SAN DIEGO, March 12 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. , 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 quarter and year ended December 31, 2007, and provided corporate and clinical program overviews for the year ended 2007 and for 2008 to date.
“During 2007, we continued to advance the Phase III clinical programs for our two product candidates, Acetavance(TM), an intravenous formulation of acetaminophen for the treatment of pain and fever, and Omigard(TM), a topical antimicrobial gel for the prevention of catheter-related infections”, stated Ted Schroeder, President and CEO of Cadence Pharmaceuticals. “In addition, we achieved important corporate objectives of strengthening our management team and, in February 2008, raising gross proceeds of approximately $49.3 million in a registered direct equity offering. We believe we now have sufficient resources and capital to advance our two product candidates through to NDA submissions, currently anticipated in the first half of 2009.”
Financial Results
For the fourth quarter ended December 31, 2007, Cadence reported a net loss of $14.2 million, or $0.50 per share, compared to a net loss of $9.0 million, or $0.53 per share, for the same period in 2006. For the year ended December 31, 2007, Cadence reported a net loss of $51.7 million, or $1.81 per share, as compared to a net loss of $52.2 million, or $10.07 per share, for the same period in 2006. The results for the year ended December 31, 2007, included approximately $4.3 million in stock-based compensation expense.
As of December 31, 2007, Cadence held cash and cash equivalents of $55.4 million. Including the proceeds from the registered direct offering completed in February 2008, the company’s cash and cash equivalents balance as of February 29, 2008, was $98.0 million.
Total operating expenses for the fourth quarter of 2007 were $14.6 million, as compared to $9.6 million for the same period in 2006. The increased operating expenses in the fourth quarter of 2007 were primarily a result of increases of $0.5 million and $1.6 million in research and development costs related to on-going Phase III clinical trials of Acetavance and Omigard, respectively, and the addition of research and development staff to support clinical and regulatory efforts for 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, other professional and consulting fees, and costs related to operating as a public company.
Total operating expenses for the year ended December 31, 2007, were $54.2 million compared to $53.6 million for the same period in 2006. Research and development expenses decreased $6.0 million in 2007 to $41.8 million, compared to $47.8 million in 2006. This decrease was primarily due to a $25.3 million initial license fee and related costs for Acetavance incurred in March 2006. Excluding the license fee, research and development expenses for 2007 increased $19.3 million from 2006 primarily due to the advancement of the Acetavance and Omigard clinical development programs. Marketing expenses increased $2.1 million in 2007 to $2.9 million, primarily due to increased market research and related costs for Acetavance and Omigard, and increased salaries and related personnel costs from the planned addition of marketing staff in 2007 as compared to 2006. In addition, general and administrative expenses increased $4.6 million in 2007 to $9.6 million, primarily due to increases in salaries and related personnel costs (including an increase of $1.5 million in stock-based compensation charges) from the planned addition of general and administrative staff in 2007 as compared to 2006, and costs related to operating as a public company.
Financial Outlook for 2008
Cadence currently anticipates that total operating expenses for full year 2008 will be between $54 million and $59 million including an estimated $4 to $6 million in non-cash stock-based compensation expenses. Cadence expects that cash, cash equivalents and investments held for sale at December 31, 2008, will be between $41 million and $46 million.
Conference Call and Webcast on March 12, 2008, 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time)
Cadence management will host a conference call on March 12, 2008, at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) and interested investors may participate in the conference call by dialing 877-681-3375 (domestic) or 719-325-4913 (international). To access the webcast, please visit the company’s website at http://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 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 product candidates in development, Acetavance(TM) (intravenous acetaminophen) for the treatment of acute pain and fever, and Omigard(TM) (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections. For more information about Cadence’s pipeline, visit http://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. These forward-looking statements include statements regarding: the timeframes in which Cadence expects to initiate, complete enrollment in, and disclose results from its clinical trials of Acetavance and Omigard, and the timeframes for filing submissions with regulatory authorities seeking marketing authorizations for these product candidates; statements regarding the effects of management changes; Cadence’s projected operating expenses and cash balances for 2008; and the adequacy of the company’s funding to advance its product candidates through to NDA submissions. 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 press release due to the risks and uncertainties inherent in Cadence’s business, including, without limitation: the company’s dependence on the success of its only two product candidates; additional ongoing or planned clinical trials of Acetavance or Omigard conducted by the company may produce negative or inconclusive results, or may be inconsistent with clinical trials previously conducted by Cadence, its licensors or others; delays in completing Cadence’s clinical trials or achieving its product development goals, or significant issues regarding the results, design or execution of its clinical trials; the potential need or requirement to expand or modify the company’s ongoing clinical trials or to conduct additional clinical trials; the market potential for Cadence’s product candidates, and its ability to compete with new or existing products; unanticipated adverse side effects or inadequate therapeutic efficacy of the company’s product candidates; delays or quality issues with respect to completion of pre-commercialization manufacturing development activities; other difficulties or delays in developing, testing, manufacturing, obtaining regulatory approval for, and marketing Cadence’s product candidates; the scope, validity and limitations in the company’s patent rights, and its ability to maintain patent protection for its product candidates; the need to obtain substantial additional funding to complete the company’s clinical development programs and successfully launch its products, and the potential that Cadence 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(TM), Acetavance(TM) and Omigard(TM) are trademarks of Cadence Pharmaceuticals, Inc.
CONTACT: William R. LaRue, SVP & Chief Financial Officer, +1-858-436-1400,
or Anna Gralinska, Director, Investor Relations, +1-858-436-1452, both of
Cadence Pharmaceuticals, Inc.
Web site: http://www.cadencepharm.com/
