Sanofi says China vaccine rules led to logistics overhaul

Sanofi ($SNY) provided insight into the logistics hurdles faced by vaccine makers in China after distribution and sales rule changes made in response to illegal vaccine sales.

The changes implemented recently--which were rooted in the fact agents did not adhere to storage and transport protocols--have led to shortages of vaccines at clinics in China. Beyond that, they've also led to a scramble by several companies in the space, domestic and foreign, to get the infrastructure in place previously handled by third parties.

David Loew, executive vice president for vaccines unit Sanofi Pasteur, told analysts on the July 29 earnings call that work is underway. He said it may take until the end of the year until the pieces are put in place for Sanofi Pasteur, which has an important pediatric vaccine business in China.

"There is now regulation that the manufacturers need to deliver directly to 200 points of central process control in China," Loew said.

"We are setting up this logistical chain, and we anticipate that this unprecedented impact is going to last probably four to 6 months. After that, we see China coming back to normal again."

The vaccines business dominated the call because of a slow start for dengue vaccine Dengvaxia, which has been linked to political and economic turmoil in the key market of Latin America.

What's more, a glacial pace of approvals and public campaigns in Asia--with only the Philippines going for a large program so far--was noted among the 5 countries in both regions that have granted approval.

That led CEO Olivier Brandicourt to say the company would miss its 2016 target for Dengvaxia sales. He avoided making any new forecasts for now for the vaccine.

"I won't give you long-term guidance. What we have in the past 12 months mentioned for 2016 was a potential forecast or achievement, so a performance of €200 million," Brandicourt said.

"We think it's not going to be achieved in 2016, as I said earlier, because of that--what we qualify as a delay in getting these large immunization programs in Latin America. So, that's what I would say."

On Venezuela, like other firms on the second quarter, Sanofi outlined changes to sales efforts in the country by noting it now uses an exchange rate of 628 bolivars to the dollar instead of the official rate of 6.3 in place earlier this year as there "has been no indication of improvement in the economic situation in Venezuela," according to George Grofik, vice president and head of Investor Relations.

Olivier Charmeil, executive vice president for General Medicines and Emerging Markets, however, did provide an overview of the emerging market segment and lauded China in particular.

"We have been growing 6.7% for the total quarter in the emerging market. Our growth is very steady across the geographies, growing in Latin America 5.7%, growing in Eurasia 4%, growing in Asia a little bit less," Charmeil said.

"We continue to see significant momentum in China, where on the pharmaceutical side of our business we grew 11.7%. And we continue to outgrow the market and to outgrow our peers. Our portfolio, which is mainly addressing chronic diseases, well fits the need of China. We outgrow the market in the therapeutic categories where we are. And we bear the fruit of investments that we have been doing in the last three or four years with our country market strategy."

- here's the release (PDF)

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