Sanofi Reports Strong Second-Quarter 2019

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Sanofi reported overall net sales increased by 5.5% for the second quarter, driven by Sanofi Genzyme, Sanofi Pasteur and emerging markets. Sanofi Genzymes’ sales increased 21.8%, driven by the new launch performance of Dupixent. Vaccines sales grew 24.7% mostly because of recovery and growth of Pentaxim in China. Emerging markets grew up 10%, supported by vaccines and rare diseases sales.

As a result, Sanofi raised its 2019 outlook, projecting earnings per share (EPS) growth of about 5%. “Business EPS outlook is raised to the top-end,” wrote Peter Welford, a Jefferies analyst, “but suggests only minor potential upgrades to consensus, at most, in our view.”

Much of the projection is based on continuing growth of Dupixent, which is indicated for atopic dermatitis, asthma and chronic rhinosinusitis. Dupixent was co-developed with Regeneron Pharmaceuticals. In the second quarter, Dupixent sales rose 168% in constant exchange rates to $551.8 million. The drug is marketed in 28 countries with another 18 countries expected to reach the market by the end of the year.

On the downside, the company’s diabetes sales dropped 7%, largely because of pricing pressure on its Lantus insulin product, whose patent has expired.

“Sanofi continued its growth phase with a solid business performance in the second quarter, led by the strong launch of Dupixent driven by the accelerated uptake in atopic dermatitis and asthma in the U.S.,” stated Olivier Brandicourt, Sanofi’s chief executive officer. “Specialty Care and Vaccines were significant contributors across all geographies. Our increased focus in R&D delivered important results with several positive data read-outs and the achievement of regulatory milestones. We are confident in the growth outlook for the year. Consequently, we have revised upward our guidance for full-year business EPS growth to approximately 5%.”

The company reported a number of regulatory milestones for the quarter. These included Isatuximab being accepted for review by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for relapsed/refractory multiple myeloma. Libtayo was approved for advanced cutaneous squamous cell carcinoma in Europe, and Dupixent was recommended for review by the EMA’s CHMP for atopic dermatitis in adolescents and approved in the U.S. for chronic rhinosinusitis with nasal polyposis. The FDA has also accepted MenQuadfi for review. MenQuadfi is a meningococcal vaccine candidate.

Total net sales for the quarter were 8.628 billion euros. Specialty Care franchises, which included Rare Disease, Multiple Sclerosis, Oncology, Immunology and Rare Blood Disorders brought in 2.620 billion euros, its Primary Care franchises, which included Established Rx Products, Diabetes and Cardiovascular, brought in 3.844 billion euros. Consumer Healthcare reported 1.143 billion euros for the quarter and Vaccines reported 1.021 billion euros.

Sanofi’s Eloctate for hemophilia dropped 11%, hammered by the recent entry of Roche’s Hemlibra.

“It is a non-cash event of course but it is clear that the competition from Hemlibra was a surprise to everyone and it is indeed putting pressure,” Jean-Baptiste de Chatillon, Sanofi’s chief financial officer, told the media at the conference call.

Eloctate was developed by Bioverativ, formerly a Biogen company, acquired last year by Sanofi for $11.6 billion.