Table of Contents
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
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 13, 2007
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) |
Registrant’s 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)) |
TABLE OF CONTENTS
| Item 2.02. Results of Operations and Financial Condition | ||||||||
| Item 9.01. Financial Statements and Exhibits | ||||||||
| SIGNATURES | ||||||||
| EXHIBIT INDEX | ||||||||
| EXHIBIT 99.1 | ||||||||
Table of Contents
Item 2.02. Results of Operations and Financial Condition.
On March 13, 2007, Cadence Pharmaceuticals, Inc. issued a press release announcing its
financial results for the quarter and year ended December 31, 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 March 13, 2007. |
-2-
Table of Contents
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: March 13, 2007 | CADENCE PHARMACEUTICALS, INC. | |||||
| By: | /s/ William R. LaRue | |||||
| Name: | ||||||
| Title: | Senior Vice President, Chief Financial Officer, Treasurer and Secretary | |||||
-3-
Table of Contents
Exhibit 99.1
Cadence Pharmaceuticals Reports Fourth Quarter and Full Year 2006 Financial Results
SAN DIEGO, CA — March 13, 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 financial results
for the fourth quarter and year ended December 31, 2006. For the fourth quarter ended December 31,
2006, Cadence reported a net loss of $9.0 million, or $0.53 per share, compared to a net loss of
$2.1 million, or $1.74 per share, for the same period in 2005. For the year ended December 31,
2006, Cadence reported a net loss of $52.2 million, or $10.07 per share, as compared to a net loss
of $7.7 million, or $6.67 per share, for the same period in 2005. The results for the year ended
December 31, 2006 included approximately $2.1 million, or $0.41 per share, in stock-based
compensation expense.
As of December 31, 2006, Cadence held cash and cash equivalents of $86.8 million.
“We continued to make great strides in 2006, as we in-licensed IV APAP, an intravenous formulation
of acetaminophen for the treatment of acute pain and fever and initiated its Phase III clinical
development program, completed our initial public offering and strengthened our management team and
board of directors,” said Ted Schroeder, President and CEO of Cadence Pharmaceuticals. “In 2007,
we look forward to reporting top-line results from the Phase III clinical trial of our other
product candidate, Omigard™, and advancing the Phase III clinical trials for IV APAP.”
Financial Results
Total operating expenses for the fourth quarter of 2006 were $9.6 million, as compared to $2.2 million for the same period of 2005. The increased operating expenses in the fourth quarter of 2006 were primarily a result of increases of $2.8 million and $2.1 million in costs related to the on-going Phase III clinical trials of Omigard and IV APAP, respectively, and the addition of research and development staff to support the clinical and regulatory efforts related to both product candidates. In addition, general and administrative costs increased $1.2 million as a result of stock-based compensation expenses and other personnel related charges, costs related to operating as a public company, a new corporate facility lease and other professional and consulting fees.
Total operating expenses for the fourth quarter of 2006 were $9.6 million, as compared to $2.2 million for the same period of 2005. The increased operating expenses in the fourth quarter of 2006 were primarily a result of increases of $2.8 million and $2.1 million in costs related to the on-going Phase III clinical trials of Omigard and IV APAP, respectively, and the addition of research and development staff to support the clinical and regulatory efforts related to both product candidates. In addition, general and administrative costs increased $1.2 million as a result of stock-based compensation expenses and other personnel related charges, costs related to operating as a public company, a new corporate facility lease and other professional and consulting fees.
Total operating expenses for the year ended December 31, 2006 were $53.6 million, as compared to
$7.8 million for the same period in 2005. The increased operating expenses in the year ended
December 31, 2006 were primarily a result of a $25 million license fee for IV APAP, which was
expensed as in-process research and development, increases of $9.5 million and $2.8 million in
costs related to the ongoing trial of Omigard and the initiation of the IV APAP trials,
respectively, and the addition of research and development staff to support the clinical and
regulatory efforts for both product candidates. In addition, general and administrative costs
increased by $3.5 million as a result of stock-based compensation expenses and other personnel
related charges, a new corporate facility lease and other professional and consulting fees.
Recent Highlights
| • | Cadence priced its initial public offering (IPO) on October 24, 2006 and began trading on The NASDAQ Global Market under the symbol “CADX” on October 25, 2006. The IPO generated net proceeds to Cadence 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 in November 2006. | ||
| • | In December 2006, Cadence initiated Phase III clinical trials for the development of IV APAP for the treatment of acute pain and fever in adults and children. The clinical development program 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 gynecologic surgery and adult pharmacokinetic trials are ongoing and the remaining trials will begin patient enrollment in 2007. The company believes that these trials, in addition to the clinical trials completed or being conducted by the licensor, Bristol-Myers Squibb Company (BMS), will satisfy the 505(b)(2) new drug application regulatory requirements. |
Anticipated Corporate Milestones for 2007
| • | Cadence expects to sign a manufacturing agreement for the commercial supply of the finished drug product for IV APAP. |
| • | Cadence expects to complete the Phase III clinical trial of Omigard for the prevention of local catheter site infections in the second half of 2007, with top-line results available by the end of 2007. |
| • | Cadence expects to complete enrollment in the IV APAP clinical trials during 2007. Cadence also anticipates receiving top-line results from a Phase III trial conducted by BMS evaluating IV APAP as a treatment of acute pain following hip replacement surgery. Results from the two Phase III efficacy trials being conducted by Cadence are expected to be available in the first half of 2008. |
Financial Outlook for 2007
Cadence currently anticipates that total operating expenses for the full year 2007 will be between $49 million and $53 million including an estimated $3 to $4 million in non-cash stock-based compensation expenses. Cadence currently expects that cash, cash equivalents and investments held for sale at December 31, 2007 will be between $37 million and $41 million.
Cadence currently anticipates that total operating expenses for the full year 2007 will be between $49 million and $53 million including an estimated $3 to $4 million in non-cash stock-based compensation expenses. Cadence currently expects that cash, cash equivalents and investments held for sale at December 31, 2007 will be between $37 million and $41 million.
Conference Call and Webcast Today at 8:30 a.m. Eastern Time
Cadence management will host a conference call today, March 13, 2007, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss financial results for the fourth quarter and year ended December 31, 2006. Interested investors may participate in the conference call by dialing 800-810-0924 (domestic) or 913-981-4900 (international). To access the webcast, please log on to the company’s 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 company’s website until the next earnings call.
Cadence management will host a conference call today, March 13, 2007, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss financial results for the fourth quarter and year ended December 31, 2006. Interested investors may participate in the conference call by dialing 800-810-0924 (domestic) or 913-981-4900 (international). To access the webcast, please log on to the company’s 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 company’s website until the next earnings call.
About Cadence Pharmaceuticals
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 Omigard (omiganan pentahydrochloride 1% aqueous gel) for the prevention of catheter-related infections. For more information about Cadence’s pipeline, visit www.cadencepharm.com.
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 Omigard (omiganan pentahydrochloride 1% aqueous gel) for the prevention of catheter-related infections. For more information about Cadence’s 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 Cadence’s business, including, without limitation: anticipated future financial results; anticipated timing of completion of ongoing clinical trials for IV APAP and Omigard; the adequacy of the clinical trial design or final results 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, including the ability to finalize a commercial supply agreement for IV APAP finished drug product; 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 Cadence’s prior press releases as well as in Cadence’s public filings with the Securities and Exchange Commission.
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 Cadence’s business, including, without limitation: anticipated future financial results; anticipated timing of completion of ongoing clinical trials for IV APAP and Omigard; the adequacy of the clinical trial design or final results 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, including the ability to finalize a commercial supply agreement for IV APAP finished drug product; 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 Cadence’s prior press releases as well as in Cadence’s 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.
CONTACTS:
William R. LaRue
|
Susan Neath | |
Cadence Pharmaceuticals
|
Porter Novelli Life Sciences | |
SVP, Chief Financial Officer
|
Media & Investor Relations | |
858-436-1450
|
619-849-6007 |
CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED STATEMENTS OF OPERATIONS
(a development stage company)
CONDENSED STATEMENTS OF OPERATIONS
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2006 | 2005 | 2006 | 2005 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | 7,775,168 | $ | 1,686,140 | $ | 47,826,761 | $ | 6,126,226 | ||||||||
Marketing |
249,490 | 80,078 | 810,315 | 240,361 | ||||||||||||
General and administrative |
1,615,590 | 463,615 | 4,946,121 | 1,411,810 | ||||||||||||
Total operating expenses |
9,640,248 | 2,229,833 | 53,583,197 | 7,778,397 | ||||||||||||
Loss from operations |
(9,640,248 | ) | (2,229,833 | ) | (53,583,197 | ) | (7,778,397 | ) | ||||||||
Other income (expense) |
690,033 | 138,938 | 1,410,256 | 72,785 | ||||||||||||
Net loss |
$ | (8,950,215 | ) | $ | (2,090,895 | ) | $ | (52,172,941 | ) | $ | (7,705,612 | ) | ||||
Basic and diluted net
loss per share |
$ | (0.53 | ) | $ | (1.74 | ) | $ | (10.07 | ) | $ | (6.67 | ) | ||||
Shares used to compute basic and
diluted net loss per share |
16,816,445 | 1,198,828 | 5,181,920 | 1,155,879 | ||||||||||||
CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
(a development stage company)
CONDENSED BALANCE SHEETS
| December 31, | December 31, | |||||||
| 2006 | 2005 | |||||||
| (unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 86,825,526 | $ | 8,025,285 | ||||
Securities available-for-sale |
— | 7,000,000 | ||||||
Prepaid expenses and other current assets |
1,168,160 | 526,173 | ||||||
Total current assets |
87,993,686 | 15,551,458 | ||||||
Property and equipment, net |
3,558,618 | 117,740 | ||||||
Restricted cash |
1,233,281 | — | ||||||
Other assets |
536,042 | 222,000 | ||||||
Total assets |
$ | 93,321,627 | $ | 15,891,198 | ||||
Liabilities and Stockholders’ Equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,073,726 | $ | 715,781 | ||||
Accrued liabilities |
7,378,750 | 430,220 | ||||||
Current portion of long-term debt |
2,338,010 | — | ||||||
Total current liabilities |
11,790,486 | 1,146,001 | ||||||
Deferred rent |
1,460,109 | — | ||||||
Long-term debt, less current portion |
4,661,990 | — | ||||||
Total stockholders’ equity |
75,409,042 | 14,745,197 | ||||||
Total liabilities and stockholders’ equity |
$ | 93,321,627 | $ | 15,891,198 | ||||
# # # #