2025-06-02-Bernstein-赛诺菲（SAN）_赛诺菲-伊特佩奇单抗在呼吸道疾病的三期试验消息喜忧参半；但研发管线仍具潜力_17页_962kb

Sanofi Summary: Mixed News on Itepekimab in Respiratory, But Strong Pipeline and Diversified Portfolio

Core Content

Sanofi recently reported mixed results from its phase III trials of itepekimab in COPD. The first trial (AERIFY-1) showed a 27% reduction in moderate to severe exacerbations, while the second trial (AERIFY-2) did not demonstrate any benefit in the same category. These mixed results may be attributed to differences in patient profiles between trials, potential site-related issues, and the impact of the pandemic on enrollment. Despite these findings, the FDA is unlikely to approve the drug based on just one positive trial, as two positive trials are typically required.

Main Points

• Itepekimab (a collaboration with Regeneron) was expected to complement Sanofi's COPD franchise, particularly in former smokers.
• Dupixent, Sanofi's biological drug for COPD, was the first to be approved for this indication in 2024 and is projected to maintain strong sales through 2030.
• Lunsekimib, a new nanobody targeting IL-13 and TSLP, is a potential successor to itepekimab and may show synergistic effects when used in combination. It is expected to enter phase II trials in 2026.
• Sanofi's pipeline remains robust with 12 late-stage projects in immunology and inflammation, and diversified therapeutic areas such as vaccines and rare diseases.
• Vaccines account for ~20% of sales, while rare diseases contribute ~14%, both of which are expected to drive growth beyond the Dupixent patent expiry in 2030.
• Recent acquisitions, such as Blueprint, are expected to further enhance the pipeline.

Key Information

Financial Highlights

• Price Target: 124.00 EUR (44% upside from current price)
• Market Cap (EUR): 105,345 million
• EV (EUR): 114,115 million
• Dividend Yield: 4.6%
• Performance (YTD): -8.4%
• Adjusted EPS (2024A): 7.12 EUR
• Reported EPS (2024A): 4.44 EUR
• EPS Growth (2024-2026): 7.12 → 8.20 → 9.28 (CAGR: +12%)
• Adjusted P/E (2025E): 10.5
• Reported P/E (2025E): 16.6

Investment Implications

• Despite the mixed results for itepekimab, the firm reiterates its Outperform rating.
• Sanofi's earnings growth is expected to be above sector averages, supporting its valuation.
• Next catalysts in 2H25 include:
  • Tolebrutinib (BTKi) in multiple sclerosis (50% above consensus for 2030e)
  • Amlitelimab (OX40L) in atopic dermatitis (with more results in 2026)
• Sanofi is expected to maintain strong visibility in sales and earnings due to its diversified product portfolio and limited generics risks.

Key Pipeline Projects

Investment Justification

• Sanofi's earnings growth is expected to be above sector averages.
• The company trades at a 20% discount to the European Pharma sector on 2025 P/E.
• The pipeline optionality and diversified portfolio should more than offset the impact of Dupixent patent expiry.
• Clinical trial read-outs are expected annually, with limited market expectations.

COPD Overview

• COPD affects over 200 million people globally, with ~70% of patients undiagnosed.
• It is projected to affect 600 million people by 2050 and is responsible for 3 million deaths annually.
• Type 2 inflammation is a key focus for new therapies, with IL-13 and TSLP being central targets.
• Lung destruction over time makes symptom improvement more challenging to demonstrate.
• Itepekimab was intended for former smokers and high BEC populations, but approval is unlikely without two positive phase III trials.

Competitive Landscape in COPD

Valuation and Growth Prospects

• Sanofi's 2030 sales are expected to be €60,347 million, with immunology contributing ~22.88% and vaccines ~20%.
• The company's adjusted P/E ratio is expected to decrease over time, from 12.1 in 2025 to 9.3 in 2030, reflecting strong earnings growth.
• The pipeline is expected to generate €4,932 million in 2030, with multiple high-potential projects across various indications.

Conclusion

Despite the mixed results for itepekimab, Sanofi's broad pipeline and diversified portfolio in vaccines and rare diseases continue to support its long-term growth and investment potential. The Outperform rating is reiterated, based on above-sector earnings growth, strong visibility, and pipeline optionality. The next catalysts are tolebrutinib in multiple sclerosis and amlitelimab in atopic dermatitis, both of which are expected to exceed consensus estimates.