EXHIBIT 99.1
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): November 29, 2006
CADENCE PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)
|
|
|
|
|
Delaware
|
|
001-33103
|
|
41-2142317 |
(State or Other Jurisdiction
|
|
(Commission
|
|
(IRS Employer |
of Incorporation)
|
|
File Number)
|
|
Identification No.) |
|
|
|
|
|
12481 High Bluff Drive, Suite 200, San Diego, California
|
|
|
|
92130 |
(Address of Principal Executive Offices)
|
|
|
|
(Zip Code) |
Registrants telephone number, including area code: (858) 436-1400
(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 November 29, 2006, Cadence Pharmaceuticals, Inc. issued a press release announcing its
financial results for the quarter ended September 30, 2006. A copy of this press release is
attached hereto as Exhibit 99.1.
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.
(c) Exhibits.
|
|
|
Exhibit |
|
|
Number |
|
Description of Exhibit |
|
|
|
99.1
|
|
Press Release dated November 29, 2006. |
-2-
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.
|
|
|
|
|
Date: December 1, 2006 |
CADENCE PHARMACEUTICALS, INC.
|
|
|
By: |
/s/
David A. Socks |
|
|
Name: |
David A. Socks |
|
|
Title: |
Vice President, Business Development |
|
-3-
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description of Exhibit |
|
|
|
99.1
|
|
Press Release dated November 29, 2006. |
-4-
Exhibit 99.1
Exhibit 99.1
CADENCE PHARMACEUTICALS REPORTS THIRD QUARTER 2006 FINANCIAL RESULTS
AND DEVELOPMENT HIGHLIGHTS
SAN DIEGO, CA November 29, 2006 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, today announced unaudited financial
results for the third quarter ended September 30, 2006. For the three months ended September 30,
2006, Cadence reported a net loss of $7.8 million, or $6.01 per share, as compared to a net loss of
$2.4 million, or $2.04 per share, for the same period in 2005. For the nine months ended September
30, 2006, the company reported a net loss of $43.2 million, or $34.27 per share, as compared to a
net loss of $5.6 million, or $4.92 per share, for the same period in 2005.
As of September 30, 2006, Cadence held cash and cash equivalents of $38.2 million. In the fourth
quarter of 2006, Cadence completed its initial public offering (IPO) which generated net proceeds
of $56 million from the sale of 6.9 million shares of common stock at $9.00 per share, including
the exercise of the underwriters over-allotment option.
Cadences IPO was preceded by a third quarter during which we made important progress in our
development programs and augmented our executive team and board of directors as we prepared to
become a publicly traded company, said Ted Schroeder, President and CEO of Cadence. We expect the
funds raised through our IPO will allow us to complete the clinical trials necessary to support New
Drug Application filings for both of our product candidates, IV APAP and OmigardÔ.
Financial Results
Total operating expenses for the third quarter of 2006 were $8.0 million compared to $2.5 million
for the third quarter of 2005. The increased operating expenses in the third quarter of 2006 were
primarily a result of an increase of $2.3 million in costs related to Cadences on-going Phase III
clinical trial of Omigard for the prevention of local catheter site infections and the need for
increased personnel to support the companys development efforts related to both IV APAP and
Omigard. In addition, general and administrative costs increased $1.0 million as a result of
stock-based compensation and other personnel related charges, a new corporate facility lease and
other professional and consulting fees.
Total operating expenses for the nine months ended September 30, 2006 were $43.9 million, compared
to $5.5 million for the corresponding period in 2005. The increased operating expenses in the nine
months ended September 30, 2006 were primarily a result of a $25 million license fee for IV APAP,
which was expensed as in-process research and development, and an increase of $6.7 million in costs
for the ongoing Phase III trial of Omigard and the addition of research and development staff to
support the clinical and regulatory efforts related to both IV APAP and Omigard. In addition,
general and administrative costs increased $2.4 million as a
result of stock-based compensation and other personnel related charges, legal fees related to the
IV APAP agreement, a new corporate facility lease and other professional and consulting fees.
Recent Highlights
|
§ |
|
Cadence priced its initial public offering on October 24, 2006 and began trading on the
NASDAQ Global Market under the trading symbol CADX on October 25, 2006. |
|
|
§ |
|
Cadence met with the U.S. Food and Drug Administration (FDA) in August 2006 to determine
the Phase III clinical program necessary for submission of a 505 (b)(2) new drug
application (NDA) for IV APAP. Based on input received from the FDA, Cadence has developed
a clinical program that will enroll approximately 750 patients in two Phase III efficacy
trials (gynecologic surgery and fever), two safety trials (adults and children), and two
pharmacokinetic trials (adults and children). The company believes that these trials, in
addition to the clinical trials completed or being conducted by the licensor, Bristol-Myers
Squibb, will satisfy the NDA requirements for indications including the treatment of acute
pain in adults and children and fever in adults and children. The first of Cadences six
trials, an adult pharmacokinetic trial, was initiated in October of this year and a Phase
III trial assessing post operative pain following gynecological surgery is expected to
begin before the end of 2006. |
|
|
§ |
|
Cadence expects that the planned enrollment of 1,250 patients in a single confirmatory
Phase III clinical trial for Omigard for the prevention of local catheter site infections
will be complete in the second half of 2007. The company anticipates top-line trial results
will be available by the end of 2007. |
Conference Call and Webcast Tomorrow at 8:00 a.m. Eastern Time
Cadence management will host a conference call tomorrow, November 30, at 8:00 a.m. Eastern Time
(5:00 a.m. Pacific Time) to discuss financial results for the third quarter ended September 30,
2006. Interested investors may participate in the conference call by dialing (800) 819-9193
(domestic) or (913) 981-4911 (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, including IV APAP, (acetaminophen for
injection) for the treatment of acute pain and fever, and OmigardÔ (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: anticipated timing of
initiation or completion of ongoing clinical trials for IV APAP and Omigard; the adequacy of the
clinical trial design to support regulatory approvals for IV APAP or Omigard in the stated
indications or at all; the potential for IV APAP and Omigard to receive regulatory approval for
one or more indications on a timely basis or at all; 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; 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
market potential for pain, fever, local catheter site infections and other target markets, and our
ability to compete; the potential to attract a strategic collaborator and terms of any related
transaction; our ability to raise sufficient capital; and other risks detailed in Cadences prior
press releases as well as in Cadences 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.
Omigard is a registered trademark of Cadence Pharmaceuticals, Inc.
# # # #
CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,387,623 |
|
|
$ |
2,038,497 |
|
|
$ |
40,051,593 |
|
|
$ |
4,440,086 |
|
Marketing |
|
|
244,284 |
|
|
|
17,782 |
|
|
|
560,825 |
|
|
|
160,283 |
|
General and administrative |
|
|
1,362,551 |
|
|
|
408,281 |
|
|
|
3,330,531 |
|
|
|
948,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
7,994,458 |
|
|
|
2,464,560 |
|
|
|
43,942,949 |
|
|
|
5,548,564 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(7,994,458 |
) |
|
|
(2,464,560 |
) |
|
|
(43,942,949 |
) |
|
|
(5,548,564 |
) |
Other income (expense) |
|
|
211,617 |
|
|
|
102,851 |
|
|
|
720,223 |
|
|
|
(66,153 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,782,841 |
) |
|
$ |
(2,361,709 |
) |
|
$ |
(43,222,726 |
) |
|
$ |
(5,614,717 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share |
|
$ |
(6.01 |
) |
|
$ |
(2.04 |
) |
|
$ |
(34.27 |
) |
|
$ |
(4.92 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute basic
and diluted net loss
per share |
|
|
1,295,807 |
|
|
|
1,160,469 |
|
|
|
1,261,127 |
|
|
|
1,141,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
38,186,823 |
|
|
$ |
8,025,285 |
|
Securities available-for-sale |
|
|
|
|
|
|
7,000,000 |
|
Prepaid expenses and other current assets |
|
|
605,556 |
|
|
|
526,173 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
38,792,379 |
|
|
|
15,551,458 |
|
Property and equipment, net |
|
|
2,854,549 |
|
|
|
117,740 |
|
Restricted cash |
|
|
1,581,130 |
|
|
|
|
|
Other assets |
|
|
1,834,549 |
|
|
|
222,000 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
45,062,607 |
|
|
$ |
15,891,198 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,694,566 |
|
|
$ |
715,781 |
|
Accrued liabilities |
|
|
5,068,886 |
|
|
|
430,220 |
|
Current portion of long-term debt |
|
|
1,675,919 |
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
10,439,371 |
|
|
|
1,146,001 |
|
Deferred rent |
|
|
1,516,629 |
|
|
|
|
|
Long-term debt, less current portion |
|
|
5,324,081 |
|
|
|
|
|
Total stockholders equity |
|
|
27,782,526 |
|
|
|
14,745,197 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
45,062,607 |
|
|
$ |
15,891,198 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts:
|
|
William R. LaRue
|
|
Susan Neath |
|
|
SVP & Chief Financial Officer
|
|
Media & Investor Relations |
|
|
Cadence Pharmaceuticals, Inc.
|
|
Porter Novelli Life Sciences |
|
|
858-436-1400
|
|
619-849-6007 |