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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
May 14, 2007
Cadence Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-33103
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41-2142317 |
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(State or other jurisdiction of
incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.) |
12481 High Bluff Drive, Suite 200
San Diego, California 92130
(Address of principal executive offices, including zip code)
(858) 436-1400
(Registrants telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition
On May 14, 2007, Cadence Pharmaceuticals, Inc. issued a press release and on May
15, 2007, it is holding a conference call announcing its financial results for the three months
ended March 31, 2007. A copy of this press release is attached hereto as Exhibit 99.1 to this Form
8-K.
In accordance with General Instruction B.2. of Form 8-K, the information in this Current
Report on Form 8-K, including Exhibit 99.1, shall not be deemed filed for purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to
the liability of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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Exhibit No. |
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Description |
99.1
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Press Release of Cadence Pharmaceuticals, Inc. dated May 14, 2007 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CADENCE PHARMACEUTICALS, INC.
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By: |
/s/ WILLIAM R. LARUE
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William R. LaRue |
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Senior Vice President, Chief Financial
Officer, Treasurer and Assistant Secretary |
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Date: May 14, 2007
EXHIBIT INDEX
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Exhibit No. |
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Description |
99.1
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Press Release of Cadence Pharmaceuticals, Inc. dated May 14, 2007 |
exv99w1
Exhibit
99.1
CADENCE PHARMACEUTICALS REPORTS FIRST QUARTER 2007
FINANCIAL RESULTS AND DEVELOPMENT HIGHLIGHTS
SAN DIEGO, CA May 14, 2007 Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical
company focused on in-licensing, developing and commercializing proprietary product candidates
principally for use in the hospital setting, announced today unaudited financial results for the
first quarter ended March 31, 2007. Cadence reported a net loss for the first quarter of 2007 of
$9.6 million, or $0.34 per share, compared to a net loss of $29.2 million, or $23.84 per share, in
the first quarter of 2006.
As of March 31, 2007, Cadence held cash and cash equivalents of $77.4 million.
We continue to make steady progress with our Phase III development programs for our two product
candidates, IV APAP for the treatment of acute pain and fever in both adults and children, and
Omigard for the prevention of catheter-related infections. Our product candidates are intended to
address major issues that patients and hospitals face everyday, including controlling pain and
reducing infections, said Ted Schroeder, President and Chief Executive Officer of Cadence. In
the coming months, we plan to continue to advance the enrollment of these two clinical programs and
anticipate that we will fully enroll all of our planned clinical trials of IV APAP for the
treatment of acute pain and fever by the end of this year.
Financial Results
Total operating expenses for the first quarter of 2007 were $10.4 million, compared to $29.4
million for the first quarter of 2006. The $19.0 million decrease in operating expenses in the
first quarter of 2007 was primarily due to the $25.3 million initial license fee for IV APAP that
Cadence incurred during the first quarter of 2006. This decrease was partially offset by increased
costs during the first quarter of 2007 related to the companys ongoing Phase III clinical trial of
Omigard, its Phase III clinical trial of IV APAP, which began enrollment in December 2006, and the
hiring of additional research and development staff to support its clinical and regulatory efforts.
In addition, general and administrative expenses increased by $1.3 million as a result of
stock-based compensation expenses and other personnel-related costs, costs related to operating as
a public company, and costs related to a new corporate facility.
Recent Highlights and Developments
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Cadence recently appointed two new important members to its management team. Hazel M.
Aker, J.D., joined the company as Senior Vice President, General Counsel and Corporate
Secretary, and Catherine J. Hardalo, M.D. joined the company as Vice President, Clinical
Development. Ms. Aker is responsible for overseeing legal affairs and has previously held
positions at Ambrx, Inc., and Micromet, Inc. (formerly CancerVax Corporation), where she
served as General Counsel, among other roles. Dr. Hardalo will direct the companys
anti-infective program and joins Cadence from Schering-Plough Corporation, where she was
most recently Senior Director, Infectious Diseases and Dermatology Global Clinical
Development. |
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In April 2007, Cadence presented data from an adult pharmacokinetic study that
demonstrated that IV APAP has comparable pharmacokinetics and pharmcodynamics to oral
acetaminophen. In addition, the study showed that IV APAP appeared to be well tolerated
with a side effect profile similar to oral acetaminophen. The study, presented at the
American Society of Regional |
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Anesthesia and Pain Medicines 32nd Annual Meeting held in Vancouver, British Columbia, was
a randomized, four-period, crossover trial that enrolled 32 healthy adult men. |
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Also in April 2007, Cadence announced that it plans to discuss with the U.S. Food and
Drug Administration (FDA) a proposal to increase the number of patients to be enrolled in
its ongoing Phase III clinical trial of Omigard in order to maintain the statistical power
of the trial. The modification of this clinical trial was prompted by Cadences planned
re-analysis of data from the initial Phase III clinical trial of Omigard. The company
plans to announce details regarding the number of patients to be added to the trial, the
anticipated financial impact, and other potential implications on the Omigard development
program following the completion of discussions with FDA. If the FDA agrees with the
companys plans to increase enrollment in this clinical trial, the company currently
anticipates that enrollment will be completed in mid-2008. |
Conference Call and Webcast Tomorrow at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time
Cadence management will host a conference call on Tuesday, May 15, 2007 at 8:30 a.m. Eastern Time
(5:30 a.m. Pacific Time) to discuss financial results for the first quarter ended March 31, 2007.
Interested investors may participate in the conference call by dialing 800-289-0572 (domestic) or
913-981-5543 (international). To access the webcast, please log on to the companys website at
www.cadencepharm.com and go to the Investor Relations page. A replay of the webcast will be
available approximately two hours after the call and remain available on the companys website
until the next earnings call.
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and
commercializing proprietary product candidates principally for use in the hospital setting. The
company currently has two Phase III products in development, IV APAP (acetaminophen for injection)
for the treatment of acute pain and fever, and Omigard (omiganan pentahydrochloride 1% aqueous gel)
for the prevention of catheter-related infections. For more information about Cadences pipeline,
visit www.cadencepharm.com.
Forward-Looking Statements
Cadence cautions you that statements included in this press release that are not a description of
historical facts are forward-looking statements. The inclusion of forward-looking statements should
not be regarded as a representation by Cadence that any of its plans will be achieved. Actual
results may differ materially from those set forth in this release due to the risks and
uncertainties inherent in Cadences business, including, without limitation: the progress and
results of the companys clinical trials of IV APAP and Omigard, including any delays in commencing
or completing enrollment; unexpected adverse side effects or inadequate therapeutic efficacy of IV
APAP or Omigard that could delay or prevent regulatory approval or commercialization, or that could
result in recalls or product liability claims; the potential that FDA may not agree with the
companys proposal to increase patient enrollment in the ongoing Phase III clinical trial of
Omigard, or that discussions with FDA may delay the proposed increase in patient enrollment, or
that FDA may apply a statistical penalty to this clinical trial; the results of the companys
continuing re-analysis of the data provided by its licensor concerning the earlier Phase III
clinical trial of Omigard; other difficulties or delays in development, testing, manufacturing and
marketing of and obtaining regulatory approval for IV APAP or Omigard; the scope and validity of
patent protection for IV APAP or Omigard; the companys ability to maintain patent protection for
its product candidates and to commercialize its product candidates without infringing the patent
rights of others; the market potential for pain, fever, local catheter site infections and other
target markets, and its ability to compete; the potential to attract a strategic collaborator and
terms of any related transaction; the companys ability to raise sufficient capital; and other
risks detailed in Cadences prior press releases as well as in Cadences periodic public filings
with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only
as of the date hereof. All forward-looking statements are qualified in their entirety by this
cautionary statement and Cadence undertakes no obligation to revise or update this news release to
reflect events or circumstances after the date hereof. This caution is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Cadence and Omigard are trademarks of Cadence Pharmaceuticals, Inc.
# # #
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Contacts:
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William R. LaRue
SVP & Chief Financial Officer
Cadence Pharmaceuticals, Inc.
858-436-1400
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Susan Neath
Media & Investor Relations
Porter Novelli Life Sciences
619-849-6007 |
CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
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Three Months Ended |
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March 31, |
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2007 |
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2006 |
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Operating expenses: |
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Research and development |
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$ |
8,241,804 |
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$ |
28,735,246 |
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Marketing |
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302,183 |
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95,758 |
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General and administrative |
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1,827,592 |
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537,349 |
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Total operating expenses |
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10,371,579 |
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29,368,353 |
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Loss from operations |
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(10,371,579 |
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(29,368,353 |
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Other income, net |
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811,881 |
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127,273 |
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Net loss |
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$ |
(9,559,698 |
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$ |
(29,241,080 |
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Basic and diluted
net loss per share |
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$ |
(0.34 |
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$ |
(23.84 |
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CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
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March 31, |
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December 31, |
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2007 |
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2006 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
77,442,626 |
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$ |
86,825,526 |
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Prepaid expenses and other current assets |
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1,177,718 |
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1,168,160 |
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Total current assets |
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78,620,344 |
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87,993,686 |
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Property and equipment, net |
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4,309,501 |
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3,558,618 |
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Restricted cash |
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2,867,281 |
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1,233,281 |
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Other assets |
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608,521 |
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536,042 |
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Total assets |
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$ |
86,405,647 |
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$ |
93,321,627 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
3,226,431 |
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$ |
2,073,726 |
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Accrued liabilities |
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8,489,538 |
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7,378,750 |
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Current portion of long-term debt |
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2,612,168 |
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2,338,010 |
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Total current liabilities |
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14,328,137 |
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11,790,486 |
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Deferred rent |
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1,403,589 |
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1,460,109 |
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Long-term debt, less current portion |
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3,980,733 |
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4,661,990 |
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Other long-term liabilities |
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22,048 |
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Total stockholders equity |
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66,671,140 |
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75,409,042 |
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Total liabilities and stockholders equity |
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$ |
86,405,647 |
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$ |
93,321,627 |
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