Cadence Pharmaceuticals, Inc. (CADX) Q1 2010 Earnings Call Transcript May 6, 2010 4:30 pm ET Executives Bill LaRue – SVP, CFO, Treasurer and Assistant Secretary Ted Schroeder – President and CEO Analysts Eric Schmidt – Cowen and Company Gary Nachman – Leerink Swan John Newman – Oppenheimer Greg Beicher [ph] – Banc of America/Merrill Lynch Presentation Operator
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the potential that the FDA may require additional data or information as part of its review of the resubmitted NDA for OFIRMEV, including potential requirements for additional safety and stability batches or other manufacturing data, which may require significant time and expense to produce. Our reliance on our third party manufacturer to respond to the FDA's concern in addressing the manufacturing facility deficiencies.The risk that further FDA scrutiny of the manufacturing site may raise additional issues and that must be resolved prior to obtaining approval of the NDA, causing us to incur further delays and expense. The risk that we may not regulatory approval for OFIRMEV on a timely basis or at all, are dependent upon the success of OFIRMEV, which is our only product candidate, the potential that we may require substantial additional funding in order to obtain regulatory approval for and commercialize OFIRMEV, and the risk that we may not be able to raise sufficient capital when needed or at all; and the risk of delays in the approval of the NDA for OFIRMEV and its commercial launch will enable competitors to further entrench their existing products or develop and bring new products to market before OFIRMEV. These and other risks are detailed in our prior press releases and 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 of the date hereof. All forward looking statements are qualified by this cautionary statement, and we undertake no obligation to revise or update such statements. This caution is made under the Safe Harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. If anyone has not seen our press release issued earlier today, you can access it on our website at www.cadencepharm.com. Additionally, this conference call is being webcast through the company's website and will be archived there for future reference.
Ted?Ted Schroeder Thanks, Bill; and good afternoon, everyone. Thank you for joining us today. I know it has been quite an awful day in the markets and appreciate you taking the time to join our first quarter 2010 financial results call. I will start by providing you with a brief summary of the first quarter and more recent events related to our efforts to obtain regulatory approval for OFIRMEV, our intravenous acetaminophen investigational product candidate. Bill will then provide an overview of the first quarter financial results. After the financial results, we will open the call for your questions. As first announced on February 11, we received a Complete Response letter from the FDA on our OFIRMEV NDA, indicating that approval could not be granted due to deficiencies observed during the FDA's inspection of our third-party manufacturer's facility. The Complete Response letter did not supply any safety or efficacy issues, or require the completion of any additional studies prior to approval. Our third-party manufacturer submitted a timely response to the FDA regarding the inspectional observations, and on April 15, we and representatives from our third-party manufacturer met with the FDA to discuss the deficiencies outlined in the Complete Response letter. During this meeting, the agency did not request any new safety, efficacy, or stability studies. As a result, on May 4, 2010, we submitted the NDA for OFIRMEV. We expect the agency will inform us within the next several weeks whether our NDA is deemed a Class I or a Class II resubmission. If the agency determines that a re-inspection of our third-party manufacturer is needed, then we anticipate that the NDA will be designated as a Class II re-submission. A Class I designation would result in a two-month review timeline, and a Class II designation would result in a six-month review timeline. In the meantime, we continue to prepare for the launch of OFIRMEV at the earliest possible time following approval. Read the rest of this transcript for free on seekingalpha.com