Sarepta Therapeutics, Inc. (SRPT)

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Sarepta Therapeutics (SRPT)

Q3 2012 Earnings Call

November 7, 2012 5:00 p.m. ET


Chris Garabedian - President and CEO

Sandy Mahatme - CFO

Mike Jacobsen - VP, Finance


Ted Tenthoff - Piper Jaffray

Christopher Marai - Wedbush Securities

Bill Tanner - Lazard Capital

Reni Benjamin - Burrill



Hello, and welcome to the Sarepta third quarter 2012 earnings call. [Operator instructions.] I will now turn the call over to Erin Cox. Erin, you may begin.

Erin Cox

Thank you, operator, and thank you for joining today's call. Earlier today, we released our financial results for the third quarter of 2012. The press release is available on our website at and our 10-Q was filed earlier today.

Joining me on the call are Chris Garabedian, our president and chief executive officer; Sandy Mahatme, our new chief financial officer; and Mike Jacobsen our vice president of finance.

I would like to note that during this call we will make a number of statements that are forward-looking, including statements about the development and clinical status of Sarepta's product candidates and the potential efficacy, clinical results, intellectual property position, revenues, expenses, potential funding from the government and other sources, and collaboration and partnering opportunities.

These forward-looking statements involve risks and uncertainties, any of which are beyond Sarepta’s control. Any such risks could materially and adversely affect the business, results of operations, and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties we face, you are encouraged to review the company's official corporate documents filed with the Securities and Exchange Commission.

With that let me turn the call over to Chris Garabedian, Sarepta’s president and CEO. Chris?

Chris Garabedian

Thank you, Erin. Good afternoon everyone and thank you for joining us. I’m pleased to provide you with an update and overview of our activities and accomplishments since our last quarterly earnings call, along with our financial performance in the third quarter of 2012.

I will soon speak about how the recent data with eteplirsen, our lead program for the treatment of Duchenne muscular dystrophy, has us preparing for a number of activities to move the program forward successfully. But first, I’d like to speak about the financial health of the company.

I’m pleased to announce that we have strengthened our cash position in recent months, and have a current cash balance of approximately $57.4 million as of today. This cash position was achieved through utilization of our ATM, or at the market, facility, in addition to warrants that were exercised in the month of October.

We have drawn down $38.7 million between September 6 and October 16 from our ATM, with the majority of the $38.7 million being drawn down prior to receipt and release of our 48-week data. The overall average price of the stock sold under the ATM was $19.05, on a total of 1.984 million shares.

Additionally, we started to receive proceeds from the exercise of warrants in October, and raised an additional $5.6 million in cash as of today, November 7, on the exercise of approximately 532,000 shares.

We also filed a shelf registration today as our previous $100 million shelf was largely accounted for due to the $40 million ATM facility and the $46 million registration of our outstanding warrants. Our new shelf of $180 million will replace our existing shelf, and allows flexibility to continue to finance the company’s operations for the coming years.

The company has made significant changes to our operations over the last year to run more efficiently and to reduce the cash burn, as we move the DMD program forward. The current cash balance of more than $57 million has us well-positioned to prepare for many of the activities that will take place in 2013, including preparing for our regulatory discussions with the FDA on the requirements for approval of eteplirsen; planning our confirmatory studies with eteplirsen, including the initiation of enrollment of a confirmatory pivotal study by the end of 2013; and the setup costs and production runs required to scale up manufacturing to prepare for additional studies of eteplirsen and our follow-on DMD drug candidates.

This has been a big quarter for the company, and many activities have been set in motion as a result, and we have a lot to cover. We announced an important data set from our lead clinical program with eteplirsen for the treatment of DMD.

Specifically, we announced on October 3 the 48-week data set from our Phase IIB study of eteplirsen in Duchenne muscular dystrophy. This analysis, from our study 202 protocol, which is our long term safety and efficacy extension study of eteplirsen, showed that we met our primary endpoint, the production of dystrophin, measured as a percentage of dystrophin-positive muscle fibers.

We produced meaningful dystrophin levels across the entire patient population, with a statistically significant benefit across both of the 48-week treatment dose cohorts as well as the placebo-delayed treatment group that received 24 weeks of eteplirsen treatment.

I’ll briefly go over some of the highlights of that data set before I go on to other activities that are ongoing. The primary efficacy endpoint defined in our protocol and statistical analysis part of study 202 - again, our long term safety and efficacy extension study - was the increase in dystrophin-positive muscle fibers at 48 weeks as a percentage of normal compared to baseline. Eteplirsen is administered once weekly at either 30 mg/kg for 48 weeks resulted in statistically significant mean increase of dystrophin-positive fibers of 47% as a percentage of normal across all treated patients with a P value of 0.001.

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