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5 = Summary =
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7 * Sanofi India is 100% subsidiary of Hoechst GmbH a world's leading healthcare companies
8 * Sanofi India Limited is amongst the leading multinational companies in the Indian Pharmaceutical Market.
9 * It offers a wide array of medicines for therapy areas such as Diabetes, Cardiology, Thrombosis, Central Nervous System and Anti-histamines.
10 * The company's healthcare solutions are available in 170 countries
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12 [[image:Sanofi0.jpg||height="388" width="689"]]
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15 = Company Overview =
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18 Sanofi India Limited (NSE:SANOFI) is one of the entities through which Sanofi operates in India. It was incorporated in May 1956 under the name Hoechst Fedco Pharma Private Limited. Over the years, its name was changed to Hoechst Pharmaceuticals Private Limited, Hoechst India Limited, Hoechst Marion Roussel Limited and Aventis Pharma Limited. Today, it employs more than 3,000 employees across India.{{footnote}}https://www.sanofiindialtd.com/en/about-us{{/footnote}}
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21 Sanofi, one of the world's leading healthcare companies, and its 100% subsidiary - Hoechst GmbH, are the major shareholders of Sanofi India Limited and together hold 60.4% of its paid-up share capital. The shares of Sanofi India Limited are quoted on the Bombay Stock Exchange and the National Stock Exchange.
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24 Sanofi India Limited is amongst the leading multinational companies in the Indian Pharmaceutical Market. It offers a wide array of medicines for therapy areas such as Diabetes, Cardiology, Thrombosis, Central Nervous System and Anti-histamines. The products manufactured by the Company are distributed in India and exported to many developed as well as developing countries.
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27 [[image:Sanofi2.jpg]]
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30 == Manufacturing Facilities ==
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32 Sanofi India has two manufacturing sites in Ankleshwar and Goa. These sites manufacture products with the stringent global quality guidelines, also approved by regulatory agencies. Sanofi India Limited also manufactures its products through third party manufacturers. The different types of dosage forms include tablets, capsules (hard and soft), Eye/Ear drops, ampoules, vials, creams and ointments. These products are manufactured in accordance with the same quality standards as those prevalent at its own manufacturing sites for domestic consumption and for export to Russia, the Ukraine and other CIS countries.
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35 **Goa**
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37 Formulations development centre with 35 bioequivalence studies and 17 patents to its credit, and manufacture pharmaceuticals
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40 **Hyderabad**
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42 Shantha Biotechnics (an affiliate of Sanofi Pasteur - the vaccines business unit) where the company do R&D and manufacture vaccines at affordable prices to serve people in India and other low & middle-income countries.
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44
45 == Research & Development ==
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47
48 **R&D Pipeline**
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50 As of 30 June 2021, the drugs and vaccines in Sanofi's R&D pipeline include 83 projects, 35 of which are in phase 3 or have been submitted to regulatory authorities for approval. These projects represent new molecular entities as well as existing therapeutics being investigated for additional indications, or different formulations.{{footnote}}https://www.sanofi.com/en/science-and-innovation/research-and-development/{{/footnote}}
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53 **Research areas**
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55 * Immunology & Inflammation
56 * Oncology
57 * Neurology
58 * Rare Blood Disorders
59 * Rare Diseases
60 * Vaccines
61 * Next Generation Approaches to Pioneer Breakthrough Therapies
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63 [[image:Sanofi4.jpg]]
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65 = Industry Overview =
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67 From 9% CAGR seen until 2019 (over previous 4 years), the unprecedented impact of COVID-19 on the Indian Pharmaceuticals Industry, resulted in subdued performance with annual industry value growth plummeting to 4.4% in year 2020. For the year ended 31st December 2020, IQVIA estimated the Indian Pharmaceuticals Market size to be Rs.1,535 billion.{{footnote}}https://www.sanofiindialtd.com/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-INLTD/Home/Investors/annual-reports/Annual-Report-2020.pdf?la=en{{/footnote}}
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69 The IQVIA Prognosis Report September 2020 projected the Indian Pharmaceuticals Market to grow at CAGR ~~7.7% (+/-2%) between 2019-2024, estimated to cross Rs. 2,231 billion by year 2024. It is expected that much of this growth will be driven by improved access to healthcare, increase in awareness, coupled with diagnosis of non-communicable diseases, new product launches and burgeoning hospital infrastructure. Growth is also expected from expansion of co-marketing agreements, introduction of OTC regulations, expansion of pharmacy chains and emergence of online pharmacies. With over 80% of the market contribution stemming from branded generics, these are also expected to play a relevant role in driving market growth.
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71 First half of the year 2020 saw tepid business scenario for the Indian Pharmaceuticals Market with multitude of concerns around supply chain, prices, impact on demand and availability assuming significance. Owing to the nature of the business, while the chronic therapies remained relatively insulated from the impact of the pandemic, the acute business witnessed a drop, with recovery signs beginning only in later part of the year 2020. Notable that therapies such as cardiac and acute respiratory witnessed high growth during the pandemic. Clearly, the impact of lockdown was felt more in urban regions versus non-urban regions.
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74 = Business Overview =
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77 Over the last 65 years, the Company has been at the forefront in supplying innovative and affordable medicines for patients in India. It offers a wide array of medicines for therapy areas such as Diabetes (both Insulins and Orals), Cardiology, Thrombosis, Anti-infectives, Central Nervous System, Allergy and Vitamins, Minerals & Supplements. As per IQVIA TSA MAT December 2020, three brands of the Company viz. Lantus®, Allegra® and Combiflam® feature in the top 100 pharmaceutical brands in India.
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80 During lockdown, digital mediums were actively leveraged to stay connected with key stakeholders. For sales activities, a multi-channel engagement campaign through remote calling, brand e-detailing, representative triggered emails, e-Scientific Information Event (eSIEs), e-RTMs were used to connect with the healthcare professionals.
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83 == Diabetes Care ==
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85 As per the latest International Diabetes Federation estimation, India has the 2nd highest Diabetic patient load with over 78 million adults affected by ailment. As a leading organization within Diabetes care, the Company through its wide range of quality medicines and patient support programs is committed to improving lives of Diabetic patients.
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88 The Insulin portfolio of the Company grew by 19.2% in value in the year 2020. Currently ranked #2 in the Indian Pharmaceuticals Market. Lantus®, the flagship brand of the Company touched lives of more than 6.7 lakh patients during the year 2020 and grew by TM 19.8% in value, further strengthening its position as the leading analog Insulin. Launched in 2018, Toujeo augmented the existing Insulin portfolio, offering an advanced standard of care and on a small base, registering 34% value growth during the year.
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90 The oral Anti-diabetic drug portfolio continued to grow in volumes led by Amaryl®, while registering 9% growth in value.
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93 == Established Products ==
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95 The Established Products of the Company comprises brands which are standards of care for treatment in multiple therapy areas such as Thrombosis, Cardiology, Anti-infectives and Epilepsy
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97 In the anti-coagulant space, Clexane® became the 1st brand in India to cross Rs.1,000 million in 2020 and continued to strengthen its leadership position through its vision of ‘VTE free India’. An increase in level of awareness of risk of Venous Thromboembolism (VTE) among COVID-19 patients, coupled with significant uptick in VTE prophylaxis was observed during the year.
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100 The flagship brands of the Company in Cardiology, Cardace® group, continues to be the leading Angiotensin Converting Enzymes (ACE) inhibitor prescribed by Cardiologists, Diabetologists and Consulting Physicians alike.
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103 In the resistant Gram+ segment, sales of Company’s leading Anti-infective brand Targocid® was impacted during the lockdown period in early part of the year. Clear recovery signs were seen by the brand starting mid-year, once hospitals picked up pace in admitting and treating non-COVID patients.
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106 While CNS epilepsy portfolio of the Company recorded 6% growth during the year, Frisium® was the most prescribed brand across all anti-convulsant brands
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108
109 == Consumer Healthcare ==
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112 The Company has structured its Consumer Healthcare business under three verticals i.e., Allergy, Pain relief and Nutritional Health.
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115 Allergy – Assuming rank 1 within allergy category, Company’s product group in this category grew faster than the market with a strong 12% market share during the year. Both the flagship brands Allegra® & Avil® oral witnessed share gain (1.28% and 1.19% respectively) during the period, despite the onset of the pandemic during the year.
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118 Pain Care – The oral solid analgesics market grew at 6% in the year 2020, while Combiflam® tablets witnessed double digit growth of 14%.
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120 Nutritional Health - Company’s flagship nutritional health brand DePura by Sanofi promotion which was centered around ‘Vitamin TM D and the Immune System: Implications during the pandemic’, was well received by the healthcare community. DePura by Sanofi portfolio witnessing 13% growth in the year 2020.
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123 == Export Market ==
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125 During the year ended 31st December 2020, the Company exported its products to 50 countries, with Germany, United Kingdom, Australia, Czech Republic and Russia ranking as the main markets. The key drug products were Ramilich tablets, Paracetamol & Codeine tablets, Metformin tablets, Ibuflam Tablets, Festal dragees and API’s like Articaine & Pentoxifylline.
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128 For the year ended 31st December 2020, exports revenue decreased from Rs. 9,220 million in 2019 to Rs. 6,097 million in 2020, due to the slump sale and transfer of the manufacturing facility at Ankleshwar along with few products that were exported to European markets, to Zentiva Private Limited.
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131 [[image:Sanofi3.png]]
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134 = Financial Highlights =
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136 During the year ended 31st December 2020, the Company registered Revenue from Operations of Rs. 29,019 million as against Rs. 30,706 million in the previous year, representing degrowth by 5.49%.
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138 Net revenue from India, which constituted 78.99% of Net Revenue from Operations, increased from Rs. 21,486 million in 2019 to Rs. 22,922 million in 2020, reflecting a growth of 6.68%
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140 Exports revenue, which contributed 21.01% of Net Revenue from Operations, decreased from Rs. 9,220 million in 2019 to Rs. 6,097 million in 2020, representing a degrowth of 33.87%.
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142 The Profit before Tax increased from Rs. 5,999 million to Rs. 6,772 million, representing a growth of 12.89% for the year ended 31st December 2020.
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144 The Profit after Tax increased from Rs. 4,142 million to Rs. 4,776 million, representing a growth of 15.31% for the year ended 31st December 2020.
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146
147 == Second Quarter 2021 Results ==
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149 **Sanofi India reports Q2 net profit at Rs 178.3 crore**.{{footnote}}https://www.moneycontrol.com/news/business/earnings/sanofi-india-reports-q2-net-profit-at-rs-178-3-crore-7234031.html{{/footnote}}
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151 July 27, 2021 Drug firm Sanofi India reported a net profit of Rs 178.3 crore for the second quarter ended in June.
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153 The company had posted a net profit of Rs 136.3 crore for the corresponding period of the previous financial year, Sanofi India said in a regulatory filing.
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155 Revenue from operations of the company stood at Rs 789.1 crore for the quarter under consideration. It was Rs 710.5 crore for the same period a year ago, it added.
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157 "On account of Ankleshwar manufacturing facility transfer to Zentiva, export sales reduced in the current period and accordingly the export sales performance for the quarter and period ended June 30, 2021, is not comparable with quarter and period ended June 30, 2020," Sanofi India said.
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160 [[image:Sanofi5.jpg]]
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163 = Recent developments =
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166 **Sanofi and GSK receive approval for Phase 3 efficacy trial of their COVID-19 vaccine candidate in India**.{{footnote}}https://www.sanofi.in/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-IN/Home/Media/press-release/2021/Sanofi-and-GSK-receive-approval-for-Phase-3-efficacy-trial-of-their-COVID19-vaccine-candidate-in-Ind.pdf?la=en{{/footnote}}
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168 July 08, 2021; Sanofi and GSK received approval for their Phase 3 clinical study in India, to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. The global, randomized, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the US, Asia, Africa, and Latin America.
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170 As COVID-19 vaccination becomes available, study participants are encouraged to receive an approved COVID-19 vaccine during the study, if they wish to do so. As part of the study design, all participants including the control group will be offered the study vaccine as soon as it is determined to be safe and effective.
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173 **About the Sanofi and GSK partnership**
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175 In the partnership between the two Companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. The recombinant technology combined with GSK’s adjuvant is designed to offer the advantages of stability at temperatures used for routine vaccines, making it easily implementable and easier to distribute at a global scale through existing infrastructures where vaccines are stored at normal refrigerator temperature. It is also designed to offer the potential to generate high and sustained immune responses, and the potential to prevent virus transmission.
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178 [[image:Sanofi6.jpg]]
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181 **Sanofi India Limited announces sale and transfer of its Nutraceuticals’ business to Universal Nutriscience**. {{footnote}}https://www.sanofi.in/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-IN/Home/Media/press-release/2021/Sanofi-India--Universal-Nutriscience--July-28-2021.pdf?la=en{{/footnote}}
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183 July 28, 2021; Sanofi India Limited (SIL) announced today that its Board of Directors have approved the sale and transfer of its Nutraceuticals’ business to Universal Nutriscience Pvt. Ltd. This decision will help SIL focus strongly on its growth pillars, while allowing the Nutraceuticals business to have more opportunities for expansion in an organisation where it will have a better strategic fit.
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185 Universal Nutriscience is a strategic partnership between Kedaara Capital (one of India’s leading private equity firms) and Universal Medicare (one of the pioneers in Nutraceuticals), with a vision to become India’s leading Nutraceuticals company.
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187 Sanofi India Limited’s (SIL) growth strategy is to ensure that patients have sustainable access to its medicines by developing new business models, leveraging technologies and simplifying the portfolio.
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189 The transaction is valued at INR 5,870 million. Subject to fulfilment of conditions, closing is anticipated within the next 3 months.
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191 16 nutraceutical brands in the portfolio would be transferred to Universal Nutriscience as part of the transaction. These would include market-leading brands such as Seacod®, E-Cod®, CoQ®, Primosa®, and Collaflex®. All employees who are associated with this business, will also have a smooth transition to Universal Nutriscience.
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194 = References =
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