2017 sales: $6.12 billion (€5.10 billion)
2016 sales: $5.50 billion (€4.58 billion)
Vaccine business led by: David Loew
By the numbers, Sanofi’s vaccines business did quite well in 2017. Revenue grew an impressive 11.4% to reach €5.1 billion ($6.12 billion). But beyond the income statement, last year wasn’t without headline-hogging controversies and setbacks.
First, the good news. Sanofi’s flu vaccines franchise itself delivered 9.5% growth at constant exchange rates, to €1.59 billion ($1.91 billion), with its Fluzone products—including quadrivalent and high-dose forms—leading the charge.
Sanofi Pasteur also made an important move to keep that franchise fresh: It grabbed a leading position in next-generation flu vaccine technology with a $750 million deal to acquire Protein Sciences and its Flublok Quadrivalent, the only FDA-approved recombinant protein-based flu shot. With their egg-free production process, recombinant platforms can produce vaccines more quickly and do a better job battling strain mutations. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, has publicly deemed such platforms as the way forward for flu vaccines.
Other big performers for Sanofi last year were its polio/pertussis/Hib combination vaccines, including Pentacel. They together put up sales of €1.83 billion ($2.19 billion), a 24.3% year-over-year jump at constant exchange rates. Travel vaccines and adult booster vaccines grew by double digits, while its meningitis/pneumonia portfolio held firm.
Now to the bad news. Revenue from dengue vaccine Dengvaxia dropped to almost nothing, thanks to new long-term data that pushed Sanofi into the middle of a safety controversy.
Last November, Sanofi revealed that a new analysis found Dengvaxia could cause more severe dengue cases in people who hadn't been exposed to the virus before receiving the shot. The announcement triggered an uproar in the Philippines, which immediately pulled the shot from its national vaccination program.
Lawmakers and government agencies are targeting Sanofi in ongoing investigations and potential lawsuits and though Sanofi has bought back the country’s unused shots, it’s still under pressure to pay for the doses that had already been administered. The vaccine’s future looks even more gloomy now that the WHO recommends diagnostic testing for dengue before Dengvaxia is administered. The catch is that such a test doesn't yet exist, and it could take years to develop.
Meanwhile, in the U.S., a controversy erupted around Sanofi’s work on a Zika vaccine. The French drugmaker was practically forced out of a Zika vaccine development alliance with the U.S. Army. Despite the fact that their government-funded candidate was still in the early stages of development, lawmakers demanded that Sanofi set a price limit for the shot, should it ever hit the market. Sanofi refused, and the episode drew intense public and political scrutiny, and as the controversy raged, HHS’ Biomedical Advanced Research and Development Authority withdrew funding, tanking the program. That vaccine later returned promising results from a trio of phase 1 studies.
Then, in December, Sanofi abandoned its late-stage C. difficile program after an interim analysis turned negative, leaving Pfizer and Valneva on track to split a market potentially worth $1 billion.
Elsewhere in R&D, Sanofi is developing a live attenuated RSV vaccine for infants under an NIH deal. Last March, it teamed up with AstraZeneca’s MedImmune to co-develop a monoclonal antibody to prevent RSV. But many companies—such as Novavax, Pfizer and Bavarian Nordic—are all eyeing the same field.