Research analysts who have asked questions during Sanofi earnings calls.
Florent Cespedes
Bernstein
6 questions for SNY
Peter Verdult
Citigroup Inc.
6 questions for SNY
David Risinger
Leerink Partners
5 questions for SNY
Luisa Hector
Berenberg
5 questions for SNY
Richard Vosser
JPMorgan Chase & Co.
5 questions for SNY
Seamus Fernandez
Guggenheim Partners
5 questions for SNY
Simon Baker
Redburn Atlantic
5 questions for SNY
Sarita Kapila
Morgan Stanley
4 questions for SNY
Ben Jackson
Jefferies
3 questions for SNY
Graham Parry
Bank of America Corporation
3 questions for SNY
James Quigley
Goldman Sachs
3 questions for SNY
Jo Walton
UBS
3 questions for SNY
Matthew Weston
UBS Group AG
3 questions for SNY
Sachin Jain
Bank of America
3 questions for SNY
Steve Scala
Cowen
3 questions for SNY
Eric Le Berrigaud
Stifel
2 questions for SNY
Michael Leuchten
Jefferies
2 questions for SNY
Shirley Chen
Barclays
2 questions for SNY
Shirley Shin
Barclays
2 questions for SNY
Colleen Garvey
Guggenheim Securities
1 question for SNY
Emily Field
Barclays
1 question for SNY
Emmanuel Papadakis
Deutsche Bank
1 question for SNY
Gary Steventon
BNP Paribas Exane
1 question for SNY
Luisa Caroline Hector
Berenberg
1 question for SNY
Peter Welford
Jefferies
1 question for SNY
Ricardo Benevides Freitas
Santander
1 question for SNY
Timothy Anderson
BofA Securities
1 question for SNY
Xiaobin Gao
Barclays
1 question for SNY
Recent press releases and 8-K filings for SNY.
- Sanofi has entered into an agreement to acquire Dynavax Technologies Corporation for approximately $2.2 billion in total equity value, offering a cash tender of $15.50 per share for all outstanding shares.
- The acquisition will integrate Dynavax's marketed adult hepatitis B vaccine, HEPLISAV-B®, and a phase 1/2 shingles vaccine candidate (Z-1018) into Sanofi's portfolio, strengthening its adult immunization presence.
- The transaction has been unanimously approved by the Dynavax board of directors and is anticipated to close in the first quarter of 2026.
- Sanofi plans to fund the acquisition with available cash resources and expects no impact on its financial guidance for 2025.
- Sanofi's Wayrilz (rilzabrutinib) has received European Commission approval as the first BTK inhibitor to treat immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.
- The approval is based on the LUNA 3 phase 3 study, which demonstrated a statistically significant durable platelet response at week 25 (23% of patients in the Wayrilz arm vs. 0% in the placebo arm) and a faster time to first platelet response (36 days in the Wayrilz arm).
- Wayrilz, an oral, reversible BTK inhibitor, addresses the underlying causes of ITP through multi-immune modulation.
- Wayrilz has previously been approved in the US and the United Arab Emirates (UAE), and is currently under regulatory review for ITP in Japan and China.
- The US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Sanofi's new drug application for tolebrutinib, intended to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS).
- Sanofi expressed disappointment with the FDA's decision, noting it was a significant change from prior feedback, and affirmed its commitment to finding a path forward for tolebrutinib.
- An impairment test on tolebrutinib's intangible asset value is underway, with results expected in January 2026, but this will not impact business net income/EPS or alter the 2025 financial guidance.
- Tolebrutinib received provisional approval in the United Arab Emirates in July 2025 and is under regulatory review in the EU and other global jurisdictions.
- Sanofi received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on December 24, 2025, for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS).
- The company expressed disappointment, noting this decision is a significant change from previous FDA feedback, especially as tolebrutinib had previously received breakthrough therapy designation.
- Sanofi will conduct an impairment test on the intangible asset value attached to tolebrutinib, with results to be provided with Q4 and FY 2025 results in January 2026; however, this will not impact business net income/business EPS and there is no change to the financial guidance for 2025.
- Tolebrutinib was provisionally approved in the United Arab Emirates in July 2025 and is currently under regulatory review in the EU and other jurisdictions worldwide.
- The European Medicines Agency (EMA) has granted orphan designation to Sanofi's efdoralprin alfa for the potential treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema.
- Efdoralprin alfa, an investigational recombinant therapy, recently met all primary and key secondary endpoints in a global Phase 2 study, demonstrating superiority to a standard of care plasma-derived therapy.
- The US Food and Drug Administration (FDA) had previously granted both Fast Track and Orphan Drug designations to efdoralprin alfa for AATD related emphysema.
- This designation reinforces Sanofi's commitment to developing treatments for rare diseases with significant unmet medical need, as no new therapies for AATD have been introduced since 1987.
- Sanofi and Regeneron's Dupixent (dupilumab) has been granted marketing and manufacturing authorization in Japan for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease.
- The approval, issued by the Ministry of Health, Labour and Welfare in Japan on December 23, 2025, expands the existing approval for patients aged 12 years and older in this indication.
- Clinical data from the VOYAGE global phase 3 study showed Dupixent significantly reduced exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo in the 6 to 11 years age group.
- Dupixent is noted as the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized phase 3 study.
- Sanofi announced an agreement with the US government on December 19, 2025, to lower medicine costs for American patients and support US biopharmaceutical manufacturing and innovation.
- The agreement will reduce Medicaid prices by an average of 61 percent for certain medicines and offer consumers direct access to medicines with an average savings of nearly 70 percent.
- Sanofi will build on its $20 billion planned investment in US manufacturing and receive a three-year period free from Section 232 tariffs on imported products.
- The agreement does not impact Sanofi's financial outlook or growth strategy during its three-year term.
- Sanofi's investigational recombinant therapy, efdoralprin alfa (SAR447537), has been granted orphan designation by the European Medicines Agency (EMA) for the treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema.
- This designation is for potential new medicines addressing rare, life-threatening or debilitating medical diseases or conditions that affect no more than 5 in 10,000 individuals in the EU.
- Efdoralprin alfa previously received both fast track and orphan drug designation from the US Food and Drug Administration (FDA) for the same condition.
- The therapy recently met all primary and key secondary endpoints in its global phase 2 ElevAATe study, demonstrating superiority to a standard of care plasma-derived therapy in adults with AATD.
- Sanofi announced three key approvals in 2025: Fitusiran for hemophilia A and B in the U.S. and China, Rilzabrutinib for ITP in the U.S. (with a positive CHMP recommendation in the EU), and Nuvaxovid as the first recombinant COVID-19 vaccine fully approved in the U.S. and EU.
- The company reported positive Phase 3 results for Amlitelimab in atopic dermatitis (Quest 1 study), Efdamrofusp alfa in alpha-1 antitrypsin deficiency emphysema, and the subcutaneous formulation of Sarclisa in refractory multiple myeloma.
- In neurology, Tolebrutinib demonstrated a 31% delay in time to onset of six-month confirmed disability progression in secondary progressive multiple sclerosis, with a regulatory decision anticipated in the U.S. and EU during the first half of 2026, though it did not meet the primary endpoint in primary progressive multiple sclerosis.
- Sanofi anticipates significant near-term pipeline activity, with more than 15 regulatory decisions, over 30 regulatory submissions, and more than 15 Phase 3 readouts across biopharma and vaccines expected in 2026 and 2027.
- Sanofi reported three new product approvals in 2025: Qfitlia for hemophilia A and B in the U.S. and China, Wayrilz for ITP in the U.S. (with EU recommendation), and NUVAXOVID as the first recombinant COVID-19 vaccine in the U.S. and EU. Additionally, Dupixent received U.S. approval for bullous pemphigoid and approval for chronic spontaneous urticaria in the U.S., EU, and Japan.
- In clinical development, Amlitelimab met primary and secondary endpoints in its first Phase III study for atopic dermatitis, demonstrating clinically meaningful improvements and potential for quarterly dosing. Conversely, Tolebrutinib did not meet its primary endpoint in non-relapsing and primary progressive multiple sclerosis but showed a 31% delay in disability progression in secondary progressive multiple sclerosis, with a regulatory decision anticipated in H1 2026 for SPMS.
- The company anticipates substantial pipeline activity in 2026 and 2027, projecting over 15 regulatory decisions, more than 30 new regulatory submissions, and over 15 Phase III readouts across its biopharma and vaccine portfolios.
- Sanofi is actively replenishing its pipeline through internal innovation and external opportunities, including seven new molecules entering Phase I development, three AAV gene therapy programs, and strategic acquisitions such as Blueprint and Dren Bio.
Quarterly earnings call transcripts for Sanofi.
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