Following its Play to Win strategy, Sanofi looks to the future with a new corporate identity and charitable foundations.

By Christiane Truelove • chris.truelove@medadnews.com

Sanofi

54, rue La Boétie 

75008 Paris, France 

+ 33 (0)1 53 77 40 00 • sanofi.com

2021 sales

• Dupixent $6,210 
• Lantus $2,950 
• Aubagio $2,313 
• Lovenox $1,758 
• Myozyme, Lumizyme $1,187 
  
• Toujeo $1,146 
• Plavix $1,099 $
• Fabrazyme $998 
• Cerezyme $808 
• Eloctate $666 
• Jevtana $538

1H 2022

• Dupixent $4,232 
• Lantus $1,504 
• Aubagio $1,203 
• Lovenox $845
• Toujeo $640 
• Plavix $601 
• Myozyme, Lumizyme $576 
  
• Fabrazyme $542 
• Cerezyme $434 
• Eloctate $344 
• Avapro/Aprovel, CoAprovel $289 
• Alprolix $280 

Outcomes Creativity Index Score: 22

• Manny Awards — N/A
• Cannes Lions — N/A
• Clio Health — N/A
• Creative Floor Awards — 19
• London International Awards – N/A
• MM+M Awards — 3
• One Show — N/A

In summing up Sanofi’s performance at the end of 2021, CEO Paul Hudson cites “impressive record sales” of Dupixent, and “another year of record influenza sales in the company’s vaccines division.”

CEO Paul Hudson

“In R&D, we continue to be relentless in our commitment to expand our innovative pipeline,” Hudson stated. “Last quarter (Q4 2021), Sanofi achieved a new milestone, a first in recent years, by moving seven molecules into Phase I and seven pipeline programs into Phase II trials, showcasing our success in rapidly advancing potentially transformative medicines. We further strengthened our R&D capabilities with a series of value-creating M&A transactions in 2021. “

Hudson continued, “Our excellent financial performance validates our ability to increase profitability through improved product mix, supported by expense management and the reinvestment of savings behind our growth drivers, all of which puts us on a trajectory to achieving our 2022 financial targets.” 

And in their strategy, Sanofi executives are thinking about much more than just financial results. In February 2022, Sanofi kicked unveiled a new “bold and unifying” corporate brand that “supports the modernization and transformation the company launched in December 2019.”

“Over the last 50 years, Sanofi has grown into a diverse, global healthcare leader, with a rich heritage of patient-centric scientific discovery,” company executives say. “This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease. Sanofi’s commitment to public health has helped protect hundreds of millions of people from influenza every year for decades and pushed polio to the brink of eradication, while its scientific vision has led to breakthrough innovations in the treatment of inflammatory diseases.”

Management says with its roots in a variety of diverse companies, Sanofi is now the combination of many cultures, identities and brands,. The new brand brings this diverse history together in a single common identity for the first time, manifesting the company’s journey and highlighting an ambitious strategy for the future.

“As we approach the half-century mark of our company’s existence, we have undertaken the most important transformation and modernization in our history,” Hudson says. “In 2019, we launched our ‘Play to Win’ strategy, which focuses on applying our platform for innovation to produce first- and best-in-class treatments and vaccines. Our new brand is a natural and important next step in this journey and represents the integrated way in which the company will work to achieve our shared ambition to transform the practice of medicine.”

Under the new corporate identity, the vaccine unit Sanofi Pasteur and the specialty medicines unit Sanofi Genzyme, as well as all other acquired brands, will be united under the singular Sanofi name and brand. 

“These brands have for years symbolized the impact that innovation can have on people’s lives,” company executives say. “Thinking, acting, and behaving as a single entity under a new shared purpose and identity will position Sanofi to have greater impact by more strategically applying the resources that exist across the company to drive innovations that matter.”

Management maintains that the new logo (see this magazine’s cover) is a representation of Sanofi’s new purpose and ambition, which is inspired by the simple and motion-oriented codes of the tech industry. The two purple dots embody the scientific journey between a starting point – the curiosity of questioning the status-quo and wondering “what if?” – and a finish line – the eureka moment where innovative solutions are unlocked to impact people’s lives. 

“With our new brand, we have sought to provide our people, our partners, patients and healthcare professionals with a clear and strong understanding of who we are and what we are set to achieve,” says Josep Catllà, head of corporate affairs at Sanofi. “Sanofi’s attitude is humble, authentic – and a little bit unconventional, too. We believe that our new brand and logo carve out a unique space in the healthcare industry that perfectly represents our new purpose to chase the miracles of science to improve people’s lives.”

In another effort to display its vision beyond just pharmaceuticals, Sanofi in May 2022 launched Foundation S – The Sanofi Collective, its philanthropic endowment fund aiming to create healthier futures for generations. Using donations, partnerships and collective action, Foundation S will focus on three critical areas: childhood cancer, the health of communities most vulnerable to the effects of climate change and pollution, and access to lifesaving medicines and vaccines.

Foundation S will incorporate as its cornerstone initiative the former Sanofi Espoir Foundation’s “My Child Matters” program in childhood cancer. Additionally, Foundation S will fund awareness and research for childhood cancer in various countries. 

Foundation S also will work to increase the health resilience of vulnerable populations most impacted by climate change and pollution, collaborating with the international NGO Friendship, with a project focused on Bangladesh’s hard-to-reach, climate-vulnerable islands of Gaibandha. There, Foundation S will help train healthcare workers, and fund satellite clinics and a floating hospital in a region outside mainstream healthcare services.

Also, Foundation S will leverage Sanofi’s longstanding emergency aid expertise and improve the connection between humanitarian and development financing, renewing Sanofi’s emergency aid donations program and expanding proactive support notably for displaced populations.

“The launch of Foundation S is a new cornerstone of Sanofi’s commitment to society and a pivotal moment for the life of our company and our people,” Hudson says. “With Foundation S, we aim to weigh in and act on targeted areas where we know we can make a real difference for populations exposed to health difficulties.”

Advancing the company’s fully integrated social impact strategy once more in July 2022, Sanofi launched Impact, a dedicated brand for non-profit distribution to enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries. 

The Impact brand includes insulin, glibenclamide, and oxaliplatin among others. Considered essential by the World Health Organization, these medicines cover a wide range of therapeutic areas, including diabetes, cardiovascular disease, tuberculosis, malaria, and cancer.

The launch of the Impact brand is among the steps taken since the formation last year of Sanofi Global Health, a nonprofit unit within the company aiming to increase access to healthcare through the distribution of medicines, and the building and bolstering of local healthcare systems in countries with among the lowest per-capita GDP. Executives say Sanofi Global Health is the first and only global initiative to provide access to such a broad portfolio of medicines in so many countries and across multiple therapeutic areas while funding local support programs and strengthening local inclusive businesses.

“At Sanofi, we believe we have a responsibility to make a difference for the health of those most in need, and we know we have the ability and the ambition to bring about lasting change,” Hudson says. “With critical medicines, relentless drive and impactful partnerships, we can take our innovation beyond the lab and use it to strengthen health systems and access to medicines for those most vulnerable communities of patients. Sanofi Global Health aims to improve the lives of millions of people who now cannot get the help they need. Sanofi’s renewed purpose is to chase the miracles of science to improve people’s lives. And our quest to make life better for all people must include helping to provide better access to care and quality medicines for underserved populations.”

Performance & Outlook

Sanofi’s sales in 2021 grew to €37.76 billion ($44.67 billion), 4.8 percent more than in 2020. First-half 2022 revenue was €19.79 billion ($23.41 billion), 14.2 percent more than in the same period last year. 

The company’s 2021 net income was €6.22 billion ($7.36 billion) compared with 2020’s €12.29 billion ($14.54 billion). Diluted earnings per share in 2021 were €4.95 ($5.86) compared with 2020’s €9.76 ($11.55). 2020’s net income and earnings per share reflect the divestment of the Animal Health business that year. 

For the first half of 2022, net income was €4.59 billion ($5.43 billion), 22.6 percent more than in the same period last year. Earnings per share were €3.68 ($4.35), 22.7 percent more than in first-half 2021.

“As we continue to deliver ahead of schedule on our Play to Win strategy, we are confident in our business outlook for the second half and as a result, we are reiterating our commitment to achieving the BOI margin target of 30 percent in 2022,” Hudson says.

Sanofi’s top pharma product in terms of 2021 sales was Dupixent, which generated €5.25
billion ($6.21 billion) compared with €3.53 billion ($4.18 billion) in 2020.

First-half 2022 Dupixent sales were €3.58 billion ($4.23 billion), 44.4 percent more than in the first six months of 2021.

In a distant second place was the insulin Lantus, generating €2.49 billion ($2.95 billion), 6.3 percent less than in 2020. Sales in the first half of 2022 continued to decline compared with the same period last year, dropping to €1.27 billion ($1.5 billion), 6.7 percent less than in first-half 2021. 

Coming in at No. 3 was the multiple sclerosis drug Aubagio, at €1.96 billion ($2.31 billion), a decline of 4.4 percent from 2021. In first-half 2022, Aubagio sales totaled €1.27 billion ($1.5 billion), another 4.4 percent less than in the first six months of 2021.

Lovenox sales increased to $1.76 billion in 2021, but decreased to $845 million for the first six months of 2022.

Sanofi’s fourth best-selling product in 2021 was the antithrombotic Lovenox, at €1.49 billion ($1.76 billion). The drug’s performance, despite competition from biosimilars, was driven by sales growth in what Sanofi designates as the Rest of the World region and the effect of WHO recommendations on the use of low molecular weight heparins in hospitalized COVID-19 patients. First-half 2022 sales were €714 million ($845 million).

The company’s fifth best-selling pharma product line in 2021 was the Pompe disease franchise comprising Myozyme and Lumizyme. Together, the products generated €1 billion ($1.19 billion), an increase of 5.8 percent from 2020. First-half 2022 sales were €487 million ($576 million), a 3.3 percent decrease because of the impact of the launch of Sanofi’s Nexviazyme and conversion in the United States and Japan. 

No. 6 in 2021 sales was the insulin Toujeo, generating €969 million ($1.15 billion), 6.4 percent more than in the previous year. Sales for first-half 2022 were €541 million ($640 million), 8.2 percent more than in the first six months of 2021.

The seventh best seller in 2021 was the blood thinner Plavix, which generated €929 million ($1.1 billion), 1.8 percent more than in 2020. First-half 2022 sales were €508 million ($601 million), an increase of 4.7 percent compared with first-half 2021.

The Fabry disease drug Fabrazyme was Sanofi’s No. 8 best-selling drug in 2021, with €844 million ($998 million), an increase of 3.3 percent from the previous year. Sales during the first six months of 2022 reached €458 million ($542 million), 11.2 percent more than in the same period of 2021.

The Type 1 Gaucher disease drug Cerezyme had 2021 sales of €683 million ($808 million), about 1 percent less than in 2020. First-half 2022 sales amounted to €367 million ($434 million), 7 percent more compared to the same period last year.

Sanofi’s hemophilia A drug Eloctate posted 2021 sales of €563 million ($666 million), 11.8 percent less than in 2020 due to a decrease in sales in the Rest of World region. For the first six months of 2022, sales totaled €291 million ($344 million), 4.7 percent more than in the same period last year.

Jevtana, for treating prostate cancer, generated 2021 sales of €455 million ($538 million), 15.1 percent less than in 2020. First-half 2022 sales were €203 million ($240 million), down 15.4 percent versus first-half 2021. Decreased sales are attributed to increased generic competition in the United States and Europe.

Pipeline progress

Dupixent indications expanded in 2022 to include eosinophilic esophagitis, with FDA approval making it the first drug in the United States to treat this condition.

Sanofi achieved various pipeline goals throughout 2021. The blockbuster brand Dupixent won FDA approval for treating moderate-to-severe asthma for children aged 6 to 11 years. Dupixent also had positive pivotal trial results in prurigo nodularis and eosinophilic esophagitis. 

The company reported that Sanofi had moved various projects into its early-stage pipeline, with seven entering Phase I and seven added to Phase II.

“In 2018, we reimagined innovation in Sanofi R&D and changed the allocation of our resources to focus on delivering transformative medicines for the most urgent unmet patient needs,” stated John Reed, executive VP and global head of R&D. “Since then, we’ve gone through rapid transformation not only of our pipeline, but also our processes so that we can accelerate the pace of delivery for patients. The global pandemic stress-tested our revamped and reinvigorated approaches, pushing our teams to adopt more agile ways of working that are now becoming embedded as the new normal. One of the most remarkable transformations over the past couple of years has been in our immunology and inflammation pipeline, which has become one of the most vibrant elements of the company’s portfolio, with our flagship medicine growing rapidly in numbers of patients treated.”

Reed added, “Immunoscience is the bedrock of our work on immunological and inflammatory diseases, and is driving our progress across multiple therapeutic areas, including neurology, hematology, oncology and, of course, vaccines.”

There have been several notable pipeline achievements so far for 2022. In September, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. If approved, Beyfortus would be the first and only single-dose passive immunization for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Beyfortus is being developed jointly by Sanofi and AstraZeneca.

CHMP also in September recommended the approval of Enjaymo (sutimlimab), a C1 protein (C1s) inhibitor for treatment of hemolytic anemia in adult patients with cold agglutinin disease (CAD). CAD is a rare, serious, and chronic autoimmune hemolytic anemia. Sanofi expects a decision by the end of 2022. The drug was approved by the FDA in February 2022 as the first treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD.

Also in September 2022, positive Phase III data was published in The Lancet for Dupixent in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The FDA approved the drug in June 2022 for this indication based on the Phase III data. Data from this trial showed that adding Dupixent to low-potency topical corticosteroids (TCS) significantly improved skin clearance and reduced overall disease severity and itch compared to TCS alone (placebo) at 16 weeks. 

The drug’s indications expanded again in May 2022, when FDA approved Dupixent for adults and children aged 12 and older with eosinophilic esophagitis (EoE). With this approval, Dupixent became the first medicine specifically indicated to treat EoE in the United States. A regulatory filing for EoE is under review by the European Medicines Agency, and submissions to regulatory authorities in additional countries were planned by the end of 2022.

In September, FDA granted Dupixent approval for prurigo nodularis, making it the only drug approved for this indication. 

In August, FDA approved Xenpozyme (olipudase alfa-rpcp) for treating non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. Xenpozyme is the first therapy indicated specifically for the treatment of ASMD, and is the only approved treatment for this disease. 

Xenpozyme is an enzyme replacement therapy designed to replace deficient or defective acid sphingomyelinase (ASM), an enzyme that allows for the breakdown of the lipid sphingomyelin. In individuals with ASMD, the insufficient amount of the ASM enzyme means sphingomyelin is poorly metabolized, potentially leading to lifelong accumulation in, and damage to, multiple organs.

“Sanofi teams have been dedicated to bringing hope to patients living with ASMD and their families,” says Bill Sibold, VP, head, specialty care, at Sanofi. “This is a devastating and extremely rare disease that affects both children and adults. The approval of Xenpozyme represents the culmination of bold work done in research and development, and our unwavering commitment to this historically overlooked community.” There are fewer than 120 patients diagnosed with ASMD in the United States, with approximately two-thirds of these patients being children.

Xenpozyme was approved by the European Commission in June 2022. The European Medicines Agency (EMA) granted Xenpozyme PRIority MEdicines (PRIME) designation.

Also in August, FDA accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of hemophilia A. The target action date is Feb. 28, 2023. The BLA is supported by data from the XTEND-1 Phase III study. Sanofi executives say the data demonstrate a clinically meaningful prevention of bleeds and superiority to prior factor prophylaxis based on an intra-patient comparison. 

Not everything has been a success. Sanofi announced in August that the company is discontinuing the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). The decision is based on the outcome of a prespecified interim analysis of the Phase III AMEERA-5 trial evaluating amcenestrant in combination with palbociclib compared with letrozole in combination with palbociclib in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2) advanced breast cancer. An independent data monitoring committee found that amcenestrant in combination with palbociclib did not meet the prespecified boundary for continuation in comparison with the control arm and recommended stopping the trial.

Nexviadyme (avalglucosidase alfa) was approved by the European Commission in June 2022 as a potential new standard of care for the treatment of Pompe disease. The drug is indicated for the treatment of the full spectrum of both late-onset Pompe disease and infantile-onset Pompe disease, and is the first new treatment option approved for the Pompe community in Europe in more than 15 years.

Nexviadyme has also been approved in the United States, Japan, Canada, Switzerland, Australia, Brazil, Taiwan, and the United Arab Emirates. Outside of Europe, the treatment is marketed under the brand name Nexviazyme. 

In the area of COVID-19 prevention, Sanofi and GSK in June announced positive data from their vaccine trial, which evaluated an adjuvanted bivalent D614 and Beta (B.1.351) vaccine candidate. Company executives state that the Sanofi-GSK’s vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial in an environment of high Omicron variant circulation. 

Earlier in June, Sanofi reported positive data from two trials conducted with the company’s new next-generation COVID-19 booster vaccine candidate modeled on the Beta variant antigen and including GSK’s pandemic adjuvant. The data supporting this next-generation booster vaccine will be submitted to regulatory authorities and indicate the potential of Sanofi-GSK’s next-generation Beta-based booster to be a relevant response to public health needs.

“With the immunogenicity data from our Beta-booster vaccine, they support our belief that, in a largely seropositive world, a next-generation Beta booster vaccine could provide protection against variants like Omicron,” says Thomas Triomphe, executive VP, vaccines, Sanofi. “mRNA has proven speed to market; we are demonstrating here the efficacy that our recombinant protein platform can provide to the world.

Digital Accelerator

In 2022, Sanofi announced the launch of its first Digital Accelerator to foster its ambition to become a leading digital healthcare company. The Accelerator will develop products and solutions that will support Sanofi’s mission to transform the practice of medicine with the use of digital, data and artificial intelligence (AI). 

Management says the Digital Accelerator is first focusing on addressing unmet needs in patients suffering from atopic dermatitis in France, Italy, and Spain. The team is developing an integrated platform and data solution to better engage with healthcare professionals and enhance their awareness as well as their patients’ awareness of the disease and the available treatment options.

“Sanofi’s digital transformation is driven by a business and cultural shift as much as it is by technology,” says Arnaud Robert, executive VP and chief digital officer, Sanofi. “The Digital Accelerator will help us democratize the use of data, develop an agile mindset across the company, and accelerate innovation for patients and healthcare professionals – at speed and scale. Our investment in the Digital Accelerator is another demonstration of our commitment to transform the practice of medicine and deliver better outcomes for patients.”

Sanofi executives say the ongoing digital transformation has already led to significant achievements including accelerating the discovery of new targets using AI; accelerating R&D image analysis using AI, improving clinical trial efficiency by using real-world evidence to reduce the number of patients that must be enrolled and by enabling participants to provide their data and digital biomarkers remotely; and optimizing advertising and promotional spend across multiple markets and products.

By 2025, management predicts that Sanofi’s digital healthcare platform will support new digital businesses, fuel new digital experiences for patients and HCPs, and drive innovation and efficiencies across the entire value chain.

Acquisition/partnerships

Sanofi enhanced itself with two acquisitions in 2021. In December 2021, Sanofi agreed to acquire Amunix, an immuno-oncology company that adds a pipeline with conditionally activated biologics. The company also agreed in December 2021 to acquire Origimm, a biotechnology company specialized in research of skin diseases.

The Amunix acquisition, which was completed during February 2022, brought the Pro-XTEN, XPAT, and XPAC technology to deliver next-generation conditionally activated biologics. Company management says the technology platform is highly complementary to Sanofi’s existing R&D platforms and supports the company’s efforts to accelerate and expand its contributions to innovative medicines for oncology patients. Amunix’s pipeline includes lead candidate AMX-818, a masked HER2-directed TCE that company executives say offers a strong strategic fit with Sanofi’s focus on developing potentially transformative cancer therapies in immuno-oncology.

Origimm adds ORI-001 to Sanofi’s early-stage pipeline. ORI-001 is a therapeutic vaccine candidate for acne vulgaris based on recombinant proteins, which entered preliminary clinical studies in third-quarter 2021. In parallel, Sanofi is working to develop additional antigen versions and expects to leverage its next-generation mRNA platform in a comprehensive Phase I/II trial to start in 2023.

The company continues to explore new partnerships as well. Sanofi and Innovent Biologics announced in August 2022 a collaboration to bring innovative medicines to patients in China with difficult-to-treat cancers. Both companies are committed to accelerating the development and commercialization of two Sanofi key clinical stage oncology assets: Phase III SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody-drug conjugate) and Phase II SAR444245 (non-alpha IL-2), combining with sintilimab, the leading checkpoint inhibitor in China.

In addition to the collaboration and license agreement, Sanofi will invest €300 million in Innovent through subscription of new common shares.

“This strategic collaboration with Innovent will not only accelerate the development, market access and future commercialization of two of our key oncology medicines in selected combinations with sintilimab, but also bolster our overall presence in oncology in China,” Reed says. “We look forward to a successful partnership with Innovent, one of the most innovative companies in China, and to leveraging their development capabilities and market leadership in the country.

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