SAN DIEGO, Nov. 7, 2017 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA), today provided a corporate
update and reported financial results for the third quarter ended
September 30, 2017.
"We are pleased with the progress we achieved during the third
quarter, hitting multiple milestones for our lead programs," said
Amit D. Munshi, President and CEO of
Arena. "We remain highly focused on continuing to advance our lead
programs and driving shareholder value. We look forward to meeting
with the FDA about the Phase 3 program for ralinepag and reporting
top-line Phase 2 data for etrasimod in ulcerative colitis and for
APD371 in pain associated with Crohn's disease."
Pipeline Update
Ralinepag – Oral, selective, next generation IP receptor
agonist targeting the prostacyclin pathway for the potential
treatment of pulmonary arterial hypertension
- Meeting request submitted to the FDA; Phase 3 clinical program
preparations continue to progress
Etrasimod – Orally available next generation
sphingosine-1-phosphate (S1P) receptor modulator for the potential
treatment of a number of autoimmune diseases
- Ulcerative colitis (UC):
-
- Expect to complete enrollment of Phase 2 trial this week
- Data expected Q1 2018
- Primary biliary cholangitis (PBC):
-
- Pyoderma gangrenosum (PG):
-
- Phase 2 trial currently enrolling patients
- Dermatological extraintestinal manifestations (EIM):
-
- Phase 2 study enrolled; intend to evaluate in combination with
UC study
APD371 – Orally available full agonist of the cannabinoid-2
receptor for the potential treatment of visceral pain, specifically
pain associated with Crohn's disease
- Phase 2 trial currently enrolling patients
- Data expected Q1 2018
Collaborations Update
- Nelotanserin - Axovant collaboration
-
- Visual hallucinations in Lewy body dementia (LBD):
-
- Phase 2 data expected Q1 2018
- REM sleep behavior disorder in subjects with LBD:
-
- Phase 2 data expected Q2 2018
Corporate Update
- Appointed Chris Cabell, M.D.,
MHS, FACC, as Senior Vice President, Clinical Development
- Closed a public offering that raised aggregate net proceeds of
$162.0 million through the issuance
of approximately 7.2 million shares of common stock
Financial Update
Third Quarter 2017 Financial Results
- Revenues totaled $7.9 million,
including $3.1 million in net product
sales of BELVIQ, $1.7 million in
manufacturing support payments from Eisai, and approximately
$1.9 million of revenue from
Boehringer Ingelheim and Axovant collaborations
- Research and development expenses totaled $17.3 million
- General and administrative expenses totaled $7.8 million
- Litigation settlement expense, net related to tentative
settlement of the 2010 securities class action litigation totaled
$12.0 million
- Net loss was $32.4 million, or
$0.86 per share
At September 30, 2017, cash and
cash equivalents totaled $278.7
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, Tuesday, November 7,
2017, at 4:30 p.m. EST to
discuss the financial results and provide a corporate update.
When: November 7, 2017,
4:30 p.m. EST
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 1910287
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 a
biopharmaceutical company focused on developing novel, small
molecule drugs with optimized receptor pharmacology designed to
deliver broad clinical utility across multiple therapeutic areas.
Our proprietary pipeline includes potentially first- or
best-in-class programs for which we own global commercial rights.
Our three most advanced investigational clinical programs are
ralinepag (APD811) which has completed a Phase 2 trial for
pulmonary arterial hypertension (PAH), etrasimod (APD334) in Phase
2 evaluation for multiple autoimmune indications, and APD371 in
Phase 2 evaluation for the treatment of pain associated with
Crohn's disease. In addition, Arena has collaborations with the
following pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc.
(commercial stage), Axovant Sciences (Phase 2 candidate), and
Boehringer Ingelheim International GmbH (preclinical
candidate).
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 "expect", "look forward to",
"preparations", "intend", "potential", "will", "may", and similar
words, and include, without limitation, statements about timing
relating to ongoing or intended clinical trials, planned meetings
with the FDA, patient enrollment in ongoing or intended clinical
trials, advancement of our pipeline, expected results, anticipated
data readouts, the significance of clinical data, shareholder value
creation, and Arena's focus, goals, strategy and clinical programs.
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 timing and outcome of research, development and regulatory
review is uncertain; enrolling patients in our ongoing and intended
clinical trials is competitive and challenging; we expect to need
additional funds to advance all of our programs, and you and others
may not agree with the manner we allocate our resources; our drug
candidates may not advance in development or be approved for
marketing; risks related to developing and commercializing drugs;
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;
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; unexpected or
unfavorable new data; nonclinical and clinical data are 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; topline data may not accurately reflect the
complete results of a particular study or trial; Arena's and third
parties' intellectual property rights; results of clinical trials
and other studies are subject to different interpretations and may
not be predictive of future results; clinical trials and other
studies may not proceed at the time or in the manner expected or at
all; and satisfactory resolution of litigation or other
disagreements with others. 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@lifescipublicrelations.com
646.627.8384
(Tables Follow)
Arena
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(In thousands, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Nine months
ended
|
|
September
30,
|
|
September
30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
(unaudited)
|
|
(unaudited)
|
Revenues
|
|
|
|
|
|
|
|
Net product
sales
|
$
3,075
|
|
$
3,323
|
|
$
7,845
|
|
$
11,104
|
Other Eisai
collaboration revenue
|
2,223
|
|
12,954
|
|
5,539
|
|
18,155
|
Other collaboration
revenue
|
1,881
|
|
1,737
|
|
5,439
|
|
6,066
|
Toll
manufacturing
|
769
|
|
1,228
|
|
2,241
|
|
3,276
|
Total
revenues
|
7,948
|
|
19,242
|
|
21,064
|
|
38,601
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
Cost of product
sales
|
1,739
|
|
882
|
|
5,768
|
|
4,161
|
Cost of toll
manufacturing
|
1,222
|
|
1,930
|
|
3,215
|
|
4,876
|
Research &
development
|
17,307
|
|
17,466
|
|
50,740
|
|
54,514
|
General &
administrative
|
7,791
|
|
8,590
|
|
23,191
|
|
23,979
|
Litigation settlement
expense, net
|
11,975
|
|
—
|
|
11,975
|
|
—
|
Restructuring
charges
|
—
|
|
231
|
|
—
|
|
6,346
|
Total
operating costs & expenses
|
40,034
|
|
29,099
|
|
94,889
|
|
93,876
|
|
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
|
|
|
Interest
income
|
13
|
|
54
|
|
63
|
|
247
|
Interest
expense
|
(1,516)
|
|
(1,609)
|
|
(4,624)
|
|
(4,907)
|
Other
|
925
|
|
(1,067)
|
|
(391)
|
|
(1,275)
|
Total interest
& other income (expense), net
|
(578)
|
|
(2,622)
|
|
(4,952)
|
|
(5,935)
|
Net loss
|
(32,664)
|
|
(12,479)
|
|
(78,777)
|
|
(61,210)
|
Less net loss
attributable to noncontrolling interest in consolidated variable
interest entity
|
311
|
|
122
|
|
1,054
|
|
122
|
Net loss attributable
to stockholders of Arena
|
$
(32,353)
|
|
$
(12,357)
|
|
$
(77,723)
|
|
$
(61,088)
|
|
|
|
|
|
|
|
|
Net loss attributable
to stockholders of Arena per share:1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
$
(0.86)
|
|
$
(0.51)
|
|
$
(2.24)
|
|
$
(2.51)
|
Diluted
|
$
(0.86)
|
|
$
(0.51)
|
|
$
(2.24)
|
|
$
(2.51)
|
|
|
|
|
|
|
|
|
Shares used in
calculating net loss attributable to stockholders of Arena per
share:1
|
|
|
|
|
|
|
|
Basic
|
37,776
|
|
24,325
|
|
34,692
|
|
24,307
|
Diluted
|
37,776
|
|
24,325
|
|
34,692
|
|
24,307
|
|
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)
|
(unaudited)
|
|
|
|
|
|
September 30,
2017
|
|
December 31,
2016
|
|
|
|
1
|
Assets
|
|
|
|
Cash &
cash equivalents
|
$ 278,738
|
|
$ 90,712
|
Accounts
receivable
|
2,373
|
|
20,162
|
Insurance
recovery receivable
|
12,025
|
|
—
|
Inventory
|
6,848
|
|
6,708
|
Prepaid
expenses & other current assets
|
3,717
|
|
2,307
|
Land, property
& equipment, net
|
39,425
|
|
43,828
|
Intangibles
& other non-current assets
|
4,695
|
|
5,293
|
Total
assets
|
$ 347,821
|
|
$ 169,010
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
Accounts
payable & accrued liabilities
|
$
12,787
|
|
$
25,073
|
Accrued
litigation settlement
|
24,000
|
|
—
|
Total deferred
revenues
|
29,258
|
|
37,455
|
Total lease
financing obligations & other long-term liabilities
|
63,655
|
|
66,087
|
Total
stockholders' equity
|
218,121
|
|
40,395
|
Total
liabilities & stockholders' equity
|
$ 347,821
|
|
$ 169,010
|
|
1
The Condensed Consolidated Balance Sheet Data have been derived
from the audited financial statements as of that date.
|
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SOURCE Arena Pharmaceuticals, Inc.