SAN DIEGO, Aug. 7, 2017 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA), a biopharmaceutical company
focused on developing novel, small molecule drugs across multiple
therapeutic areas, today provided a corporate update and reported
financial results for the second quarter ended June 30, 2017.
"We are excited about the continued transformation of Arena in
the past quarter, punctuated by the significant results achieved in
the Phase 2 trial of ralinepag," said Amit
Munshi, President and CEO of Arena. "With preparations
underway for an end of Phase 2 meeting with the FDA for ralinepag,
as well as multiple clinical data readouts from our other pipeline
programs expected over the next several quarters, we are excited
about the opportunity to continue driving shareholder value."
Pipeline Update
Ralinepag – oral, selective, next generation IP receptor
agonist targeting the prostacyclin pathway for the potential
treatment of pulmonary arterial hypertension
- In May, completed a pharmacokinetic and pharmacodynamic study
comparing current twice-daily formulation with a new once-daily
formulation in healthy volunteers
- In July, achieved positive Phase 2 results for ralinepag
- Currently preparing for end of Phase 2 meeting with the FDA;
Phase 3 clinical program preparations underway
Etrasimod – orally available next generation
sphingosine-1-phosphate (S1P) receptor modulator for the potential
treatment of a number of autoimmune diseases
- Phase 2 study in ulcerative colitis - data readout expected
around year-end 2017 to Q1 2018
- Exploratory Phase 2 studies currently enrolling patients
-
- Phase 2 study in dermatological extraintestinal manifestations
in patients with inflammatory bowel disease
- Phase 2 study in pyoderma gangrenosum
- Phase 2 study in primary biliary cholangitis
-
- Expected to initiate in 2017
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 readout
expected around year-end 2017 to Q1 2018
Corporate Update
- Appointed Jennifer Jarrett to
the Company's Board of Directors
Financial Update
Second Quarter 2017
Financial Results
- Revenues totaled $6.5 million,
including $2.1 million in net product
sales of BELVIQ, $1.8 million in
manufacturing support payments from Eisai, and approximately
$1.9 million of revenue associated
with upfront payments from Boehringer Ingelheim and Axovant
collaborations
- Research and development expenses totaled $17.9 million
- General and administrative expenses totaled $7.2 million
- Net loss was $23.6 million, or
$0.77 per share
In June 2017, the Company
completed a 1-for-10 reverse stock split. All per-share figures in
this update, including in the attached tables, have been adjusted
to account for the impact of the reverse stock split.
At June 30, 2017, cash and cash
equivalents totaled $130.8 million,
and approximately 31.8 million shares of Arena common stock were
outstanding. This does not include the $162.0 million in net proceeds received through
July 28, 2017, for issuing and
selling approximately 7 million shares of common stock under an
equity financing.
Conference Call & Webcast Information
The Company
will host a conference call and live webcast with the investment
community today, Monday, August 7,
2017, at 4:30 p.m. ET to
discuss the financial results and provide a corporate update.
When: August 7, 2017, 4:30 p.m. ET
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 60106084
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 "will", "may", "expect", "potential"
and similar words, and include, without limitation, statements
about the significance of clinical data, shareholder value
creation, advancement of our pipeline, expected results,
anticipated data readouts, planned meetings with the FDA, timing
relating to ongoing or intended clinical trials, patient enrollment
in ongoing or intended clinical trials, 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.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
|
|
Six months
ended
|
|
|
|
June 30,
|
|
June 30,
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
Net product
sales
|
$
2,059
|
|
$
4,263
|
|
$
4,770
|
|
$
7,781
|
|
|
Other Eisai
collaborative revenue
|
1,781
|
|
1,975
|
|
3,316
|
|
5,201
|
|
|
Other collaborative
revenue
|
1,898
|
|
2,249
|
|
3,558
|
|
4,329
|
|
|
Toll
manufacturing
|
754
|
|
1,025
|
|
1,472
|
|
2,048
|
|
|
Total
revenues
|
6,492
|
|
9,512
|
|
13,116
|
|
19,359
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
1,497
|
|
851
|
|
4,029
|
|
3,279
|
|
|
Cost of toll
manufacturing
|
1,074
|
|
1,758
|
|
1,993
|
|
2,946
|
|
|
Research &
development
|
17,922
|
|
18,546
|
|
33,433
|
|
37,048
|
|
|
General &
administrative
|
7,236
|
|
8,465
|
|
15,400
|
|
15,389
|
|
|
Restructuring
charges
|
—
|
|
6,115
|
|
—
|
|
6,115
|
|
|
Total
operating costs & expenses
|
27,729
|
|
35,735
|
|
54,855
|
|
64,777
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
|
|
|
|
|
Interest
income
|
16
|
|
105
|
|
50
|
|
193
|
|
|
Interest
expense
|
(1,538)
|
|
(1,619)
|
|
(3,108)
|
|
(3,298)
|
|
|
Other
|
(857)
|
|
554
|
|
(1,316)
|
|
(208)
|
|
|
Total interest
& other income (expense), net
|
(2,379)
|
|
(960)
|
|
(4,374)
|
|
(3,313)
|
|
|
Net loss
|
(23,616)
|
|
(27,183)
|
|
(46,113)
|
|
(48,731)
|
|
|
Less net loss
attributable to noncontrolling interest in consolidated variable
interest entity
|
299
|
|
—
|
|
743
|
|
—
|
|
|
Net income (loss)
attributable to stockholders of Arena
|
$
(23,317)
|
|
$
(27,183)
|
|
$
(45,370)
|
|
$
(48,731)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income(loss)
attributable to stockholders of Arena per
share:1
|
|
|
|
|
|
|
|
|
|
Basic
|
$
(0.77)
|
|
$
(1.12)
|
|
$
(1.66)
|
|
$
(2.01)
|
|
|
Diluted
|
$
(0.77)
|
|
$
(1.12)
|
|
$
(1.66)
|
|
$
(2.01)
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net loss attributable to stockholders of Arena per
share:1
|
|
|
|
|
|
|
|
|
|
Basic
|
30,229
|
|
24,308
|
|
27,371
|
|
24,298
|
|
|
Diluted
|
30,229
|
|
24,308
|
|
27,371
|
|
24,298
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1
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)
|
|
|
|
|
|
|
June 30,
2017
|
|
December 31,
2016
|
|
|
|
|
1
|
|
Assets
|
|
|
|
|
Cash &
cash equivalents
|
$ 130,763
|
|
$ 90,712
|
|
Accounts
receivable
|
2,404
|
|
20,162
|
|
Inventory
|
7,058
|
|
6,708
|
|
Prepaid
expenses & other current assets
|
3,373
|
|
2,307
|
|
Land, property
& equipment, net
|
40,997
|
|
43,828
|
|
Intangibles
& other non-current assets
|
4,770
|
|
5,293
|
|
Total
assets
|
$ 189,365
|
|
$ 169,010
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
Accounts
payable & accrued liabilities
|
$
9,913
|
|
$
25,073
|
|
Total deferred
revenues
|
32,442
|
|
37,455
|
|
Total lease
financing obligations & other long-term liabilities
|
64,487
|
|
66,087
|
|
Total
stockholders' equity
|
82,523
|
|
40,395
|
|
Total
liabilities & stockholders' equity
|
$ 189,365
|
|
$ 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.