- Significant pipeline progress with
potentially first- or best-in-class drug candidates
- Strong cash position of $1.1 billion as of
December 31, 2020
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a
corporate update and reported financial results for the fourth
quarter and full year ended December 31, 2020.
“This quarter we were pleased to announce the completion of
enrollment of the ELEVATE UC 52 trial for etrasimod and expansion
of our cardiovascular franchise to include temanogrel. Our growing
and diverse pipeline is supported by a strong cash position,” said
Amit D. Munshi, President and CEO of Arena. “Adapting to the impact
of the global COVID-19 pandemic, our team has continued to put
safety of trial participants first while striving to maintain
important momentum across our programs.”
Fourth Quarter and Recent Updates
- In February 2021, dosed first participant in the Phase 2b
VOYAGE trial for etrasimod for eosinophilic esophagitis (EoE)
- In February 2021, Garry Neil named Board Chair, and Nawal
Ouzren named to the Board of Directors
- In January 2021, etrasimod ELEVATE UC 52 Phase 3 trial in
ulcerative colitis (UC) completed enrollment; both ELEVATE UC 52
and ELEVATE UC 12 Phase 3 trials on track for topline data in Q1
2022; we continue to monitor the impact of the COVID-19 resurgence
on study progress for both UC 52 and UC 12
- In January 2021, temanogrel program announced at JP Morgan
Health Care Conference
- In November 2020, etrasimod atopic dermatitis (AD) ADVISE Phase
2b trial delivered topline results; moving forward into a Phase 3
registrational program
- In October 2020, olorinab CAPTIVATE Phase 2b trial in abdominal
pain associated with irritable bowel syndrome (IBS-C, IBS-D)
enrollment completed; topline data expected Q1 2021
Fourth Quarter and Full-Year 2020 Financial Updates
Fourth Quarter 2020 Financial Results
- Revenues for the fourth quarter were zero compared to $3.0
million in the fourth quarter of 2019
- Research and development (R&D) expenses for the fourth
quarter totaled $100.4 million compared to $74.6 million in the
same period 2019. This increase was primarily driven by our
advancing clinical studies, including the etrasimod Phase 3
program. The R&D non-cash share-based compensation was $6.5
million in the fourth quarter as compared to $7.0 million in the
same period 2019
- Selling, general and administrative (SG&A) expenses for the
fourth quarter totaled $34.9 million, compared to $22.2 million in
the fourth quarter of 2019. This increase is primarily attributed
to non-cash share-based compensation expenses. The SG&A
non-cash share-based compensation was $13.5 million in the fourth
quarter as compared to $6.3 million in the same period 2019
- Net loss for the fourth quarter was $122.2 million compared to
net loss of $88.3 million for the same period in 2019
- Basic and diluted net loss per share for the fourth quarter was
$2.10 compared to basic and diluted net loss per share of $1.76 for
the same period in 2019
Full-Year 2020 Financial Results
- Revenues totaled $0.3 million
- Research and development expenses totaled $323.7 million,
including $26.0 million related to non-cash share-based
compensation
- Selling, general and administrative expenses totaled $103.2
million, including $33.9 million related to non-cash share-based
compensation
- Net loss was $404.7 million, or $7.39 per share
At December 31, 2020, Arena’s cash, cash equivalents and
investments balance was approximately $1.1 billion and
approximately 58.6 million shares of Arena common stock were
outstanding.
Conference Call & Webcast Information
Arena will host a live and webcast question and answer session
via conference call with the investment community today, Tuesday,
February 23, 2021, at 4:30 PM ET, to discuss the financial results
and corporate update.
When: Tuesday, February 23, 2021, at 4:30 PM ET Dial-in: (877)
643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 1778476
Please join the conference call at least 20 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 event 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 team with a singular purpose –
deliver our important medicines to patients.
In a rapidly changing global market, we work with a sense of
urgency every day to understand the needs of all our stakeholders,
identify bold, sometimes disruptive, ideas to get our medicines to
patients, and relentlessly execute until it’s done.
ARENA - Care More. Act Differently.
Etrasimod, olorinab, and temanogrel 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
“potentially,” “striving to,” “can,” “on track for,” “expected,”
“guidance,” and “will,” and include, without limitation, statements
about the following: Arena’s clinical programs, including study
initiation, enrollment of study participants, participant safety,
study momentum, and timing of data readouts; Arena’s planned
conference call and webcast with the investment community; the
potential of Arena’s drug candidates, including to be first- or
best-in-class and be delivered to patients; and Arena’s purpose,
work, understanding, ideas, and execution. 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 participants in
Arena’s ongoing and intended clinical trials is competitive and
challenging; the duration and severity of the coronavirus disease
(COVID-19) outbreak, including but not limited to the impact on
Arena’s clinical trials and operations, the operations of Arena’s
suppliers, partners, collaborators, and licensees, and capital
markets, which in each case remains uncertain; 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 quarterly report on Form 10-Q for the quarter
ended September 30, 2020, which was filed with the SEC on November
9, 2020. 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.
Arena Pharmaceuticals,
Inc.
Condensed Consolidated
Statements of Operations
(In thousands, except per share
amounts)
Three months ended
Year ended
December 31,
December 31,
2020
2019
2020
2019
(unaudited)
Revenues
United Therapeutics revenue
$
—
$
—
$
—
$
800,000
Royalty revenue
—
(3,578
)
262
(853
)
Collaboration and other revenue
37
6,580
57
7,284
Total revenues
37
3,002
319
806,431
Operating Costs & Expenses
Research & development
100,441
74,632
323,740
231,496
Selling, general & administrative
34,897
22,243
103,218
77,616
Transaction costs
—
—
—
14,573
Total operating costs & expenses
135,338
96,875
426,958
323,685
(Loss) income from operations
(135,301
)
(93,873
)
(426,639
)
482,746
Total interest & other income, net
13,140
5,562
21,905
25,142
(Loss) income before income taxes
(122,161
)
(88,311
)
(404,734
)
507,888
Income tax provision
—
—
—
(110,333
)
Net (loss) income
$
(122,161
)
$
(88,311
)
$
(404,734
)
$
397,555
Net (loss) income per share,
basic:
$
(2.10
)
$
(1.76
)
$
(7.39
)
$
7.99
Net (loss) income per share,
diluted:
$
(2.10
)
$
(1.76
)
$
(7.39
)
$
7.69
Shares used in calculating net income
(loss) per share, basic:
58,288
50,113
54,767
49,779
Shares used in calculating net income
(loss) per share, diluted:
58,288
50,113
54,767
51,698
Arena Pharmaceuticals,
Inc.
Condensed Consolidated Balance
Sheet Data
(In thousands)
(Unaudited)
December 31, 2020
December 31, 2019
1
1
Assets
Cash & cash equivalents
$
219,544
$
243,274
Prepaid expenses & other current
assets
35,266
20,369
Total available-for-sale investments
884,497
867,229
Land, property & equipment, net
22,090
25,128
Other non-current assets
29,323
18,123
Total assets
$
1,190,720
$
1,174,123
Liabilities & Stockholders’
Equity
Accounts payable & accrued
liabilities
$
53,676
$
41,153
Total lease financing obligations &
other long-term liabilities
56,575
61,505
Total stockholders’ equity
1,080,469
1,071,465
Total liabilities & stockholders’
equity
$
1,190,720
$
1,174,123
1 The Condensed Consolidated Balance Sheet Data has been derived
from the audited financial statements as of that date.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210223006073/en/
Corporate Contacts: Patrick Malloy Arena Pharmaceuticals,
Inc. Vice President, Investor Relations & Corporate
Communications pmalloy@arenapharm.com 847.987.4878
Media Contact: IR@arenapharm.com 858-453-7200
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