SAN DIEGO, Aug. 5, 2020 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate
update and reported financial results for the second quarter ended
June 30, 2020.
"Over the quarter, we delivered positive Phase 1 data from the
etrasimod controlled-release program, fully enrolled the Phase
2b ADVISE trial in atopic dermatitis
– meeting the high-end of our enrollment range and allowing for the
availability of data in 2020 as guided, and completed a capital
raise to further strengthen our balance sheet," said Amit D. Munshi, President and CEO of Arena. "I
am extremely proud of the resiliency and tenacity that our team has
demonstrated during the past several months as they overcame
challenges that our industry is facing as a result of the global
COVID-19 pandemic. Our team has adapted quickly and focused on
execution in order to achieve key milestones for the company, and I
want to acknowledge the hard work that went on across the
organization. As a leadership team, we are consistently evaluating
the impact of the pandemic and assessing the appropriate level of
action needed as circumstances evolve."
Program Update
- Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial enrollment completed; topline data
expected Q4 2020
- Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis
(UC) ongoing and on track; ELEVATE UC 12 Phase 3 trial expected to
initiate in H2 2020; topline data for both trials expected by year
end 2021
- Etrasimod CULTIVATE Phase 2b
dose-ranging trial in Crohn's disease (CD) initiated and ongoing;
confirming plans to help facilitate availability of topline data in
2021; continue to suspend overall program guidance based on
expected COVID-19 impact
- Etrasimod eosinophilic esophagitis (EoE) Phase 2b and alopecia areata (AA) Phase 2 planning
ongoing; initiation in 2020 dependent on COVID-19 situation in
Q3/4
- Olorinab CAPTIVATE Phase 2b trial
in abdominal pain associated with irritable bowel syndrome (IBS-C,
IBS-D) ongoing; experiencing some COVID-19 related impact on trial
enrollment; topline data expected Q1 2021
- APD418 in acute heart failure (AHF) with Fast Track
designation; Phase 1 trial has resumed; topline data expected Q4
2020
Financial Update
Second Quarter 2020
Financial Results
- Revenues for the second quarter were zero compared to
$1.0 million in the second quarter of
2019
- Research and development (R&D) expenses for the second
quarter totaled $64.9 million
compared to $51.2 million in the same
period 2019. This increase was primarily driven by our advancing
clinical studies, including the etrasimod Phase 3 program, as well
as an increase in personnel expenses as we staff to support our
clinical programs. The R&D non-cash share-based compensation
was $6.3 million in the second
quarter as compared to $7.0 million
in the same period 2019
- General and administrative (G&A) expenses for the second
quarter totaled $22.9 million,
compared to $18.4 million in the
second quarter of 2019. This increase is primarily attributed to
personnel expenses. The G&A non-cash share-based compensation
was $6.0 million in the second
quarter as compared to $6.4 million
in the same period 2019
- Net loss for the second quarter was $84.9 million compared to net loss of
$61.4 million for the same period in
2019
- Basic and diluted net loss per share for the second quarter was
$1.61 compared to basic and diluted
net loss per share of $1.24 for the
same period in 2019
- Cash, cash equivalents and marketable securities were
$1.3 billion at June 30, 2020, including $301.8 million in net proceeds received from the
sale of approximately 6.3 million shares of common stock under an
equity financing, as compared to $1.0
billion at March 31, 2020
Financial Outlook for 2020
Arena's 2020 financial
guidance range:
- No change from the previous guidance, cash used in operating
activities for the full-year 2020 is expected to be $400 million to $430
million
Conference Call & Webcast Information
Arena will
host a live and webcast question and answer session via conference
call with the investment community today, Wednesday, August 5, 2020, at 4:30 PM ET, to discuss the financial results and
corporate update.
When: Wednesday, August 5, 2020,
at 4:30 PM ET
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 5343486
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 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 "expected," "ensure," "begin to,"
"will," "long-term," "outlook," "guidance," "uniquely positioned
to," and "drive to" and include, without limitation, statements
about the following: Arena's clinical programs, including clinical
study site activations, enrollment of study subjects, patient
safety, study momentum, drug supply, timing of data readouts, and
potential future updates on Arena's clinical programs; Arena's
financial outlook and guidance, including expectations regarding
cash to be used in operating activities and the rate of change
thereof; Arena's planned conference call and webcast with the
investment community; the potential of Arena's drug candidates,
including to be best-in-disease or transformational, have optimized
efficacy and safety, satisfy unmet patient needs, and be delivered
to patients globally; 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; the
duration and severity of the recent coronavirus disease (COVID-19)
outbreak, including but not limited to the impact on Arena's
clinical operations, the operations of Arena's suppliers, partners,
collaborators, 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 Annual Report on Form 10-K for the year
ended December 31, 2019, which was
filed with the SEC on February 27,
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.
Corporate
Contact:
Megan E. Knight
Arena Pharmaceuticals, Inc.
Director, Investor Relations
mknight@arenapharm.com
858.210.3635
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
|
|
|
Six months
ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United Therapeutics
revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
800,000
|
|
Royalty
revenue
|
|
|
—
|
|
|
|
941
|
|
|
|
262
|
|
|
|
1,914
|
|
Collaboration and
other revenue
|
|
|
—
|
|
|
|
81
|
|
|
|
—
|
|
|
|
165
|
|
Total
revenues
|
|
|
—
|
|
|
|
1,022
|
|
|
|
262
|
|
|
|
802,079
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research &
development
|
|
|
64,946
|
|
|
|
51,211
|
|
|
|
143,479
|
|
|
|
96,607
|
|
General &
administrative
|
|
|
22,877
|
|
|
|
18,367
|
|
|
|
49,319
|
|
|
|
34,945
|
|
Transaction
costs
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
14,573
|
|
Total operating costs
& expenses
|
|
|
87,823
|
|
|
|
69,578
|
|
|
|
192,798
|
|
|
|
146,125
|
|
Income (loss) from
operations
|
|
|
(87,823)
|
|
|
|
(68,556)
|
|
|
|
(192,536)
|
|
|
|
655,954
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest &
other income (expense), net
|
|
|
2,895
|
|
|
|
7,153
|
|
|
|
7,401
|
|
|
|
13,110
|
|
Income (loss) before
income taxes
|
|
|
(84,928)
|
|
|
|
(61,403)
|
|
|
|
(185,135)
|
|
|
|
669,064
|
|
Income tax
provision
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(110,333)
|
|
Net income
(loss)
|
|
$
|
(84,928)
|
|
|
$
|
(61,403)
|
|
|
$
|
(185,135)
|
|
|
$
|
558,731
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
per share, basic:
|
|
$
|
(1.61)
|
|
|
$
|
(1.24)
|
|
|
$
|
(3.59)
|
|
|
$
|
11.27
|
|
Net income (loss)
per share, diluted:
|
|
$
|
(1.61)
|
|
|
$
|
(1.24)
|
|
|
$
|
(3.59)
|
|
|
$
|
10.86
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net income (loss) per share, basic:
|
|
|
52,771
|
|
|
|
49,653
|
|
|
|
51.500
|
|
|
|
49,566
|
|
Shares used in
calculating net income (loss) per share,
diluted:
|
|
|
52,771
|
|
|
|
49,653
|
|
|
|
51,500
|
|
|
|
51,459
|
|
Arena
Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
(In thousands)
(Unaudited)
|
|
|
|
June
30, 2020
|
|
|
December 31, 2019
|
|
|
|
|
|
|
|
1
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash & cash
equivalents
|
|
$
|
550.176
|
|
|
$
|
243,274
|
|
Prepaid expenses &
other current assets
|
|
|
33,296
|
|
|
|
20,369
|
|
Total
available-for-sale investments
|
|
|
715,296
|
|
|
|
867,229
|
|
Land, property &
equipment, net
|
|
|
23,769
|
|
|
|
25,128
|
|
Other non-current
assets
|
|
|
17,213
|
|
|
|
18,123
|
|
Total
assets
|
|
$
|
1,339,750
|
|
|
$
|
1,174,123
|
|
|
|
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
|
|
|
|
Accounts payable &
accrued liabilities
|
|
$
|
37,771
|
|
|
$
|
41,153
|
|
Total lease financing
obligations & other long-term liabilities
|
|
|
59,342
|
|
|
|
61,505
|
|
Total stockholders'
equity
|
|
|
1,242,637
|
|
|
|
1,071,465
|
|
Total liabilities
& stockholders' equity
|
|
$
|
1,339,750
|
|
|
$
|
1,174,123
|
|
|
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.