SAN DIEGO, Calif., Nov. 9, 2020 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate
update and reported financial results for the third quarter ended
September 30, 2020.
"Over the quarter we made significant progress across our
pipeline – most importantly with the results from the ADVISE trial
giving us confidence to move expeditiously into a registrational
program. Additionally, we initiated the ELEVATE UC 12, GLADIATOR UC
and alopecia areata trials. We completed enrollment of the
CAPTIVATE Phase 2b trial for
olorinab, keeping us on track for expected topline data in Q1. In
addition, we have completed the Phase 1 trial of APD418 and have
plans to initiate our Phase 2 program in 2021. We also successfully
spun-off our neurology franchise with the inception of Longboard
Pharmaceuticals, to help unlock the value of those assets," said
Amit D. Munshi, President and CEO of
Arena. "We are optimistic about the next 12-18 months as we
continue our efforts to build long-term value for all of our
stakeholders and execute on key catalysts."
Program Updates
- Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial delivered topline results; moving
forward into a Phase 3 registrational program
- Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis
(UC) ongoing and on track to complete enrollment by year-end 2020,
with the 52-week treatment period ending by year-end 2021 and data
expected shortly thereafter; ELEVATE UC 12 Phase 3 trial was
initiated, continues to make strong progress with data expected in
the same timeframe as UC 52; we continue to monitor the impact of
the COVID-19 resurgence on study enrollment for both UC 52 and UC
12
- Etrasimod GLADIATOR UC Phase 2 planning; initiation expected in
Q1 2021 dependent on COVID-19 impact
- Etrasimod CULTIVATE Phase 2/3 trial in Crohn's disease (CD)
ongoing; confirming topline dose-ranging data in 2021; continue to
suspend overall program guidance based on COVID-19 impact
- Etrasimod eosinophilic esophagitis (EoE) Phase 2b VOYAGE trial with initiation expected in 2020
but dependent on COVID-19 impact
- Etrasimod alopecia areata (AA) Phase 2 initiated; topline data
expected H2 2021
- Olorinab CAPTIVATE Phase 2b trial
in abdominal pain associated with irritable bowel syndrome (IBS-C,
IBS-D) enrollment completed; topline data expected Q1 2021
- APD418 in acute heart failure (AHF) with Fast Track
designation; completed the first-in-human Phase 1 trial; APD418 was
generally well tolerated; Phase 2 planning ongoing
Business Update
- In October 2020, Arena announced
the launch and the completion of a $56
million financing of Longboard (formerly Arena
Neuroscience), an independent company focused on advancing
investigational therapies for rare neurological diseases. Arena
shareholders will continue to participate in the value of these
assets via Arena's equity position in the new company and potential
future royalty streams.
Financial Update
Third Quarter 2020
Financial Results
- Revenues for the third quarter were $20,000 compared to $1.4
million in the third quarter of 2019
- Research and development (R&D) expenses for the third
quarter totaled $79.8 million
compared to $60.3 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 $6.6 million in the third quarter
as compared to $6.7 million in the
same period 2019
- Selling, general and administrative (SG&A) expenses for the
third quarter totaled $19.0 million,
compared to $20.4 million in the
third quarter of 2019. This decrease was primarily driven by a
decrease in legal, accounting and other professional fees partially
offset by an increase in personnel expenses. The SG&A non-cash,
share-based compensation was $5.8
million in the third quarter as compared to $6.6 million in the same period 2019
- Net loss for the third quarter was $97.4
million compared to net loss of $72.9
million for the same period in 2019
- Basic and diluted net loss per share for the third quarter was
$1.69 compared to basic and diluted
net loss per share of $1.46 for the
same period in 2019
- Cash, cash equivalents and marketable securities were
$1.2 billion at September 30, 2020, as compared to $1.3 billion at June 30,
2020
Financial Outlook for 2020
Arena's 2020 financial
guidance range:
- Cash used in operating activities for the full-year 2020 is
expected to be $345 to $355 million, down compared to our previous
guidance of $400 to $430 million. Arena continues to achieve key
milestones while 2020 full-year operating expenses decrease due to
clinical trial efficiency and continued focus on optimizing
spend
Conference Call & Webcast Information
Arena will
host a conference call and live webcast the investment community
today, Monday, November 9, 2020, at
4:30 PM ET, to discuss the financial
results and corporate update.
When: Monday, November 9, 2020, at
4:30 PM ET
Dial-in: (877) 643-7155 (United
States) or (914) 495-8552 (International)
Conference ID: 6166976
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," "will," "long-term,"
"outlook," and "guidance" and include, without limitation,
statements about the following: Arena's clinical programs,
including plans to advance etrasimod into a registrational program
in atopic dermatitis, expectations regarding enrollment of study
participants and the timing of data readouts for ongoing and
anticipated trials, and expectations for the commencement of
additional trials; the statements under "Program Updates" above;
and Arena's financial outlook and guidance, including expectations
regarding cash to be used in operating activities and the rate of
change thereof. 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: topline data may not accurately reflect the complete
results of a particular study or trial; 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; 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 coronavirus disease
(COVID-19) pandemic, 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 will need additional funds to advance
all of its programs; the impact of competition; risks related to
unexpected or unfavorable new data; the risk that 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;
satisfactory resolution of litigation or other disagreements with
others; and risks related to the enforcement of 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, and Arena's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020, which
was filed with the SEC on August 5,
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 Contacts:
Patrick
Malloy
Arena Pharmaceuticals, Inc.
Vice President, Investor Relations & Corporate
Communications
pmalloy@arenapharm.com
847.987.4878
Megan E. Knight
Arena Pharmaceuticals, Inc.
Director, Investor Relations
mknight@arenapharm.com
858.210.3635
(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,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United Therapeutics
revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
800,000
|
|
Royalty
revenue
|
|
|
—
|
|
|
|
811
|
|
|
|
262
|
|
|
|
2,725
|
|
Collaboration and
other revenue
|
|
|
20
|
|
|
|
539
|
|
|
|
20
|
|
|
|
704
|
|
Total
revenues
|
|
|
20
|
|
|
|
1,350
|
|
|
|
282
|
|
|
|
803,429
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research &
development
|
|
|
79,820
|
|
|
|
60,257
|
|
|
|
223,299
|
|
|
|
156,864
|
|
Selling, general
& administrative
|
|
|
19,002
|
|
|
|
20,428
|
|
|
|
68,321
|
|
|
|
55,373
|
|
Transaction
costs
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
14,573
|
|
Total operating costs
& expenses
|
|
|
98,822
|
|
|
|
80,685
|
|
|
|
291,620
|
|
|
|
226,810
|
|
Income (loss) from
operations
|
|
|
(98,802)
|
|
|
|
(79,335)
|
|
|
|
(291,338)
|
|
|
|
576,619
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest &
other income (expense), net
|
|
|
1,364
|
|
|
|
6,470
|
|
|
|
8,765
|
|
|
|
19,580
|
|
Income (loss) before
income taxes
|
|
|
(97,438)
|
|
|
|
(72,865)
|
|
|
|
(282,573)
|
|
|
|
596,199
|
|
Income tax
provision
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(110,333)
|
|
Net income
(loss)
|
|
$
|
(97,438)
|
|
|
$
|
(72,865)
|
|
|
$
|
(282,573)
|
|
|
$
|
485,866
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
per share, basic:
|
|
$
|
(1.69)
|
|
|
$
|
(1.46)
|
|
|
$
|
(5.27)
|
|
|
$
|
9.78
|
|
Net income (loss)
per share, diluted:
|
|
$
|
(1.69)
|
|
|
$
|
(1.46)
|
|
|
$
|
(5.27)
|
|
|
$
|
9.39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculating net income (loss) per share, basic:
|
|
|
57,779
|
|
|
|
49,864
|
|
|
|
53.608
|
|
|
|
49,667
|
|
Shares used in
calculating net income (loss) per share, diluted:
|
|
|
57,779
|
|
|
|
49,864
|
|
|
|
53,608
|
|
|
|
51,763
|
|
Arena
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheet Data
(In
thousands)
(Unaudited)
|
|
|
|
September
30, 2020
|
|
|
December 31, 2019
|
|
|
|
|
|
|
|
|
1
|
|
Assets
|
|
|
|
|
|
|
|
|
Cash & cash
equivalents
|
|
$
|
460,145
|
|
|
$
|
243,274
|
|
Prepaid expenses &
other current assets
|
|
|
34,383
|
|
|
|
20,369
|
|
Total
available-for-sale investments
|
|
|
741,005
|
|
|
|
867,229
|
|
Land, property &
equipment, net
|
|
|
22,913
|
|
|
|
25,128
|
|
Other non-current
assets
|
|
|
17,097
|
|
|
|
18,123
|
|
Total
assets
|
|
$
|
1,275,543
|
|
|
$
|
1,174,123
|
|
|
|
|
|
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
|
|
|
|
|
Accounts payable &
accrued liabilities
|
|
$
|
47,647
|
|
|
$
|
41,153
|
|
Total lease financing
obligations & other long-term liabilities
|
|
|
57,969
|
|
|
|
61,505
|
|
Total stockholders'
equity
|
|
|
1,169,927
|
|
|
|
1,071,465
|
|
Total liabilities
& stockholders' equity
|
|
$
|
1,275,543
|
|
|
$
|
1,174,123
|
|
|
1 The Condensed Consolidated
Balance Sheet Data has been derived from the audited financial
statements as of that date.
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/arena-reports-third-quarter-financial-results-with-strong-cash-position-advancing-etrasimod-into-a-phase-3-registrational-program-in-atopic-dermatitis-301169036.html
SOURCE Arena Pharmaceuticals, Inc.