Sanofi at forefront of fight against COVID-19 in Q1 2020
Sanofi at forefront of fight against COVID-19 in Q1 2020
Rapid and decisive response to COVID-19 global health crisis
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Sanofi Chief Executive Officer, Paul Hudson, commented: “I am proud of the way Sanofi employees responded to the immense challenges of the COVID-19 pandemic. They continue to put patients first while embracing and delivering on the new Company strategy. This is exemplified by the multi-pronged approach to fight COVID-19 with the accelerated development of vaccine candidates and therapeutics while sustaining the impressive growth of Dupixent®, the strength of the Vaccines business as well as driving efficiencies and cash flow. In R&D, we took actions to maintain clinical trial programs and to advance our pipeline of potentially transformative medicines. While the duration of the pandemic remains unknown at this point, I am confident Sanofi is well positioned to navigate these challenges and deliver on our commitment to patients.” |
Q1 2020 | Change | Change at CER | |
IFRS net sales reported | €8,973m | +6.9% | +6.6% |
IFRS net income reported | €1,683m | +48.0% | - |
IFRS EPS reported | €1.35 | +48.4% | - |
Free cash flow(4) | €1,558m | +90.0% | - |
Business operating income | €2,659m | +15.8% | +15.9% |
Business net income(2) | €2,042m | +15.9% | +16.1% |
Business EPS(2) | €1.63 | +15.6% | +15.6% |
(1) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9); (2) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 9). The consolidated income statement for Q1 2020 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (3) Base for business EPS growth is €5.97, reflecting 2 cents impact from IFRS 16 (Appendix 9); (4) Free cash flow is a non-GAAP financial measure (definition in Appendix 9).
2020 first-quarter Sanofi sales
Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(5). |
In the first quarter of 2020, Company sales were €8,973 million, up 6.9% on a reported basis. Exchange rate movements had a positive effect of 0.3 percentage points, mainly driven by the strength of the U.S. dollar and the Japanese yen, partially offset by the decrease in the Brazilian real and the Argentine peso. At CER, Company sales increased 6.6%.
Global Business Units
With effect from January 1, 2020, Sanofi has structured its business into three core Global Business Units (GBUs) to support the Company’s strategy: Specialty Care, General Medicines and Vaccines. Its Consumer Healthcare business is in the process of being established as a standalone business with integrated R&D and manufacturing functions.The table below presents first-quarter 2020 sales by Global Business Unit, including Consumer Healthcare, and by reporting region.
Net sales by GBU (€ million) | Q1 2020 | Change at CER | U.S. | Change at CER | Europe | Change at CER | Rest of the World | Change at CER |
Specialty Care | 2,695 | +31.3% | 1,639 | +36.8% | 589 | +21.2% | 467 | +27.2% |
Dupixent | 776 | +129.8% | 613 | +123.7% | 90 | +140.5% | 73 | +176.9% |
Multiple Sclerosis/ Neurology/Other I&I | 645 | +13.2% | 446 | +17.9% | 151 | +2.7% | 48 | +9.3% |
Rare Disease | 794 | +11.2% | 280 | +6.3% | 268 | +9.9% | 246 | +18.5% |
Oncology | 186 | +28.7% | 83 | +19.4% | 71 | +36.5% | 32 | +37.5% |
Rare Blood Disorder | 294 | +3.6% | 217 | +1.9% | 9 | +80.0% | 68 | +3.2% |
General Medicines | 4,069 | -3.8% | 742 | -10.7% | 1,220 | +1.4% | 2,107 | -4.1% |
Diabetes | 1,282 | -1.2% | 375 | -18.0% | 325 | +4.8% | 582 | +9.3% |
Cardiovascular and Established Rx Products | 2,787 | -5.0% | 367 | -1.7% | 895 | +0.2% | 1,525 | -8.4% |
Vaccines | 909 | +3.7% | 288 | +2.9% | 153 | +0.7% | 468 | +5.1% |
Consumer Healthcare | 1,300 | +4.2% | 302 | -5.2% | 420 | +6.1% | 578 | +8.1% |
Total net sales | 8,973 | +6.6% | 2,971 | +13.1% | 2,382 | +6.5% | 3,620 | +2.1% |
Pharmaceuticals
First-quarter 2020 Pharmaceutical sales were up 7.5% to €6,764 million, mainly driven by Dupixent® and Aubagio®, partially offset by the decline in Plavix® sales in China.
Specialty Care GBU
Dupixent
Net sales (€ million) | Q1 2020 | Change at CER |
Total Dupixent® | 776 | +129.8% |
Dupixent® (collaboration with Regeneron) generated sales of €776 million in the first quarter (up 129.8%). In the U.S., Dupixent® sales of €613 million (up 123.7%) were driven by continued growth in atopic dermatitis which benefited from increased penetration in adult and adolescent patients, together with rapid uptake in asthma and the most recent launch in chronic rhinosinusitis with nasal polyposis (CRSwNP, approved in June 2019). In the U.S., Dupixent® NBRx and TRx increased strongly compared to the first quarter of 2019, growing at 76% and 118%, respectively. First-quarter sales of Dupixent® in Europe rose to €90 million (up 140.5%) driven by continued growth in atopic dermatitis in key markets and additional launches. In Japan, where sales were €41 million (up 166.7%), a governmental price decrease was implemented on April 1. Dupixent® is now launched in 38 countries for adult atopic dermatitis; among these, Dupixent® is also launched in adolescent atopic dermatitis in 12 countries, in asthma in 14 countries and in CRSwNP in 5 countries. Potentially as many as 68 additional country launches are planned across these indications in the remainder of 2020.
(5) See Appendix 9 for definitions of financial indicators. .
Multiple Sclerosis/Neurology/Other Inflammation & Immunology
Net sales (€ million) | Q1 2020 | Change at CER |
Aubagio® | 541 | +21.3% |
Lemtrada® | 49 | -46.7% |
Kevzara® | 55 | +80.0% |
Total Multiple Sclerosis/ Neurology/Other I&I | 645 | +13.2% |
First-quarter Multiple Sclerosis/Neurology/Other I&I sales increased 13.2% to €645 million.
First-quarter Aubagio® sales increased 21.3% to €541 million, driven by the U.S. (up 23.0% to €391 million) and European performance (up 21.4% to €118 million). Sales growth reflected increased demand, together with inventory build some of which was partially related to COVID-19, and pricing.
In the first quarter, Lemtrada® sales decreased 46.7% to €49 million due to lower sales in the U.S. (down 43.9% to €23 million) and in Europe (down 69.0% to €13 million), reflecting increased global competition and reduced new patient starts as a result of COVID-19.
Kevzara® (collaboration with Regeneron) sales were €55 million (up 80.0%) in the first quarter, of which €32 million was generated in the U.S. (up 72.2%) and €20 million in Europe (150.0%).
Rare Disease
Net sales (€ million) | Q1 2020 | Change at CER |
Myozyme® / Lumizyme® | 246 | +11.8% |
Fabrazyme® | 214 | +14.6% |
Cerezyme® | 189 | +9.7% |
Aldurazyme® | 67 | 0.0% |
Cerdelga® | 58 | +20.8% |
Others Rare Disease | 20 | 0.0% |
Total Rare Disease | 794 | +11.2% |
In the first quarter, Rare Disease sales increased 11.2% to €794 million. In Europe, sales were up 9.9% (to €268 million), with growth elevated by an increase in stock driven by the COVID-19 pandemic. In the U.S., Rare Disease sales were up 6.3% (to €280 million). Strong Rest of the World growth (up 18.5% to €246 million) reflected ongoing demand trends and favorable timing of favorable tenders.
First-quarter Gaucher (Cerezyme® and Cerdelga®) sales increased 12.1% to €247 million. Cerezyme® sales increased 9.7% to €189 million, sustained by strong performance in Rest of the World (up 20.9% to €76 million). Cerezyme® growth was due to new patient starts and positive phasing of shipments in the Rest of the World. First-quarter Cerdelga® sales increased 20.8% to €58 million, with sales up 41.2% in Europe (to €24 million) and up 7.1% in the U.S. (to €31 million). Cerdelga® growth reflected new patient starts and competitive switches especially in Europe.
First-quarter Pompe (Myozyme®/Lumizyme®) sales grew 11.8% to €246 million,mainly reflecting new patient starts and reduced competition from clinical trials enrolling patients. In the Rest of the World, Myozyme®/Lumizyme® sales were up 28.3% to €55 million. In the U.S. and in Europe, Myozyme®/Lumizyme® sales increased 6.3% (to €87 million) and 8.4% (to €104 million), respectively.
First-quarter Fabry (Fabrazyme®) sales grew 14.6% to €214 million, driven by the Rest of the World (up 28.3% to €58 million). In the U.S. and Europe, Fabrazyme® sales increased 7.4% (to €104 million) and 15.6% (to €52 million), respectively. Growth was driven by new patient starts, especially in Europe and the Rest of the World which also benefited from positive order phasing.
Oncology
Net sales (€ million) | Q1 2020 | Change at CER |
Jevtana® | 138 | +22.5% |
Fasturtec® | 35 | +9.4% |
Libtayo® | 12 | - |
Sarclisa® | 1 | - |
Total Oncology | 186 | +28.7% |
First-quarter Oncology sales increased 28.7% to €186 million driven by double-digit growth in all regions.
First-quarter Jevtana® sales increased 22.5% to €138 million driven by the U.S. (up 23.4% to €60 million) and Europe (up 18.6% to €51 million). Sales performance benefited from publication of the results of the CARD study in metastatic castration-resistant prostate cancer at ESMO (European Society for Medical Oncology) and in the NEJM (New England Journal of Medicine) in September 2019. In the Rest of the World, Jevtana® sales increased 28.6% (to €27 million).
Libtayo® (collaboration with Regeneron) approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation had ex-U.S. sales of €12 million in the first quarter. Libtayo® has been launched in 12 countries outside the U.S. and 10 additional country launches are planned by the end of 2020. U.S. Libtayo® sales are reported by Regeneron.
Sarclisa® (isatuximab-irfc) was approved by the U.S. Food and Drug Administration (FDA), in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor on March 2, 2020. The U.S. pre-launch was impacted by COVID-19. Sarclisa® also received marketing authorization in Switzerland. In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sarclisa® in RRMM at the end of March.
Rare Blood Disorder
Net sales (€ million) | Q1 2020 | Change at CER |
Eloctate® | 161 | -10.9% |
Alprolix® | 109 | +11.6% |
Cablivi® | 24 | ns |
Total Rare Blood Disorder | 294 | +3.6% |
First-quarter sales of the Rare Blood Disorder franchise were €294 million, up 3.6%. First-quarter U.S. sales were €217 million, up 1.9%. Non U.S. sales were €77 million with Japan as the primary contributor.
Eloctate® sales were €161 million in the first quarter, down 10.9%. U.S. sales were down 16.1% to €119 million as a result of ongoing competitive pressure. In the Rest of the World, first-quarter Eloctate® sales increased 8.1% to €42 million.
Alprolix® sales were €109 million in the first quarter, up 11.6% driven by the U.S., where sales increased 15.7% to €83 million reflecting switches from short acting therapies and conversion to prophylaxis treatment. In the Rest of the World, Alprolix® sales were stable at €26 million.
Cablivi® for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) generated first-quarter sales of €24 million. Sales of Cablivi® in the U.S. and Europe were €15 million and €9 million, respectively. In Europe, the product is commercially available in Germany, Denmark, Austria, Belgium, Netherlands, Italy and Finland. Additionally, Cablivi® has a temporary license to be sold in France.
General Medicines GBU
Diabetes
Net sales (€ million) | Q1 2020 | Change at CER |
Lantus® | 724 | -6.6% |
Toujeo® | 257 | +20.9% |
Total glargine | 981 | -0.7% |
Apidra® | 89 | +1.1% |
Admelog® | 50 | -27.3% |
Soliqua® | 37 | +68.2% |
Other diabetes | 125 | -4.5% |
Total Diabetes | 1,282 | -1.2% |
In the first quarter, global Diabetes sales decreased 1.2% to €1,282 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S. which were partly offset by increased sales in the Rest of the World and patient stockpiling due to the COVID-19 pandemic notably in Europe. First-quarter U.S. Diabetes sales were down 18.0% to €375 million, reflecting a continued decline in average U.S. glargine net prices. First-quarter sales in Europe increased 4.8% to €325 million driven by Toujeo®. First-quarter sales in the Rest of the World were up 9.3% to €582 million.
In the first quarter, Lantus® sales were €724 million, down 6.6%. In the U.S., Lantus® sales decreased 21.5% to €230 million, mainly reflecting lower average net price. In Europe, first-quarter Lantus® sales were €149 million, down 3.9% reflecting biosimilar glargine competition and patients switching to Toujeo®. In the Rest of the World, first-quarter Lantus® sales increased 4.8% to €345 million driven by strong performance in China.
First-quarter Toujeo® sales increased 20.9% to €257 million, driven by strong performance in Europe (up 22.0% to €100 million) mainly driven by patient switches from Lantus® to Toujeo® and in the Rest of the World (up 48.3% to €89 million). In the U.S., first-quarter Toujeo® sales were €68 million, down 4.3% mainly reflecting lower average net price.
First-quarter Amaryl® sales decreased 8.9% to €82 million, due to lower sales in China (down 13.2% to €33 million) reflecting the anticipated net price adjustments and inventory reduction in the channel due to the second wave of the nationwide VBP (volume-based procurement) program which includes glimepiride (compound name of Amaryl®). As previously disclosed, Sanofi opted not to bid with Amaryl® and expects sales of Amaryl® in China to decline significantly in 2020.
First-quarter Apidra® sales increased 1.1% to €89 million. Lower sales in the U.S. (down 30.8% to €9 million) offset growth in the Rest of the World (up 9.5% to €46 million) and Europe (up 2.9% to €34 million).
Admelog® (insulin lispro injection) generated sales of €50 million (down 27.3%) in the first quarter. Admelog® sales in the U.S. were €44 million, down 31.7% due to the WAC price adjustment of -44% which took effect on July 1, 2019. Sanofi expects lower Admelog® sales in 2020 due to the full-year impact of the U.S. WAC price adjustment.
First-quarter Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) and Suliqua™ sales increased 68.2% (to €37 million) of which €22 million (up 37.5%) was generated in the U.S.
Cardiovascular and Established Rx Products
Net sales (€ million) | Q1 2020 | Change at CER |
Lovenox® | 329 | -2.9% |
Plavix® | 273 | -32.7% |
Aprovel®/Avapro® | 174 | -13.4% |
Thymoglobulin® | 85 | +3.7% |
Multaq® | 81 | 0.0% |
Praluent® | 73 | +28.6% |
Renvela®/Renagel® | 71 | -11.4% |
Synvisc® /Synvisc-One® | 58 | -16.2% |
Mozobil® | 54 | +20.5% |
Eloxatin® | 47 | -11.1% |
Taxotere® | 39 | -17.0% |
Generics | 270 | -0.4% |
Other | 1,233 | +2.5% |
Total Cardiovascular and Established Rx Products | 2,787 | -5.0% |
In the first quarter, Cardiovascular and Established Rx Products sales decreased 5.0% to €2,787 million, primarily reflecting the decline in Plavix® and Aprovel® family sales in China due to net price adjustments following the nationwide implementation of the VBP program in December. Excluding China, Cardiovascular and Established Rx Products sales increased 0.6%. Established Rx Products benefited from a favorable impact from COVID-19 on sales of chronic disease treatments, which reflected longer duration prescriptions and patient stocking despite lower sales of hospital-administered therapies.
First-quarter Lovenox® sales decreased 2.9% to €329 million, reflecting lower European sales (down 13.2% to €171 million) due to biosimilar competition in several countries in Europe. In the Rest of the World, Lovenox® sales grew 12.4% to €150 million.
In the first quarter, Plavix® sales were down 32.7% to €273 million, primarily reflecting the decrease in China (sales down 53.5% to €118 million) due to net price adjustments following the implementation of the VBP program. As expected, volume growth of Plavix® increased significantly in China over the quarter. In Japan, Plavix® sales decreased 19.4% to €26 million due to a price reduction in October 2019.
First-quarter Aprovel®/Avapro® sales were down 13.4% to €174 million, primarily reflecting the decrease in China (sales down 32.7% to €68 million) due to net price adjustments following implementation of the VBP program. As expected, volume growth of Aprovel® family increased significantly in China over the quarter.
As previously announced, Sanofi expects sales of Plavix® and the Aprovel® family in China to decline by around 50% in 2020 due to implementation of the VBP program. In the first quarter 2020, volume growth of Plavix® and CoAprovel® increased more than 60% in China in line with Sanofi’s full-year expectations.
First-quarter Praluent® sales increased 28.6% to €73 million, driven by the U.S. (up 55.0% to €32 million) and Rest of the World (up 83.3% to €11million). In Europe, Praluent® sales were stable at €30 million reflecting the suspension of sales in Germany in August 2019 following the Regional Court of Dusseldorf ruling in the ongoing patent litigation.
On April 6, Sanofi announced that it had finalized the planned restructuring related to Praluent® with Regeneron. Effective April 1, 2020, Sanofi has sole responsibility for Praluent® outside the U.S. while Regeneron has sole responsibility for Praluent® in the U.S. The restructuring simplifies the antibody collaboration, increases efficiency and streamlines operations for Praluent®. As a consequence, Sanofi will no longer consolidate Praluent sales in the U.S. from April 1.
First-quarter Renvela®/Renagel® (sevelamer) sales decreased 11.4% to €71 million, due to generic competition in the U.S. (down 29.7% to €26 million) and despite growth in China.
First-quarter sales of Eloxatin® and Taxotere® were down 11.1% (€47 million) and down 17.0% (€39 million), respectively driven by lower sales in China reflecting the adverse impact of COVID-19 on sales of hospital-administered drugs.
Vaccines GBU
Net sales (€ million) | Q1 2020 | Change at CER |
Polio/Pertussis/Hib vaccines (incl. Hexaxim® / Hexyon®, Pentacel®, Pentaxim® and Imovax®) | 484 | -0.8% |
Meningitis/Pneumo vaccines (incl. Menactra®) | 131 | +16.1% |
Adult Booster vaccines (incl. Adacel ®) | 115 | +14.0% |
Travel and other endemic vaccines | 99 | -17.6% |
Influenza vaccines (incl. Vaxigrip®, Fluzone HD®, Fluzone® & Flublok®) | 63 | +100.0% |
Other vaccines | 17 | -29.2% |
Total Vaccines | 909 | +3.7% |
First-quarter Vaccines sales increased 3.7% to €909 million reflecting the high base for comparison (first-quarter 2019 Vaccines sales increased by 20.1%). Performance was driven by Rest of the World (up 5.1% to €468 million). In the U.S. and Europe, first-quarter Vaccines sales were up 2.9% (to €288 million) and up 0.7% (to €153 million), respectively. The impact from COVID-19 was marginal in the first quarter, as favorable effects on influenza vaccines sales were offset by negative impacts on travel vaccines.
In the first quarter, Polio/Pertussis/Hib (PPH) vaccines sales decreased 0.8% to €484 million due to a 3.5% decrease in Rest of the World (to €306 million) relecting the high base for comparison (in the first quarter of 2019, PPH vaccines sales benefited from favorable phasing in Japan). In the U.S., first quarter PPH vaccines sales were up 9.8% to €104 million driven by Pentacel® and Quadracel®. In Europe, PPH vaccines sales were down 2.6% to €74 million.
First-quarter Menactra® sales increased 16.1% to €131 million, reflecting a tender awarded in Brazil.
First-quarter Adult Booster vaccines sales were up 14.0% to €115 million, reflecting favorable phasing in Europe (up 24.3% to €46 million).
First-quarter Travel and other endemic vaccines sales were €99 million, down 17.6%, reflecting travel restrictions related to COVID-19.
Influenza vaccines sales increased strongly (up 100.0%) to €63 million in the first quarter, reflecting the late season in the north hemisphere and higher vaccines delivery in the south hemisphere favorably impacted by COVID-19.
Consumer Healthcare
CHC sales by geography and category are provided in Appendix 1.
Net sales (€ million) | Q1 2020 | Change at CER |
Allergy Cough & Cold | 398 | +8.5% |
of which Allegra® | 147 | +8.1% |
of which Mucosolvan® | 34 | +21.4% |
of which Xyzal® | 17 | +14.3% |
Pain | 358 | +13.1% |
of which Doliprane® | 95 | +20.3% |
of which Buscopan® | 50 | +17.0% |
Digestive | 232 | -12.7% |
of which Dulcolax® | 57 | +3.6% |
of which Enterogermina® | 62 | +8.6% |
of which Essentiale® | 44 | -10.2% |
of which Zantac® | 0 | -100% |
Nutritionals | 154 | +8.3% |
Other | 158 | +0.6% |
of which Gold Bond® | 56 | +3.8% |
Total Consumer Healthcare | 1,300 | +4.2% |
In the first quarter, Consumer Healthcare (CHC) sales increased 4.2% to €1,300 million. Sales growth in the quarter benefited from higher demand related to COVID-19. This performance more than offset the impact of the Zantac® voluntary recall, divestments of non-core products and product suspensions due to changing regulatory requirements.
In September 2019, the U.S. Food and Drug Administration (FDA) and Health Canada issued public statements alerting that some ranitidine medicines, including Zantac® OTC, could contain NDMA at low levels and asked manufacturers to conduct testing. Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi decided to conduct the voluntary recall in the U.S. and Canada in October 2019. On April 1, 2020, the FDA requested the immediate removal of all ranitidine medicines from the U.S. market.
In Europe, first-quarter CHC sales increased 6.1% to €420 million, reflecting demand related to COVID-19 for Pain and Cough & Cold products particularly Doliprane® in France. Pain category sales increased 14.4% to €159 million. First-quarter sales of the Allergy, Cough & Cold and Digestive categories showed growth of 3.6% (to €115 million) and 3.3% (to €93 million), respectively.
In the U.S., first-quarter CHC sales decreased 5.2% to €302 million, reflecting the impact of the Zantac® recall (-€28 million) which was partially offset by consumer stockpiling due to COVID-19. First-quarter sales of the Pain and Allergy, Cough & Cold categories showed growth of 8.9% (to €51 million) and 1.9% (to €112 million), respectively. Gold Bond sales increased 3.8% due to strong demand increase.
In the Rest of the World, first-quarter CHC sales increased 8.1% to €578 million, driven by double-digit growth in Allergy, Cough & Cold (up 17.1% to €171 million), Pain (up 13.3% to €148 million) and Nutritional (up 12.0% to €108 million) categories, supported by continued underlying demand as well as a favorable COVID-19 impact.
Company sales by geographic region
Sanofi sales (€ million) | Q1 2020 | Change at CER |
United States | 2,971 | +13.1% |
Europe | 2,382 | +6.5% |
Rest of the World | 3,620 | +2.1% |
of which China | 680 | -14.4% |
of which Japan | 505 | -8.6% |
of which Brazil | 270 | +14.6% |
of which Russia | 194 | +15.7% |
Total Sanofi sales | 8,973 | +6.6% |
First-quarter sales in the U.S. increased 13.1% to €2,971 million, driven mainly by the strong performance of Dupixent®. Aubagio® also contributed to U.S. growth in part due to higher inventories partially related with the COVID-19 environment.
First-quarter sales in Europe were up 6.5% to €2,382 million, driven by Dupixent®, Rare Disease, CHC, Aubagio® and oncology performance. As noted, sales in some categories in Europe (notably chronic diseases within General Medicines, including Diabetes, and CHC) were significantly impacted by patient stocking associated with COVID-19.
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