SOUTH SAN FRANCISCO,
Calif., March 3, 2015
/PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL)
today reported financial results for the fourth quarter and year
ended December 31, 2014. For the
fourth quarter of 2014, Rigel reported a net loss of $22.3 million, or $0.25 per share, compared to a net loss of
$16.9 million, or $0.19 per share, in the fourth quarter of 2013.
Weighted average shares outstanding for the fourth quarters of 2014
and 2013 were 87.8 million and 87.4 million,
respectively.
Contract revenues from collaborations of $8.3 million and $5.8
million in the fourth quarters of 2014 and 2013,
respectively, were comprised of non-refundable payments earned from
AstraZeneca AB (AZ) as a result of its continued development of
R256 in asthma.
Rigel reported total costs and expenses of $30.6 million in the fourth quarter of 2014,
compared to $22.7 million in the
fourth quarter of 2013. The increase in costs and expenses was
primarily due to a charge related to the loss on executing a
sublease during the quarter, as well as an increase in stock-based
compensation expense and severance costs related to the retirement
of Rigel's former chief executive officer, partially offset by the
decrease in research and development costs. The
loss on the sublease is determined based on the present value of
the excess of Rigel's future remaining payments to its landlord
through January 2018 associated with
the applicable subleased space over its contractual sublease income
from its subtenant over the term of the sublease agreement Rigel
executed in December 2014. The
research and development costs in the fourth quarter of 2013 were
comprised of certain non-recurring development costs related to the
transfer of fostamatinib raw materials from AZ.
Research and development costs decreased in 2014
due to the completion of a Phase 2 clinical study with R348 in dry
eye and the discontinuation of a Phase 1 clinical study with R118,
Rigel's indirect AMPK activator program.
For the year ended December 31,
2014, Rigel reported contract revenues from collaborations
of $8.3 million and a net loss of
$90.9 million, or $1.04 per basic and diluted share, compared to
contract revenues from collaborations of $7.2 million and a net loss of $89.0 million, or $1.02 per basic and diluted share, in
2013. Contract revenues from collaborations in
2014 and 2013 included $8.3 million
and $5.8 million, respectively, of
non-refundable payments earned from AZ, and a non-refundable
payment of $1.4 million in 2013 from
Daiichi Sankyo related to their investigational new drug
application filing for an oncology compound.
As of December 31, 2014,
Rigel had cash, cash equivalents and short-term investments of
$143.2 million, compared to
$212.0 million as of December 31, 2013. In
December 2014, Rigel entered into an
agreement with an unrelated third party to sublease a portion of
Rigel's research and office space under which it expects to receive
over $14.0 million of sublease income
and reimbursement from the subtenant's share of facilities
operating expenses through January
2018. Rigel expects to end 2015 with cash and
investments in excess of $100.0
million, which is expected to be sufficient to
fund operations into the first quarter of
2017.
In January 2015, Rigel
issued a press release providing an overview of its product
pipeline and near term clinical study plans. The fostamatinib Phase
3 clinical program for the treatment of immune thrombocytopenic
purpura (ITP), called fostamatinib for immune thrombocytopenia
(FIT), is actively enrolling patients in the United
States and Europe. The program consists of two identical
studies that together will include more than 90 sites and 150
patients. Rigel expects to separately report top line results
of the studies with the first study reporting in the first quarter
of 2016 and the other study in the second quarter of 2016.
Additionally, in February 2015, Rigel
announced the collaboration agreement with Bristol-Myers Squibb
(BMS) for the discovery, development and commercialization of
cancer immunotherapies based on Rigel's extensive portfolio of
small molecule transforming growth factor (TGF) beta receptor
kinase inhibitors. BMS will pay $30.0 million upfront and
Rigel will be eligible to receive development and regulatory
milestones that could total more than $309.0 million for
a successful compound approved in multiple
indications.
"The upfront payment of $30.0
million we expect to receive from the recently executed BMS
deal will extend our current runway into the first quarter of
2017," said Raul R. Rodriguez,
president and chief executive officer of Rigel. "We are on track to
meet our financial goal of having at least twelve months of cash
following the first readout of our ITP Phase 3 clinical studies,
which is expected in the first quarter of 2016," he
added.
About Rigel
Rigel Pharmaceuticals, Inc. is a clinical-stage drug
development company that discovers and develops novel,
small-molecule drugs for the treatment of inflammatory and
autoimmune diseases, immuno-oncology related diseases, and muscle
disorders. Rigel's pioneering research focuses on signaling
pathways that are critical to disease mechanisms. Rigel currently
has the following product candidates in development: fostamatinib,
an oral spleen tyrosine kinase (SYK) inhibitor, which is in Phase 3
clinical trials for ITP and has initiated a Phase 2 clinical trial
for IgA nephropathy (IgAN); R348, a topical JAK/SYK inhibitor, in a
Phase 2 clinical trial for dry eye in ocular graft-versus-host
disease (GvHD); two oncology product candidates in Phase 1
development with partners BerGenBio AG and Daiichi;
and two preclinical programs with partners AZ for R256 in
asthma and BMS for TGF beta inhibitors in
immuno-oncology.
This release contains forward-looking statements
relating to, among other things, updates on Rigel's product
pipeline and development programs, the timing and expected results
of its clinical programs, partnerships, the timing and amount of
income and reimbursements under its sublease agreement and other
financial information, including Rigel's expected cash
runway. Any statements contained in this press release that
are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "planned," "will," "may,"
"expect," and similar expressions are intended to identify these
forward-looking statements. These forward-looking statements are
based on Rigel's current expectations and inherently involve
significant risks and uncertainties. Actual results and the timing
of events could differ materially from those anticipated in such
forward looking statements as a result of these risks and
uncertainties, which include, without limitation, the availability
of resources to develop Rigel's product candidates, Rigel's need
for additional capital in the future to sufficiently fund Rigel's
operations and research, the uncertain timing of completion of and
the success of clinical trials, market competition, risks
associated with and Rigel's dependence on Rigel's corporate
partnerships, as well as other risks detailed from time to time in
Rigel's reports filed with the Securities and Exchange
Commission, including its Quarterly Report on Form 10-Q for the
quarter ended September 30, 2014. Rigel does not undertake any
obligation to update forward-looking statements and expressly
disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained
herein.
Contact: Ryan D.
Maynard
Phone: 650.624.1284
Email: invrel@rigel.com
Media Contact: Susan C.
Rogers, Rivily, Inc.
Phone: 650.430.3777
Email: susan@rivily.com
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
2014
|
2013
|
|
2014
|
2013
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Contract revenues
from collaborations
|
$
8,250
|
$
5,750
|
|
$
8,250
|
$
7,150
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Research and
development (see Note A)
|
14,613
|
18,046
|
|
67,696
|
75,328
|
|
General and
administrative (see Note A)
|
6,703
|
4,648
|
|
22,501
|
19,612
|
|
Loss on
sublease
|
9,302
|
-
|
|
9,302
|
-
|
|
Restructuring charges
(see Note A)
|
-
|
-
|
|
-
|
1,679
|
|
Total costs and
expenses
|
30,618
|
22,694
|
|
99,499
|
96,619
|
Loss from
operations
|
(22,368)
|
(16,944)
|
|
(91,249)
|
(89,469)
|
Interest
income
|
44
|
83
|
|
243
|
426
|
Gain on disposal of
assets
|
52
|
-
|
|
98
|
16
|
Net loss
|
$
(22,272)
|
$
(16,861)
|
|
$
(90,908)
|
$
(89,027)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.25)
|
$
(0.19)
|
|
$
(1.04)
|
$
(1.02)
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net
loss per share, basic and diluted
|
|
|
|
|
|
87,793
|
87,430
|
|
87,662
|
87,288
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
Research and
development
|
$
1,020
|
$
870
|
|
$
4,674
|
$
3,930
|
|
General and
administrative
|
2,191
|
693
|
|
5,113
|
2,997
|
|
Restructuring
charges
|
-
|
-
|
|
-
|
239
|
|
|
$
3,211
|
$
1,563
|
|
$
9,787
|
$
7,166
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
December
31,
|
|
|
|
|
|
2014
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
143,159
|
$
211,975
|
|
|
|
|
Total
assets
|
154,135
|
226,058
|
|
|
|
|
Stockholders'
equity
|
128,246
|
208,251
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.