadcyla on a global basis. We expect it to also include
more insight into the development programs for several other
compounds as well as the advancement of additional experimental
therapies into clinical testing. Sanofi, for example, has now
advanced another ADC compound, SAR408701, into phase I
testing.”
ImmunoGen Wholly Owned Product Candidates
IMGN853, an ADC, is a potential new therapy for folate receptor
α (FRα)-positive cancers, including ovarian and endometrial
cancers.
- IMGN853 has demonstrated initial
evidence of activity – used as a single agent –against both ovarian
and endometrial cancer tumors and has been granted orphan drug
status by the US FDA for ovarian cancer. The Company is currently
assessing IMGN853 dosed once every three weeks (Q3W) and on a
modified weekly (Q1W) basis.
- For the Q3W schedule, the recommended
phase II dose has been established and IMGN853 is beginning to be
assessed in patients who specifically have platinum-resistant
ovarian cancer or relapsed endometrial cancer.
- Dose escalation with Q1W is ongoing, as
assessment of this schedule began more recently.
IMGN529, a CD37-targeting ADC, is a potential new treatment for
B-cell malignancies, including non-Hodgkin lymphoma.
- The first clinical data with IMGN529
were reported at the American Society of Clinical Oncology (ASCO)
in June and showed initial evidence of activity. Dose escalation is
ongoing.
IMGN289, an EGFR-targeting ADC, is a potential new treatment for
squamous cell head/neck cancers, squamous and non-squamous
non-small cell lung cancers, and other EGFR-positive cancers.
- Phase I testing is underway and dose
escalation is ongoing.
IMGN779, a preclinical CD33-targeting ADC, is a potential
treatment for acute myeloid leukemia (AML). IMGN779 utilizes
DGN462, one of the Company’s new DNA-acting payloads.
- ImmunoGen presented preclinical data at
the European Hematology Association (EHA) meeting that showed
IMGN779 has potent, targeted activity against AML cells with
desired tolerability.
- IND submission is expected in
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 125 million CHF (approximately $140 million) for its
quarter ending June 30, 2014, comprising 70 million CHF in the US
and 55 million CHF internationally. ImmunoGen receives and
recognizes royalties on Kadcyla sales in the quarter after the
quarter in which Roche records the sales.
- Patient enrollment is now underway in
the KRISTINE phase III trial, which assesses Kadcyla in the
neo-adjuvant setting. Among the three phase III trials assessing
Kadcyla in early stage breast cancer, this is expected to be the
first to reach its primary endpoint, which is pathologic complete
response (pCR).
- A number of other phase III Kadcyla
trials are underway, as previously reported. These include the
MARIANNE trial assessing Kadcyla for the first-line treatment of
HER2-positive metastatic breast cancer (readout expected in 2H2014;
filing – with positive results – in 2015); KAITLIN assessing
Kadcyla for adjuvant use in early stage HER2-positive breast
cancer; KATHERINE assessing Kadcyla to treat residual invasive
disease in early stage HER2-positive breast cancer; and GATSBY
assessing Kadcyla as a treatment for advanced HER2-positive gastric
cancer (with data and – if positive – filing expected in
2015).
Numerous clinical and preclinical anti-cancer compounds are
being developed by leading healthcare companies through
partnerships with ImmunoGen.
- These include Amgen, Bayer HealthCare,
Novartis, Lilly, and Sanofi as well as Roche.
- Nine compounds are now in clinical
testing through ImmunoGen partnerships, reflecting Sanofi’s
advancement of the ADC SAR408701 into the clinic as a potential new
treatment for solid tumors.
- Impressive data with two other Sanofi
compounds were reported at ASCO in June: proof of concept data for
the ADC SAR3419, which were selected for Best of ASCO, and findings
with the CD38-targeting therapeutic, or "naked" antibody,
SAR650984.
- In July, Sanofi advanced SAR650984 into
Phase II clinical testing, triggering a $3 million milestone
payment to ImmunoGen which will be reflected in the Company’s first
quarter fiscal year 2015 financial results. As a naked antibody,
SAR650984 is not covered by ImmunoGen ADC patents, and Company
inventions specifically related to this antibody were assigned to
Sanofi with the product license. Accordingly, ImmunoGen expects the
royalty rates on sales of SAR650984, should it be successfully
developed and commercialized, to be in the low single digits.
Fiscal Year 2014 Financial Results
For the Company’s fiscal year ended June 30, 2014 (FY2014),
ImmunoGen reported a net loss of $71.4 million, or $0.83 per basic
and diluted share, compared to a net loss of $72.8 million, or
$0.87 per basic and diluted share, for its fiscal year ended June
30, 2013 (FY2013). For the quarter ending June 30, 2014, ImmunoGen
reported a net loss of $26.5 million, or $0.31 per basic and
diluted share, compared to a net loss of $21.9 million, or
$0.26 per basic and diluted share, for the same quarter in
FY2013.
Revenues in FY2014 were $59.9 million, compared to
$35.5 million in FY2013. Revenues in FY2014 include $39.5
million of license and milestone fees compared to
$24.2 million in FY2013. The increase in FY2014 revenues is
primarily driven by the number of development and commercialization
licenses taken by Novartis and Lilly during the period and the
associated amortization of their upfront license fees. Revenues in
FY2014 also include $10.3 million of royalty payments received from
Roche in FY2014 for sales of Kadcyla during the twelve-month period
ended March 31, 2014, compared to $0.6 million of royalty payments
received in FY2013. Kadcyla was approved and launched in the US in
late February 2013, and has since been launched in an increasing
number of other countries. Additionally, revenues in FY2014 include
$7.2 million of research and development support fees,
compared to $7.9 million in such fees for FY2013, and $2.9 million
of clinical materials revenue, compared to $2.8 million for
FY2013. The level of research support and the number of batches of
clinical materials produced and released to partners varies on a
year-to-year basis.
Operating expenses in FY2014 were $131.4 million, compared
to $108.5 million in FY2013. Operating expenses in FY2014 include
research and development expenses of $107.0 million, compared to
$87.1 million in FY2013. In FY2014, the Company recorded a
$12.8 million ($0.15/share) non-cash charge to research and
development expense related to technology rights under the
collaboration agreement executed with CytomX in January 2014. Also
driving the change from the prior year are increased personnel
expenses, principally resulting from increased staffing and stock
compensation expense. Operating expenses also include general and
administrative expenses of $24.5 million in FY2014, compared
to $21.5 million in FY2013. This increase is primarily due to
increased personnel expenses, patent expenses and other
professional service fees.
ImmunoGen had approximately $142.3 million in cash and cash
equivalents as of June 30, 2014, compared with $195.0 million as of
June 30, 2013 and had no debt outstanding in either period.
Cash used in operations was $53.7 million in FY2014, compared
with $60.3 million in FY2013. Capital expenditures were $8.2
million and $3.8 million for FY2014 and FY2013, respectively.
Financial Guidance for 2015 Fiscal Year
For its fiscal year ending June 30, 2015, 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.
“The top priority at ImmunoGen is establishing the potential
benefit to patients of our wholly owned compounds,” commented David
Johnston, EVP and CFO. “That information is key not only to the
value associated with ImmunoGen, but also to development path and
funding decisions. We believe our existing financial resources and
expected inflows are sufficient to establish this for our lead
product programs.”
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 913-905-3226; the conference ID is 2600176. 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
August 15, 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, 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) June
30, June 30, 2014 2013 ASSETS Cash
and cash equivalents $ 142,261 $ 194,960 Other assets 23,057
18,636 Total assets $ 165,318 $
213,596 LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 21,254 $ 19,173 Long-term portion of deferred
revenue and other long-term liabilities 68,365 72,576 Shareholders'
equity 75,699 121,847 Total
liabilities and shareholders' equity $ 165,318 $ 213,596
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended
Fiscal Year Ended June 30, June 30,
2014
2013
2014 2013 Revenues: License and
milestone fees $ 305 $ 855 $ 39,455 $ 24,227 Royalty revenue 3,400
592 10,346 592 Research and development support 1,327 2,203 7,187
7,873 Clinical materials revenue 711 181
2,908 2,843 Total revenues 5,743
3,831 59,896 35,535
Expenses: Research and development 25,787 20,399 106,958 87,073
General and administrative 6,456 5,373
24,469 21,471 Total operating expenses
32,243 25,772 131,427 108,544
Loss from operations (26,500 ) (21,941 ) (71,531 ) (73,009 )
Other income, net 1 66 167
198 Net loss $ (26,499 ) $ (21,875 ) $ (71,364
) $ (72,811 )
Net loss per common share, basic and
diluted $ (0.31 ) $ (0.26
) $ (0.83 ) $ (0.87
) Weighted average common shares
outstanding, basic and diluted 85,802
84,554 85,481
84,063
ContactsFor Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Pure Communications,
Inc.Dan Budwick, 973-271-6085
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