Hepatitis C Drug Sovaldi Shatters Record for New Product Launch with $2.3 Billion First Quarter Sales

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Gilead Sciences, Inc. (GILD) announced today its results of operations for the quarter ended March 31, 2014. Total revenues for the first quarter of 2014 increased to $5.00 billion from $2.53 billion for the first quarter of 2013, largely due to sales of Sovaldi® (sofosbuvir 400 mg), which launched in December 2013. The drug treats hepatitis C infection, which afflicts 130 million people worldwide, including 3 million Americans.  
The $2.3 billion in sales of Sovaldi, which easily surpassed analysts’ estimates of $1 billion, appears to have shattered the previous record for sales of a drug in its first full quarter on the market, making Sovaldi the best-selling new drug of all time according to analysts. It even appears to have already eclipsed the record for first-year sales, at least in the United States.  
“This is the biggest launch of a new drug in first-quarter sales that we’re aware of,” said Michael Yee, an analyst for RBC Capital Markets. “I think it’s a testament to the transformation breakthrough this drug is providing, which is essentially a cure in a pill.” Sovaldi could easily earn $10 billion worldwide by the end of 2014, said Ying Huang, a senior biotechnology analyst for Barclays.  
The rapid uptake of Sovaldi reflects pent-up demand, as many patients were holding off treatment until it was approved in December. The drug, a pill taken once a day, has a higher cure rate, a shorter duration of treatment and fewer side effects than previous treatments. Sovaldi can eliminate the virus in more than 90 percent of patients in 12 or 24 weeks with relatively mild side effects. Traditional therapies, which can last up to a year, cure only about half of patients, many of whom experience nausea and extreme fatigue.  
“I couldn’t be more proud of the teams at Gilead who rapidly brought this product to market,” Gilead CEO John Martin told investors in a conference call. Trial data released this month showed that Sovaldi cured the majority of hepatitis C patients with advanced liver diseases. And within six months, the Food and Drug Administration could approve a single-pill version of Sovaldi that would eliminate the most common strain of the disease in just eight or 12 weeks.  
“Sovaldi’s profile has the potential to transform the treatment of hepatitis C,” Martin said.  
In 2011, Gilead spent more than $11 billion to acquire Pharmasset, Inc., a biotechnology company that discovered and developed Sovaldi.