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Rockwell Medical Technologies, Inc. (RMTI)
Q3 2008 Earnings Call Transcript
November 13, 2008 4:30 pm ET
Jessica Lloyd – The Trout Group
Rob Chioini – Founder, Chairman, President and CEO
Tom Klema – VP, CFO and Secretary
Todd Lewis [ph] – South Street Capital [ph]
Laura Jennings [ph] – Strategic Investments
Tom Andrea [ph] – TD Ameritrade
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Thank you and welcome everyone to our third quarter 2008 conference call. We appreciate your continued interest in our company. I’m Jessica Lloyd from the Trout Group; and with me today is Rob Chioini, Chairman and CEO, and Tom Klema, Chief Financial Officer of Rockwell.
Before we get started, I’d like to remind everyone that this conference call may contain forward-looking statements. All forward-looking statements involve risk and uncertainty, including without limitation the risks detailed in the company’s filings and reports with the Securities and Exchange Commission. Such statements are only predictions and actual results may differ materially than those projected.
I will now turn the call over to Mr. Robert Chioini, Chairman and CEO of Rockwell.
Thank you, Jessica. Good afternoon. Thank you for joining us today. I’m proud to report another quarter demonstrating strong sales growth for Rockwell. Sales were $13.5 million for the quarter, a 22% increase compared to the same period in 2007. I will address Rockwell’s progress in developing our lead drug candidate SFP and then I’ll pass the call on to Tom Klema, our CFO, to explain this past quarter’s financial analysis.
I do want to note that we just returned from the American Society of Nephrology Conference, which took place in Philadelphia last week, and we were pleased to experience a high level of enthusiasm and interest in SFP amongst our clinical investigators as well as nephrologists both in the US and abroad. SFP represents an innovative opportunity to physicians to effectively manage iron therapy for patients suffering from end-stage renal disease, which is a population of approximately 370,000 in the US and 1.2 million worldwide.
We are making progress in the two ongoing SFP clinical studies, the NIH funded study and our FDA Phase IIb study. The NIH study is a 9-month, 30 patients, multi-site study comparing SFP and IV iron. It was examined in maintenance of hemoglobin, iron parameters, need for IV iron, and oxidative stress markers in patients receiving SFP via dialysis. We remain on schedule with patient enrollment and estimate data results in late 2009.
Our FDA Phase IIb dose-ranging study is a 6-month, 25 to 30 sites study with 100 to 120 patients. The primary objectives are to evaluate both safety and efficacy of SFP in varying dose levels and to determine the optimal concentration that will maintain iron balance within the target hemoglobin range in patients undergoing hemodialysis.
As in many clinical studies, enrollment has presented some challenges for us, and as a result we have taken a number of positive steps during the quarter that will enable us to complete enrollment as fast as possible. We have added a dedicated enrollment specialist to work directly with the study sites and to facilitate the CROs interaction with those sites.
We have increased the number of trial sites to more than double the original number. We have amended patient inclusion and exclusion criteria to optimize enrollment, and we have developed a pre-screening protocol to effectively choose those patients best suited to pass screening criteria at each site. These steps have been essential in accelerating our patient enrollment throughout the third quarter and we have started to see positive results.
Our goal is to complete enrollment for this study by the end of the year. However, we do note that the holiday season is coming quickly and that may affect our target date. Given these assumptions, however, we anticipate seeing results from the Phase IIb study in mid 2009.
The independent Data Safety Monitoring Board recently provided positive oversight for the SFP Phase IIb study. The DSMB reviewed the cumulative data from the study and concluded that there were no safety concerns. As a result, the DSMB recommended that we continue to study as planned with no modifications. This encouraging and expected feedback strengthens our confidence in SFP in its safety profile.
It’s important to note there had been more than 1,500 doses of SFP administered since the Phase IIa study and not one adverse reaction has been reported. This is an exceptional safety profile. The successful completion of our SFP development program remains our top priority and we will continue to take actions to achieve FDA market approval. With that in mind, we have made significant headway in our recruitment search for a Chief Medical Officer. We have identified an ideal candidate and we hope to have that individual secured very shortly.
As we progress with our SFP clinical development, we’re evaluating the other applications and opportunities that SFP presents. We plan to expand SFP and those other indications in markets. Those markets include prescription oral iron, iron delivered in TPN solution, iron delivered in PD solution, and iron delivered in the oncology setting. A few of these new markets look to be even greater in size than SFP’s $400 million domestic and $800 million global market potential.