Cadence Pharmaceuticals Inc. (CADX)
Q2 2010 Earnings Call
August 05, 2010
Ted Schroeder - President and CEO
Jim Breitmeyer - EVP and Chief Medical Officer
Bill LaRue - EVP and CFO
Charles Duncan - JMP Securities
Eric Schmidt - Cowen and Company
Adam Cutler - Canaccord
Greg Fraser - Banc of America-Merrill Lynch
John Newman - Oppenheimer
Previous Statements by CADX
» Cadence Pharmaceuticals, Inc. Q1 2010 Earnings Call Transcript
» Cadence Pharmaceuticals, Inc., Q4 2008 Earnings Call Transcript
» Cadence Pharmaceuticals, Inc. Q3 2008 Earnings Call Transcript
Welcome to the Cadence Pharmaceuticals Second Quarter 2010 Financial Results Conference Call. On the call today are Ted Schroeder, President and CEO, Jim Breitmeyer, Executive Vice President and Chief Medical Officer, and Bill LaRue, Senior Vice President and Chief Financial Officer.
At this time, I would like to inform you that this conference is being recorded and that all participants are in a listen-only mode. (Operator Instruction)
Our first is speaker is Bill LaRue. Go ahead, sir.
Before we get started today, I would like to remind you that statements included in this conference call that are not a description of historical facts are forward-looking statements. Such forward-looking statements include statements regarding: the timeframe in which the FDA is expected to complete its review of our NDA for OFIRMEV, and our belief that our NDA will be sufficient for the FDA to approve this product candidate; our readiness to launch OFIRMEV, and the potential strength of any such launch; the sufficiency of the our capital resources to fund our operations through the approval of initial launch period of OFIRMEV; our ability to complete future drawdowns under our loan facility; the potential for us acquire Incline Therapeutics and the anticipated strategic benefit of any such acquisition, and all of our financial estimates and projections.
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?
Good 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.