SAN DIEGO, May 3, 2012 /PRNewswire/
-- Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a
biopharmaceutical company focused on acquiring, in-licensing,
developing and commercializing proprietary products principally for
use in the hospital setting, today reported financial results for
the first quarter ended March 31,
2012.
During the first quarter of 2012, Cadence reported net
product revenue of $8.0 million, an
increase of $7.6 million as compared
to the first quarter of 2011. As compared to the quarter ended
December 31, 2011, net product
revenue for the first quarter of 2012 increased $2.1 million, or 36%, from $5.9 million.
As of March 31, 2012,
approximately 2,700 unique accounts had ordered OFIRMEV®
(acetaminophen) injection, an increase of approximately 20%
quarter-over-quarter, and an estimated 330,000 to 410,000 patients
were treated with OFIRMEV in just the first three months of
2012.
"Demand for OFIRMEV continued to grow at a strong pace in the
first quarter, and I am encouraged by the underlying trends. Our
customer base has increased and our customers made larger orders of
the product as compared to the previous quarter," said Ted Schroeder, President and CEO of Cadence.
"Our team is focused on expanding on these positive trends and
driving continued adoption and revenue growth of OFIRMEV."
Cadence believes that returns related to the voluntary recall of
a single lot of OFIRMEV that was announced in February 2012 have been substantially completed.
While some customers experienced a short-term supply delay as a
result of the temporary suspension of shipments from the supplier
of the recalled lot, the company was able to accelerate the
delivery of product from another supplier and quickly resumed
normal shipments.
Financial Results
Net product revenue was $8.0
million for the three months ended March 31, 2012, an increase of $7.6 million from the $0.4
million in net product revenue reported for the three months
ended March 31, 2011. Cadence defers
revenue recognition on shipments to wholesale distributors until
the product is sold through to end-user hospitals and as of
March 31, 2012, the company had recorded net deferred revenue
of $1.6 million, an increase of
$1.2 million from the $0.4 million in net deferred revenue reported at
March 31, 2011.
For the three months ended March 31,
2012, Cadence reported a net loss of $22.7 million, or $0.27 per share, compared to a net loss of
$24.4 million, or $0.39 per share, for the comparable period in
2011. Costs and expenses for the three months ended March 31, 2012 increased $6.0 million to $29.6
million, from $23.6 million
reported for the same period in 2011. This increase in costs and
expenses for the 2012 period was primarily a result of higher costs
of product sales and higher selling, general and administrative
expenses incurred during the current period as compared to the
same period in 2011. The increase in product sales costs in
the first quarter of 2012 was mostly attributable to increased net
sales and higher freight and unabsorbed manufacturing costs as
compared to the first quarter of 2011. Cadence suspended production
by its primary supplier in connection with an ongoing investigation
into the cause of unidentified particulate matter observed during
routine product stability testing, and it incurred higher freight
costs to expedite certain shipments of OFIRMEV in connection with
the transition to its secondary supplier. The company also incurred
unabsorbed manufacturing costs due to fixed costs that continued be
incurred despite the temporary suspension of production by the
company's primary supplier. The increase in selling, general and
administrative costs was mostly attributable to increased
commissions paid to Cadence's hospital sales specialists as a
result of increased revenue, combined with increased selling costs
incurred by the sales specialists as they implemented a variety of
marketing programs during the first quarter of 2012 to inform
customers about OFIRMEV.
As of March 31, 2012, Cadence held
cash, cash equivalents and short-term investments of $108.6 million and net accounts receivable of
$3.2 million.
Guidance
As of May 3, 2012, Cadence expects
that net product revenue from sales of OFIRMEV for the three months
ending June 30, 2012 will range from
approximately $10.0 million to $10.4
million.
Conference Call and Webcast on May 3, 2012 at 1:30 p.m.
Pacific Time (4:30 p.m. Eastern
Time)
Cadence management will host a conference call on May 3, 2012 at 1:30 p.m.
Pacific Time (4:30 p.m. Eastern
Time) and interested investors may participate in the
conference call by dialing (877) 303-9145 (domestic) or (760)
536-5203 (international). To access the webcast, please visit the
company's website at www.cadencepharm.com and go to the Investors
page. A replay of the webcast will be available approximately two
hours after the call and remain available on the company's website
until the next quarterly financial results call.
About OFIRMEV® (Acetaminophen) Injection
OFIRMEV (acetaminophen) injection (1000 mg / 100 mL, 10 mg / mL;
for intravenous use only), Cadence Pharmaceuticals' proprietary
intravenous formulation of acetaminophen, is indicated for the
management of mild to moderate pain, the management of moderate to
severe pain with adjunctive opioid analgesics, and the reduction of
fever. The FDA approval of OFIRMEV was based on data from clinical
trials in approximately 1,020 adult and 355 pediatric patients.
These trials included two studies evaluating the safety and
effectiveness of OFIRMEV in the treatment of pain, and one study
evaluating OFIRMEV in the treatment of fever. The effectiveness of
OFIRMEV for the treatment of acute pain and fever has not been
studied in pediatric patients less than 2 years of age.
Important Safety Information
Do not exceed the maximum recommended daily dose of
acetaminophen. Administration of acetaminophen by any route in
doses higher than recommended may result in hepatic injury,
including the risk of severe hepatotoxicity and death. OFIRMEV is
contraindicated in patients with severe hepatic impairment, severe
active liver disease or with known hypersensitivity to
acetaminophen or to any of the excipients in the formulation.
Acetaminophen should be used with caution in patients with the
following conditions: hepatic impairment or active hepatic disease,
alcoholism, chronic malnutrition, severe hypovolemia, or severe
renal impairment. OFIRMEV should be administered only as a
15-minute intravenous infusion. Discontinue OFIRMEV immediately if
symptoms associated with allergy or hypersensitivity occur. Do not
use in patients with acetaminophen allergy. The most common adverse
reactions in patients treated with OFIRMEV were nausea, vomiting,
headache, and insomnia in adult patients and nausea, vomiting,
constipation, pruritus, agitation, and atelectasis in pediatric
patients. The antipyretic effects of OFIRMEV may mask fever in
patients treated for post-surgical pain.
For more information, please see the complete OFIRMEV
Prescribing Information, available at
www.OFIRMEV.com or www.cadencepharm.com.
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused
on acquiring, in-licensing, developing and commercializing
proprietary products principally for use in the hospital setting.
The current version of Cadence Pharmaceuticals' corporate
presentation may be viewed on the Investors page of
www.cadencepharm.com under "Events & Presentations" by
selecting "Corporate Overview."
Forward-Looking Statements
Statements included in this press release and Cadence's
conference call that are not a description of historical facts are
forward-looking statements. Words such as "plans," "believes,"
"expects," "anticipates," and "will," and similar expressions, are
intended to identify forward-looking statements, and are based on
Cadence's current beliefs and expectations. Such statements
include, without limitation, statements regarding: Cadence's
financial guidance, expectations regarding sales and revenue growth
and the market opportunity for OFIRMEV; the status of the recall of
a single lot of OFIRMEV; the status of Cadence's ongoing
investigation into certain quality issues; and Cadence's ability to
execute its strategies for acquiring, in-licensing, developing and
commercializing proprietary products principally for use in the
hospital setting. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. Cadence's actual future results may differ materially from
Cadence's current expectations due to the risks and uncertainties
inherent in its business. These risks include, but are not limited
to: Cadence's dependence on the successful commercialization of
OFIRMEV, which is Cadence's only product; Cadence's ability to
achieve broad market acceptance and generate revenues from sales of
OFIRMEV; Cadence's dependence on its contract manufacturers and its
ability to ensure an adequate and continued supply of OFIRMEV to
meet market demand; Cadence's ability to successfully enforce its
marketing exclusivities and intellectual property rights, and to
defend the patents covering OFIRMEV, including in current patent
litigation with the parties that have submitted abbreviated new
drug applications ("ANDAs") for generic versions of OFIRMEV; the
potential that Cadence may be required to continue patent
litigation for substantial lengths of time or file additional
lawsuits to defend its patent rights from challenges by companies
that have submitted ANDAs for generic versions of OFIRMEV, and the
substantial costs associated with such lawsuits; the potential
introduction of generic competition to OFIRMEV in the event Cadence
is unsuccessful in current or future patent litigation; Cadence's
dependence on its licensors for the maintenance and enforcement of
its intellectual property rights; the potential product liability
exposure associated with pharmaceutical products such as OFIRMEV
and other products Cadence may in-license or acquire; Cadence's
ability to fully comply with numerous federal, state and local laws
and regulatory requirements that apply to its commercial
activities; public concern regarding the safety of drug products
such as OFIRMEV, which could result in the implementation by
regulatory agencies of new requirements to include unfavorable
information in the labeling for OFIRMEV; the risk that Cadence may
not be able to raise sufficient capital when needed, or at all; and
other risks detailed under "Risk Factors" and elsewhere in
Cadence's periodic reports and other filings made with the
Securities and Exchange Commission from time to time. All
forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation
Reform Act of 1995, and Cadence undertakes no obligation to revise
or update this press release to reflect events or circumstances
after the date hereof.
Cadence® and OFIRMEV® are trademarks of
Cadence Pharmaceuticals, Inc.
Contact:
|
William R.
LaRue
|
Kelli
France
|
|
SVP &
Chief Financial Officer
|
Media
Relations
|
|
Cadence
Pharmaceuticals, Inc.
|
WCG
|
|
Phone:
858-436-1400
|
Phone:
415-946-1076
|
CADENCE
PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
(in
thousands, except per share amounts)
|
|
|
|
|
|
|
Three
Months Ended
|
|
|
|
March
31,
|
|
|
|
2012
|
|
2011
|
|
Revenue:
|
|
|
|
|
|
Product
revenue, net
|
$
8,004
|
|
$
350
|
|
Total
revenues
|
8,004
|
|
350
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
Cost of
product sales
|
4,246
|
|
289
|
|
|
Amortization of patent license
|
336
|
|
560
|
|
|
Research
and development
|
1,511
|
|
2,746
|
|
|
Selling,
general and administrative
|
23,531
|
|
19,978
|
|
Total
costs and expenses
|
29,624
|
|
23,573
|
|
|
|
|
|
|
|
Loss from
operations
|
(21,620)
|
|
(23,223)
|
|
|
|
|
|
|
|
Other
expense, net
|
(1,053)
|
|
(1,149)
|
|
|
|
|
|
|
|
Net
loss
|
$(22,673)
|
|
$(24,372)
|
|
|
|
|
|
|
|
Basic and
diluted net loss per share(1)
|
$
(0.27)
|
|
$
(0.39)
|
|
|
|
|
|
|
|
Shares
used to compute basic and
|
|
|
|
|
diluted
net loss per share(1)
|
85,519
|
|
63,184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
There is a lack of comparability in the per
share amounts between the periods
presented as a result of the issuance of 21,800 shares of common
stock pursuant to a public offering in November
2011.
|
CADENCE
PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in
thousands)
|
|
|
|
|
|
March
31,
|
|
December 31,
|
|
2012
|
|
2011
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash, cash equivalents and
short-term investments
|
$
108,633
|
|
$
127,227
|
Restricted cash
|
450
|
|
450
|
Accounts receivable,
net
|
3,196
|
|
2,703
|
Inventory
|
2,561
|
|
1,388
|
Prepaid expenses and other current
assets
|
1,485
|
|
1,161
|
Total
current assets
|
116,325
|
|
132,929
|
|
|
|
|
Property
and equipment, net
|
10,736
|
|
10,569
|
Intangible
assets, net
|
13,097
|
|
13,433
|
Restricted
cash
|
190
|
|
190
|
Other
assets
|
7,032
|
|
7,039
|
Total
assets
|
$
147,380
|
|
$
164,160
|
|
|
|
|
Liabilities and Stockholders'
Equity
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable
|
$
5,736
|
|
$
3,801
|
Accrued
liabilities
|
11,351
|
|
10,945
|
Deferred revenue
|
1,595
|
|
1,291
|
Current debt, less
discount
|
2,541
|
|
-
|
Total
current liabilities
|
21,223
|
|
16,037
|
|
|
|
|
Other
liabilities
|
272
|
|
117
|
Long-term
debt, less discount
|
26,290
|
|
28,696
|
Total
stockholders' equity
|
99,595
|
|
119,310
|
Total
liabilities and stockholders' equity
|
$
147,380
|
|
$
164,160
|
|
|
|
|
SOURCE Cadence Pharmaceuticals, Inc.