SAN DIEGO, Feb. 28, 2014 /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 three and twelve months
ended December 31, 2013.
Recent highlights included:
- Cadence entered into an agreement and plan of merger agreement
with Mallinckrodt plc and one of its
wholly owned indirect subsidiaries pursuant to which Mallinckrodt commenced a tender offer on
February 19, 2014, to acquire all of
the outstanding shares of Cadence common stock at a purchase price
of $14.00 per share in cash.
- Net product revenue for the fourth quarter of 2013 was
$33.3 million, representing increases
of $16.2 million, or 95%, from the
fourth quarter of 2012, and $4.3
million, or 15%, from the third quarter of 2013.
- License revenue of $2.0 million
was recognized in the fourth quarter of 2013 from a one-time
commercial milestone payment pursuant to the company's license
agreement with Terumo Corporation.
- Gross margin on sales of OFIRMEV was 65% for the fourth quarter
of 2013, compared to 58%, for the fourth quarter of 2012.
- Cash, cash equivalents and investments were $57.4 million as of December 31, 2013.
Financial Results
Cadence's net product revenue for
the three months ended December 31,
2013, was $33.3 million, an
increase of 95% from the $17.1
million in net product revenue recognized for the three
months ended December 31, 2012. For
the year ended December 31, 2013,
Cadence's net product revenue was $110.5
million, an increase of 121% from the $50.1 million reported in 2012.
For the three months ended December 31,
2013, Cadence reported a net loss of $4.1 million, or $0.05 per share, compared to a net loss of
$21.4 million, or $0.25 per share, for the comparable period in
2012. For the year ended December 31,
2013, Cadence reported a net loss of $24.3 million, or $0.28 per share, compared to a net loss of
$81.0 million, or $0.95 per share, in 2012. Included in the
company's net loss for the twelve months ended December 31, 2013, was a gain of $7.7 million recorded with respect to the waiver,
termination and sale of Cadence's Incline assets in January 2013, for which the company received cash
payments totaling $14.7 million. The
company's net loss for the three and twelve months ended
December 31, 2012, included
impairment charges and a loss on the sale of equipment totaling
$8.6 million pertaining to certain
assets involved with the manufacture of OFIRMEV under the
terminated development and supply agreement with Baxter Healthcare
Corporation. Additionally, the Company recognized disposal costs of
$0.3 million during the fourth
quarter of 2012 for the inventory held while manufacturing was
suspended at Baxter.
The company's gross margin on sales of OFIRMEV for the three
months ended December 31, 2013, was
65%, compared to 58% for the same period in 2012. For the twelve
months ended December 31, 2013,
Cadence reported a gross margin of 66%, compared to 54% for 2012.
These year-over-year increases were primarily the result of lower
freight costs in 2013 and the impact of price increases implemented
in 2012 and 2013. Operating expenses, including patent
amortization, decreased $3.6 million,
or 12%, for the three months ended December
31, 2013, to $26.8 million,
from $30.3 million for the same
period in 2012. This decrease was primarily attributable to
impairment charges and a loss on the sale of equipment totaling
$8.6 million pertaining to certain
assets involved with the manufacture of OFIRMEV under the
terminated development and supply agreement with Baxter that were recognized during the three
months ended December 31, 2012.
Similar charges were not recorded in 2013, however the company
incurred higher legal and clinical trial expenses during the
three-months ended December 31, 2013
as compared to the same period in 2012. For the twelve months ended
December 31, 2013, Cadence reported
operating expenses of $102.1 million,
a decrease of $1.5 million, or 1%, as
compared to $103.6 million for 2012.
This decrease was primarily attributable to the impairment charge
and loss on equipment sale recorded during the fourth quarter of
2012, mostly offset by higher legal expenses, clinical trial
expenses and corporate development activities in 2013 as compared
to 2012.
As of December 31, 2013, Cadence
held cash, cash equivalents and short-term investments of
$57.4 million, a decrease of
$4.7 million from $62.1 million at December
31, 2012. Net accounts receivable at December 31, 2013, was $9.3 million, representing approximately 30 days
of sales outstanding.
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
RISK OF MEDICATION
ERRORS AND HEPATOTOXICITY
Take care when prescribing, preparing, and administering OFIRMEV
injection to avoid dosing errors which could result in accidental
overdose and death.
OFIRMEV contains acetaminophen. Acetaminophen has been associated
with cases of acute liver failure, at times resulting in liver
transplant and death. Most of the cases of liver injury are
associated with the use of acetaminophen at doses that exceed the
recommended maximum daily limits, and often involve more than one
acetaminophen-containing product.
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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. Rarely, acetaminophen may
cause serious skin reactions such as acute generalized
exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS),
and toxic epidermal necrolysis (TEN), which can be fatal.
Discontinue OFIRMEV immediately if symptoms associated with allergy
or hypersensitivity occur, or at the first appearance of skin rash.
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 with postsurgical pain.
OFIRMEV is approved for use in patients ≥ 2 years of age. Do not
exceed the recommended maximum daily dose of OFIRMEV. OFIRMEV
should be administered only as a 15-minute infusion.
For more information, please see the full OFIRMEV Prescribing
Information, including the complete boxed warning, which is
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 overview 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 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 the pending
acquisition of Cadence by Mallinckrodt
plc. 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: uncertainties as to the timing of the pending Mallinckrodt acquisition; uncertainties as to the
percentage of Cadence stockholders tendering their shares in the
tender offer; the possibility that competing offers will be made;
the possibility that various closing conditions for the
Mallinckrodt acquisition may not be
satisfied or waived, including that a governmental entity may
prohibit, delay or refuse to grant approval for the consummation of
the transaction; the effects of disruption caused by the
Mallinckrodt acquisition making it more
difficult to maintain relationships with employees, collaborators,
vendors and other business partners; the risk that stockholder
litigation in connection with the Mallinckrodt acquisition may result in significant
costs of defense, indemnification and liability; Cadence's
dependence on the successful commercialization of OFIRMEV, which is
the company'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
intellectual property litigation with the parties that have
submitted new drug applications ("NDAs") or abbreviated new drug
applications ("ANDAs") for generic versions of OFIRMEV; the
potential that Cadence may be required to continue intellectual
property litigation for substantial lengths of time or file
additional lawsuits to defend its patent rights from challenges by
companies that have submitted NDAs or ANDAs for generic versions of
OFIRMEV, and the substantial costs associated with such lawsuits;
the potential for the U.S. patent and trademark office to grant the
reexamination of U.S. patent no. 6,992,218 (the "'218 patent"),
which is related to OFIRMEV, and the potential that any claims in
the '218 patent or in U.S. patent no. 6,028,222, which also relates
to OFIRMEV and is currently undergoing reexamination, are
invalidated or narrowed in scope; the potential introduction of
generic competition to OFIRMEV in the event Cadence is unsuccessful
in defending the patents covering OFIRMEV or in current or future
intellectual property litigation, and the impact it may have on the
sales and pricing of the product; 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, and the potential 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:
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William R.
LaRue
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SVP & Chief
Financial Officer
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Cadence
Pharmaceuticals, Inc.
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Phone:
858-436-1400
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CADENCE
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
(unaudited)
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
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Three Months
Ended
|
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Twelve Months
Ended
|
|
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December
31,
|
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December
31,
|
|
|
2013
|
|
2012
|
|
2013
|
|
2012
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Revenues:
|
|
|
|
|
|
|
|
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Product revenue,
net
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$ 33,286
|
|
$
17,089
|
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$ 110,529
|
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$
50,066
|
|
License
revenue
|
2,027
|
|
85
|
|
2,027
|
|
118
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Total
revenues
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35,313
|
|
17,174
|
|
112,556
|
|
50,184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Costs and
expenses:
|
|
|
|
|
|
|
|
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Cost of product
sales
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11,548
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|
7,178
|
|
37,973
|
|
23,256
|
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Amortization of
patent license
|
335
|
|
335
|
|
1,343
|
|
1,343
|
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Research and
development
|
2,045
|
|
1,073
|
|
6,743
|
|
6,519
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Selling, general and
administrative
|
24,221
|
|
20,032
|
|
94,482
|
|
86,843
|
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Impairment of
long-lived assets
|
-
|
|
7,723
|
|
-
|
|
7,723
|
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Other
|
161
|
|
1,160
|
|
(441)
|
|
1,174
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Total
costs and expenses
|
38,310
|
|
37,501
|
|
140,100
|
|
126,858
|
|
|
|
|
|
|
|
|
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Loss from
operations
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(2,997)
|
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(20,327)
|
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(27,544)
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(76,674)
|
|
|
|
|
|
|
|
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Other (expense)
income, net
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(1,121)
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|
(1,094)
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|
3,250
|
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(4,299)
|
|
|
|
|
|
|
|
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Net loss
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$ (4,118)
|
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$ (21,421)
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$ (24,294)
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$ (80,973)
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|
|
|
|
|
|
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Basic and diluted net
loss per share
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$
(0.05)
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$
(0.25)
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$
(0.28)
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$
(0.95)
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|
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|
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Shares used to
compute basic and
|
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|
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diluted net loss per
share
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86,344
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85,591
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85,969
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85,556
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CADENCE
PHARMACEUTICALS, INC.
CONDENSED BALANCE
SHEETS
(in
thousands)
|
|
|
|
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December
31,
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December
31,
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2013
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2012
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(unaudited)
|
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Assets
|
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Current
assets:
|
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Cash, cash equivalents and short-term investments
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$
57,401
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$
62,072
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Restricted cash
|
548
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|
640
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Accounts receivable, net
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9,300
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|
6,152
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Inventory
|
8,646
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|
6,498
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Prepaid expenses and other current assets
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1,993
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|
1,154
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Total
current assets
|
77,888
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|
76,516
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|
|
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Property and
equipment, net
|
2,060
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|
1,967
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Intangible assets,
net
|
10,747
|
|
12,090
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Other
assets
|
108
|
|
7,106
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Total
assets
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$
90,803
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$
97,679
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|
|
|
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Liabilities and
Stockholders' Equity
|
|
|
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Current
liabilities:
|
|
|
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Accounts payable
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$
7,724
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$
5,796
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Accrued liabilities
|
18,042
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|
12,969
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Deferred revenue
|
-
|
|
2,234
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Current portion of long-term debt, less discount
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10,777
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|
-
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Total
current liabilities
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36,543
|
|
20,999
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|
|
|
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Other
liabilities
|
844
|
|
51
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Long-term debt, less
discount
|
18,538
|
|
28,818
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Total stockholders'
equity
|
34,878
|
|
47,811
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Total
liabilities and stockholders' equity
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$
90,803
|
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$
97,679
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SOURCE Cadence Pharmaceuticals, Inc.