Novo CEO: Correcting course after troubling setbacks

Victoza just keeps on spinning gold for Novo Nordisk ($NVO). The diabetes drug's sales grew 25% in the second quarter to 2.87 billion Danish kroner, or about $514 million. Add double-digit growth for the company's modern insulins and a 26% increase in quarterly profit, and you have the reasons why Novo raised its 2013 sales forecast once again.

Novo CEO Lars Rebien Sørensen

Overall, Novo's quarterly sales hit 21.38 billion kroner, or about $3.8 billion. Profits amounted to 6.7 billion kroner. And now, the company expects 2013 sales to grow by 11% to 13%, with operating profits up 12% to 15%; previously it was looking for sales growth of 9% to 11%.

But the numbers aren't all that has CEO Lars Rebien Sørensen feeling good about the second half of the year. The company is moving into a "more normal business situation," he said during an interview with FiercePharma today, "compared to a very unsure, uncertain situation in the first half."

The company now has an agreement with the FDA on gathering additional safety data for its recently rejected diabetes hopeful Tresiba. Public debate about the pancreatic risks of GLP-1 drugs, including Victoza, is easing up now that European and U.S. regulators have backed their safety.

Meanwhile, Tresiba was welcomed by European and Japanese regulators, and the company has been rolling out the drug market by market. The company has run into reimbursement restrictions in some countries and has chosen to defer a launch in Germany because of the country's byzantine new pricing process. But in Japan and Switzerland, where Tresiba is fully reimbursed, Novo has seen "very nice uptake."

Still, it's the U.S. market that will make the difference for the new drug. Until Tresiba wins the FDA's blessing, its sales outlook is pretty muted. "I would say we won't have any real substantial impact [from Tresiba] until we're able to launch in the U.S.," he said.

The only new uncertainty lies in China, where government watchdogs are investigating corruption and pricing in the pharma industry. Authorities from the Administration for Industry and Commerce dropped by a Novo manufacturing site in Tianjin this month, and the company doesn't yet know why, Sørensen said. "They do come by routinely and inquire about our business," he said. "Whether or not the visit was prompted by the other case is unknown to us."

Novo strengthened its compliance programs all over the world after it got caught up in the oil-for-food scandal in 2009 and signed a deferred prosecution deal with the U.S. government, Sørensen said. In China, Novo has been well established for many years and has "never had any problems whatsoever," he said. "No requests for bribes or anything."

"I have to believe that we have it under control," he added. But, he said, "whether individuals have not done something, I can't guarantee that."

The company's China sales continue to grow in the double digits, with a 14% increase this quarter. Adding Tresiba to the product mix there will help, but that's going to take some time because the government requires local clinical trials, Sørensen said. In fact, he's expecting to have to wait as long to launch in China as in the U.S.

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