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 5, 2010
Cadence Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-33103 | 41-2142317 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(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
(Registrant’s 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):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | 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 5, 2010, Cadence Pharmaceuticals, Inc. issued a press release and is holding a conference call announcing its financial results for the three and nine months ended September 30, 2010. A copy of this press release is attached 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 |
| Exhibit |
Description | |
| 99.1 | Press Release of Cadence Pharmaceuticals, Inc. dated November 5, 2010 | |
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.
| CADENCE PHARMACEUTICALS, INC. | ||
| By: | /S/ WILLIAM R. LARUE | |
| William R. LaRue | ||
| Senior Vice President, Chief Financial Officer, Treasurer and Assistant Secretary | ||
Date: November 5, 2010
EXHIBIT INDEX
| Exhibit |
Description | |
| 99.1 | Press Release of Cadence Pharmaceuticals, Inc. dated November 5, 2010 | |
Exhibit 99.1
Cadence Pharmaceuticals Reports Third Quarter 2010 Financial Results
—Prepares for Launch of OFIRMEV™ (Acetaminophen) Injection—
SAN DIEGO, CA – November 5, 2010 – 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 reported financial results for the three and nine months ended September 30, 2010.
On November 2, Cadence announced that the U.S. Food and Drug Administration (FDA) approved OFIRMEV™ (acetaminophen) injection for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
“We believe that there is a clear need for OFIRMEV in the U.S., as the classes of IV analgesics available to treat acute pain – opioids and NSAIDS – are associated with significant side effects. OFIRMEV is an important new treatment option that provides patients with significant pain relief while reducing opioid consumption” said Ted Schroeder, President and CEO of Cadence. “The approval of OFIRMEV marks Cadence’s transition into a commercial enterprise poised to support the successful launch of our first product early in the first quarter of 2011.”
Financial Results
For the three months ended September 30, 2010, Cadence reported a net loss of $11.7 million, or $0.23 per share, compared to a net loss of $11.4 million, or $0.23 per share, for the comparable period in 2009. For the nine months ended September 30, 2010, Cadence reported a net loss of $37.9 million, or $0.75 per share, compared to a net loss of $30.2 million, or $0.63 per share, for the comparable period in 2009.
Operating expenses for the three months ended September 30, 2010 decreased $0.2 million to $11.1 million, from the $11.3 million reported for the same period in 2009. This decrease was primarily a result of lower research and development spending and general and administrative costs from lower clinical and regulatory-related costs, combined with lower stock-based compensation charges. Partially offsetting these decreases was an increase in sales and marketing expenses during the 2010 period as a result of the development of our commercial infrastructure during the previous several quarters in preparation for the commercial launch of OFIRMEV.
Operating expenses for the nine months ended September 30, 2010 increased $7.3 million to $36.7 million, from the $29.4 million reported for the same period in 2009. This increase was primarily due to a significant increase in the company’s sales and marketing expenses as a result of preparations for the commercial launch of OFIRMEV, including developing a commercial infrastructure and the addition of headcount to support the launch. Cadence also incurred a charge of $1.5 million during the nine months ended September 30, 2010 related to the partial cancellation of a capital equipment order. Partially offsetting these increases, was a decrease in the company’s research and development expenses, primarily due to the discontinuation of the company’s omiganan pentahydrochloride product candidate in March 2009 and the completion of its clinical development program for OFIRMEV in May 2009.
As of September 30, 2010, Cadence held cash, cash equivalents and short-term investments of $59.7 million.
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Conference Call and Webcast on November 5, 2010 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time)
Cadence management will host a conference call on November 5, 2010 at 5:30 a.m. Pacific Time (8:30 a.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 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 quarterly financial results call.
About OFIRMEV™ (Acetaminophen) Injection
OFIRMEV (acetaminophen) injection is Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen. The FDA approval of OFIRMEV was based on data from clinical trials in which a total of 1,020 adult and 355 pediatric patients received IV acetaminophen. 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.
For more information, please see the complete OFIRMEV Prescribing Information, available at
www.Ofirmev.com or www.cadencepharm.com.
Important Safety Information: OFIRMEV should be administered only as a 15 minute intravenous infusion. 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. 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.
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. For more information about Cadence, please visit www.cadencepharm.com.
Forward-Looking Statements
Statements included in this press release and the 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. Forward-looking statements include, but are not limited to, statements regarding: the readiness of Cadence for and the timing of the planned commercial launch of OFIRMEV; the market potential for OFIRMEV; OFIRMEV’s ability to fulfill unmet medical needs in the treatment of pain and fever in the hospital setting; the sufficiency of the company’s capital resources to fund its operations through the launch of OFIRMEV; and all of the company’s financial estimates or projections. Actual results may differ materially from those set forth in this press release and the conference call due to the risks and uncertainties inherent in the company's business, including, without limitation: our dependence on the successful commercialization of OFIRMEV; the potential that we will require substantial additional funding in order to effectively commercialize OFIRMEV, and the risk that we may not be able to raise sufficient capital when needed, or at all; the risk that delays in commercially launching OFIRMEV would enable
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competitors to further entrench their existing products or develop and bring new products to market before OFIRMEV; our ability to ensure an adequate and continued supply of OFIRMEV to successfully launch commercial sales or meet anticipated market demand; our ability to comply with the terms of our loan agreement, and draw down additional amounts under our loan agreement; the potential for an event of default under our loan agreement, and the corresponding risk of acceleration of repayment and potential foreclosure on the assets pledged to secure the line of credit; the impact of healthcare reform legislation; our ability to timely complete a required post-marketing efficacy study of OFIRMEV in infants and neonates; and other risks detailed in Cadence's prior press releases as well as in Cadence's 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 press 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 OFIRMEV™ are trademarks of Cadence Pharmaceuticals, Inc.
# # #
| Contact: | William R. LaRue | Nicole Foderaro | ||
| SVP & Chief Financial Officer | Media & Investor Relations | |||
| Cadence Pharmaceuticals, Inc. | WCG | |||
| Phone : 858-436-1400 | Phone : 415-946-1058 – office | |||
| 415-215-5643 – cell |
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CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| Operating expenses: |
||||||||||||||||
| Research and development |
$ | 3,537,167 | $ | 4,464,587 | $ | 10,564,603 | $ | 14,683,908 | ||||||||
| Sales and marketing |
4,129,008 | 3,068,632 | 14,857,958 | 4,790,886 | ||||||||||||
| General and administrative |
2,937,269 | 3,762,851 | 9,526,633 | 9,549,203 | ||||||||||||
| Other |
483,469 | (944 | ) | 1,781,731 | 412,141 | |||||||||||
| Total operating expenses |
11,086,913 | 11,295,126 | 36,730,925 | 29,436,138 | ||||||||||||
| Loss from operations |
(11,086,913 | ) | (11,295,126 | ) | (36,730,925 | ) | (29,436,138 | ) | ||||||||
| Other expense, net |
(625,235 | ) | (145,979 | ) | (1,119,252 | ) | (742,411 | ) | ||||||||
| Net loss |
$ | (11,712,148 | ) | $ | (11,441,105 | ) | $ | (37,850,177 | ) | $ | (30,178,549 | ) | ||||
| Basic and diluted net loss per share(1) |
$ | (0.23 | ) | $ | (0.23 | ) | $ | (0.75 | ) | $ | (0.63 | ) | ||||
| Shares used to compute basic and diluted net loss per share(1) |
50,554,803 | 50,364,493 | 50,529,050 | 48,189,177 | ||||||||||||
| (1) | As a result of the issuance of 12,039,794 shares of common stock pursuant to placement in the first quarter of 2009, there is a lack of comparability in the per share amounts between the nine month periods presented. |
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CADENCE PHARMACEUTICALS, INC.
(a development stage company)
CONDENSED BALANCE SHEETS
| September 30, 2010 |
December 31, 2009 |
|||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: |
||||||||
| Cash, cash equivalents and short-term investments |
$ | 59,726,983 | $ | 82,006,153 | ||||
| Restricted cash |
1,150,000 | 1,497,848 | ||||||
| Prepaid expenses and other current assets |
213,981 | 549,243 | ||||||
| Total current assets |
61,090,964 | 84,053,244 | ||||||
| Property and equipment, net |
7,939,651 | 8,300,529 | ||||||
| Restricted cash |
189,738 | 189,738 | ||||||
| Other assets |
3,571,195 | 19,708 | ||||||
| Total assets |
$ | 72,791,548 | $ | 92,563,219 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ | 1,308,973 | $ | 2,656,597 | ||||
| Accrued liabilities |
5,626,661 | 7,739,527 | ||||||
| Current debt, less discount |
736,166 | 6,442,327 | ||||||
| Other current liabilities |
— | 22,048 | ||||||
| Total current liabilities |
7,671,800 | 16,860,499 | ||||||
| Other liabilities |
441,100 | 640,208 | ||||||
| Long-term debt, less discount |
17,833,972 | — | ||||||
| Total stockholders’ equity |
46,844,676 | 75,062,512 | ||||||
| Total liabilities and stockholders’ equity |
$ | 72,791,548 | $ | 92,563,219 | ||||
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