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)

March 15, 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 March 15, 2010, Cadence Pharmaceuticals, Inc. issued a press release and is holding a conference call announcing its financial results for the three and twelve months ended December 31, 2009. 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 No.		Description
99.1		Press Release of Cadence Pharmaceuticals, Inc. dated March 15, 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.

 

Date: March 15, 2010

---

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press Release of Cadence Pharmaceuticals, Inc. dated March 15, 2010

Exhibit 99.1

Cadence Pharmaceuticals Reports Fourth Quarter and Full Year 2009 Financial Results

SAN DIEGO, CA – March 15, 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 fourth quarter and year ended December 31, 2009.

During 2009, Cadence completed its clinical development program and submitted a New Drug Application (NDA) for its investigational product candidate, OFIRMEV™ (acetaminophen) injection, which was accepted for filing and designated for Priority Review by the U.S. Food and Drug Administration (FDA). On February 10, 2010, the company received a Complete Response letter from the FDA, which stated that the NDA could not be approved in its present form due to deficiencies observed during an FDA inspection of Cadence’s third-party manufacturer. A response to the inspectional observations was submitted to the FDA by the third party manufacturer on February 18, 2010, and Cadence plans to re-submit the NDA for OFIRMEV once it has been determined that the inspectional observations are resolved.

“Our third party manufacturer has now submitted its response to the FDA’s observations, and we will be prepared to re-submit our NDA for OFIRMEV at the earliest possible opportunity,” stated Ted Schroeder, President and CEO. “We believe it is important to note that no safety or efficacy deficiencies were noted in the Complete Response letter and the FDA did not request that any additional clinical trials be completed in order to obtain approval of the NDA. As a result, we believe that we have sufficient capital resources to fund our operations through re-submission of the NDA and approval of OFIRMEV.”

Financial Results

For the three months ended December 31, 2009, Cadence reported a net loss of $15.3 million, or $0.30 per share, compared to a net loss of $14.0 million, or $0.37 per share, for the same period in 2008. Operating expenses for the three months ended December 31, 2009 increased $1.6 million to $15.1 million, from the $13.5 million reported for the comparable period in 2008. The increase in operating expense was primarily due to an increase in sales and marketing expenses as the company continued to focus significant resources on establishing its commercial infrastructure in preparation for the commercial launch of OFIRMEV, if approved. This increase was partially offset by a reduction in research and development expenses related to the completion of the clinical development program for OFIRMEV in early 2009 and discontinuation of the development program for omiganan in March 2009. As a result of the discontinuation of the omiganan development program, the company recorded an impairment charge on the manufacturing assets for this product candidate during the three months ended December 31, 2008. There was no similar charge recorded during the 2009 period.

For the year ended December 31, 2009, Cadence reported a net loss of $45.5 million, or $0.93 per share, compared to a net loss of $57.1 million, or $1.55 per share, for 2008. Operating expenses for 2009 were $44.5 million, a decrease of $12.0 million from the $56.5 million reported for 2008. The decrease in the current year expenses is primarily due to a reduction in research and development costs as a result of the company’s discontinuation of its omiganan development program and the completion of its clinical development program and submission of an NDA for OFIRMEV. Further, the impairment charge taken in 2008 on the company’s omiganan manufacturing equipment was significantly greater than the restructuring charges taken in 2009 as a result of the discontinuation of the omiganan program. Partially offsetting these

 

Page 1 of 5

---

reductions was an increase in sales and marketing expenses in 2009 as the company began establishing its commercial and supply functions in preparation for the potential commercial launch of OFIRMEV, including an increase in sales and marketing staff from 2 at the end of 2008 to 40 at the end of 2009.

As of December 31, 2009, Cadence held cash, cash equivalents and short-term investments of $82.0 million.

Conference Call and Webcast on March 15, 2010 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time)

Cadence management will host a conference call on March 15, 2010 at 1:30 p.m. Pacific Time (4:30 p.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 is Cadence Pharmaceuticals’ proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used medication for the treatment of pain and fever in the United States and is available in more than 600 combination and single-ingredient prescription and over-the-counter products. Cadence acquired the exclusive rights to OFIRMEV in the United States and Canada in 2006 from Bristol-Myers Squibb, which markets the product as Perfalgan® in Europe and other parts of the world. IV acetaminophen is approved in approximately 80 countries, including major markets in Europe, where the product is the market leader among all injectable analgesics. Approximately 90 million vials of IV acetaminophen were sold in Europe in 2008, representing an increase of approximately 13 percent over 2007.

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 that are not a description of historical facts are forward-looking statements. Words such as “believes,” “expects,” “anticipates,” “plans,” “will,” and “assuming,” and similar expressions, are intended to identify forward-looking statements, and are based on Cadence’s current beliefs and expectations. Forward-looking statements include statements regarding: Cadence’s plans to re-submit an NDA for OFIRMEV, and the potential timing of any such re-submission; the company’s belief that no additional clinical trials are required in order to obtain approval of the NDA for OFIRMEV; and Cadence’s belief that it has sufficient capital resources to fund its operations through the approval of OFIRMEV. All such forward-looking statements are based on Cadence’s current beliefs and expectations, and 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 press release due to the risks and uncertainties inherent in the company’s business, including, without limitation: Cadence’s dependence on the success of OFIRMEV, its only product candidate; the risk that the company may not receive regulatory approval for OFIRMEV, or its approval may be further delayed; Cadence’s reliance on its third party manufacturer to respond to the FDA’s concerns and address any manufacturing facility deficiencies; the possibility that the company may not yet fully understand all of the corrective actions that will be required to resolve deficiencies identified during the inspection of the manufacturing facility for OFIRMEV, and that Cadence will experience significant delays and incur additional costs in order to fully resolve such deficiencies; the potential that further FDA scrutiny of the manufacturing site may raise additional issues that must be resolved prior to

 

Page 2 of 5

---

obtaining approval of the NDA, causing further delays and cost increases; the potential for Cadence to require substantial additional funding in order to complete the necessary corrective actions at the manufacturing site for OFIRMEV, obtain regulatory approval for and commercialize this product candidate, and the risk that the company may not be able to raise sufficient capital when needed, or at all; 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. Perfalgan^® is a registered trademark of Bristol-Myers Squibb Company.

# # #

 

Contact:		William R. LaRue		Aimee Corso
		SVP & Chief Financial Officer		Media & Investor Relations
		Cadence Pharmaceuticals, Inc.		WCG
		Phone : 858-436-1400		Phone : 310-780-2661

 

Page 3 of 5

---

CADENCE PHARMACEUTICALS, INC.

(a development stage company)

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

 

		Three Months Ended December 31,								Twelve Months Ended December 31,
		2009				2008				2009				2008
Operating expenses:
Research and development		$	4,780,291			$	7,554,993			$	19,464,200			$	40,018,204
Sales and marketing			6,938,217				808,676				11,729,102				2,983,796
General and administrative			3,341,787				2,822,216				12,890,990				11,146,212
Other			200				2,355,485				412,341				2,384,251
Total operating expenses			15,060,495				13,541,370				44,496,633				56,532,463
Loss from operations			(15,060,495	)			(13,541,370	)			(44,496,633	)			(56,532,463	)
Other (expense) income, net			(251,895	)			(494,734	)			(994,306	)			(566,387	)
Net loss		$	(15,312,390	)		$	(14,036,104	)		$	(45,490,939	)		$	(57,098,850	)
Basic and diluted net loss per share(1)		$	(0.30	)		$	(0.37	)		$	(0.93	)		$	(1.55	)
Shares used to compute basic and diluted net loss per share(1)			50,429,965				38,170,993				48,753,978				36,823,660

 

(1)

As a result of the issuance of 12,039,794 shares of common stock pursuant to a private placement in the first quarter of 2009 and 9,240,307 shares of common stock pursuant to an effective shelf registration in the first quarter of 2008, there is a lack of comparability in the per share amounts between the 2009 and 2008 periods presented.

 

Page 4 of 5

---

CADENCE PHARMACEUTICALS, INC.

(a development stage company)

CONDENSED BALANCE SHEETS

 

		December 31, 2009			December 31, 2008
		(unaudited)
Assets
Current assets:
Cash, cash equivalents and short-term investments		$	82,006,153		$	47,627,246
Restricted cash			1,497,848			2,195,696
Prepaid expenses and other current assets			549,243			219,674
Total current assets			84,053,244			50,042,616
Property and equipment, net			8,300,529			4,477,020
Restricted cash			189,738			537,586
Other assets			19,708			90,792
Total assets		$	92,563,219		$	55,148,014
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	2,656,597		$	4,877,854
Accrued liabilities			7,739,527			9,063,310
Current portion of long-term debt, less discount			6,442,327			7,694,173
Other current liabilities			22,048			22,048
Total current liabilities			16,860,499			21,657,385
Deferred rent			640,208			952,274
Long-term debt, less current portion and discount			—			6,098,113
Total stockholders’ equity			75,062,512			26,440,242
Total liabilities and stockholders’ equity		$	92,563,219		$	55,148,014

 

Page 5 of 5