Cadence Pharmaceuticals Inc. (CADX) Q2 2010 Earnings Call August 05, 2010 Executives Ted Schroeder - President and CEO Jim Breitmeyer - EVP and Chief Medical Officer Bill LaRue - EVP and CFO Analysts Charles Duncan - JMP Securities Eric Schmidt - Cowen and Company Adam Cutler - Canaccord Greg Fraser - Banc of America-Merrill Lynch John Newman - Oppenheimer Presentation Operator
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All such forward-looking statements are based on our current beliefs and expectations, and should not be regarded as a representation that our plans will be achieved. Our actual results may differ materially due to the risks and uncertainties inherent in the our business, which include, the potential that the FDA may not approve OFIRMEV; our dependence on the success of OFIRMEV, which is our only product candidate; the potential that the FDA may require additional data or information as part of its review of the our NDA for OFIRMEV or that's the review will not be completed within the expected timeframe, our reliance on our third-party manufacturer to address any deficiencies related to the manufacture of OFIRMEV; the risk that further FDA scrutiny of the manufacturing site for OFIRMEV may raise additional issues that must be resolved prior to approval, the potential that we will require substantial additional financing in order to obtain regulatory approval for and commercialize OFIRMEV, and do exercise our option to acquire Incline, the risk that we may not be able to raise sufficient capital when needed, or at all; the risk that delays in obtaining approval for and commercially launching OFIRMEV will enable competitors to further entrench their existing products or bring new products to market before OFIRMEV; and our ability to comply with the terms of our loan agreement.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 unduly rely on these forward-looking statements, and we undertake no obligation to revise or update such statements. All forward-looking statements are qualified by this cautionary statement. 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 SchroederGood afternoon everyone and thank you for joining us today. I will start by providing a brief summary of the second quarter events and provide an update on our efforts to obtain regulatory approval for OFIRMEV, our intravenous acetaminophen investigational product candidate. Bill then provide an overview of the second quarter and year-to-date financial results. After the financial results, we will open the call for your questions. First, I would like to provide a brief update on our NDA for OFIRMEV. As we have discussed previously in February of this year, we received a complete response letter from the FDA, which stated that our NDA could not be approved due to deficiencies with respect to good manufacturing practices observed during the agency's inspection of the facilities of our third-party manufacture. Following a meeting with FDA to discuss the observations, we resubmitted our NDA for OFIRMEV in May, and we are subsequently notified that the FDA had classified our resubmission as a complete class to response to the February letter. We have received a new PDUFA action date of November 4, 2010 and our third-party manufacturer has responded to the deficiencies noted during the inspection of the manufacturing facility. We have not been notified by FDA, as to whether or not the agency will re-inspect the manufacturing facility prior to completing its review of our NDA. In the mean time, we are working with our third-party manufacturer to ensure that they are ready to supply commercial product as soon as the NDA is approved. We are finalizing our commercial readiness activities in order to be well position for a strong launch of OFIRMEV as soon as possible of following approval by the FDA. We also announced the very exciting opportunity for our company in the second quarter. In June we signed an agreement to secure an option to acquire Incline Therapeutics, a newly formed privately-held specialty pharmaceutical company. Read the rest of this transcript for free on seekingalpha.com