On July 25th, Sanofi announced its Q2 2024 results, with revenue of 10.745 billion euros, a year-on-year increase of 10.2%, achieving unexpected growth. After adding the first quarter performance, the total revenue for the first half of 2024 reached 21.209 billion euros, with a growth rate of 8.4%.
Among them, the pharmaceutical business revenue was 16.059 billion euros, a year-on-year increase of 9.6%; Vaccine revenue was 2.319 billion euros, a year-on-year increase of 0.3%, and consumer healthcare business revenue was 2.831 billion euros, a year-on-year increase of 9.2%. Driven by Dupixent, Toujeo, and Plavix, Sanofi's sales in China increased by 2.8% to 1.522 billion euros.
The performance of Sanofi's flagship product Dupilumab remains impressive. Thanks to strong market demand, Prumumab grew by 29.2% in the second quarter, with global sales reaching 3.303 billion euros. In addition, the first quarter revenue was 2.835 billion euros, bringing the total sales for the first half of the year to 6.138 billion euros, with an expected annual sales of 13 billion euros.
At present, the global incidence of autoimmune diseases is about 5% to 8%, making it the third largest chronic disease autoimmune disease after cancer and cardiovascular disease. The patient population is large, and the estimated number of autoimmune diseases worldwide is over 500 million. According to Frost&Sullivan data, the global market size for self administered drugs is expected to reach approximately $132.3 billion in 2022, and is projected to reach $176.7 billion by 2030, making it the second largest disease market in the world.
Multiple star products have emerged in the field of self sparing diseases. Among the top 10 global drug sales in 2023, three are self sparing drugs with a total sales revenue of 48.4 billion US dollars, including Sanofi/Regeneron's Primumab, AbbVie's Adalimumab, and Johnson&Johnson's Ulsinumab. However, Adalimumab lost its 11 year reign as the "king of drugs" in 2023, with revenue declining by 32.2% to $14.404 billion. And Sanofi's Dupilumab sales surged 34% year-on-year, reaching $11.717 billion, second only to AbbVie's Xiumeile, and leading the third place Johnson&Johnson's Ulsunumab by nearly $1 billion.
Sanofi's dazzling commercialization achievements in the field of atopic dermatitis have also successfully triggered many pharmaceutical companies to enter the market for atopic immune drugs, challenging the use of Prumumab.
Dupixent's revenue exceeds 6.1 billion euros
As a star product of Sanofi, Dupilumab's net sales in the second quarter reached 3.303 billion euros, an increase of 29%, far exceeding the expected 3.16 billion euros. The US market has made the most outstanding contribution, reaching 4.437 billion euros in the first half of 2024.
In Europe, due to the continued growth of atopic dermatitis (AD), asthma, and chronic sinusitis with nasal polyps (CRSwNP), the net sales of Dupilumab in the first half of 2024 totaled 770 million euros, an increase of 31.2%. In other parts of the world, the net sales of Dupilumab were 931 million euros, a year-on-year increase of 63.9%, mainly from the Japanese and Chinese markets.
In the Chinese market, Dupilumab has also achieved impressive results. Data shows that from 2020 to 2022, the sales of Dupilumab in China have been increasing year by year. In 2022, the sales revenue of Dupilumab in domestic public medical institutions reached 959 million yuan, an increase of 209% compared to 2021.
Industry insiders believe that the sharp increase in sales of Dupilumab is mainly due to two reasons: on the one hand, it is the first and only approved IL-4R monoclonal antibody, and there are no similar competitors; On the other hand, Dupilumab voluntarily chose to lower its price in order to quickly enter the medical insurance catalog and achieved sales volume after being included in the national medical insurance.
Dupilumab, as the first biological agent targeting the key pathogenesis of atopic dermatitis, can regulate IL-4 and IL-13 signaling and inhibit type 2 inflammatory response. Over the past four years, it has been approved in China as an indication for moderate to severe atopic dermatitis in adults, adolescents, children, and infants over 6 months of age.
At the same time, based on the unique mechanism of type 2 inflammation, Dupilumab continues to expand its indications. In addition to being approved for moderate to severe adult nodular prurigo, it has also been approved for maintenance treatment of adolescents and adult asthma patients aged 12 years and above, chronic sinusitis with nasal polyps, eosinophilic esophagitis and other indications, covering different diseases in dermatology and spanning across respiratory and dermatological treatment fields. The continuous expansion of indications means that the patient population of Dupilu continues to grow, which contributes to the sustained increase in Dupilu's sales.
In the second half of this year, Dupilumab will experience further market expansion.
On July 3rd, Sanofi and Regeneron jointly announced that Dupilumab has been approved by the European Medicines Agency as an additional maintenance therapy for uncontrolled chronic obstructive pulmonary disease (COPD) patients characterized by elevated levels of blood eosinophils. As a chronic lung disease, COPD has a high disability and mortality rate, and is expected to reach a market size of $27.8 billion by 2030. However, there are currently no approved biologics for therapeutic drugs. Dupilumab is expected to become the first biological agent for the treatment of COPD.
In addition to Dupilumab, Sanofi is also developing Itepekimab, the world's first IL-33 monoclonal antibody targeting COPD. Sanofi expects that these two drugs will be able to help up to 80% of patients with chronic obstructive pulmonary disease, and their combined annual sales peak is expected to reach 5 billion euros.
In addition, the supplementary biological product approval application for Dupilumab in the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adolescent patients has also been given priority review by the FDA, with a PDUFA date of September 15th. If approved, Dupilumab will become the first therapy in the United States targeting adolescent CRSwNP patients aged 12-17 years. The indications for pediatric patients with eosinophilic esophagitis (EoE) and chronic spontaneous urticaria are also expected to receive EU approval in the second half of the year.
The key Phase III study data of Dupilumab for skin diseases such as bullous pemphigus and chronic spontaneous urticaria will also be released in the second half of the year. In February of this year, Dupilumab was approved for marketing in Japan based on the Study A study data from the LIBERTY-CUPID clinical trial project, for the treatment of chronic spontaneous urticaria aged 12 and above that cannot be fully controlled by existing treatment methods.
The market competition for atopic dermatitis is fierce
Due to the large number of patients, long medication cycles, and significant unmet clinical needs, the atopic dermatitis track has attracted major pharmaceutical companies to enter the market.
According to a report by Marketus, the global market for treating atopic dermatitis is expected to reach $24.5 billion by 2032. The considerable market size has attracted many pharmaceutical companies to try to enter the field of atopic dermatitis drugs, including innovative therapeutic drugs targeting different targets and pathways such as IL-4R monoclonal antibodies, JAK inhibitors, IL-13 inhibitors, OX40 inhibitors, etc.
The competition for IL-4R antibodies in China is fierce, and many pharmaceutical companies are laying out IL-4 targets. Among them, the fastest progressing products, Kangnuo and Kangnaide, are one step away from being launched. Products related to Maiji Biology and Kangnaide/Xiansheng Pharmaceutical have entered Phase III clinical trials, while products related to Zhengda Tianqing, Hengrui Pharmaceutical, Sansheng Guojian, Quanxin Biotechnology and other companies have entered Phase II clinical trials.
In addition to IL-4R antibodies, JAK1 inhibitors are also a rising star in the field of moderate to severe atopic dermatitis. Currently, two JAK1 inhibitors have been approved for AD indications worldwide, namely Ubatinib from AbbVie and Abuxitinib from Pfizer. One JAK inhibitor, Jakatinib, under Zejing Pharmaceutical in China, is currently in clinical phase III for moderate to severe atopic dermatitis. However, previous cases of death from JAK inhibitors such as Abu Xitinib and Upatinib in clinical settings have made their safety unable to compete with Dupilumab. Nevertheless, the latest data from Phase IIIb/IIII LEVELUP studies have shown the advantage of Upatinib over Dupilumab, but to what extent it can ultimately replace Dupilumab remains to be observed.
In addition, IL-13 is considered a novel target with excellent efficacy and safety. In December 2023, the official website of the Drug Evaluation Center of the China National Medical Products Administration showed that the Lebrikizumab injection declared by Eli Lilly and Company had obtained implied clinical trial approval and was intended to be developed for the treatment of moderate to severe atopic dermatitis in adolescent and adult patients. As an IL-13 specific antibody therapy jointly developed by Almirall and Eli Lilly, lebrikizumab injection has obtained the first global batch in the European Union in November this year for use in moderate to severe atopic dermatitis patients in adolescents and adults.
In addition to the above two targets, the performance of OX40 in the treatment of atopic dermatitis is also worth looking forward to. Not long ago, Sanofi's OX40 inhibitor Amlitelimab achieved phase II clinical success. The average eczema area and severity score of patients treated with Amlitelimab improved by 61.5% compared to baseline at week 16, and continued to improve within 24 weeks, achieving good treatment outcomes. In addition to Sanofi, pharmaceutical companies such as Amgen, IchnosSciences, and Hutchison Pharma/Innolux are also focusing on this target.
Not only that, some pharmaceutical companies also invest heavily in mergers and acquisitions to lay out the track of atopic dermatitis. For example, Johnson&Johnson made two acquisitions within a month around the atopic dermatitis track. On May 16th, Johnson&Johnson announced the acquisition of Proteologix for $850 million in cash. Proteologix's product portfolio includes bispecific antibodies targeting interleukin-13 (IL-13) and TSLP for the treatment of moderate to severe atopic dermatitis and moderate to severe asthma. On May 28th, Johnson&Johnson announced that it will acquire Numab subsidiary YellowJersey Therapeutics for approximately $1.25 billion in cash, aiming to acquire ownership of a first in class bispecific antibody NM26 for the treatment of atopic dermatitis. NM26 is a bispecific antibody targeting IL-4R α and IL-31, used to treat atopic dermatitis, prevent IL-4/IL-13 and IL-31 induced keratinocyte immunopathology, immune cell activation, skin barrier dysfunction, and itching.
With the continuous increase in clinical indications and demand from various pharmaceutical companies, the market size of atopic dermatitis will further expand, and the market for atopic dermatitis treatment drugs will become a major red ocean. Faced with the temptation of a billion dollar market, many pharmaceutical companies are committed to building their own competitive advantages and finding new targets. The battle for the market of atopic immune drugs has already begun.