Sanofi Reports Strong H1 2023 Results: Dupixent Generates $5.3B, Tzield Succeeds in Phase III for Type 1 Diabetes

On July 28, Sanofi announced its 2023H1 financial results, with net income increasing by 4.4% year-over-year to €20.187 billion (approximately $21.806 billion, exchange rate for 2023: 1 euro = 1.0802 dollars; all data in this article are calculated at constant exchange rates CER).

Among them, the biopharmaceuticals business revenue was 17.467 billion euros, a year-on-year increase of 4.1%. The细分的 vaccine business contributed 1.223 billion euros, a year-on-year increase of 9.1%; the consumer health business revenue was 2.720 billion euros, a year-on-year increase of 6.1%.

Dupixent Shows Blockbuster Potential, Generating 4.878 Billion Euros (Approx. $5.269 Billion) in Just Six Months, with a Growth Rate of 36.7%; Breaking $10 Billion by Year-End Is Certain. The drug has now secured five indications: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, and eosinophilic esophagitis.

As Sanofi's most relied-upon flagship product, Dupixent is far ahead in the new branded prescription volume (NBRx) across departments such as dermatology, allergy, and respiratory medicine. Additionally, Dupixent has achieved milestone Phase III data in the chronic obstructive pulmonary disease (COPD) field, with potential to further unlock market growth in the future.

As strong as Dupixent, it also has times of clinical failure. Due to not meeting efficacy standards,Dupixent Falters in a Study of Chronic Inducible Cold Urticaria (CIndU).A search on the clinicaltrials website reveals that this study is a randomized, double-blind, placebo-controlled Phase III clinical trial (NCT04681729).

In 2H2023, Dupixent may reach several regulatory milestones, including the expansion of a new indication for the treatment of chronic spontaneous urticaria in the United States, with a PDUFA date of October 22; and a new indication in China for the treatment of atopic dermatitis in children aged 6 months to 5 years.

Nexviazyme, a new drug for Pompe disease launched in 2021, showed strong growth with an increase of 153.4% year-over-year to 184 million euros. Sarclisa, a CD38 monoclonal antibody, also performed well, generating 181 million euros in revenue from an indication for multiple myeloma, representing a 43.4% year-over-year increase.

Sanofi is also looking for new growth engines,It pins its hopes on three key products: Altuviiio, a long-acting therapy for hemophilia A; Beyfortus, a long-acting RSV monoclonal antibody; and Tzield, a new drug for type 1 diabetes (T1D).

Specifically, Altuviiio (efanesoctocog alfa) is a first-in-class, long-lasting Factor VIII replacement therapy that received FDA approval for marketing in February 2023, requiring only once-weekly prophylactic dosing. Sanofi believes that with this dosing advantage, Altuviiio will steadily penetrate the multi-billion-dollar market for Hemophilia A.

Beyfortus (nirsevimab), jointly developed by AstraZeneca and Sanofi, is the first approved preventive solution to protect all infants from birth through their first RSV season with a single injection. In November 2022, the drug received its global first approval in the EU, followed by regulatory approval from the FDA in July this year.

In the RSV field, although GSK and Pfizer have also developed corresponding vaccines and successively received FDA approval for marketing in May this year, their approved RSV vaccines currently only cover the elderly population aged 60 and above, while Beyfortus targets another RSV-susceptible group—infants.With the first-mover advantage, Beyfortus has no competitors in the field of infant RSV prevention.Sanofi expects that by 2030, the market size for infant RSV prevention will be approximately 2.5 billion euros.

Tzield (teplizumab) is the world's first and only therapy to delay the onset of T1D, and was approved for marketing in the U.S. in November 2022. Sanofi acquired it through an acquisition deal worth approximately $2.9 billion.

Sanofi stated: "Tzield is approved for use in adults and pediatric patients aged 8 years and older with Type 1 Diabetes (T1D), with approximately 65,000 people diagnosed with T1D annually in the United States." Of course, the market for T1D is not small, but the indication approved for Tzield is somewhat restrictive regarding disease progression. It is used to delay the progression of these patients from Stage 2 T1D to Stage 3, as patients who progress to Stage 3 require lifelong insulin injections—meaning that currently, only patients with Stage 2 T1D are eligible for Tzield.

Notably, Sanofi is making every effort to expand the coverage of Tzield among a broader population. The financial report revealed,In the Phase III PROTECT study conducted among newly diagnosed clinical stage 3 T1D patients, Tzield met the primary endpoint.At week 78, Tzield significantly improved the C-peptide area under the curve (AUC) compared to placebo, indicating that Tzield can protect β-cell function in newly diagnosed stage 3 T1D patients. However, exogenous insulin usage and time in range (TIR) showed a positive trend but did not reach statistical significance. Based on the above data, Sanofi will engage in discussions with regulatory authorities.

Sanofi CEO Paul Hudson summarized: "We have achieved another quarter of growth, with Specialty Care and Vaccines as the main drivers. As we enter the second half of our Play to Win strategy, we are particularly excited about the substantial positive R&D data and regulatory outcomes in Q2, which highlight the significant growth potential of our innovative pipeline assets. As we kick off the second half of 2023, we are advancing our new drug launches, encouraged by the rollouts of Altuviiio and Tzield, while also adjusting for the anticipated impact of generic competition for Aubagio. The strong performance in the first six months has made us confident about the H2 outlook, and therefore we..."Raise the full-year 2023 earnings per share guidance target to mid-single-digit growth.”