Year Established: 2004
Revenues: $39,419 (-2%)
Net Income: $4,925 (+1%)
R&D: $6,742 (+8%)
TOP SELLING DRUGS
|Aubagio||Relapsing-Remitting MS (RRMS)||$1,945||10%|
|Plavix||heart attack, stroke||$1,701||2%|
|Myozyme / Lumizyme||Pompe disease||$992||11%|
Revenue fell slightly for Sanofi in 2018 as it continued to restructure its operations to focus on mature markets and across emerging markets. The French pharma major reported sales of $39.4 billion, down 2% from the year prior, and slid two spots to number five in this year’s ranking.
During the year, Sanofi changed the organizational structure of two of its global business units, creating a new primary care unit that combines the product portfolios of the existing diabetes and cardiovascular unit with established products. The new primary care unit will focus exclusively on mature markets.
Sanofi also created a second new global business unit called China and emerging markets. This newly-formed business will focus on the growth opportunities in emerging markets, particularly in China, which is Sanofi’s second largest market after the U.S.
In-line with these plans to focus efforts on emerging markets, particularly China, Sanofi launched global R&D operations in the country during the year. The new Global R&D Operations Hub is focused on digitalization and big data analysis and located in Chengdu, Sichuan province, China. The new R&D operations in China will serve as Sanofi’s third pillar of Sanofi Global Clinical Sciences and Operations, joining facilities in France and the U.S.
The €66 million investment will support the clinical research and development of Sanofi’s drugs by focusing on the management of global multi-center clinical trials data and files. The hub will bring together global data and analysis in an effort to accelerate the availability of trial results, from Phase I to Phase IV.
The Chengdu Hub will target therapeutic areas including diabetes and cardiovascular diseases, vaccines, oncology, immunology and inflammation, rare diseases, multiple sclerosis and neurology. It will leverage global cutting-edge biological technology for polypeptides, gene therapy, monoclonal antibodies and multi-specific antibodies. The Hub plans to recruit 300 local pharmaceutical R&D professionals by 2020.
In another major investment, Sanofi is pouring nearly $400 million into the construction of a new state-of-the-art vaccine manufacturing facility at the Sanofi Pasteur Canadian headquarters in Toronto, Ontario, Canada. The new facility will allow Sanofi Pasteur, the vaccines global business unit of Sanofi, to meet the growing demand of five-component acellular pertussis (5-acP) antigen. Upon completion in 2021, the new building will also be equipped to produce the antigens used in the diphtheria and tetanus vaccines.
M&A deals and divestments
Sanofi signed a few acquisition and divestment agreements during the year as part of its refocused strategy. The largest deal in terms of dollars was the $11.6 billion acquisition of Bioverativ, a biopharma company focused on therapies for hemophilia and other rare blood disorders. Bioverativ was created from Biogen’s hemophilia-focused spinoff launched in early 2017.
Hemophilia represents the largest market for rare diseases, with approximately 181,000 people affected worldwide, and is expected to grow above 7% per year through 2022. Bioverativ has approximately $10 billion in annual sales. It’s extended half-life therapies, Eloctate and Alprolix for the treatment of hemophilia A and B, respectively, represented the first major advancements in the hemophilia market in nearly two decades when launched. In 2016, Bioverativ generated $847 million in sales and $41 million in royalties.
Sanofi believes factor replacement therapy will remain the standard of care in hemophilia for many years due to its safety and increasingly superior long-acting profile. Sanofi will be able to leverage Bioverativ’s clinical expertise and commercial platform to advance fitusiran, an investigational RNA interference (RNAi) therapeutic for hemophilia A and B, with or without inhibitors.
Bioverativ’s pipeline includes a Phase III program for cold agglutinin disease, and early stage research programs and collaborations in hemophilia, and other rare blood disorders, including sickle cell disease and beta thalassemia.
In another acquisition, Sanofi purchased Ablynx, a biopharma company focused on the discovery and development of nanobodies, for approximately $4.8 billion. Sanofi said the acquisition is part of its innovation efforts focused on technologies addressing multiple disease targets with single multi-specific molecules.
Nanobodies are a new class of next-gen biologics. Ablynx’s nanobody technology supports an extensive pipeline of more than 45 proprietary and partnered candidates for a range of therapeutic areas such as hematology, inflammation, immuno-oncology and respiratory diseases. Eight nanobodies have entered clinical development.
On the divestment front, Sanofi sold its European generics business to Advent International for roughly €1.9 billion, as part of a continued effort to focus on its core areas of global medicines and emerging markets, specialty care and diabetes and cardiovascular. Sanofi’s chief executive officer at the time, Olivier Brandicourt*, had planned to sell the business back in 2015 as part of the refocusing effort. Since then, Sanofi also sold its animal health business Merial, purchased Boehringer Ingelheim’s consumer health assets, and made the aforementioned acquisitions of Ablynx and Bioverativ.
Sanofi also sold off its UK contract manufacturing organization (CMO) business. Recipharm bought the manufacturing center and business in Holmes Chapel, UK. The site manufactures flutiform for Vectura Group. As part of the transaction, Sanofi entered into a long-term supply agreement for the products currently manufactured at the facility, including metered dose inhalers and nasal sprays.
*Note: As this issue goes to press, Paul Hudson will be getting ready to take over the chief executive role upon Mr. Brandicourt’s retirement.