SAN DIEGO, Nov. 14 /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 unaudited financial results for the third quarter and nine months ended September 30, 2007, as well as an update on the company’s clinical development program for intravenous acetaminophen.
“During the quarter, we continued to make progress in advancing our Phase III clinical development programs for our two drug candidates, intravenous acetaminophen, which we have recently branded Acetavance(TM), for the treatment of pain and fever, and Omigard(TM), a topical gel for the prevention of catheter-related infections,” stated Ted Schroeder, President and Chief Executive Officer of Cadence. “We remain on track to meet our clinical and pre-commercialization milestones for the rest of this year, to announce top line results from our first three pivotal efficacy trials of Acetavance in early 2008, to complete patient enrollment in our Phase III clinical trial of Omigard in the second quarter of 2008 and to submit a New Drug Application, or NDA, for Acetavance to the U.S. Food and Drug Administration in the second half of 2008.”
“In October 2007, we completed patient enrollment in our two pivotal Phase III clinical trials of Acetavance for the treatment of fever in adults,” added Jim Breitmeyer, Executive Vice President, Development and Chief Medical Officer of Cadence. “Before year end, we also plan to begin enrollment in our two planned safety studies of this product candidate. We will also initiate an additional pivotal, Phase III clinical trial of Acetavance for the treatment of acute pain in adults following abdominal laparoscopic surgery. This study is not expected to delay our NDA submission timeline.”
“The additional study is a nice complement to the rest of the Acetavance program, because it will provide data in laparoscopic surgery, an increasingly common alternative to more extensive procedures,” said Eugene R. Viscusi, M.D., Director, Acute Pain Management Service, Thomas Jefferson University, Jefferson Medical College, a member of Cadence’s advisory board for Acetavance. “If the studies are successful and Acetavance is approved, I believe that physicians will also appreciate the flexibility of two different doses and dosing intervals, and having prescribing information in patients with mild to moderate pain, which will supplement findings from the more severe pain models studied in the other Acetavance clinical trials.”
Financial Results
Cadence reported a net loss for the third quarter of 2007 of $13.0 million, or $0.45 per share, compared to a net loss of $7.8 million, or $6.01 per share, in the third quarter of 2006. For the nine months ended September 30, 2007, the company reported a net loss of $37.5 million, or $1.31 per share, compared to a net loss of $43.2 million, or $34.27 per share for the nine months ended September 30, 2006.
As of September 30, 2007, Cadence held cash and cash equivalents of $54.5 million.
Total operating expenses for the third quarter of 2007 were $13.6 million, compared to $8.0 million for the third quarter of 2006. The increase in operating expenses was primarily due to a $4.0 million increase in research and development expenses related to the company’s ongoing Phase III clinical trials of Omigard and Acetavance. In addition, the increased operating expenses were due to pre-commercialization manufacturing development activities for Acetavance, increased personnel-related costs due to the planned hiring of staff to support the company’s clinical and regulatory activities, and a $1.2 million increase in general and administrative expenses due to increases in salaries and related personnel costs, including stock-based compensation charges and costs related to operating as a public company.
For the nine months ended September 30, 2007, operating expenses were $39.6 million, compared to $43.9 million for the nine months ended September 30, 2006. The decrease in operating expenses was primarily related to a one-time, initial license fee of $25.3 million incurred by Cadence during the first quarter of 2006 in connection with the company’s acquisition of rights to Acetavance. This decrease was partially offset by a $16.5 million increase in costs during the first nine months of 2007 related to the company’s ongoing Phase III clinical trials of Omigard and Acetavance, pre-commercialization manufacturing development activities for both product candidates, personnel-related costs due to the planned hiring of staff to support the company’s clinical and regulatory efforts, and a $3.5 million increase in general and administrative expenses due to increases in salaries and related personnel costs, including stock-based compensation charges, depreciation expenses and costs related to operating as a public company.
Cadence expects that its total operating expenses for 2007 will be between $54 and $57 million, which is lower than the $57 to $60 million range previously announced and includes approximately $4 million in non-cash, stock-based compensation. The reduction is primarily related to changes in the timing of certain pre-commercialization manufacturing development expenditures and the initiation of certain clinical trials. Cadence also anticipates that cash and cash equivalents at December 31, 2007 will be between $37 and $ 40 million.
Conference Call and Webcast at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time
Cadence management will host a conference call on Thursday, November 15, 2007 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to provide the company’s clinical program update and discuss financial results for the third quarter ended September 30, 2007. Interested investors may participate in the conference call by dialing 800-289-0461 (domestic) or 913-312-6680 (international). To access the webcast, please log on to 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 complete and disclose results from its clinical trials of Acetavance and Omigard; the potential for filing and indications for use to be included in its NDAs for Acetavance and Omigard and the timing of any such filings; the company’s projected operating expenses and cash balances; and its expectations for completing clinical and pre- commercialization manufacturing development objectives for both product candidates. 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: Cadence’s dependence on the success of Acetavance and Omigard; any delays in completing enrollment in, or significant regulatory issues concerning the execution of, the company’s clinical trials for Acetavance and Omigard; unexpected adverse side effects or inadequate therapeutic efficacy of Acetavance or Omigard that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; the adequacy of the clinical trial designs for Acetavance and Omigard to generate data that are deemed sufficient by regulatory authorities to support potential regulatory filings in the desired indications for use; delays or quality issues with respect to the completion of required pre-commercialization manufacturing development activities for Acetavance and Omigard, which could increase costs and delay or limit Cadence’s ability to obtain regulatory approvals; any failure by Cadence’s contract manufacturers and suppliers to produce its product candidates in the required volumes on a timely basis, or to comply with applicable regulations; any uncured, material breaches of the agreements with, or termination or disruption of the company’s relationships with, its contract manufacturers and suppliers; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for Acetavance or Omigard; the company’s ability to maintain patent protection for Acetavance and Omigard and to commercialize these product candidates without infringing the patent rights of others; the market potential for pain, fever, local catheter site infections and other target markets, and the company’s ability to compete in these markets; fluctuations in quarterly and annual financial results; the company’s need to obtain substantial additional funding to complete its product development plans and the potential that it may not be able to raise sufficient capital when needed; 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.; or Susan Neath, Media Relations of Porter
Novelli Life Sciences, +1-619-849-6007, for Cadence Pharmaceuticals, Inc.
Web site: http://www.cadencepharm.com/
