Year Established: 2004
Revenues: $40,486 (-1%)
Net Income: $8,053 (+8%)
R&D: $5,863 (-5%)
TOP SELLING DRUGS
|Plavix||heart attack, stroke||$2,107||-7%|
After a bit of a turbulent close to 2014 that saw the ouster of former chief executive officer Chris Viehbacher, who was fired amid whistleblower lawsuit claims that the company was involved in a kickback scheme, Sanofi brought in Olivier Brandicourt as the new chief executive to right the ship. With nearly 30 years experience in the pharma industry and the former chair of Bayer Healthcare’s management board, Mr. Brandicourt led the French pharma giant to $40.5 billion in revenue in 2015.
Pharmaceutical segment sales rose by 7.5% and includes Genzyme operations as well as a broad range of prescription medicines, generic medicines, and consumer health products.
Sales for the diabetes division were down nearly 7% mainly due to lower sales of Lantus in the U.S., where sales dropped 17%. Outside the U.S., the division posted 9% growth driven by emerging markets, which were up 16%. Western Europe posted more modest sales growth of 3% due to the entry of a biosimilar of insulin glargine into the market in the second half of the year. As a result, sales for the glargine franchise, which includes Lantus and Toujeo, a new-generation basal insulin launched in 2015, fell by 8.5%.
In the oncology business sales were down 1.9%. The company says solid performances from Jevtana and Mozobil were offset by the impact of generic versions of Taxotere in Japan. Sales of Jevtana were up 9.5% driven by a strong performance in the U.S. and Japan, where the product was launched in September 2014. Mozobil sales were up 16% mainly on sales growth in the U.S. Taxotere saw net sales fall sharply by 22% because the product is facing competition from generics in emerging markets and in Japan.
The Genzyme business posted sales growth of nearly 30% driven by a solid performance from the multiple sclerosis franchise. Aubagio sales surged by 78% while the ongoing launch of Lemtrada continued to yield very positive results.
Sales for the consumer health care business rose by 3% on strong sales from Allegra OTC in the U.S. following the launch of a new formulation. The generics business posted sales growth of 7.6% in 2015 driven by increased sales of the authorized generic of Lovenox.
In 2015, net sales for the Vaccines segment, which includes the Sanofi Pasteur MSD joint venture with Merck, were up 19%.
Within the vaccines segment sales of Polio/Pertussis/Hib vaccines rose by 8% boosted by the performances of Pentaxim and Hexaxim. Sales in emerging markets grew strongly by 33% due to sales of Pentaxim and polio vaccines in China.
Sales of influenza vaccines rose by 2% with strong growth in the U.S., while in emerging markets sales declined by 15%. Sales of meningitis/pneumonia vaccines climbed 17%. Adult booster vaccines net sales increased by 10%.
In 2015 Sanofi announced a number of strategic alliances designed to drive product innovation and business growth. On the cancer front, Regeneron Pharmaceuticals and Sanofi entered into a immuno-oncology global collaboration to discover, develop and commercialize new antibody cancer treatments. The companies will jointly develop a programmed cell death protein 1 (PD-1) inhibitor currently in Phase I and plan to initiate trials in 2016 with new preclinical therapeutic candidates. Regeneron received a $640 million upfront, and the companies will invest $1 billion for discovery through proof of concept/Phase IIa of monotherapy and novel combinations of immuno-oncology antibody candidates to be funded 25% by Regeneron ($250 million) and 75% by Sanofi ($750 million). The companies have also committed to equally fund an additional $650 million for development of REGN2810, a PD-1 inhibitor. Also, Sanofi will pay Regeneron a one-time milestone of $375 million should sales of a PD-1 product and any other collaboration antibody exceed $2 billion in any consecutive 12-month period.
In another cancer deal, Sanofi and BioNTech A.G. entered into a multi-year exclusive collaboration and license agreement to discover and develop as many as five cancer immunotherapies, each consisting of a mixture of synthetic messenger RNAs (mRNAs).
BioNTech received $60 million in upfront and near-term milestone payments, and is eligible to receive more than $300 million in development, regulatory and commercial milestones per product, as well as royalties on sales. Also, BioNTech has the option to co-develop and co-commercialize two of the five mRNA therapeutics products with Sanofi in the EU and U.S.
Leveraging Sanofi’s global oncology footprint and scientific expertise, BioNTech will combine the use of its mRNA technology platform to develop immune-stimulating pharmaceuticals. As part of this effort, BioNTech will utilize its mRNA formulation technology, which enables targeted mRNA delivery in vivo, to generate novel cancer immunotherapies. BioNTech will also supply part of the mRNA material needed for development activities from its GMP manufacturing unit.
Also in the field of cancer research, Evotec AG and Apeiron Biologics AG, a biotech company with a focus on immunological approaches to treat cancer, formed a strategic collaboration with Sanofi to develop novel small molecule-based cancer immunotherapies.
This collaboration includes major research and development efforts to advance a first-in-class small molecule approach to treat solid and haematopoietic cancers by enhancing the anti-tumor activity of human lymphocytes. Based on Evotec’s technological expertise and Apeiron Biologics’ immunological know-how, the collaboration will also focus on the identification of novel small molecule hits and their targets for next-generation therapies in immuno-oncology, which are expected to complement the current offerings of checkpoint inhibitors.
The collaboration is set up as an initiative to support long-term pipeline building for Evotec, Apeiron Biologics and Sanofi. All three companies will make contributions to this collaboration in terms of scientific expertise, technological platforms and resources.
The agreement triggers two years of research payments for Evotec and Apeiron Biologics with the opportunity to receive preclinical, clinical, regulatory and commercial milestones which could total over €200 million as well as royalties upon commercialization.
Evotec and Sanofi also formed a collaboration in the field of diabetes. The goal of this collaboration is to develop a beta cell replacement therapy based on functional human beta cells derived from human stem cells. In addition, Sanofi and Evotec will also use human beta cells for high-throughput drug screening to identify beta cell active small molecules or biologics. The agreement triggers an upfront payment of €3 million, potential preclinical, clinical, regulatory and commercial milestones, which could total over €300 million as well as significant royalties and research payments.
Also in diabetes, Sanofi and Lexicon Pharmaceuticals entered into a collaboration and license agreement for the development and commercialization of sotagliflozin, an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), which could be a potential treatment option for people with diabetes. The developmental medicine sotagliflozin (LX4211) is currently being studied in two Phase III trials in type 1 diabetes, which are expected to report top-line results during the second half of 2016. Phase III trials in type 2 diabetes are expected to begin in 2016.
Sotagliflozin could have the potential to become an important option among oral anti-diabetic medicines and provide a strong rationale for the further investigation of this compound as a treatment for people with diabetes. Lexicon received an upfront payment of $300 million and is eligible to receive development, regulatory and sales milestone payments of up to $1.4 billion. Lexicon is also entitled to tiered, escalating double digit percentage royalties on net sales of sotagliflozin.
During the year Adimab entered a multi-target discovery and optimization collaboration with Sanofi to use its platform to generate bispecific molecules against multiple targets. Sanofi has the right to develop and commercialize any resulting therapeutic antibodies and bispecifics. Adimab receives an undisclosed upfront payment, research fees and technical milestones. Also, for each target, Sanofi will have the option to exclusively license antibodies and bispecifics generate during the collaboration, at which point, Adimab would receive license fees, clinical milestones and royalties on product sales.
Sanofi and Boehringer Ingelheim entered an alliance to extend Sanofi’s manufacturing capacity network for therapeutic monoclonal antibodies. Boehringer’s cell culture operations will provide contract manufacturing capacities to support the production of Sanofi’s biologics pipeline. Under the agreement, Sanofi will have access to Boehringer’s capabilities to transfer and manufacture therapeutic monoclonal antibodies for global market supply. Initial product transfers will begin in early 2015.
Sanofi also entered into a collaboration with Catalent Pharma Solutions to implement Catalent’s SMARTag technology in the development of next generation antibody-drug conjugates (ADCs). Catalent will develop site-specifically modified antibody conjugates using Sanofi’s antibodies, enabling Sanofi to evaluate site selective payload conjugation in order to enhance ADC pharmacokinetics, efficacy and safety. The collaboration involves teams at Sanofi and Catalent’s facility in Emeryville, CA.
Three new global business units for general medicines and emerging markets, specialty care, and diabetes and cardiovascular
In July of last year Sanofi released plans to create five global business units: General Medicines and Emerging Markets; Specialty Care; Diabetes and Cardiovascular; Sanofi Pasteur; and Merial.
“The new organization simplifies and focuses Sanofi to optimize growth,” said Olivier Brandicourt, chief executive officer, Sanofi. “This is a necessary step for ensuring that Sanofi’s new medicines and vaccines continue to build on our heritage of providing innovative healthcare therapies.”
The General Medicines and Emerging Markets global business unit is led by Peter Guenter and consists of Sanofi’s established products, generics, consumer healthcare, and all pharmaceutical businesses in emerging markets.
The Specialty Care global business unit, called Sanofi Genzyme, is led by David Meeker and consists of Sanofi’s medicines in rare diseases, multiple sclerosis, oncology and immunology, including the two, investigational biologics, sarilumab and dupilumab.
The Diabetes and Cardiovascular global business unit is led by Pascale Witz and consists of Sanofi’s diabetes care medicines as well as cardiovascular, including Praluent (alirocumab), which is currently under review by the U.S. FDA and the European Medicines Agency (EMA).
Sanofi Pasteur and Merial are both global business units and will continue to manage their current portfolios of vaccines and animal health products. Olivier Charmeil will continue to lead Sanofi Pasteur and Carsten Hellmann will continue to lead Merial.
The composition of the executive committee remains unchanged and the leadership roles announced above became effective January 1, 2016.