SAN DIEGO, March 2, 2015 /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,
2014.
"2014 was a pivotal year for Arena, marked by the advancement of
multiple development programs and the growth of sales of BELVIQ,"
stated Jack Lief, Arena's President and Chief Executive Officer.
"We reported impressive clinical trial results from our pipeline of
internally discovered GPCR drug candidates, including for our
lorcaserin lifecycle management programs. In 2015 and beyond, we
plan to build on this momentum by aggressively pursuing our
promising drug development opportunities both internally and
through collaboration, while continuing to support the delivery of
patient benefits with BELVIQ."
Fourth Quarter and Recent Developments
BELVIQ® (lorcaserin HCl) Commercial
Update
- IMS Health estimates that approximately 149,000 prescriptions
for BELVIQ were filled in the fourth quarter of 2014, representing
growth in total prescriptions of approximately 4% compared to the
previous quarter, despite an overall market decline of 4%.
- During the fourth quarter of 2014, Eisai recorded net product
sales for BELVIQ of $10.0 million.
These results reflect the impact of a new savings card launched by
Eisai in early 2015 that enables eligible patients without
commercial coverage for BELVIQ to pay no more than $75 for each monthly prescription.
- Ildong Pharmaceutical Co., Ltd., commenced marketing of BELVIQ
for weight management in South
Korea in February 2015,
following regulatory approval by the Ministry of Food and Drug
Safety.
Arena Research & Development
- Announced top-line results from a Phase 1b multiple-ascending
dose clinical trial for APD334, an oral drug modulator of the
sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential
treatment of autoimmune diseases.
- Initiated patient dosing in a Phase 2 clinical trial of
ralinepag, an oral, non-prostanoid prostacyclin (IP) receptor
agonist intended for the treatment of pulmonary arterial
hypertension.
- Arena and Eisai announced top-line results of a pilot study to
assess the safety of lorcaserin when coadministered with
phentermine.
- Arena and Eisai announced top-line results from the Phase 2
clinical trial investigating lorcaserin for smoking cessation.
Arena Financial Update
- Raised approximately $100.7
million in net proceeds in the first quarter of 2015 through
the sale of 21.0 million shares of common stock at a price to the
underwriters of $4.8139 per
share.
Fourth Quarter 2014 Financial Results
- Revenues totaled $9.2 million,
including $3.8 million in net product
sales of BELVIQ, of which $3.2
million represented 31.5% of Eisai's net product sales and
$0.6 million related to redemptions
of the 15-day free voucher and product samples.
- Research and development expenses totaled $27.8 million.
- General and administrative expenses totaled $8.9 million.
- Net loss was $32.1 million, or
$0.15 per share.
- At December 31, 2014, cash and
cash equivalents totaled $163.2
million, not including net proceeds of $100.7 million from the issuance of common stock
in the first quarter of 2015.
- At December 31, 2014,
approximately 220.3 million shares of common stock were
outstanding, not including 21.0 million shares of common stock
issued in the financing in the first quarter of 2015.
Full Year 2014 Financial Results
- Revenues totaled $37.0 million,
including $16.0 million in net
product sales of BELVIQ, of which $14.2
million represented 31.5% of Eisai's net product sales and
$1.8 million related to redemptions
of the 15-day free voucher and product samples.
- Research and development expenses totaled $100.3 million.
- General and administrative expenses totaled $34.1 million.
- Gain on sale of available-for-sale securities of $49.6 million related to Arena's former
investment in TaiGen.
- Net loss was $60.5 million, or
$0.28 per share.
2015 Financial Guidance
Arena expects the majority of its 2015 revenues will be payments
from collaborators based on their net product sales of BELVIQ:
Arena will receive 31.5% and 35% of Eisai's and Ildong's net
product sales of BELVIQ, respectively. Arena is currently not able
to predict the amount of these sales and, accordingly, is not
providing guidance for its overall 2015 revenues at this time. A
lesser amount of Arena's total 2015 revenues will consist of
regulatory milestones (including the $3.0
million milestone achieved from the approval of BELVIQ in
South Korea in February 2015), amortization of upfront payments
from existing collaborations (expected to be approximately
$8.0 million), development and patent
reimbursements from Eisai (expected to be approximately
$7.0 million), and toll manufacturing
from Siegfried (expected to be approximately $1.0 million).
Arena expects full year 2015 research and development expenses
of approximately $114.0 million to $122.0
million, including non-cash expenses of approximately
$13.0 million and $6.0 million in development expenses reimbursed
by Eisai (with such reimbursed expenses included in revenue). Arena
also expects full year 2015 general and administrative expenses of
approximately $33.0 million to $39.0
million, including non-cash expenses of approximately
$9.0 million and approximately
$1.0 million in patent expenses
reimbursed by Eisai (and included in revenue). In addition, Arena
expects to spend approximately $8.0 million
to $9.0 million for capital expenditures, primarily related
to its manufacturing facility in Switzerland. Arena may moderate its planned
level of expenses based on its revenues and shared costs with
collaborators.
Scheduled Conference Call and Webcast
Arena will host a conference call and webcast today at
5:00 p.m. Eastern Time
(2:00 p.m. Pacific Time) to provide a corporate update and
report fourth quarter and full year 2014 financial results. The
conference call may be accessed by dialing 877.643.7155 for
domestic callers and 914.495.8552 for international callers. Please
specify to the operator that you would like to join the "Arena
Pharmaceuticals' Fourth Quarter and Full Year 2014 Financial
Results Call." The conference call will be webcast live under the
investor relations section of Arena's website at
www.arenapharm.com, and will be archived there for 30 days
following the call. Please connect to Arena's website several
minutes prior to the start of the broadcast to ensure adequate time
for any software download that may be necessary.
Upcoming Conference Participation
Arena is planning to participate at upcoming investment and
industry conferences, including:
- Needham & Company's 14th Annual Healthcare
Conference, April 14-15, 2015,
New York, New York
- Bank of America Merrill Lynch 2015 Health Care Conference,
May 12-14, 2015, Las Vegas, Nevada
About BELVIQ® (lorcaserin HCl) CIV
BELVIQ is believed to decrease food consumption and promote
satiety by selectively activating serotonin 2C receptors in the
brain. The exact mechanism of action is not known.
BELVIQ is approved by the US Food and Drug Administration to be
used along with a reduced-calorie diet and increased physical
activity for chronic weight management in adult patients with an
initial body mass index of:
- 30 kg/m2 or greater (obese), or
- 27 kg/m2 or greater (overweight) in the presence of
at least one weight-related comorbid condition (e.g., hypertension,
dyslipidemia, type 2 diabetes).
Limitations of Use:
- The safety and efficacy of coadministration of BELVIQ with
other products intended for weight loss including prescription
drugs (e.g., phentermine), over-the-counter drugs, and herbal
preparations have not been established.
- The effect of BELVIQ on cardiovascular morbidity and mortality
has not been established.
In clinical trials, the most common adverse reactions for
patients without diabetes treated with BELVIQ were headache,
dizziness, fatigue, nausea, dry mouth, and constipation, and, in
patients with diabetes, the most common adverse reactions were
hypoglycemia, headache, back pain, cough, and fatigue.
For additional information about BELVIQ, including important
safety information, click here for the full Prescribing Information
or visit www.BELVIQ.com.
Arena has granted exclusive marketing and distribution rights
for BELVIQ to Eisai Inc. and Eisai Co., Ltd., for most territories
worldwide; to Ildong Pharmaceutical Co., Ltd., for South Korea; to CY Biotech Company Limited for
Taiwan; and to Teva Pharmaceutical
Industries Ltd.'s local Israeli subsidiary, Abic Marketing Limited,
for Israel. Composition of matter
patents for BELVIQ are issued in major jurisdictions globally that,
in most cases, are capable of continuing into at least 2023,
without taking into account any patent term adjustment or extension
regimes of any country or any additional term of exclusivity Arena
might obtain by virtue of later filed patent applications.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. Arena's focus is discovering, developing and
commercializing drugs to address unmet medical needs, and
BELVIQ® (lorcaserin HCl) is Arena's first internally
discovered drug approved for marketing. Arena's US operations are
located in San Diego, California,
and its operations outside of the United
States, including its commercial manufacturing facility, are
located in Zofingen, Switzerland.
For more information, visit Arena's website at
www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® is a registered trademark of Arena
Pharmaceuticals GmbH.
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 include statements about the
significance of 2014 for Arena; building on momentum; aggressively
pursuing drug development opportunities; the therapeutic
indication, use, safety, efficacy, mechanism of action and
potential of BELVIQ; supporting the delivery of patient benefits
with BELVIQ; Eisai's new savings card; the marketing of BELVIQ in
South Korea; progress, promise,
potential therapeutic indication and other aspects of the research
and development programs; financial guidance; patent coverage;
participation at conferences; embracing the challenge of improving
health; seeking to bring innovative medicines to patients; and
Arena's focus, plans, goals, strategy, expectations, research and
development programs, and ability to discover and develop compounds
and commercialize drugs. 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: risks related to commercializing drugs,
including regulatory, manufacturing, supply and marketing issues
and the availability and use of BELVIQ; cash and revenues generated
from BELVIQ, including the impact of competition; 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; the timing and
outcome of regulatory review is uncertain, and BELVIQ may not be
approved for marketing in combination with another drug, for
another indication or using a different formulation or in any other
territory for any indication; regulatory decisions in one territory
may impact other regulatory decisions and Arena's business
prospects; government and commercial reimbursement and pricing
decisions; risks related to relying on collaborative arrangements;
the timing and receipt of payments and fees, if any, from
collaborators; the entry into or modification or termination of
collaborative arrangements; 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;
data and other information related to any of Arena's research and
development may not meet regulatory requirements or otherwise be
sufficient for (or Arena or a collaborator may not pursue) further
research and development, regulatory review or approval or
continued marketing; Arena's and third parties' intellectual
property rights; the timing, success and cost of Arena's research
and development; 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; having adequate
funds; 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.
Arena
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(In thousands, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
Three months
ended
|
|
Year ended
|
|
December
31,
|
|
December
31,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
(unaudited)
|
|
(Note)
|
Revenues
|
|
|
|
|
|
|
|
Net product
sales
|
$ 3,846
|
|
$ 2,372
|
|
$ 15,983
|
|
$ 5,702
|
Other Eisai
collaborative revenue
|
4,577
|
|
3,483
|
|
18,611
|
|
72,416
|
Toll
manufacturing
|
313
|
|
509
|
|
1,497
|
|
2,690
|
Other collaborative
revenue
|
455
|
|
152
|
|
879
|
|
586
|
Total
revenues
|
9,191
|
|
6,516
|
|
36,970
|
|
81,394
|
|
|
|
|
|
|
|
|
Operating Costs
& Expenses
|
|
|
|
|
|
|
|
Cost of product
sales
|
2,320
|
|
289
|
|
6,369
|
|
1,803
|
Cost of toll
manufacturing
|
266
|
|
1,091
|
|
1,390
|
|
4,377
|
Research &
development
|
27,826
|
|
19,040
|
|
100,347
|
|
66,468
|
General &
administrative
|
8,939
|
|
8,067
|
|
34,137
|
|
31,681
|
Total
operating costs & expenses
|
39,351
|
|
28,487
|
|
142,243
|
|
104,329
|
|
|
|
|
|
|
|
|
Interest &
Other Income (Expense)
|
|
|
|
|
|
|
|
Interest
income
|
14
|
|
21
|
|
83
|
|
89
|
Interest
expense
|
(1,710)
|
|
(1,758)
|
|
(6,915)
|
|
(7,091)
|
Gain from valuation
of derivative liabilities
|
929
|
|
49
|
|
4,418
|
|
10,150
|
Gain on sale of
available-for-sale securities
|
0
|
|
0
|
|
49,553
|
|
0
|
Other
|
(1,134)
|
|
200
|
|
(2,374)
|
|
352
|
Total interest
& other income (expense), net
|
(1,901)
|
|
(1,488)
|
|
44,765
|
|
3,500
|
Net loss
|
$ (32,061)
|
|
$ (23,459)
|
|
$ (60,508)
|
|
$(19,435)
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
Basic
|
$ (0.15)
|
|
$ (0.11)
|
|
$ (0.28)
|
|
$ (0.09)
|
Diluted
|
$ (0.15)
|
|
$ (0.11)
|
|
$ (0.28)
|
|
$ (0.09)
|
|
|
|
|
|
|
|
|
Shares used in
calculating net loss per share:
|
|
|
|
|
|
|
|
Basic
|
220,152
|
|
218,643
|
|
219,734
|
|
218,104
|
Diluted
|
220,152
|
|
218,643
|
|
219,734
|
|
218,104
|
Note: The Condensed
Consolidated Statements of Operations have been derived from the
audited financial statements for the year ended December 31, 2013,
and from the unaudited financial statements for the year ended
December 31, 2014.
|
Arena
Pharmaceuticals, Inc.
|
Condensed
Consolidated Balance Sheet Data
|
(In
thousands)
|
|
|
|
|
|
December 31,
2014
|
|
December 31,
2013
|
|
(Note)
|
Assets
|
|
|
|
Cash &
cash equivalents
|
$ 163,209
|
|
$ 221,878
|
Accounts
receivable
|
3,712
|
|
10,602
|
Inventory
|
10,831
|
|
12,759
|
Prepaid
expenses & other current assets
|
4,144
|
|
3,571
|
Land, property
& equipment, net
|
82,919
|
|
77,388
|
Acquired
technology & other non-current assets
|
11,570
|
|
13,609
|
Total
assets
|
$ 276,385
|
|
$ 339,807
|
|
|
|
|
Liabilities &
Stockholders' Equity
|
|
|
|
Accounts
payable & accrued liabilities
|
$ 49,158
|
|
$ 30,827
|
Total deferred
revenues
|
108,302
|
|
139,190
|
Total
derivative liabilities
|
474
|
|
4,892
|
Total lease
financing obligations & other long-term liabilities
|
71,106
|
|
73,041
|
Total
stockholders' equity
|
47,345
|
|
91,857
|
Total
liabilities & stockholders' equity
|
$ 276,385
|
|
$ 339,807
|
Note: The Condensed
Consolidated Balance Sheet Data has been derived from the audited
financial statements as of December 31, 2013, and from the
unaudited financial statements as of December 31, 2014.
|
Contact: Arena
Pharmaceuticals, Inc.
|
Media Contact: Russo
Partners
|
|
|
Scott A.
Rieger
|
David
Schull
|
Senior Director,
Investor Relations
|
President
|
srieger@arenapharm.com
|
david.schull@russopartnersllc.com
|
858.453.7200, ext.
1347
|
858.717.2310
|
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SOURCE Arena Pharmaceuticals, Inc.