SAN DIEGO, March 14, 2018 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA), today provided a corporate
update and reported financial results for the fourth quarter and
full-year ended December 31,
2017.
"We've made significant progress in 2017, achieving the clinical
and corporate objectives we set forth as a new team," said
Amit D. Munshi, president and CEO of
Arena. "Our focus remains on advancing our potentially
best-in-class or best-in-disease pipeline and driving further value
in the Company. We look forward to the etrasimod Phase 2 data
readout this month and are enthusiastic about the Phase 3 clinical
program for ralinepag, which we expect to begin in the second half
of 2018."
Pipeline Update
Ralinepag – Oral, next generation, selective prostacyclin
receptor agonist intended for the treatment of pulmonary arterial
hypertension (PAH)
- Phase 3 clinical program preparations continue to progress
- Expect to initiate three studies within the Phase 3 clinical
program in H2 2018
Etrasimod – Oral, next generation, selective
sphingosine-1-phosphate (S1P) receptor modulator intended for the
potential treatment of multiple immune and inflammatory
diseases
- Ulcerative colitis (UC):
-
- Phase 2 data expected March
2018
- Primary biliary cholangitis (PBC):
-
- Phase 2 trial currently enrolling patients
- Pyoderma gangrenosum (PG):
-
- Phase 2 trial currently enrolling patients
APD371 – Oral, peripherally restricted, full agonist of the
cannabinoid 2 (CB2) receptor intended for the potential treatment
of visceral pain, specifically pain associated with Crohn's
disease
- Phase 2 trial currently enrolling patients
- Data expected Q2 2018
Collaborations Update
- Everest Medicines Limited (Everest) partnership
-
- In December, Arena entered into a development and
commercialization partnership with Everest, a C-Bridge
Capital-backed biopharmaceutical company focused on developing and
commercializing innovative pharmaceutical products in China, for ralinepag and etrasimod in mainland
China, Taiwan, Hong
Kong, Macau, and
South Korea.
- Arena received an upfront payment of $12.0 million, is eligible to receive up to
$212.0 million in development and
commercial milestone payments, and is entitled to receive up to low
double-digit royalties on future net annual sales of both ralinepag
and etrasimod.
Corporate Update
- On March 9, 2018 we entered into
an Asset Purchase Agreement for the sale of our manufacturing
operations located in Zofingen, Switzerland, to Siegfried. The transaction is
expected to close on or about March 31,
2018.
Financial Update
Fourth Quarter 2017 Financial Results
- Revenues totaled $15.4 million,
consisting of $14.2 million in
collaboration revenue, and $1.2
million in royalty revenue from Eisai. Included in the
collaboration revenue is the $12.0
million upfront fee Arena received from Everest in
connection with the development and commercialization
partnership.
- Research and development expenses totaled $20.7 million
- General and administrative expenses totaled $8.3 million
- Net loss attributable to stockholders of Arena was $13.7 million, or $0.35 per share
Full-Year 2017 Financial Results
- Revenues totaled $21.3 million,
consisting of $19.6 million in
collaboration revenue, and $1.7
million in royalty revenue from Eisai. Included in the
collaboration revenue is the $12.0
million upfront fee Arena received from Everest in
connection with the development and commercialization partnership,
and approximately $7.3 million of
revenue from the Boehringer Ingelheim and Axovant
collaborations.
- Research and development expenses totaled $71.0 million
- General and administrative expenses totaled $30.3 million
- Litigation settlement expense, net related to the tentative
settlement of the 2010 securities class action litigation totaled
$12.0 million
- Discontinued operations income of $3.1
million includes all revenues and expenses associated with
our manufacturing operations that are classified as held-for-sale
as a result of our planned divestiture of the Zofingen
facility
- Net loss attributable to stockholders of Arena was $91.4 million, or $2.77 per share
At December 31, 2017, the
Company's cash, cash equivalents and investments balance was
$271.3 million and approximately 39.3
million shares of Arena common stock were outstanding.
Conference Call & Webcast Information
The Company
will host a conference call and live webcast with the investment
community today, Wednesday, March 14,
2018, at 8:30 a.m. EDT to
discuss the financial results and provide a corporate update.
When: March 14, 2018, 8:30 a.m. EDT
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 2074279
Please join the conference call at least 10 minutes early to
register. You can access the live webcast under the investor
relations section of Arena's website at: www.arenapharm.com.
A replay of the conference call will be archived under the investor
relations section of Arena's website for 30 days shortly after the
call.
About Arena Pharmaceuticals
Arena Pharmaceuticals is
focused on developing novel, small molecule drugs with optimized
receptor pharmacology and pharmacokinetics designed to deliver
broad clinical utility across several therapeutic areas. Arena's
proprietary pipeline includes potentially first- or best-in-class
programs. The most advanced investigational clinical programs
are ralinepag (APD811), which will be commencing a Phase 3 program
for pulmonary arterial hypertension (PAH), and etrasimod (APD334),
which is in Phase 2 for a broad range of immune and inflammatory
conditions. Arena is also evaluating APD371 in Phase 2 for
the treatment of pain associated with Crohn's disease. In addition,
Arena has collaborations with the following pharmaceutical
companies: Everest Medicines Limited (ralinepag and etrasimod in
Greater China and select Asian
countries), Axovant Sciences GmbH (nelotanserin - Phase 2),
Boehringer Ingelheim International GmbH (undisclosed target -
preclinical), and Eisai Co., Ltd. and Eisai Inc.
(BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements
in this press release are forward-looking statements that involve a
number of risks and uncertainties. Such forward-looking statements
may be identified by words such as "anticipated," "focus,"
"potential," "look forward to," "expect," "intended for," "entitled
to," "planned," "designed to," and "will," and include, without
limitation, statements about initiation, enrollment, results, data
readouts and timing relating to ongoing and intended clinical
trials; the potential of Arena's drug candidates; the planned sale
of Arena's manufacturing operations in Zofingen, Switzerland; Arena's investment community
conference call and webcast; and Arena's focus, goals, strategy,
clinical programs, and collaborators. For such statements, Arena
claims the protection of the Private Securities Litigation Reform
Act of 1995. Actual events or results may differ materially from
Arena's expectations. Factors that could cause actual results to
differ materially from the forward-looking statements include, but
are not limited to, the following: the risk that we may need
additional funds to advance all of our programs, and you and others
may not agree with the manner we allocate our resources; risks
related to developing and commercializing drugs; risks and
uncertainties relating to cash and revenues that may be generated
from product sales or other sources, including the impact of
competition; the risk that Arena's revenues are based in part on
estimates, judgment and accounting policies, and incorrect
estimates or disagreement regarding estimates or accounting
policies may result in changes to Arena's guidance or previously
reported results; the timing and outcome of research, development
and regulatory review is uncertain, and our drug candidates may not
advance in development or be approved for marketing; enrolling
patients in our ongoing and intended clinical trials is competitive
and challenging; clinical trials and other studies may not proceed
at the time or in the manner expected or at all; unexpected or
unfavorable new data; nonclinical and clinical data is voluminous
and detailed, and regulatory agencies may interpret or weigh the
importance of data differently and reach different conclusions than
Arena or others, request additional information, have additional
recommendations or change their guidance or requirements before or
after approval; results of clinical trials and other studies are
subject to different interpretations and may not be predictive of
future results; topline data may not accurately reflect the
complete results of a particular study or trial; satisfactory
resolution of litigation or other disagreements with others;
government and third-party payor actions, including relating to
reimbursement and pricing; risks related to relying on
collaborative arrangements; the entry into or modification or
termination of collaborative arrangements; and Arena's and third
parties' intellectual property rights. Additional factors that
could cause actual results to differ materially from those stated
or implied by Arena's forward-looking statements are disclosed in
Arena's filings with the Securities and Exchange Commission. These
forward-looking statements represent Arena's judgment as of the
time of this release. Arena disclaims any intent or obligation to
update these forward-looking statements, other than as may be
required under applicable law.
Corporate
Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial
Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
(Tables Follow)
Arena
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(In thousands, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Year ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
(unaudited)
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
Collaboration and
other revenue
|
$
14,193
|
|
$
69,225
|
|
$
19,632
|
|
$
92,163
|
|
Royalty
revenue
|
1,171
|
|
—
|
|
1,705
|
|
—
|
|
Total
revenues
|
15,364
|
|
69,225
|
|
21,337
|
|
92,163
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
Research &
development
|
20,711
|
|
11,567
|
|
70,988
|
|
63,782
|
|
General &
administrative
|
8,253
|
|
6,981
|
|
30,341
|
|
27,529
|
|
Litigation settlement
expense, net
|
—
|
|
—
|
|
11,975
|
|
—
|
|
Restructuring
charges
|
—
|
|
—
|
|
—
|
|
6,115
|
|
Total
operating costs & expenses
|
28,964
|
|
18,548
|
|
113,304
|
|
97,426
|
|
|
|
|
|
|
|
|
|
|
Total interest
& other expense, net
|
(670)
|
|
(1,751)
|
|
(3,887)
|
|
(7,037)
|
|
Income (loss) from
continuing operations
|
(14,270)
|
|
48,926
|
|
(95,854)
|
|
(12,300)
|
|
Income (loss) from
discontinued operations
|
315
|
|
(10,612)
|
|
3,122
|
|
(10,596)
|
|
Net income
(loss)
|
(13,955)
|
|
38,314
|
|
(92,732)
|
|
(22,896)
|
|
Less net loss
attributable to noncontrolling interest in consolidated variable
interest entity
|
271
|
|
258
|
|
1,325
|
|
380
|
|
Net (income) loss
attributable to stockholders of Arena
|
$
(13,684)
|
|
$
38,572
|
|
$
(91,407)
|
|
$
(22,516)
|
|
|
|
|
|
|
|
|
|
|
Amounts
attributable to stockholders of Arena:
|
|
|
|
|
|
|
|
|
Income (loss)
from continuing operations
|
(13,999)
|
|
49,184
|
|
(94,529)
|
|
(11,920)
|
|
Income (loss)
from discontinued operations
|
315
|
|
(10,612)
|
|
3,122
|
|
(10,596)
|
|
|
$
(13,684)
|
|
$
38,572
|
|
$
(91,407)
|
|
$
(22,516)
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
attributable to stockholders of Arena per share,
diluted:1
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
$
(0.36)
|
|
$
2.02
|
|
$
(2.87)
|
|
$
(0.49)
|
|
Discontinued operations
|
0.01
|
|
(0.43)
|
|
0.10
|
|
(0.44)
|
|
|
$
(0.35)
|
|
$
1.59
|
|
$
(2.77)
|
|
$
(0.93)
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
attributable to stockholders of Arena per share,
diluted:1
|
|
|
|
|
|
|
|
|
Continuing operations
|
$
(0.36)
|
|
$
2.02
|
|
$
(2.87)
|
|
$
(0.49)
|
|
Discontinued operations
|
0.01
|
|
(0.44)
|
|
0.10
|
|
(0.44)
|
|
|
$
(0.35)
|
|
$
1.58
|
|
$
(2.77)
|
|
$
(0.93)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net loss attributable to stockholders of Arena per
share, basic1
|
39,268
|
|
24,333
|
|
32,990
|
|
24,313
|
|
Shares used in
calculating net loss attributable to stockholders of Arena per
share, diluted1
|
39,268
|
|
24,343
|
|
32,990
|
|
24,313
|
|
1
Comparative period data adjusted to give effect to Arena's June
2017 1-for-10 reverse stock split.
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2017
|
|
December 31,
2016
|
|
|
1
|
|
1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 158,837
|
|
$ 90,712
|
|
Accounts
receivable
|
2,357
|
|
573
|
|
Insurance
recovery receivable
|
12,025
|
|
—
|
|
Prepaid
expenses & other current assets
|
2,681
|
|
2,169
|
|
Total
available for sale investments
|
112,482
|
|
—
|
|
Land, property
& equipment, net
|
30,131
|
|
35,109
|
|
Other
non-current assets
|
3,622
|
|
2,841
|
|
Total assets
of disposal group held for sale
|
17,140
|
|
37,606
|
|
Total
assets
|
$ 339,275
|
|
$ 169,010
|
|
|
|
|
|
|
Liabilities &
Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$
15,622
|
|
$
9,559
|
|
Accrued
litigation settlement
|
24,000
|
|
—
|
|
Total deferred
revenues
|
2,177
|
|
6,577
|
|
Total lease
financing obligations & other long-term liabilities
|
62,737
|
|
66,087
|
|
Total
liabilities of disposal group held for sale
|
27,595
|
|
46,392
|
|
Total
equity
|
207,144
|
|
40,395
|
|
Total
liabilities & equity
|
$ 339,275
|
|
$ 169,010
|
|
|
1 The
Condensed Consolidated Balance Sheet Data has been derived from the
audited financial statements as of that date.
|
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SOURCE Arena Pharmaceuticals, Inc.