Sanofi 2019 Financial Report: Dupixent's Breakthrough Performance Signals Path to €10 Billion Blockbuster

On February 5, Sanofi announced its 2019 financial results, reporting net sales of €36.126 billion (+4.8%). By Global Business Unit (GBU), Specialty Care generated revenues of €9.195 billion (+22.4%), Primary Care generated €9.076 billion (-14.8%), China and Emerging Markets contributed €7.437 billion (+6.4%), Consumer Healthcare amounted to €4.687 billion (-0.8%), and Vaccines reached €5.731 billion (+9.3%).

In terms of specific products, double-digit growth was primarily driven by strong contributions from pharmaceuticals in the oncology and immuno-inflammation sectors. The most standout performer was Dupixent (dupilumab), a treatment for atopic dermatitis, which surpassed €2 billion in sales within just three years of launch. Sanofi has explicitly stated its expectation that Dupixent will achieve peak sales exceeding €10 billion.

2019 Sanofi Major Drug Sales (€ billion)

Dupilumab binds to the IL-4Rα subunit, which is shared by the IL-4 and IL-13 receptors, thereby simultaneously blocking both IL-4 and IL-13. Consequently, it is effective in the treatment of asthma, chronic rhinosinusitis with nasal polyps, and atopic dermatitis, demonstrating superior clinical efficacy compared to anti-IL-13 antibodies.

As a breakthrough therapy, dupilumab is currently approved for the indications of atopic dermatitis (in patients aged 12 years and older), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP). It is the first drug approved for the treatment of inadequately controlled CRSwNP, the only biologic agent approved for oral corticosteroid-dependent asthma (regardless of phenotype), and the only anti-asthma biologic that allows for self-administration via home injection. These milestone achievements have enabled dupilumab to achieve explosive market performance within just three years of its launch. Furthermore, dupilumab is currently under development for additional indications, including chronic obstructive pulmonary disease (COPD), esophagitis, and peanut allergy.

Sanofi achieved multiple advancements in the development and registration of several key frontier products in 2019, including the successful completion of the Phase II proof-of-concept study of the BTK inhibitor SAR442168 for multiple sclerosis (with Phase III trials scheduled to commence in mid-2020), the submission of marketing applications to the FDA and EMA for dupilumab in pediatric patients aged 6–11 years with atopic dermatitis, positive results from the Phase III study of the breakthrough complement C1s antibody drug sutimlimab for cold agglutinin disease, and the advancement of the anti-CEACAM5 antibody-drug conjugate SAR408701 into pivotal Phase III studies for non-small cell lung cancer. Meanwhile, Sanofi announced in late 2019 its acquisition of Synthorx for $2.5 billion, further strengthening its product pipeline in oncology and immunology.

Although the innovative drug and vaccine businesses are thriving, Sanofi’s growth in China and other emerging markets was only 6.4%, failing to achieve the robust double-digit growth seen by companies such as Novartis and AstraZeneca in these regions. This sluggish performance is primarily attributable to significant changes in China’s generic drug market, particularly the impact of the volume-based procurement (VBP) policy. Plavix (clopidogrel), a former flagship product, generated €1.334 billion in sales revenue in 2019. While its annual decline was a modest 8.8%, its global performance plummeted by 36.9% in the fourth quarter of 2019 (Q4 2019), with sales in the Chinese market experiencing an even more dramatic 66% drop to just €55 million. A similar fate befell Aprovel (irbesartan), whose Q4 2019 sales in China fell by 40% to €40 million.

However, Sanofi China had already anticipated the changes in the market environment, previously announcing that revenues from Plavix and Aprovel in the Chinese market would continue to decline by 50% in 2020. The financial report disclosed this time still maintains the previous statement.

Overall, Sanofi’s new CEO, Paul Hudson, expressed strong satisfaction with the company’s performance in 2019. In his comments, he stated, “I am highly encouraged by the performance of dupilumab and the progress made in our pipeline. Over the past year, we have made significant strides in transforming and enhancing Sanofi’s R&D capabilities. I am particularly excited about the positive results from the Phase II proof-of-concept study of our BTK inhibitor, SAR442168, for the treatment of multiple sclerosis. The operational efficiency across the entire organization has improved markedly, and I am confident in the company’s long-term growth prospects.”