Sanofi : Q1 2021 Press release

Paris, April 28, 2021

Sanofi continued its growth trajectory.

Strong increase in Q1 2021 business EPS(1) at CER.

Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent® and Vaccines

• Specialty Care sales grew 15.3%, due to strong Dupixent® performance (+45.6% to €1,047 million) and oncology launches
• Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere
• General Medicines core assets grew 4.4%, while GBU sales were down 3.8%
• CHC decreased 7.3% due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe

Q1 2021 business EPS(1) growth at CER driven by efficiency and sales performance, supported by a one-time payment

• Business EPS(1) was €1.61 up 5.2% on a reported basis and up 15.0% at CER
• Business EPS(1) includes an incremental 8 cents due to a payment related to the termination of a collaboration in Japan
• IFRS EPS was €1.25

Progress on implementation of the Corporate Social Responsibility strategy

• Sanofi has become a member of the top five companies of the 2021 Access to Medicine index
• Sanofi announced Sanofi Global Health, a newly formed non-profit unit within the company, a new cornerstone of its CSR strategy

Full-year 2021 business EPS guidance affirmed

• Sanofi expects 2021 business EPS(1) to grow high single digit(2) at CER, barring unforeseen major adverse events. Applying average April 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -4% to -5%.

Sanofi Chief Executive Officer, Paul Hudson, commented:

"Our strong first-quarter performance is the result of the continued execution of our Play to Win strategy to drive growth and bring innovative medicines to patients. Dupixent® continues its outstanding performance with impressive growth in the U.S. and strong uptake in global markets, including China. Vaccines delivered growth in its core segments. We initiated and completed enrollment of our Phase 2 study for our recombinant COVID-19 vaccine candidate in the first quarter and results are expected next month. Following the communication of our ESG strategy at the end of 2020 and embedding it into our business priorities, we have recently created the Sanofi Global Health Unit, dedicated to increasing access to 30 medicines considered essential by the WHO. Sanofi is uniquely positioned to make this difference to society, which can be scaled and sustained over time, given our portfolio of essential medicines and broad geographic presence."

	Q1 2021		Change			Change
				at CER
IFRS net sales reported	€8,591m	-4.3%		+2.4%
IFRS net income reported	€1,566m	-7.0%		_
IFRS EPS reported	€1.25	-7.4%		_
Free cash flow(3)	€1,925m	+23.6%		_
Business operating income	€2,638m	+4.0%		+13.3%
Business net income(1)	€2,017m	+5.1%		+14.7%
Business EPS(1)	€1.61	+5.2%		+15.0%

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (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-GAAP financial measure (definition in Appendix 7). The consolidated income statement for Q1 2021 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2020 restated business EPS was €5.86; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 7).

2021 first-quarter Sanofi sales

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Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER1

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In the first quarter of 2021, Sanofi sales were €8,591 million, down 4.3% on a reported basis. Exchange rate movements had a negative effect of 6.7 percentage points, mainly driven by the decrease of the U.S. dollar, Brazilian real, Russian ruble, Turkish lira, and Argentine peso and Japanese yen. At CER, Sanofi sales increased 2.4%.

Global Business Units

First-quarter 2021 net sales by Global Business Unit (variation at CER; € million; % of total sales)

First-quarter 2021 net sales by geographic region (variation at CER; € million; % of total sales)

First-quarter 2021 operating income

First-quarterbusiness operating income (BOI) increased 4.0% to €2,638 million. At CER, BOI increased 13.3%. The ratio of BOI to net sales increased 2.4 percentage points to 30.7% versus the prior year.

Pharmaceuticals

First-quarter 2021 Pharmaceutical sales increased 3.8% to €6,563 million, with double-digit growth of the Specialty Care portfolio mainly driven by the strong performance of Dupixent® which largely offset lower sales in General Medicines in Europe and the U.S.

1 See Appendix 7 for definitions of financial indicators.

Specialty Care

Dupixent

	Net sales (€ million)		Q1 2021		Change
			at CER
	Total Dupixent®		1,047	+45.6 %

In the first quarter, Dupixent® (collaboration with Regeneron) sales were strong despite the COVID-19 environment and increased 45.6% to €1,047 million. In the U.S., Dupixent® sales of €793 million (up 41.6%) were driven by continued strong demand in atopic dermatitis (AD) in adult, adolescent patients, and children aged 6 to 11 years, continued uptake in asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent® total prescriptions (TRx) increased 51% (year-over-year) and new-to-brand prescriptions (NBRx) grew 16% despite fewer in-person physician visits which remain below the pre-COVID level. In Europe, first-quarter Dupixent® sales grew 52.2% to €137 million reflecting continued growth in AD in key countries and additional launches in asthma in European markets. In Japan, sales were €59 million (up 53.7%), where strong demand was moderated by the government price decrease implemented in April 2020. Dupixent® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. At the end of the first quarter, Dupixent® was launched in 49 countries with approximately 260 000 patients on therapy.

Neurology and Immunology

	Net sales (€ million)		Q1 2021		Change
			at CER
	Aubagio®		500	-1.1 %
	Lemtrada®		24	-44.9 %
	Kevzara®		57	+10.9 %
	Total Neurology and Immunology		581	-3.4 %

In the first-quarter,Neurology and Immunology sales were down 3.4% to €581 million, impacted primarily by the decline of Lemtrada® sales.

Aubagio® sales decreased 1.1% in the first quarter to €500 million, due to lower sales in the U.S. reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe.

First-quarterLemtrada® sales decreased 44.9% to €24 million, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada®.

First-quarterKevzara® (collaboration with Regeneron) sales were up 10.9% to €57 million driven by Europe and Rest of the World which largely offset lower U.S. sales reflecting the recent strategic decision to reduce promotional efforts.

Rare Disease

Net sales (€ million)

Myozyme® / Lumizyme®

Fabrazyme®

Cerezyme®

Aldurazyme®

Cerdelga®

Others Rare Disease

Total Rare Disease

			Change
	Q1 2021
		at CER
	235		+0.8 %
	208		+4.7 %
	178		+4.2 %
	66		+7.5 %
	62		+13.8 %
	21		+10.0%
	770		+4.4 %

In the first quarter, Rare Disease sales increased 4.4% to €770 million, primarily driven by higher demand particularly in Rest of the World (up 10.2%). Sales in Europe increased 0.4% and compared to a high base in the first quarter of 2020 due to an inventory build related to the COVID-19 environment.

First-quarterCerezyme® sales increased 4.2% to €178 million, driven by strong growth in Rest of the World (up 18.4%). First-quarterCerdelga® sales increased 13.8% to €62 million driven by new patient accruals in the three regions. Sales of the Gaucher franchise (Cerezyme® + Cerdelga®) increased 6.5% (to €240 million) in the first quarter.

First-quarterMyozyme®/Lumizyme® sales increased 0.8% to €235 million supported by new patient accruals in the U.S. (up 11.5%) which offset lower sales in Europe and negative phasing effect in Rest of the World.

First-quarterFabrazyme® sales increased 4.7% to €208 million driven by higher sales in Rest of the World and Europe. In the U.S. sales decreased 2.9% reflecting lower treatment compliance during the COVID-19 pandemic.

Oncology

Net sales (€ million)

Jevtana®

Fasturtec®

Libtayo®

Sarclisa®

Total Oncology

			Change
	Q1 2021
		at CER
	126		-2.9 %
	35		+8.6 %
	26		+125.0 %
	34		+3400.0 %
			+25.8 %
	221

First-quarterOncology sales increased 25.8% to €221 million, driven by the Sarclisa® and Libtayo® launches.

First-quarterJevtana® sales decreased 2.9% to €126 million following the entry of generic competition in Europe (down 11.8%) at the end of March. In the U.S., sales were up 5.0%. In the U.S., the Jevtana® composition of matter patent will expire in September 2021. From May to July 2020, Sanofi filed patent infringement suits against all generic filers on Jevtana® under Hatch-Waxman in the U.S. District Court for the District of Delaware asserting two method of use patents (US 10,583,110 and US 10, 716,777), both of which expire in October 2030. Sanofi has reached settlement agreements with some of the defendants and the suit against the remaining defendants currently stayed. In Europe, generic competition has started in certain countries after the expiration of Jevtana®'s market exclusivity in March 2021.

Libtayo® (collaboration with Regeneron) sales were €26 million (up 125.0%) in the first quarter driven by increased demand in metastatic cutaneous squamous cell carcinoma (CSCC) as well as additional country launches. In February, Libtayo® was approved in two new indications in the U.S. as a monotherapy for patients with first-line advanced non- small cell lung cancer with PD-L1 expression of ≥50% and for patients with advanced basal cell carcinoma. Libtayo® sales in the U.S. are reported by Regeneron.

Sarclisa® was approved in March 2020 in the U.S. 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 and in June by the European Commission in certain adults with RRMM. First-quarter Sarclisa® sales were €34 million driven by additional country launches. First-quarter sales in the U.S. and in Europe were €12 million and €13 million, respectively. In Rest of the World sales (€9 million) were driven by a strong performance in Japan. At the end of March, the FDA approved Sarclisa® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma.

Rare Blood Disorder

	Net sales (€ million)		Q1 2021		Change
			at CER
	Eloctate®		134	-9.9 %
	Alprolix®		100	-1.8 %
	Cablivi®		38	+66.7 %
	Total Rare Blood Disorder		272	-0.7 %

In the first quarter, Rare Blood Disorder franchise sales were down 0.7% (€272 million). Excluding industrial sales to Sobi, first-quarter sales were up 5.1% driven by Alprolix® and Cablivi® performance which more than offset Eloctate® sales decrease in the U.S. As already communicated, Alprolix® and Eloctate® industrial sales to Sobi are expected to be significantly lower in 2021 than in 2020.

Eloctate® sales were €134 million in the first quarter, down 9.9%. Excluding industrial sales to Sobi, Eloctate sales were down 3.4% mainly due to lower U.S. sales (-5.0%) as a result of ongoing competitive pressure. Sales in the Rest of the World were down 23.8% reflecting lower industrial sales to Sobi.

First-quarterAlprolix® sales were down 1.8% to €100 million. Excluding industrial sales to Sobi, Alprolix sales were up 3.0%, mainly driven by patient switches from standard half-life factors and prophylaxis conversion. Sales in the Rest of the World were down 19.2% reflecting lower industrial sales to Sobi.

Cablivi® for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and acute blood disorder, generated sales of €38 million (up 66.7%) in the first quarter of which €22 million from the U.S. (up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. In Europe, sales were €15 million (up 66.7%) driven by new country launches. Globally, diagnosis of the disease and product awareness remain impacted by the COVID-19 environment.

General Medicines

General Medicines sales were down 3.8% to €3,672 million in the first quarter. Sales of the core assets2 were 1,474 million up 4.4% (and up 6.3% excluding Praluent® U.S. sales3), driven by strong performance of Lovenox®. Non-core assets sales were €2,010 million, down 9.9% reflecting notably portfolio streamlining, lower Lantus® and Aprovel®/Avapro® sales and some negative COVID-19 impact. First-quarter industrial sales were €188 million up 8.8%.

Diabetes

	Net sales (€ million)		Q1 2021		Change
			at CER
	Lantus®		652	-3.7 %
	Toujeo®		253	+5.1 %
	Total glargine		905	-1.4 %
	Soliqua®		44	+29.7 %
	Other diabetes		226	-7.3 %
	Total Diabetes		1,175	-1.7 %

In the first quarter, global Diabetes sales decreased 1.7% to €1,175 million. The growth in the Rest of the World (up 5.3%) was driven by Lantus®, Toujeo® launch in China and Soliqua® performance. In the U.S., the Diabetes sales decrease 5.3%. In Europe, sales decreased 10.2% largely affected by patient stockpiling related to the COVID-19 environment in the first quarter of 2020.

First-quarterToujeo® sales increased 5.1% to €253 million driven by the launch in China. Lower sales in Europe reflected the high base in the first quarter 2020 due to patient stockpiling. In the U.S., Toujeo® sales were stable with volume growth offsetting average price decrease.

Lantus® sales were €652 million, down 3.7% in the first quarter, mainly due to a continued decline in average U.S. net price, increasing usage of Toujeo®, biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). In Rest of the World, sales increased 4.9%.

First-quarterSoliqua® sales increased 29.7% to €44 million driven by growth in the three regions and notably by launches in Rest of the World (up 44.4%) and performance in the U.S. (up 27.3%).

Cardiovascular and Established Rx Products

	Net sales (€ million)		Q1 2021		Change
			at CER
	Lovenox®*		401	+30.4 %
	Plavix®*		251	-4.0 %
	Aprovel®/Avapro®		101	-39.7 %
	Thymoglobulin®		80	+1.2 %
	Multaq®		72	-3.7 %
	Praluent®		56	-20.5 %
	Mozobil®
		52	+1.9 %
	Generics		206	+3.5 %
	Other		1,090	-12.2 %
	Total Cardiovascular and Established Rx Products		2,309	-5.6 %

*Excluding Auto generics

In the first quarter, Cardiovascular and Established Rx Products sales decreased 5.6% to €2,309 million reflecting strong Lovenox® growth more than offset in particular by lower sales of Aprovel®/Avapro®, divestments and some COVID impact.

First-quarterLovenox® sales increased 30.4% to €401 million, driven by Rest of the World (up 50.7%), and Europe (up 10.5%) reflecting demand increase driven by recent guidelines recommending the use of low molecular weight heparins in hospitalized COVID-19 patients which more than offset biosimilar competition and postponed procedures.

Plavix® sales were down 4.0% in the first quarter to €251 million mainly reflecting lower sales in Europe (down 23.7%) and Japan. In China, first-quarter Plavix® sales were €117 million, up 0.8%.

1. Sanofi has prioritized core assets in its General Medicines portfolio with differentiated and/or established profiles that have significant opportunity for growth in key markets. Core assets include Toujeo, Soliqua, Praluent, Multaq, Lovenox, Plavix and others for total sales of €5.6bn in 2020
2. in market U.S. sales in Q1 2020 and U.S. sales to Regeneron in Q1 2021