SAN DIEGO, Feb. 26, 2020 /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,
2019.
"As we continue to execute on near and mid-term operational
objectives, including delivering up to eight major data readouts
between 2020 and 2021, we must also make the bold, strategic moves
necessary to unlock the critical value that we believe our pipeline
holds," said Amit D. Munshi,
President and CEO of Arena. "As a result, I am excited to announce
the appointment of Kevin Lind, as
President and Chief Executive Officer of our subsidiary, Arena
Neuroscience, Inc., and the appointment of Laurie Stelzer as Executive Vice President and
Chief Financial Officer of Arena."
"I have been tremendously privileged to have joined the company
three years ago with the charter to reset Arena and deliver
long-term shareholder value," said Mr. Lind "I am excited to
continue that mission by further leveraging the significant
potential value of Arena's world-class GPCR discovery research in
the area of neuroscience. We believe Arena Neuroscience has an
opportunity to expand treatment options in a therapeutic area where
there is an urgent unmet need for patients."
Laurie Stelzer joins Arena from
Halozyme Therapeutics, where she has spent the last five years as
the Chief Financial Officer, leading the Finance, Information
Technology, Business Development, Project Management and Site
Operations organizations. Prior to joining Halozyme, Laurie
held senior management roles at Shire Plc (acquired by Takeda),
including Senior Vice President of Finance, Division CFO for the
Regenerative Medicine Division, and Head of Investor Relations.
Previously she held positions of increasing responsibility during
her fifteen-year career at Amgen, Inc., spanning the areas of
Finance, Treasury, Global Accounting and International/Emerging
Markets. Laurie received her B.S. in Accounting from
Arizona State University, and her
M.B.A. from the Anderson School at the University of California, Los Angeles. She
currently serves on the board of directors for Surface
Oncology.
"Laurie is an accomplished executive with significant financial
expertise across both emerging and established biotechnology
companies and will be an exceptional addition to our management
team," said Mr. Munshi. "Having previously worked with Laurie at
Amgen, I am confident in her experience and leadership as we
continue to scale a sustainable, vibrant, company while being
mindful stewards of our resources."
Program Updates:
- Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative
colitis (UC) ongoing; ELEVATE UC 12 Phase 3 trial expected to
initiate at a later date
- Etrasimod CULTIVATE Phase 2b
dose-ranging trial in Crohn's disease (CD) initiated and
ongoing
- Etrasimod eosinophilic esophagitis (EoE) Phase 2b and alopecia areata (AA) Phase 2 planning
ongoing, initiation expected this year
- Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial ongoing; data expected H2 2020
- Olorinab CAPTIVATE Phase 2b
trial in abdominal pain associated with irritable bowel
syndrome
- (IBS-C, IBS-D) ongoing; data expected H2 2020
- APD418 in acute heart failure (AHF) Phase 1 trial ongoing; Fast
Track designation granted
Financial Update
Fourth Quarter 2019 Financial Results
- Revenues totaled $3.0 million,
primarily consisting of $5.0 million of development milestone
revenue from Everest offset by a reduction of estimated future
royalties from BELVIQ sales
- Research and development expenses totaled $74.6 million, including $7.0 million related to non-cash share-based
compensation
- General and administrative expenses totaled $22.2 million, including $6.3 million related to non-cash share-based
compensation
- Net loss was $88.3 million or
$1.76 per share
Full-Year 2019 Financial Results
- Revenues totaled $806.4 million,
primarily consisting of $800.0
million of revenue from the United Therapeutics upfront
payment
- Research and development expenses totaled $231.5 million, including $27.4 million related to non-cash share-based
compensation
- General and administrative expenses totaled $77.6 million, including $25.7 million related to non-cash share-based
compensation
- Income tax provision was $110.3
million as a result of utilizing the deferred tax assets
that were recorded in the fourth quarter of 2018
- Net income was $397.6 million, or
$7.99 per share
At December 31, 2019, Arena's
cash, cash equivalents and investments balance was approximately
$1.1 billion and approximately 50.2
million shares of Arena common stock were outstanding.
Conference Call & Webcast Information
Arena will
host a conference call and live webcast with the investment
community today, Wednesday, February 26,
2020, at 4:30 PM ET to discuss
the financial results and provide a corporate update.
When: Wednesday, February 26,
2020, at 4:30 PM ET
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 8286947
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 uniquely positioned to develop
best-in-disease medicines with optimized efficacy and safety for
patients globally. Our drive to deliver a robust pipeline of novel,
transformational medicines is grounded in two decades of world
class G-protein-coupled receptor (GPCR) discovery research.
It is the breadth and depth of our portfolio, prioritization of
drug development to meet unmet patient needs, strong financial
health and growing, bold-thinking world-class team that gives Arena
the ingredients and passion to build a sustainable, vibrant next
generation pharmaceutical company.
Etrasimod, olorinab and APD418 are investigational compounds
that are not approved for any use in any country.
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 "expects," "objectives," "believe,"
"excited to," "potential," "will," "confident in," "planning,"
"estimated," and "uniquely positioned to" and include, without
limitation, statements about the following: Arena's planned
conference call and webcast with the investment community; design,
initiation, enrollment, data and results, and timing relating to
ongoing and intended programs and studies, including the timing of
planned IND filings, initiation of planned clinical trials, and
timing of data readouts; the potential of Arena's drug candidates,
including to be first- or best-in-class, world-class, or best-in
disease, have optimized efficacy and safety, have critical value,
and satisfy an unmet need; the potential of Arena Neuroscience; and
Arena's position, drive, portfolio, prioritization, financial
position, team, and building of the company. 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: clinical trials and other
studies may not proceed at the time or in the manner expected or at
all; the timing and outcome of research, development and regulatory
review is uncertain, and Arena's drug candidates may not advance in
development or be approved for marketing; enrolling patients in
Arena's ongoing and intended clinical trials is competitive and
challenging; Fast Track designation may not result in an expedited
regulatory review process; risks related to developing and
commercializing drugs; Arena may need additional funds to advance
all of its programs, and you and others may not agree with the
manner Arena allocates its resources; risks and uncertainties
relating to cash and revenues that may be generated from product
sales or other sources, including the impact of competition;
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; risks related to
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
licenses or collaborative arrangements, including lack of control
and potential disputes; the entry into or modification or
termination of licenses or 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 (SEC), including but not limited to Arena's Annual
Report on Form 10-K for the year ended December 31, 2018, which was filed with the SEC
on February 28, 2019, and Arena's
Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, which was filed with the SEC
on November 8, 2019. 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
Arena Media Contact:
IR@arenapharm.com
858-453-7200
(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,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
|
(unaudited)
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United Therapeutics
revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
800,000
|
|
|
$
|
—
|
|
Collaboration and
other revenue
|
|
|
6,580
|
|
|
|
6,878
|
|
|
|
7,284
|
|
|
|
11,402
|
|
Royalty
revenue
|
|
|
(3,578)
|
|
|
|
1,770
|
|
|
|
(853)
|
|
|
|
6,568
|
|
Total
revenues
|
|
|
3,002
|
|
|
|
8,648
|
|
|
|
806,431
|
|
|
|
17,970
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research &
development
|
|
|
74,632
|
|
|
|
37,890
|
|
|
|
231,496
|
|
|
|
115,029
|
|
General &
administrative
|
|
|
22,243
|
|
|
|
12,935
|
|
|
|
77,616
|
|
|
|
45,257
|
|
Transaction
costs
|
|
|
—
|
|
|
|
2,467
|
|
|
|
14,573
|
|
|
|
2,467
|
|
Total operating costs
& expenses
|
|
|
96,875
|
|
|
|
53,292
|
|
|
|
323,685
|
|
|
|
162,753
|
|
Income (loss) from
operations
|
|
|
(93,873)
|
|
|
|
(44,644)
|
|
|
|
482,746
|
|
|
|
(144,783)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest &
other income (expense), net
|
|
|
5,562
|
|
|
|
3,090
|
|
|
|
25,142
|
|
|
|
5,949
|
|
Income (loss) from
continuing operations before income taxes
|
|
|
(88,311)
|
|
|
|
(41,554)
|
|
|
|
507,888
|
|
|
|
(138,834)
|
|
Income tax (provision)
benefit
|
|
|
—
|
|
|
|
110,265
|
|
|
|
(110,333)
|
|
|
|
110,265
|
|
Income (loss) from
continuing operations
|
|
|
(88,311)
|
|
|
|
68,711
|
|
|
|
397,555
|
|
|
|
(28,569)
|
|
Loss from
discontinued operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(830)
|
|
Net income
(loss)
|
|
$
|
(88,311)
|
|
|
$
|
68,711
|
|
|
$
|
397,555
|
|
|
$
|
(29,399)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
per share, basic:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$
|
(1.76)
|
|
|
$
|
1.39
|
|
|
$
|
7.99
|
|
|
$
|
(0.61)
|
|
Discontinued
operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(0.02)
|
|
|
|
$
|
(1.76)
|
|
|
$
|
1.39
|
|
|
$
|
7.99
|
|
|
$
|
(0.63)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
per share, diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations
|
|
$
|
(1.76)
|
|
|
$
|
1.35
|
|
|
$
|
7.69
|
|
|
$
|
(0.61)
|
|
Discontinued
operations
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(0.02)
|
|
|
|
$
|
(1.76)
|
|
|
$
|
1.35
|
|
|
$
|
7.69
|
|
|
$
|
(0.63)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net income (loss) per share, basic:
|
|
|
50,113
|
|
|
|
49,409
|
|
|
|
49,779
|
|
|
|
47,041
|
|
Shares used in
calculating net income (loss) per share, diluted:
|
|
|
50,113
|
|
|
|
50,826
|
|
|
|
51,698
|
|
|
|
47,041
|
|
Arena
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheet Data
(In
thousands)
(Unaudited)
|
|
|
|
December 31, 2019
|
|
|
December 31, 2018
|
|
|
|
|
1
|
|
|
|
1
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash & cash
equivalents
|
|
$
|
243,274
|
|
|
$
|
161,037
|
|
Accounts
receivable
|
|
|
1,654
|
|
|
|
5,086
|
|
Deferred tax
assets
|
|
|
—
|
|
|
|
110,333
|
|
Prepaid expenses &
other current assets
|
|
|
18,715
|
|
|
|
10,008
|
|
Total
available-for-sale investments
|
|
|
867,229
|
|
|
|
367,006
|
|
Land, property &
equipment, net
|
|
|
25,128
|
|
|
|
23,114
|
|
Other non-current
assets
|
|
|
18,123
|
|
|
|
10,319
|
|
Total
assets
|
|
$
|
1,174,123
|
|
|
$
|
686,903
|
|
|
|
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
|
|
|
|
Accounts payable &
accrued liabilities
|
|
$
|
41,153
|
|
|
$
|
26,635
|
|
Total lease financing
obligations & other long-term liabilities
|
|
|
61,505
|
|
|
|
54,010
|
|
Total stockholders'
equity
|
|
|
1,071,465
|
|
|
|
606,258
|
|
Total liabilities
& stockholders' equity
|
|
$
|
1,174,123
|
|
|
$
|
686,903
|
|
|
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.