On October 25, 2024 Sanofi reported Q3 15.7% sales growth boosted by earlier-than-anticipated vaccine sales; 2024 business EPS guidance raised due to strong business performance (Press release, Sanofi, OCT 25, 2024, View Source [SID1234647425]).
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Q3 sales growth of 15.7% at CER and business EPS(1) of €2.86
•Dupixent sales up 23.8% to €3,476 million; full-year 2024 target of ~€13 billion confirmed
•Pharma launches up 67.1% to €727 million, led by ALTUVIIIO, Nexviazyme and Rezurock
•Vaccines sales up 25.5%, boosted by phasing of flu sales, and by Beyfortus due to approved extra capacity
•Opella up 7.9%, driven by the Qunol acquisition
•Research and Development expenses grew 12.7%
•Selling, general and administrative expenses grew 6.4%, substantially below sales growth, having a positive impact on profitability
•Business EPS(1) of €2.86, +12.2% reported and +17.6% at CER and IFRS EPS of €2.25, +11.9% reported
Q3 pipeline progress
•Four regulatory approvals: Dupixent COPD (US, CN), Dupixent CRSwNP adolescents (US), and Sarclisa NDMM, TI (US)
•Four positive phase 3 data readouts: Dupixent BP, Dupixent CSU, tolebrutinib nrSPMS, and Sarclisa NDMM, TE
Opella (consumer healthcare)
•On October 21, Sanofi and CD&R entered exclusive negotiations to transfer a controlling stake of Opella.*
2024 business EPS(1) guidance
•On October 21, 2024, the 2024 business EPS(1) guidance was upgraded to growth of at least a low single-digit percentage at CER(2) supported by the underlying strong business performance. This reflects the new scope of guidance excluding Opella detailed in the October 21, 2024 press release. Applying the average October 2024 exchange rates, the currency impact on 2024 business EPS(1) is estimated to be -5.5% to -6.5%.
Paul Hudson, Chief Executive Officer: "We reached almost 16% sales growth in the third quarter, illustrating the underlying strength of our portfolio. Our performance was boosted by the phasing of flu and Beyfortus, while we saw steady growth of 67% for our launch medicines as well as volume-driven growth by Dupixent. Dupixent is now approved as the first-ever biologic medicine to treat COPD across the EU, China, and the US allowing us to bring this innovative new treatment to hundreds of thousands of patients. Our pipeline-driven transformation continued to progress with the delivery of four new approvals and four positive phase 3 data readouts, including for tolebrutinib in secondary progressive multiple sclerosis, a disease with significant unmet medical need. We entered exclusive negotiations with CD&R on a controlling stake in Opella, allowing Sanofi to focus on innovative medicines and vaccines. Based on the strong business performance in the quarter, we recently upgraded our business EPS guidance. This momentum is already paving the way for the strong rebound we said we expected in 2025 business EPS."
Q3 2024 Change Change
at CER YTD 2024 Change Change
at CER
IFRS net sales reported € 13,438 m +12.3 % +15.7 % € 34,647 m +7.8 % +11.1 %
IFRS net income reported € 2,815 m +11.5 % — € 5,061 m -15.0 % —
IFRS EPS reported € 2.25 +11.9 % — € 4.05 -14.9 % —
Free cash flow(3)
€ 3,327 m +79.5 % — € 3,872 m -22.3 % —
Business operating income € 4,607 m +14.4 % +19.9 % € 10,263 m +1.7 % +8.8 %
Business net income(1)
€ 3,585 m +12.2 % +17.5 % € 7,965 m -1.3 % +5.5 %
Business EPS(1)
€ 2.86 +12.2 % +17.6 % € 6.37 -1.2 % +5.6 %
Changes in net sales are expressed at constant exchange rates (CER) unless stated otherwise (definition in Appendix 7). (1) In order to facilitate an understanding of
operational performance, Sanofi comments on the business net income statement. Business net income is a non-IFRS financial measure (definition in Appendix 7). The
consolidated income statement for Q3 and YTD 2024 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in
Appendix 4. (2) Based on 2023 preliminary business EPS of €7.25 excluding Opella. (3) Free cash flow is a non-IFRS financial measure (definition in Appendix 7). *The
proposed transaction is subject to finalization of definitive agreements, completion of the appropriate social processes and subject to customary closing conditions.
1
Q3 and YTD 2024 summary
A conference call and webcast for investors and analysts will begin at 14:00 CEST. Details can be accessed via sanofi.com, including presentation slides.
— — —
The performance shown in this press release covers the three-month period to September 30, 2024 (the quarter or Q3 2024) and the nine-month period to September 30, 2024 (the year to date or YTD 2024) compared to the three-month period to September 30, 2023 (Q3 2023) and the nine-month period to September 30, 2023 (the year to date or YTD 2023) respectively. All percentage changes in sales in this press release are at CER1, unless stated otherwise.
— — —
In Q3 2024, sales were €13,438 million and increased by 15.7%. Exchange rate movements had a negative effect of 3.4 percentage points (pp); therefore, as reported, sales increased by 12.3%. In YTD 2024, sales were €34,647 million and increased by 11.1%. Exchange rate movements had a negative effect of 3.3pp; reported, sales increased by 7.8%. The commentary below emphasizes the recent quarterly performance unless stated otherwise.
Sales by segment and business
Net sales (€ million) Q3 2024 Change
at CER % of
total sales YTD 2024 Change
at CER % of
Total sales
Biopharma 12,167 +16.6 % 90.5 % 30,545 +11.5 % 88.2 %
Pharma 8,365 +13.0 % 62.2 % 24,424 +10.7 % 70.5 %
Vaccines 3,802 +25.5 % 28.3 % 6,121 +14.5 % 17.7 %
Opella 1,271 +7.9 % 9.5 % 4,102 +8.8 % 11.8 %
Total 13,438 +15.7 % 100 % 34,647 +11.1 % 100 %
Sales by geography
Net sales (€ million) Q3 2024 Change
at CER YTD 2024 Change
at CER
United States 6,886 +23.6 % 15,953 +17.6 %
Europe 2,886 +6.6 % 7,768 +0.2 %
Rest of World 3,666 +10.3 % 10,926 +10.8 %
of which China 757 +3.6 % 2,279 +3.0 %
US sales were €6,886 million and increased by 23.6%. The strong performance was driven by new launches, including Beyfortus, and by Dupixent, insulins and all Vaccines businesses with sales of legacy medicines slightly offsetting growth.
Europe sales were €2,886 million and increased by 6.6%. Growth was driven by new launches, Dupixent, and Vaccines. Some legacy medicines declined, including Aubagio from generic competition.
Rest of World sales were €3,666 million and increased by 10.3%. Performance was led by Dupixent and Vaccines, and partly by new launches and Toujeo. China sales were €757 million and increased by 3.6%, driven by strong performance by Dupixent mostly offset by Lovenox and Other medicines. With higher inflation, the contribution of Argentina to the total Sanofi sales growth rate was 1.2pp.
Business operating income
In Q3 2024, business operating income (BOI) was €4,607 million and increased by 14.4% (19.9% at CER). The ratio of BOI to net sales was 34.3% and increased by 0.6pp (34.9% at CER, up by 1.2pp). This improvement was mainly driven by a higher gross margin and operating leverage. In YTD 2024, BOI was €10,263 million and increased by 1.7% (8.8% at CER). The ratio of BOI to net sales was 29.6% and decreased by 1.8pp (30.7% at CER, down by 0.7pp).
Business development
Business development, including strategic investments in external innovation is an integrated part of Sanofi’s efforts to continuously access optionality on new and promising scientific developments and platforms and replenish the pipeline.
In September, Sanofi made an equity investment of $40 million in Ventyx Biosciences, Inc. (NASDAQ: VTYX), a clinical-stage biopharmaceutical company in autoimmune and inflammatory disorders. Ventyx granted Sanofi an exclusive right of first negotiation to an NLRP3 inhibitor. Sanofi also participated in the rights issue for $10 million in Vicore Pharma Holding AB (STO: VICO), a clinical-stage pharmaceutical company in respiratory and fibrotic diseases, including idiopathic pulmonary fibrosis.
Further in September, Sanofi entered an exclusive licensing agreement with RadioMedix, Inc. and Orano Med for the late-stage project, AlphaMedixTM (212Pb-DOTAMTATE), for the treatment of adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors, a rare cancer.
In August, Sanofi made two equity investments, including $30 million in MeiraGTx Holdings plc (NASDAQ: MGTX), a clinical-stage genetic medicine company, and $40 million in AnaptysBio (NASDAQ: ANAB), a clinical-stage biotechnology company focused on immunology therapeutics, including in rheumatoid arthritis and ulcerative colitis.
Biopharma
The Biopharma segment includes Pharma and Vaccines. In Q3 2024, sales were €12,167 million and increased by 16.6%, driven by continued strong performance of new launches and Dupixent growth. The divestments of medicines/portfolio streamlining had a negative impact of 0.7pp. In YTD 2024, sales were €30,545 million and increased by 11.5% driven by the same aforementioned factors.
Pharma
Pharma launches
Net sales (€ million) Q3 2024 Change
at CER YTD 2024 Change
at CER
ALTUVIIIO 172 +278.3 % 452 +600.0 %
Nexviazyme/Nexviadyme
163 +53.6 % 483 +69.7 %
Rezurock 131 +57.8 % 338 +50.9 %
Sarclisa
114 +23.7 % 341 +29.5 %
Cablivi
63 +12.5 % 176 +4.7 %
Xenpozyme 41 +51.9 % 113 +75.4 %
Enjaymo
28 +81.3 % 83 +75.5 %
Tzield 15 +66.7 % 36 +140.0 %
Total 727 +67.1 % 2,022 +78.2 %
ALTUVIIIO (hemophilia A) sales were €172 million of which more than 90% were in the US. Growth continued to be driven by patient switches from existing factor medicines, including some from Eloctate, and from non-factor medicines. The hemophilia A franchise (ALTUVIIIO + Eloctate) sales were €268 million and increased by 63.3%, increasing market share.
Nexviazyme/Nexviadyme (Pompe disease) sales were €163 million and increased by 53.6%. Growth was higher in Europe (104.3%) and the Rest of World (121.4%). Growth in the US was 24.7% where most patients have already converted from Myozyme/Lumizyme. The Pompe franchise (Nexviazyme/Nexviadyme + Myozyme/Lumizyme) sales were €331 million and increased by 15.2%. Nexviazyme/Nexviadyme sales now accounts for 49% of the total Pompe franchise.
Rezurock (chronic graft-versus-host disease) sales were €131 million and increased by 57.8%, driven by fast uptake in launch countries, including the US, China, and the UK, and persistence is use by patients.
Sarclisa (multiple myeloma) sales were €114 million and increased by 23.7%. Growth was driven by market share gains in Europe, and by the Rest of World, specifically Japan.
Cablivi (acquired thrombotic thrombocytopenic purpura) sales were €63 million and increased by 12.5%, driven by patient growth in the US.
Xenpozyme (acid sphingomyelinase deficiency) sales were €41 million and increased by 51.9%, driven by more patients across all regions.
Enjaymo (cold agglutinin disease) sales were €28 million and increased by 81.3%, driven by all regions. On October 4, 2024, Recordati announced the acquisition of global rights to Enjaymo. The transaction is expected to close this quarter.
Tzield (delay onset of type 1 diabetes) sales were €15 million, a sequential increase from Q2 2024 of €4 million, mostly reflecting continued growth in infusions supported by ongoing efforts to increase awareness and screening.
Immunology
Net sales (€ million) Q3 2024 Change
at CER YTD 2024 Change
at CER
Dupixent
3,476 +23.8 % 9,614 +25.9 %
Dupixent sales were €3,476 million and increased by 23.8%. In the US, sales were €2,556 million and increased by 19.1%. Growth was driven by strong demand in the approved indications of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. In Europe, Dupixent sales were €417 million and increased by 35.1% reflecting continued growth in all approved indications and emerging sales in COPD. In the Rest of World, sales were €503 million and increased by 41.9%, driven mainly by sales in Japan and China. In YTD 2024, Dupixent sales were €9,614 million and increased by 25.9%, on track to achieve ~€13 billion in sales in 2024 at constant exchange rates. More than one million patients are currently being treated with Dupixent globally.
Other main medicines
Net sales (€ million) Q3 2024 Change
at CER YTD 2024 Change
at CER
Lantus 431 +33.8 % 1,189 +10.6 %
Toujeo
303 +18.1 % 937 +15.6 %
Fabrazyme
253 +4.0 % 779 +8.0 %
Lovenox 233 -1.2 % 751 -7.1 %
Plavix 230 +8.3 % 703 +5.6 %
Myozyme/Lumizyme
168 -7.5 % 539 -11.1 %
Cerezyme
164 +8.0 % 571 +17.0 %
Alprolix
148 +8.7 % 419 +6.3 %
Praluent 126 +10.4 % 373 +23.7 %
Thymoglobulin 121 +4.1 % 367 +4.9 %
Eloctate 96 -19.2 % 287 -20.7 %
Aubagio
92 -52.3 % 301 -62.8 %
Cerdelga 81 +12.3 % 246 +11.7 %
Lantus sales were €431 million and increased by 33.8%. US sales were €175 million and increased by 162.7%, benefiting from another quarter of windfall sales due to the continued unavailability of a competing medicine as well as a lower base of comparison from net-price adjustments.
Toujeo sales were €303 million and increased by 18.1%, mainly driven by the Rest of World, including China where Toujeo continued to increase its basal insulin market share. US sales benefited from the continued unavailability of a competing medicine.
Fabrazyme sales were €253 million and increased by 4.0%, mainly driven by growth in the number of patients.
Lovenox sales were €233 million and decreased by 1.2%, reflecting the impact from volume-based procurement in China and biosimilar competition in the EU.
Plavix sales were €230 million and increased by 8.3%, underpinned by increased use and market share in the Rest of World, including China from the inclusion in volume-based procurement.
Myozyme/Lumizyme sales were €168 million and decreased by 7.5% due to the conversion to Nexviazyme/Nexviadyme.
Cerezyme sales were €164 million and increased by 8.0%, driven by growth in the number of patients in the Rest of World. The Gaucher disease franchise (Cerezyme + Cerdelga) sales were €245 million and increased by 9.2%.
Alprolix sales were €148 million and increased by 8.7%, driven by supply sales to the partner.
Praluent sales were €126 million and increased by 10.4%, underpinned by Europe.
Thymoglobulin sales were €121 million and increased by 4.1%, mostly reflecting increased sales in the Rest of World.
Eloctate sales were €96 million and decreased by 19.2%, mainly due to patients converting to ALTUVIIIO in the US.
Aubagio sales were €92 million and decreased by 52.3%, reflecting the loss of exclusivity starting in the US in March 2023 followed by Europe in September 2023. Aubagio sales are expected to continue to decrease albeit at a slower rate.
Cerdelga sales were €81 million and increased by 12.3%, primarily driven by the US and an increased number of patients.
Vaccines
Net sales (€ million) Q3 2024 Change
at CER YTD 2024 Change
at CER
Influenza vaccines 1,913 +10.9 % 2,101 +12.3 %
Polio/Pertussis/Hib vaccines incl. Boosters 760 +2.0 % 2,108 -1.2 %
RSV (Beyfortus) 645 +381.8 % 845 +537.2 %
Meningitis, Travel and endemic vaccines 485 +13.1 % 1,067 +7.9 %
Total 3,802 +25.5 % 6,121 +14.5 %
Vaccines sales were €3,802 million and increased by 25.5%, driven by Beyfortus rollout and boosted by the earlier phasing of both flu and Beyfortus deliveries. In YTD 2024, sales were €6,121 million and increased by 14.5%, driven mainly by Beyfortus, partly offset by the absence of COVID-19 sales compared to €226 million in YTD 2023.
Influenza vaccines sales reached €1,913 million and increased by 10.9%, boosted by earlier-than-anticipated deliveries.
Polio/Pertussis/Hib (PPH) vaccines sales were €760 million and increased by 2.0%, with a favorable benefit from slightly increased Boosters demand in several countries.
Beyfortus sales were €645 million, driven by early deliveries in the US and rollout in a number of countries, including Canada, France, Germany, Spain, Portugal, Belgium, and Ireland. In collaboration with AstraZeneca, responsible for manufacturing, increased supply was enabled by additional capacity after a second, external filling line was licensed.
Meningitis, Travel and endemic vaccines sales were €485 million and increased by 13.1% reflecting growth in all regions. In the US, Meningitis benefited from favorable Centers for Disease Control and Prevention buying patterns.
iopharma business operating income
In Q3 2024, Biopharma BOI was €4,340 million and increased by 15.8% (21.2% at CER). The ratio of BOI to net sales was 35.7% and increased by 0.7pp (36.3% at CER, up by 1.3pp). This improvement was mainly driven by a higher gross margin and operating leverage. In YTD 2024, BOI was €9,271 million and increased by 3.4% (9.8% at CER). The ratio of BOI to net sales was 30.4% and decreased by 1.4pp (31.3% at CER, down by 0.5pp).
5
Pipeline update
Sanofi has 78 projects in a pipeline across four main disease areas (Immunology, Rare diseases, Neurology, and Oncology) and Vaccines, including 36 potential new medicines (NMEs) and vaccines. The following section highlights significant developments in the late- and mid-stage pipeline in the quarter:
Highlights
Regulatory approvals Dupixent – COPD (US, CN)
Dupixent – CRSwNP adolescents (US)
Sarclisa – NDMM, TI (IMROZ study) (US)
Regulatory recommendations Dupixent – EoE children (EU)
Cerdelga – GD1 children (EU)
Regulatory submission acceptances
MenQuadfi – Meningitis six weeks+ (US)
Rezurock – cGvHD, 3L (EU)
Phase 3 data readouts
Dupixent – CSU (Study C) (primary endpoint met)
Dupixent – CPUO (Study A) (primary endpoint not met)
Dupixent – BP (primary endpoint met)
tolebrutinib – RMS (primary endpoint not met)
tolebrutinib – nrSPMS (primary endpoint met)
losmapimod – FSHD (primary endpoint not met)
Sarclisa – NDMM, TE (HD7 study) (primary endpoint met)
Immunology
Dupixent (dupilumab)
•The US Food and Drug Administration (FDA) approved Dupixent as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent is the first biologic medicine approved in the US to treat these patients.
The National Medical Products Administration in China approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupixent for the treatment of COPD has now been approved in more than 30 countries worldwide, including the 27 countries in the EU.
•The FDA approved Dupixent as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial FDA approval in CRSwNP from June 2019 for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under a priority review.
•The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent in the EU for eosinophilic esophagitis (EoE) in children down to one year of age. The recommendation is for children aged one to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy, supported by the two-part (Part A and B) EoE KIDS phase 3 study (clinical study identifier: NCT04394351). The European Commission is expected to announce a final decision in the coming months. Dupixent is already approved in the EU for certain adults and adolescents aged 12 years and older with EoE.
•Dupixent’s confirmatory LIBERTY-CUPID Study C phase 3 study (clinical study identifier: NCT04180488) met the primary and key secondary endpoints for the treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines. CSU is a chronic skin condition that causes sudden and debilitating hives and persistent itch, which can impact quality of life. This positive study confirms results from Study A, the first phase 3 study of Dupixent in this setting. Earlier this year, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A. The indication is under review in the EU based on results from Study A and Study B (patients uncontrolled on standard-of-care H1 antihistamines and refractory to omalizumab), and the new Study C data will support regulatory resubmission in the US by the end of the year.
•The LIBERTY-CPUO-CHIC Study A phase 3 study (clinical study identifier: NCT05263206) evaluating the use of Dupixent in adults with uncontrolled and severe chronic pruritus of unknown origin (CPUO) did not achieve statistical significance in its primary itch responder endpoint (despite favorable numerical improvements), but showed nominally significant improvements in all other itch endpoints. The Dupixent phase 3 study program in CPUO consists of Study A and Study B. Study B is planned to initiate as a subsequent pivotal study.
•Dupixent’s pivotal LIBERTY-BP phase 3 study (clinical study identifier: NCT04206553) in bullous pemphigoid (BP) met the primary and all key secondary endpoints evaluating its use in adults with moderate-to-severe disease. Dupixent was previously granted orphan drug designation by the FDA for BP, which applies to medicines intended for the treatment of rare diseases that affect fewer than 200,000 people in the US. This study will support regulatory submissions around the world in the first half of 2025. BP is a chronic and relapsing disease, characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning.
Rezurock (belumosudil)
The EMA accepted for review the regulatory submission of Rezurock for the treatment of chronic graft-versus-host disease (cGVHD), third line (3L). The EMA granted an orphan designation in 2019 for the treatment of cGVHD, and Rezurock, first approved by the FDA in 2021, is now approved in 14 other countries, including China, the UK and Canada.
amlitelimab (OX40L mAb)
•The amlitelimab proof-of concept TIDE-Asthma phase 2 study (clinical study identifier: NCT05421598) in moderate-to-severe asthma has a 60-week double-blind placebo-controlled period, in which patients are dosed once every four weeks during the initial 24 weeks and once every 12 weeks for the subsequent 36 weeks. Sanofi anticipates the internal data availability of top-line results for the full and completed 60-week treatment and follow-up period to move over the year-end and into H1 2025.
•The ASPIRION phase 2 study (clinical study identifier: NCT06557772) assessing efficacy and safety of subcutaneous injections of amlitelimab in adults with non-responsive celiac disease has commenced dosing its first patient.
lunsekimig (IL13xTSLP Nanobody VHH)
A proof-of-concept phase 2 study (clinical study identifier: NCT06454240) assessing efficacy and safety of lunsekimig compared with placebo in adults with CRSwNP has commenced dosing its first patient.
Rare diseases
ALTUVIIIO (efanesoctocog alfa)
The New England Journal of Medicine published full results from the second pivotal phase 3 study, XTEND-Kids (clinical study identifier: NCT04759131), highlighting efficacy, safety, and the pharmacokinetic profile of ALTUVIIIO, as a first-in-class, high-sustained factor VIII replacement therapy, for adults and children with hemophilia A for routine prophylaxis and on-demand treatment to control bleeding episodes as well as for perioperative management (surgery). In May, FDA updated the label for ALTUVIIIO to include the results from the XTEND-Kids phase 3 study in children with hemophilia A.
fitusiran (RNAi targeting antithrombin)
Sanofi’s collaborator Siemens Healthineers has submitted for FDA review the INNOVANCE Antithrombin Assay as a companion diagnostic that will measure antithrombin levels in people living with hemophilia who are prescribed fitusiran, a potential antithrombin-lowering medicine for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors. The prescription drug user fee act (PDUFA) action date for fitusiran is March 28, 2025.
rilzabrutinib (BTK inhibitor)
During the quarter, a single-arm phase 2 study (clinical study identifier: NCT05002777) of rilzabrutinib in warm autoimmune hemolytic anemia read out positively with clinically meaningful outcomes on response rate and additional disease markers. Data are planned to be shared at a medical meeting later this year. The results of this study build on the successful phase 3 study in immune thrombocytopenic purpura (ITP) and reinforce its efficacy in autoimmune cytopenias.
losmapimod (p38α/β MAPK inhibitor)
Fulcrum announced that the losmapimod REACH phase 3 study (clinical study identifier: NCT05397470) assessing efficacy and safety in adults with facioscapulohumeral muscular dystrophy (FSHD) did not meet the primary endpoint.
Cerdelga (eliglustat)
The CHMP adopted a positive opinion recommending the expanded approval of Cerdelga to include treatment of pediatric patients with Gaucher disease type 1 (GD1), who are six years and older with a minimum body weight of 15 kg, who have been previously treated with enzyme replacement therapy, and who are CYP2D6 poor metabolizers, intermediate metabolizers or extensive metabolizers. The EMA granted an orphan designation in 2007 for the treatment of GD1, and Cerdelga is approved in the US and EU for adults patients with GD1.
Neurology
tolebrutinib (BTK inhibitor)
Positive results from the HERCULES phase 3 study (clinical study identifier: NCT04411641) showed that tolebrutinib met the primary endpoint of improvement over placebo in delaying time to onset of confirmed disability progression (CDP) in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Specifically, tolebrutinib delayed the time to onset of 6-month CDP by 31% (HR 0.69; 95% CI 0.55-0.88; p=0.0026). Further analysis of secondary endpoints showed that the number of participants who experienced confirmed disability improvement increased by nearly two-fold, 10% with tolebrutinib compared to 5% with placebo (HR 1.88; 95% CI 1.10 to 3.21; nominal p=0.021).
In the HERCULES study, nrSPMS was defined at baseline as having a SPMS diagnosis with an expanded disability status scale score between 3.0 and 6.5, no clinical relapses for the previous 24 months and documented evidence of disability accumulation in the previous 12 months. Preliminary analysis of liver safety was consistent with previous tolebrutinib studies.
Results from the GEMINI 1 and 2 phase 3 studies (clinical study identifiers: NCT04410978/NCT04410991, respectively) evaluating tolebrutinib did not meet the primary endpoint of reducing annualized relapse rate, compared to Aubagio, a standard of care treatment, in people with relapsing MS (RMS). However, analysis of the key secondary endpoint of pooled 6-month CDW data showed a considerable delay in time to onset, which supports the CDP data observed in HERCULES.
These results were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference 2024 in Copenhagen, Denmark. Sanofi expects making regulatory submissions in SPMS starting this quarter.
frexalimab (CD40L mAb)
New efficacy and safety data at 18 months from the phase 2 open-label extension study of frexalimab (clinical study identifier: NCT04879628), for the treatment of RMS, demonstrated sustained reduction of disease activity as measured by MRI, with stable clinical surrogate endpoints. Frexalimab remained well tolerated with no new safety signals. These results were also presented at ECTRIMS 2024 and support the ongoing clinical development with two phase 3 studies in RMS and one phase 3 study in nrSPMS.
oditrasertib (RIPK1 inhibitor)
The K2 phase 2 study (clinical study identifier: NCT05630547) evaluating safety and the efficacy of oditrasertib on serum neurofilament light chain levels in patients with MS was discontinued based on not meeting the primary and key secondary endpoints.
Oncology
Sarclisa (isatuximab)
•The FDA approved Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (NDMM, TI). Sarclisa is the first anti-CD38 therapy in combination with standard-of-care VRd to significantly reduce disease progression or death (by 40%, HR 0.60; 95% CI: 0.44 to 0.81, p=0.0009) compared to VRd alone for patients with NDMM not eligible for transplant. Other regulatory submissions based on the IMROZ phase 3 study (clinical study identifier: NCT03319667) in this third indication for Sarclisa are currently under review in the EU, Japan, and China.
•New results from the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 phase 3 study (clinical study identifier: NCT03617731) showed that Sarclisa in combination with lenalidomide, bortezomib, and dexamethasone (RVd) during induction therapy in NDMM, transplant-eligible (TE), significantly prolonged progression-free survival from first randomization, resulting in a statistically significant and clinically meaningful reduction in disease progression or death, compared to RVd induction regardless of the maintenance regimen. Full results will be submitted for presentation at a forthcoming medical meeting with regulatory submission later this year in the EU.
Vaccines
Beyfortus (nirsevimab)
New data from the HARMONIE phase 3b study (clinical study identifier: NCT05437510) demonstrated that Beyfortus consistently reduced respiratory syncytial virus (RSV) hospitalizations by 82.7% (95% CI: 67.8% to 91.5%) through six months (180 days) with no evidence of waning protection after dosing compared to no intervention. Beyfortus also reduced RSV lower respiratory tract disease in infants by 87.2% (95% CI: 81.7% to 91.1%), regardless of the healthcare setting (outpatient, emergency department or inpatient) compared to no RSV intervention, according to new real-world evidence from the Beyfortus Effectiveness Against medically attended RSV events in infants (BEAR) study following 31,900 US healthy infants in their first RSV season. These findings confirm the significant positive efficacy and safety profile that Beyfortus demonstrated in multi-country, real-world conditions over a long period of time.
MenQuadfi (quadrivalent meningococcal vaccine)
The FDA accepted for review the supplemental biologics license application for MenQuadfi (clinical study identifier: NCT03547271) for the potential extension of the indication to include children aged six weeks to 23 months through active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. The PDUFA date is May 23, 2025.
NVX-CoV2705 (COVID-19 vaccine)
The EMA approved and the FDA authorized for emergency use the updated Novavax protein-based COVID-19 vaccine. The vaccine has been refined to also target the JN.1 parent strain of the COVID-19 virus. A regulatory submission for full approval in the US is being prepared. In 2025, Sanofi will take on the commercialization from Novavax.
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Anticipated major upcoming pipeline milestones
Medicine/vaccine Indication Description
H2 2024 Dupixent
EoE children
Regulatory decision (EU)
CSU (Study C) Regulatory submission (US)
rilzabrutinib ITP Regulatory submission (US, EU)
IgG4-related disease Phase 2 data
duvakitug Inflammatory bowel disease Phase 2 data
tolebrutinib Secondary progressive MS Regulatory submission (US)
Cerezyme Gaucher disease type 3 Regulatory submission (US)
Cerdelga Gaucher disease type 1 children Regulatory decision (EU)
Sarclisa MDMM, TE (HD7)
Regulatory submission (EU)
MM, relapsed/refractory (R/R) (IRAKLIA study), subcutaneous Phase 3 data
H1 2025 Dupixent COPD Regulatory decision (JP)
BP Regulatory submission
CSU Regulatory decision (EU)
amlitelimab Asthma Phase 2 data
Hidradenitis suppurativa (HS) Phase 2 data
Oral TNFR1si Psoriasis Phase 2 data
TNFa/OX40L HS Phase 2 data
IRAK4 degrader HS Phase 2 data
AD Phase 2 data
fitusiran Hemophilia A/B Regulatory decision (US)
rilzabrutinib
ITP
Regulatory submission (JP, CN)
tolebrutinib Secondary progressive MS Regulatory submission (EU)
Sarclisa
NDMM, TI (IMROZ)
Regulatory decision (EU, JP, CN)
MM, R/R (IRAKLIA), subcutaneous Regulatory submission (US, EU)
MenQuadfi Meningitis six weeks+ Regulatory decision (US)
SP0087 Rabies Phase 3 data
H2 2025 itepekimab COPD Phase 3 data
Regulatory submission (US, EU)
lunsekimig Asthma Phase 2 data
Oral TNFR1si Rheumatoid arthritis Phase 2 data
AAT recombinant Fc Alpha-1 antitrypsin deficiency Phase 2 data
fitusiran Hemophilia A/B Regulatory decision (CN)
venglustat Fabry disease Phase 3 data
Gaucher disease type 3 Phase 3 data
tolebrutinib Primary progressive MS Phase 3 data
Regulatory submission (US)
Rezurock
Chronic graft-versus-host disease, third line
Regulatory decision (EU)
Tzield
Delay onset of type 1 diabetes
Regulatory decision (CN)
SP0087 Rabies Regulatory submission (US)
SP0230 Meningitis Phase 2 data
SP0256 RSV older adults Phase 2 data
Opella (consumer healthcare)
Net sales (€ million) Q3 2024 Change
at CER YTD 2024 Change
at CER
Wellness brands 574 +24.9 % 1,832 +22.5 %
Seasonal symptoms & pain relief 538 -3.1 % 1,754 -1.1 %
Others 159 -4.1 % 516 +1.5 %
Total 1,271 +7.9 % 4,102 +8.8 %
Opella sales were €1,271 million and increased by 7.9%. Growth was enhanced by the acquisition of Qunol (c.5%), organic sales growth (c.3%), and industrial sales transferred from Biopharma in January 2024 (c.2%) but tempered by divestments (c.2%). In North America, growth benefited mainly from the Qunol acquisition with some impacts from lower demand in the Seasonal symptoms & pain relief category, more specifically in allergy. Europe delivered steady sales with improving in-market performance supported by price, offset by negative volume impact. In the Rest of World, sales were driven by the Wellness category. In YTD 2024, sales increased by 8.8%, driven by Qunol (c.6%), organic growth (c.3%) and industrial sales (c.2%). This momentum was partially offset by the negative effect of divestments linked to strategic portfolio rationalization (c.2%).
Opella business operating income
In Q3 2024, Opella BOI was €287 million and increased by 1.1% (12.0% at CER). The ratio of BOI to net sales was 22.6% and decreased by 0.2pp (23.7% at CER, up by 0.9pp). This development was mainly driven by a higher gross margin, lower R&D expenses, and higher other operating income partly offset by higher SG&A expenses. In YTD 2024, BOI was €1,026 million and decreased by 9.5% (increased by 1.7% at CER). The ratio of BOI to net sales was 25.0% and decreased by 3.6pp (26.7% at CER, down by 1.9pp).
For future Opella reporting and accounting, please refer to the separate press release from October 21, 2024.