On April 28, 2021 Sanofi reported Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent and Vaccines (Press release, Sanofi, APR 28, 2021, View Source [SID1234578570])

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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."

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

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

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%.

First-quarter 2021 operating income

First-quarter business 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.

Specialty Care

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.

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-quarter Lemtrada 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-quarter Kevzara (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.

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-quarter Cerezyme sales increased 4.2% to €178 million, driven by strong growth in Rest of the World (up 18.4%). First-quarter Cerdelga 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-quarter Myozyme/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-quarter Fabrazyme 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.

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

First-quarter Jevtana 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.

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-quarter Alprolix 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%.

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-quarter Toujeo 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-quarter Soliqua 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%)

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-quarter Lovenox 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%.

First-quarter Aprovel/Avapro sales were down 39.7%% to €101 million, primarily reflecting a short-term supply constraint.

First-quarter Praluent sales decreased 20.5% to €56 million, due to lower sales in the U.S. reflecting the restructuring of the collaboration with Regeneron which was effective on April 1, 2020. Sanofi has sole responsibility for Praluent outside the U.S. while Regeneron has sole responsibility for Praluent in the U.S. Excluding U.S. sales3 , Praluent sales grew 26.8% driven by a strong performance in Europe (up 20.0%) and Rest of the World (up 45.5%) driven by the launch in China. Praluent was relaunched in Germany at the beginning of April 2021.

Multaq sales were €72 million, down 3.7% in the first quarter due to lower sales in the U.S. impacted by the COVID-19 environment.

Pharmaceuticals business operating income

In the first quarter, business operating income (BOI) of Pharmaceuticals decreased 4.6% to €2,515 million (up 2.9% at CER). The ratio of BOI to net sales decreased by 0.7 percentage points to 38.3%. At CER, the ratio decreased 0.4 percentage points reflecting higher SG&A spends as well as increased "Other operating expenses" mainly reflected Regeneron MAbs alliance despite an improvement of the gross margin.

First-quarter Vaccines sales increased 5.3% to €915 million reflecting higher PPH vaccines sales and strong flu vaccines demand partly offset by lower sales of travel vaccines and adult booster due to the COVID-19 pandemic.

Influenza vaccines sales increased by 23.8% in the first quarter to €77 million, reflecting strong demand in the southern hemisphere which were partly offset by the U.S. due to the earlier supply to the market as compared to the 2019/2020 flu season.

In the first quarter, Polio/Pertussis/Hib (PPH) vaccines sales increased 14.9% to €533 million benefiting from the favorable phasing of shipments. In the U.S., PPH sales were up 40.4% driven by the timing of the CDC order for Pentacel and in the rest of the World, strong polio vaccines sales reflected the favorable phasing of public tenders. Supply for Vaxelis in the US will be available in June 2021. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis is the first and only hexavalent combination vaccine approved in the U.S. to help protect infants and children against six infectious diseases, including diphtheria, tetanus, pertussis (whooping cough), poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type b. Vaxelis in market sales will not be consolidated.

First-quarter Menactra sales were up 3.8% to €127 million. MenQuadfi, which is the only U.S. FDA-approved quadrivalent meningococcal vaccine indicated for all patients above 2 years of age, was launched in the U.S. in March 2021.

Adult Booster vaccines sales decreased 8.7% in the first quarter to €100 million, primarily reflecting the COVID-19 impact on Adacel in the U.S. and Repevax in Europe.

First-quarter Travel and other endemic vaccines sales decreased 37.4%, due to extensive travel restrictions globally.

Vaccines business operating income

In the first quarter, business operating income (BOI) of Vaccines increased 43.2% to €371 million reflecting the payment from Daiichi Sankyo. At CER, BOI increased 48.6%. The ratio of BOI to net sales was 40.5% (and 27.5% excluding the payment from Daiichi Sankyo).

In the first quarter, Consumer Healthcare (CHC) sales decreased 7.3% to €1,113 million primarily reflecting a weak cough and cold season due to social distancing measures and wearing of masks as well as a high base for comparison in the first quarter of 2020 which benefited from pantry loading related to COVID environment. First-quarter sales were also impacted by divestments of non-core products.

In the U.S., first-quarter CHC sales increased 2.3% to €283 million, reflecting growth of Digestive and Mental Wellness categories as well as Allergy partially offset by the decline of the Pain category.

In Europe, first-quarter CHC sales decreased 19.3% (to €334 million) mainly reflecting lower incidence of colds due to social distancing measures and wearing of masks, as well as a high base for comparison in the first quarter of 2020 which benefited from pantry loading related to COVID environment. First quarter CHC sales were also impacted by divestments of non-core products.

In the Rest of the World, first-quarter CHC sales decreased 3.6% to €496 million, reflecting lower sales in Allergy, Cough and Cold and pain categories impacted by the COVID environment partially offset by the growth of the Digestive and Mental Wellness categories.

CHC business operating income

In the first quarter, business operating income (BOI) of CHC decreased 18.4% to €394 million. At CER, BOI decreased 8.9% reflecting lower sales. The ratio of BOI to net sales decreased 1.8 percentage point to 35.4% versus the prior year.

First-quarter sales in the U.S. increased 6.4% to €2,893 million driven by the strong sales performance of Dupixent, which more than offset lower General Medicines sales.

In Europe sales decreased 5.6% in the first quarter to €2,228 million reflecting lower sales of General Medicines, CHC and Vaccines partly offset by Dupixent, Aubagio and oncology sales growth.

In the Rest of the World, sales increased 4.3% to €3,470 million in the first quarter driven mainly by the strong performance of Lovenox, Dupixent, Vaccines, Diabetes, and Rare Disease which more than offset lower CHC and Rare Blood Disorders franchise sales. Sales in China increased 8.4% to €726 million, driven by Toujeo and Dupixent launches, as well as established Rx Products and CHC performance. In Japan, first-quarter sales decreased 8.7% to €434 million due to lower sales of Established Rx Products and CHC.

R&D update at the end of the first quarter 2021

Regulatory update

The U.S. Food and Drug Administration (FDA) approved Sarclisa in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, and the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion. Sarclisa is already approved in the U.S and Europe for use combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
The FDA approved Libtayo monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of >50%. These data were published in The Lancet demonstrating superiority in extending overall survival (OS) compared to chemotherapy even with a high crossover rate. The FDA also approved Libtayo as the first immunotherapy indicated for patients with advanced basal cell carcinoma.
The European Commission approved Plavix for use in combination with aspirin in adult patients with moderate to high-risk Transient Ischemic Attack (TIA) (ABCD2 score ≥4) or minor Ischemic Stroke (IS) (NIHSS1 ≤3) within 24 hours of either the TIA or IS event. Usage under this new indication can continue for 21 days, followed by long-term single anti-platelet therapy.
The FDA accepted Dupixent for review in children with moderate-to-severe asthma. The submission is supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years in randomized Phase 3 trial, and further adds to the well-established safety profile of Dupixent. The target action date for the FDA decision is October 21, 2021. Also, the European Medicines Agency (EMA) has confirmed receipt of the submission for Dupixent in children with moderate-to-severe asthma.
Efanesoctocog alfa, formerly known as BIVV001, in collaboration with Sobi and in development for hemophilia A was granted Fast Track designation by the FDA.
SAR445136, formerly known as BIVV003, an ex-vivo cell therapy developed in collaboration with Sangamo for the treatment of sickle cell disease, was granted Fast Track designation by the FDA. Also, the EMA’s Committee for Orphan Medicinal Products (COMP) granted Orphan Drug Designation based on early data from three patients that had 52 weeks, 13 weeks, and 29 days of follow-up, respectively.
Portfolio update

Phase 3:

The XTEND-Kids trial for efanesoctocog alfa (formerly known as BIVV001) in pediatric patients with hemophilia A enrolled its first patient.
The second pivotal trial to study itepekimab in chronic obstructive pulmonary disease (COPD) (AERIFY-2) enrolled its first patient.
An Independent Data Monitoring Committee (IDMC) recommended to stop a Libtayo Phase 3 trial in advanced cervical cancer for positive results on OS. Patients with either squamous cell carcinoma or adenocarcinoma recurrent or metastatic cervical cancer were randomized to receive either Libtayo monotherapy or an investigator’s choice of commonly used chemotherapy.
Final results of Part A of the sutimlimab pivotal Phase 3 CARDINAL open label, single-arm study evaluating the safety and efficacy of sutimlimab for 26 weeks in people with cold agglutinin disease were published in the New England Journal of Medicine. Sutimlimab, a first-in-class investigational C1s inhibitor, met the primary and secondary endpoints in the study and demonstrated sustained inhibition of classical complement pathway mediated hemolysis with improvements in anemia within one week of treatment.
The amended protocol for all ongoing adult and adolescent fitusiran clinical studies, aimed at further enhancing the benefit-risk profile, was presented at the 14th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD). The dose for adults and adolescents will be reduced to 50 mg every other month (six times a year), with the potential to adjust the dose and/or dose frequency based on an individual patient’s anti-thrombin levels. A re-start of dosing and recruitment in the pediatric trial is expected later this year.

Phase 2

CARMEN-LC05, a trial investigating tusamitamab ravtansine, an anti-CEACAM5 antibody-drug conjugate (ADC), in combination with pembrolizumab versus pembrolizumab alone in patients with first-line non-squamous NSCLC started. Inclusion criteria include expression of CEACAM5 as demonstrated prospectively by a centrally assessed Immunohistochemistry (IHC) assay of ≥2+ in intensity involving at least 50% of the tumor cell population and PD-L1 positive tumor (TPS ≥1%). Patients with EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations are excluded.
Development for Dupixent for grass allergy has been discontinued.
SAR445088, a complement inhibitor formerly known as BIVV020, has entered a study in adults with persistent/chronic immune thrombocytopenia (ITP).
SAR441344, a CD40L antibody, has entered a study for Sjogren’s Syndrome, an autoimmune condition that is most common in older women and affects the tear and saliva glands.
A new study to select the most appropriate antigen dosage for Phase 3 evaluation of an adjuvanted recombinant protein COVID-19 vaccine candidate (SP0253) was initiated and already completed enrollment. In parallel, development work has commenced against emerging variants, which will be used to inform next stages of the program. Trials results and the start of a global Phase 3 study are expected in Q2 2021. The trial program is supported by the United States’ Biomedical Advanced Research and Development Authority (BARDA).
MRT5500 (SP0254), an mRNA vaccine candidate against SARS-CoV-2, entered Phase 1/2 to assess safety, immune response and reactogenicity. Three different dose levels will be investigated. Interim results are expected in Q3 2021. In parallel, preclinical studies are underway to evaluate additional mRNA candidates against emerging SARS-CoV-2 variants
SP0230, a novel multicomponent meningococcal Group B Vaccine, in development for adults, adolescents, toddlers, and infants started Phase 1/2.

Phase 1

SAR441566, a first, next generation, oral small molecule TNF inhibitor that in contrast to anti-TNF biologics blocks specifically the TNFR1 pathway, started Phase I in inflammatory conditions.
SAR444656, an IRAK4 degrader being developed for atopic dematitis in collaboration with Kymera also known as KT474, started a Phase I trial in healthy volunteers. SAR444656 is the first IRAK4 degrader to be studied outside of oncology.
Sanofi decided to not opt in on REGN4018, REGN5459, or REGN5458. Sanofi no longer has any non-compete obligations on refused candidates under the amended and restated IO Discovery and Development agreement, which terminated on March 16 2021.
Development of SAR441169, ROR gamma T antagonist in collaboration with Lead Pharma, was terminated in psoriasis.
SAR440234, T cell engaging multi specific antibody, has been discontinued in leukemia.
An update of the R&D pipeline at as of March 31, 2021, is available on our website:

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Collaborations

On January 12, 2021 Sanofi entered into a global licensing agreement with Biond Biologics for BND-22, a novel immune checkpoint inhibitor targeting the ILT2 receptor.
On February 23, 2021 Sanofi entered into a collaboration with Sirion to innovate gene therapy treatment with improved adeno-associated virus capsids.
Agreements related to COVID-19 vaccines

Sanofi will support manufacturing and supply of BioNTech’s mRNA COVID-19 vaccine, co-developed with Pfizer, providing fill and finish for over 125 million doses. Initial supplies will originate from Sanofi’s production facilities in Frankfurt from summer of 2021.
Sanofi will support manufacturing of Janssen´s COVID-19 vaccine and through its vaccine manufacturing plant in Marcy l’Etoile, France, formulate and fill vials at a rate of approximately 12 million doses per month.
Expanding affordable access to those most in need

Sanofi has become a member of the top five companies of the 2021 Access to Medicine index, recognizing its work to make medicines accessible and available in low- and middle-income countries. Sanofi has moved up two places in the overall company ranking compared to its position in 2018, performing particularly well in Research & Development (4th place) and Product Delivery (3rd place). This recognition resonates strongly with Sanofi’s Corporate Social Responsibility strategy. Embedded in Sanofi’s long-term strategy, the company’s CSR commitment is based on four pillars in which Sanofi is uniquely positioned to make a difference: access to medicines, support for vulnerable communities, preservation of the environment, and inclusion and diversity of its employees.

On April 7, 2021, Sanofi announced a new cornerstone of its CSR strategy, Sanofi Global Health, a newly formed nonprofit unit within the company, dedicated to increasing access to medicines considered essential by the World Health Organization (WHO) for patients in the world’s 40 poorest countries. Thirty of Sanofi’s medicines will be provided across a wide range of therapeutic areas, including cardiovascular disease, diabetes, tuberculosis, malaria, and cancer. Sanofi Global Health will also fund the training of healthcare professionals or the set up and development of sustainable care systems for those who suffer from chronic diseases and require complex care.
Sanofi Global Health is the first global initiative to provide access to such a broad portfolio of medicines, in so many countries and across several therapeutic areas, while funding local support programs.

Sanofi released its 2020 Integrated Report: click here to start the experience.

2021 first-quarter financial results

Business Net Income4

In the first quarter of 2021, Sanofi generated net sales of €8,591 million, a decrease of 4.3% and an increase of 2.4% at CER.

First-quarter other revenues decreased 14.0% (down 6.4% at CER) to €295 million, reflecting lower VaxServe sales of non-Sanofi products (€228 million, down 12.9% at CER).

First-quarter Gross Profit decreased 4.1% to €6,202 million (up 2.6% at CER). The gross margin ratio increased 0.1 percentage points to 72.2% (72.3% at CER) versus the first quarter of 2020. This increase mainly reflected the improvement of the Pharmaceuticals gross margin ratio (from 74.9% to 75.2%) driven by growing weight of Specialty Care as well as some efficiency gains in Industrial Affairs. Vaccines gross margin ratio decreased 2.9 percentage point to 62.0% due to product mix. CHC gross margin ratio improved from 67.7% to 68.0%.

Research and Development (R&D) expenses decreased 5.5% to €1,266 million in the first quarter. At CER, R&D expenses decreased 1.7% reflecting significant increase in key assets development offset by operational efficiencies and lower costs on mature projects. In the first quarter, the ratio of R&D to sales decreased 0.2 percentage point to 14.7% compared to the prior year.

First-quarter selling general and administrative expenses (SG&A) decreased 6.3% to €2,194 million. At CER, SG&A expenses were down 0.7%, reflecting increased investments in Specialty Care and Vaccines which were more than offset by smart spending and operational excellence initiatives. In the first quarter, the ratio of SG&A to sales decreased 0.6 percentage point to 25.5% compared to the prior year.

First-quarter operating expenses were €3,460 million, a decrease of 6.0% and 1.1% at CER.

First-quarter other current operating income net of expenses was -€101 million versus -€247 million in the prior year and included a €119 million payment from Daiichi Sankyo related to the termination of a vaccines collaboration in Japan. This line included an expense of €279 million (versus an expense of €243 million in the first quarter of 2020) corresponding to the share of profit to Regeneron of the monoclonal antibodies Alliance, reimbursement of development costs by Regeneron and the reimbursement of commercialization-related expenses incurred by Regeneron.

The share of profit from associates was stable at €9 million. Following the sale of its Regeneron stake at the end of May 2020, Sanofi restated its previously reported non-GAAP indicator (Business Net Income) and excluded the effect of equity method of accounting for Regeneron investment in 2019, Q1 2020 and Q2 2020.

First-quarter business operating income4 (BOI) increased 4.0% to €2,638 million. At CER, BOI increased 13.3% and 8.4% excluding the payment from Daiichi Sankyo. The ratio of BOI to net sales increased 2.4 percentage points to 30.7% (and to 29.3% excluding the payment from Daiichi sankyo) versus the prior year.

Net financial expenses were €85 million in the first quarter versus €75 million in the same period of 2020.

First-quarter 2021 effective tax rate was 21.0% versus 22% in the first quarter of 2020. Sanofi expects its effective tax rate to be around 21% in 2021, everything being equal in the U.S.

First-quarter business net income4 increased 5.1% to €2,017 million and increased 14.7% at CER. The ratio of business net income to net sales increased 2.1 percentage points to 23.5% (and 1 percentage point excluding the payment from Daiichi Sankyo) versus the first quarter of 2020.

In the first quarter of 2021, business earnings per share4 (EPS) was €1.61, up 5.2% on a reported basis and up 15.0% at CER (up 9.8% at CER excluding the payment from Daiichi Sankyo). The average number of shares outstanding was 1,249.3 million versus 1,251.3 million in first quarter 2020.

Reconciliation of IFRS net income reported to business net income (see Appendix 4)

In the first quarter of 2021, the IFRS net income was €1,566 million. The main items excluded from the business net income were:

An amortization charge of €389 million related to fair value remeasurement on intangible assets of acquired companies (primarily Genzyme: €126 million, Bioverativ: €79 million, Boehringer Ingelheim CHC business: €50 million and Ablynx: €42 million) and to acquired intangible assets (licenses/products: €23 million). These items have no cash impact on the Company.
Restructuring costs and similar items of €156 million related to streamlining initiatives.
A €132 million tax effect arising from the items listed above, mainly comprising €89 million of deferred taxes generated by amortization and impairments of intangible assets and €42 million associated with restructuring costs and similar items (see Appendix 4).

Capital Allocation

In the first quarter of 2021, free cash flow5 increased by 23.6% to €1,925 million, after net changes in working capital (+€422 million), capital expenditures (-€378 million) and other asset acquisitions6 (-€277 million), proceeds from disposals4 (€82 million), and payments related to restructuring and similar items (-€244 million). As a consequence, net debt decreased from €8,789 million at December 31, 2020 to €6,823 million at March 31, 2021 (amount net of €13,948 million cash and cash equivalents).

On April 28, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that a scientific poster sharing clinical data from its Phase 1 study of SRF388 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting, to be held virtually June 4-8, 2021 (Press release, Surface Oncology, APR 28, 2021, View Source [SID1234578633]). In conjunction, Surface will host a webcast on Friday, June 4, 2021 at 8:00 a.m. to review the SRF388 clinical data as well as to provide a clinical update from the company’s ongoing SRF617 Phase 1 study.

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"We’re excited to share clinical data on our lead therapeutic candidates, both of which are first-in-class," said Alison O’Neill, M.D., chief medical officer at Surface Oncology. "Findings from the ongoing Phase 1 clinical trials of SRF617 and SRF388 support our scientific hypotheses and may provide an important step forward in the treatment of patients with cancer who have not benefitted from other immuno-oncology approaches."

Presentation Type: e-poster (Abstract: 2551)
Title: Results of a phase 1 study of SRF388, a first-in-human, first-in-class, high-affinity anti-IL-27 antibody in advanced solid tumors
Session: Developmental Therapeutics – Immunotherapy
Lead Authors: Amita Patnaik, M.D. and Daniel Morgensztern, M.D.

The e-poster website will be launched on Friday, June 4, 2021, and will remain available for viewing through Tuesday, July 6, 2021. The full poster will be placed on Surface Oncology’s website following the presentation.

Webcast Information:
The webcast can be accessed online, and by telephone by dialing (866) 394-2883 (US/Canada) or (314) 888-4236 (international) five minutes prior to the start time and referring to conference ID 4567647. A recording of the webcast will be posted on the Surface website and available on-demand for one year.

About the SRF388-101 Clinical Trial:
The trial is a Phase 1, open-label, multicenter, first-in-human dose-escalation trial of SRF388, a monoclonal antibody targeting IL-27, conducted in patients with advanced solid tumors refractory to standard therapy. The first portion of the study will establish the preliminary safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of SRF388 as a monotherapy and identify a dose suitable for expansion studies. In the second portion of the study, indication-specific expansion cohorts will evaluate the safety, preliminary efficacy, tolerability, PK and pharmacodynamics of SRF388 monotherapy and SRF388 in combination with pembrolizumab in patients with advanced or metastatic kidney and liver cancer.

About SRF388:
SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including liver and kidney cancer, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immuno-suppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies including anti-PD-1 therapy, as well as potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping to identify patients most likely to respond to SRF388. In November 2020, Surface announced that SRF388 was granted Orphan Drug designation and Fast Track designation for the treatment of hepatocellular carcinoma from the FDA.

About the SRF617-101 Clinical Trial:
The trial is a Phase 1, open-label, multicenter, first-in-human dose-escalation trial of SRF617, a monoclonal antibody that binds and inhibits CD39 activity, in patients with advanced solid tumors. The monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of SRF617 as a monotherapy in patients with advanced solid tumors. The monotherapy tumor biopsy expansion portion of the study will further evaluate the safety and intratumoral pharmacodynamics of SRF617 as a monotherapy. The combination therapy dose escalation portion of the study will evaluate the safety, tolerability, PK and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel, or SRF617 in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors.

About SRF617:
SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39 in the tumor microenvironment, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, pancreatic cancer stromal cells within the tumor micro-environment express high levels of CD39 which may inhibit anti-cancer immune responses. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents.

On April 28, 2021 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported results for the quarter ended March 31, 2021 (Press release, Teva, APR 28, 2021, View Source [SID1234578650]).

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Mr. Kåre Schultz, Teva’s President and CEO, said, "As the COVID-19 pandemic continues to impact the world and our industry, our employees continue to work together to meet the needs of our customers and patients, all while we remain focused on our long-term goals and laying the foundation for future growth.

"We have improved our profitability and reduced our net debt to $23.2 billion. We have also seen solid performance from our key growth drivers: the biosimilar Truxima increased its market share to 26%, AUSTEDO continued its year-over-year growth, and AJOVY solidified its market share in the U.S. and continues to expand in Europe. Based on our results and expectations for the remainder of the year, we are reaffirming our guidance."

First Quarter 2021 Consolidated Results

Revenues in the first quarter of 2021 were $3,982 million, a decrease of 9% or 10% in local currency terms, compared to the first quarter of 2020. This decrease was mainly due to lower revenues from generic, OTC and respiratory products and from COPAXONE in our Europe segment, lower revenues from Anda, COPAXONE and BENDEKA/TREANDA in our North America segment, lower revenues from Japan resulting from the divestment of a majority of the generic and operational assets of our Japanese business venture, as well as regulatory price reductions and generic competition to off-patented products in Japan, partially offset by higher revenues from generic products and AUSTEDO in our North America segment. Revenues were also affected by changes in demand for certain products resulting from the impact of the COVID-19 pandemic.

Exchange rate movements during the first quarter of 2021, net of hedging effects, positively impacted our revenues by $74 million and negatively impacted our GAAP and non-GAAP operating income by $14 million and $10 million, respectively.

GAAP gross profit was $1,878 million in the first quarter of 2021, a decrease of 9% compared to the first quarter of 2020. GAAP gross profit margin was 47.2% in the first quarter of 2021, compared to 47.3% in the first quarter of 2020. The decrease in gross profit margin was mainly due to lower revenues from our Europe segment, partially offset by higher profitability in North America resulting from the change in mix of products. Non-GAAP gross profit was $2,144 million in the first quarter of 2021, a decrease of 7% compared to the first quarter of 2020. Non-GAAP gross profit margin was 53.8% in the first quarter of 2021, compared to 53.1% in the first quarter of 2020.

GAAP Research and Development (R&D) expenses in the first quarter of 2021 were $254 million, an increase of 15% compared to the first quarter of 2020. Non-GAAP R&D expenses were $244 million, or 6.1% of quarterly revenues, in the first quarter of 2021, compared to $221 million, or 5.1%, in the first quarter of 2020. In the first quarter of 2021, our R&D expenses related primarily to specialty product candidates in the respiratory and pain therapeutic areas, with additional activities in selected other areas and generic products including biosimilars. Our higher R&D expenses in the first quarter of 2021, compared to the first quarter of 2020, were mainly due to an increase in respiratory and biosimilar projects.

GAAP Selling and Marketing (S&M) expenses in the first quarter of 2021 were $585 million, a decrease of 5% compared to the first quarter of 2020. Non-GAAP S&M expenses were $549 million, or 13.8% of quarterly revenues, in the first quarter of 2021, compared to $570 million, or 13.1%, in the first quarter of 2020.

GAAP General and Administrative (G&A) expenses in the first quarter of 2021 were $290 million, a decrease of 5% compared to the first quarter of 2020. Non-GAAP G&A expenses were $278 million, or 7.0% of quarterly revenues, in the first quarter of 2021, compared to $290 million, or 6.7%, in the first quarter of 2020.

GAAP operating income in the first quarter of 2021 was $434 million, compared to $191 million in the first quarter of 2020. The increase was mainly due to lower intangible asset impairment charges in the first quarter of 2021, partially offset by lower profit in our Europe segment along with higher legal settlements and loss contingencies.

Non-GAAP operating income in the first quarter of 2021 was $1,077 million, a decrease of 13%, compared to $1,244 million in the first quarter of 2020. The decrease was mainly due to lower profit in our Europe segment.

EBITDA (defined as operating income, excluding depreciation and amortization expenses) was $809 million in the first quarter of 2021, an increase of 37% compared to $590 million in the first quarter of 2020. Adjusted EBITDA (defined as operating income excluding depreciation and amortization expenses and certain other items) was $1,206 million in the first quarter of 2021, a decrease of 12% compared to $1,375 million in the first quarter of 2020.

GAAP financial expenses were $290 million in the first quarter of 2021, compared to $224 million in the first quarter of 2020. Non-GAAP financial expenses were $227 million in the first quarter of 2021, compared to $213 million in the first quarter of 2020. Financial expenses in the first quarter of 2021, were mainly comprise of interest expenses of $239 million and loss on revaluation of marketable securities of $64 million. Financial expense in the first quarter of 2020 were mainly comprised of interest expenses of $241 million.

In the first quarter of 2021, we recognized a GAAP tax expense of $62 million, on pre-tax income of $144 million. In the first quarter of 2020, we recognized a tax benefit of $59 million, on pre-tax loss of $33 million. Our tax rate for the first quarter of 2021 was mainly affected by legal settlements, impairments and amortization in jurisdictions in which tax rates are lower than Teva’s average tax rate on its ongoing business operations. Non-GAAP income taxes for the first quarter of 2021 were $146 million, or 17%, on pre-tax non-GAAP income of $851 million. Non-GAAP income taxes in the first quarter of 2020 were $175 million, or 17%, on pre-tax non-GAAP income of $1,030 million. Our non-GAAP tax rate for the first quarter of 2021 was mainly affected by the mix of products we sold and interest expense disallowance.

We expect our annual non-GAAP tax rate for 2021 to be 17%-18%, unchanged from our outlook provided in February 2021.

GAAP net income attributable to Teva and GAAP EPS were $77 million and $0.07 respectively, in the first quarter of 2021, compared to $69 million and $0.06 in the first quarter of 2020. This increase was mainly due to the increase in operating income, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS in the first quarter of 2021 were $699 million and $0.63, respectively, compared to $835 million and $0.76 in the first quarter of 2020.

The weighted average diluted shares outstanding used for the fully diluted share calculation on a GAAP and non-GAAP basis for the three months ended March 31, 2021 and 2020 was 1,107 million and 1,096 million shares, respectively.

As of March 31, 2021 and 2020, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,130 million and 1,118 million, respectively.

Non-GAAP information: Net non-GAAP adjustments in the first quarter of 2021 were $621 million. Non-GAAP net income and non-GAAP EPS for the first quarter of 2021 were adjusted to exclude the following items:

Amortization of purchased intangible assets of $242 million, of which $215 million is included in cost of sales and the remaining $27 million in S&M expenses;
Impairment of long-lived assets of $127 million, comprised mainly of impairment of intangible assets of IPR&D and product rights assets in connection with the Actavis Generics acquisition;
Legal settlements and loss contingencies of $104 million, mainly related to a provision for a potential patent setlement;
Restructuring expenses of $81 million;
Finance expense of $64 million, related to revaluation of marketable securities;
Equity compensation expenses of $31 million;
Other items of $57 million; and
Income tax of $85 million.
Teva believes that excluding such items facilitates investors’ understanding of its business. For further information, see the tables below for a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and the information under "Non-GAAP Financial Measures." Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow used in operating activities during the first quarter of 2021 was $405 million, compared to $305 million generated in the first quarter of 2020. The decrease in the first quarter of 2021 was mainly due to changes in working capital items resulting from a decrease in sales reserves and allowances (SR&A) and an increase in inventory, as well as lower profit in our Europe segment.

Free cash flow (cash flow from operating activities, cash used for capital investments, beneficial interest collected in exchange for securitized accounts receivables and proceeds from divestitures of businesses and other assets) was $59 million in the first quarter of 2021, compared to $551 million in the first quarter of 2020. The decrease in the first quarter of 2021 resulted mainly from lower cash flow from operating activities, partially offset by higher sales of assets.

As of March 31, 2021, our debt was $24,986 million, compared to $25,919 million as of December 31, 2020. This decrease was mainly due to redemption of $491 million of our convertible senior debentures and exchange rate fluctuations. The portion of total debt classified as short-term as of March 31, 2021 was 11%, compared to 12% as of December 31, 2020. Our average debt maturity was approximately 5.6 years as of March 31, 2021, compared to 5.8 years as of December 31, 2020. Our financial leverage was 69% as of March 31, 2021, compared to 70% as of December 31, 2020.

Segment Results for the First Quarter of 2021

North America Segment

Our North America segment includes the United States and Canada.

Revenues from our North America segment in the first quarter of 2021 were $1,989 million, a decrease of $94 million, or 5%, compared to the first quarter of 2020, mainly due to a decrease in revenues from Anda, COPAXONE and BENDEKA/TREANDA, partially offset by higher revenues from generic products and AUSTEDO. Our North America segment has experienced some reductions in volume due to less physician and hospital activity during the COVID-19 pandemic, but has also experienced increase in demand for certain products related to the treatment of COVID-19 and its symptoms. In addition, the ability to promote certain specialty products, primarily AJOVY and AUSTEDO, has been impacted by less physician visits by patients and less physician interactions by our sales personnel.

Revenues in the United States, our largest market, were $1,854 million in the first quarter of 2021, a decrease of $87 million, or 4%, compared to the first quarter of 2020.

Revenues by Major Products and Activities

The following table presents revenues for our North America segment by major products and activities for the three months ended March 31, 2021 and 2020:

Generic products revenues in our North America segment (including biosimilars) in the first quarter of 2021 were $1,053 million, an increase of 11% compared to the first quarter of 2020. This increase was mainly due to higher revenues from emtricitabine and tenofovir disoproxil fumarate tablets (the generic equivalent of Truvada), Truxima (the biosimilar to Rituxan) and ProAir authorized generic, partially offset by lower volume and pricing of other generic products.

In January 2021, we launched etonogestrel and ethinyl estradiol vaginal ring, 0.120 mg/0.015 mg per day (the generic equivalent of NuvaRing) in the U.S., which is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.

In the first quarter of 2021, our total prescriptions were approximately 322 million (based on trailing twelve months), representing 9.2% of total U.S. generic prescriptions according to IQVIA data.

AJOVY revenues in our North America segment in the first quarter of 2021 were $31 million, an increase of $2 million, or 8% compared to the first quarter of 2020, mainly due to growth in volume. AJOVY is the only anti-CGRP product indicated for quarterly treatment and in January 2021 we launched a new triple pack product offering, providing quarterly dosing.

AUSTEDO revenues in our North America segment in the first quarter of 2021 increased by 20% to $146 million, compared to $122 million in the first quarter of 2020. This increase was mainly due to growth in volume.

BENDEKA and TREANDA combined revenues in our North America segment in the first quarter of 2021 decreased by 14% to $91 million, compared to the first quarter of 2020, mainly due to availability of alternative therapies and continued competition.

COPAXONE revenues in our North America segment in the first quarter of 2021 decreased by 17% to $164 million, compared to the first quarter of 2020, mainly due to generic competition in the United States.

ProAir (HFA and RespiClick) revenues in our North America segment in the first quarter of 2021 decreased by 9% to $54 million, compared to the first quarter of 2020. In January 2019, we launched our own ProAir authorized generic in the United States, following the launch of a generic version of Ventolin HFA, another albuterol inhaler. Revenues from our ProAir authorized generic are included in "generic products" above.

Anda revenues in our North America segment in the first quarter of 2021 decreased by 32% to $289 million, compared to $426 million in the first quarter of 2020, mainly due to lower demand. In addition, revenues were higher in first quarter of 2020 as a result of significant customer stocking due to the COVID-19 pandemic.

North America Gross Profit

Gross profit from our North America segment in the first quarter of 2021 was $1,074 million, an increase of 1%, compared to $1,062 million in the first quarter of 2020.

Gross profit margin for our North America segment in the first quarter of 2021 increased to 54.0%, compared to 51.0% in the first quarter of 2020. This increase was mainly due to the change in mix of products.

North America Profit

Profit from our North America segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.

Profit from our North America segment in the first quarter of 2021 was $577 million, an increase of 5% compared to $550 million in the first quarter of 2020, mainly due to higher gross profit, as discussed above, as well as lower S&M expenses.

Europe Segment

Our Europe segment includes the European Union and certain other European countries.

The following table presents revenues, expenses and profit for our Europe segment for the three months ended March 31, 2021 and 2020:

Revenues from our Europe segment in the first quarter of 2021 were $1,214 million, a decrease of 13%, or $188 million, compared to the first quarter of 2020. In local currency terms, revenues decreased by 20%, mainly due to higher revenues in first quarter of 2020 as a result of significant customer stocking due to the COVID-19 pandemic. In addition, revenues were impacted by lower demand of generic, OTC and respiratory products resulting from a decline in doctor and hospital visits by patients resulting in fewer prescriptions as well as lower sales of cough and cold products, both due to the COVID-19 pandemic. The decrease in revenues is also attributed to a decline in COPAXONE revenues due to competing glatiramer acetate products and price declines in oncology products as a result of generic competition.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the three months ended March 31, 2021 and 2020:

Generic products revenues in our Europe segment in the first quarter of 2021, including OTC products, decreased by 16% to $865 million, compared to the first quarter of 2020. In local currency terms, revenues decreased by 23% compared to the first quarter of 2020, mainly due to higher revenues in first quarter of 2020 as a result of significant customer stocking due to the COVID-19 pandemic. In addition, revenues were impacted by lower demand of generic and OTC products resulting from a decline in doctor and hospital visits by patients resulting in fewer prescriptions as well as lower sales of cough and cold products, both due to the COVID-19 pandemic.

AJOVY revenues in our Europe segment in the first quarter of 2021 were $16 million, compared to $4 million in the first quarter of 2020, mainly due to launches and reimbursements in additional European countries.

COPAXONE revenues in our Europe segment in the first quarter of 2021 decreased by 8% to $100 million, compared to the first quarter of 2020. In local currency terms, revenues decreased by 15%, due to price reductions and a decline in volume resulting from competing glatiramer acetate products.

Respiratory products revenues in our Europe segment in the first quarter of 2021 decreased by 12% to $93 million, compared to the first quarter of 2020. In local currency terms, revenues decreased by 19%, mainly due to significant customer stocking due to the COVID-19 pandemic in first quarter of 2020, as well as reduced demand resulting from COVID-19 restrictions in the first quarter of 2021.

Europe Gross Profit

Gross profit from our Europe segment in the first quarter of 2021 was $688 million, a decrease of 17% compared to $823 million in the first quarter of 2020.

Gross profit margin for our Europe segment in the first quarter of 2021 decreased to 56.6%, compared to 58.7% in the first quarter of 2020. This decrease was mainly due to lower revenues, as discussed above and increased write-offs and obsolescence provisions as a result of increased inventory levels.

Europe Profit

Profit from our Europe segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.

Profit from our Europe segment in the first quarter of 2021 was $338 million, a decrease of 33%, compared to $502 million in the first quarter of 2020. This decrease was mainly due to lower revenues, as discussed above.

International Markets Segment

Our International Markets segment includes all countries in which we operate other than those in our North America and Europe segments. The key markets in this segment are Japan, Russia and Israel.

On February 1, 2021, we completed the sale of the majority of the generic and operational assets of our business venture in Japan.

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended March 31, 2021 and 2020:

Revenues from our International Markets segment in the first quarter of 2021 were $490 million, a decrease of $75 million, or 13%, compared to the first quarter of 2020. In local currency terms, revenues decreased by 7% compared to the first quarter of 2020, mainly due to lower revenues in Japan resulting from the divestment mentioned above, as well as regulatory price reductions and generic competition to off-patented products in Japan and lower positive impact from hedging activity.

Revenues by Major Products and Activities

The following table presents revenues for our International Markets segment by major products and activities for the three months ended March 31, 2021 and 2020:

Generic products revenues in our International Markets segment in the first quarter of 2021, which include OTC products, decreased by 13% to $392 million, compared to the first quarter of 2020. In local currency terms, revenues decreased by 11%, mainly due to lower sales in Japan resulting from the divestment mentioned above, as well as regulatory price reductions and generic competition to off-patented products in Japan.

COPAXONE revenues in our International Markets segment in the first quarter of 2021 were $12 million, flat compared to the first quarter of 2020. In local currency terms, revenues increased by 4%.

AJOVY was launched in certain International Markets countries and we are moving forward with plans to launch in other countries.

AUSTEDO launched in China for treatment of chorea associated with Huntington disease and for the treatment of tardive dyskinesia in early 2021. We continue with additional submissions in various other countries.

International Markets Gross Profit

Gross profit from our International Markets segment in the first quarter of 2021 was $260 million, a decrease of 15% compared to $305 million in the first quarter of 2020.

Gross profit margin for our International Markets segment in the first quarter of 2021 decreased to 53.0%, compared to 54.0% in the first quarter of 2020. This decrease was mainly due to lower positive impact from hedging activity and a change in mix of products.

International Markets Profit

Profit from our International Markets segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.

Profit from our International Markets segment in the first quarter of 2021 was $122 million, a decrease of 22%, compared to $156 million in the first quarter of 2020. This decrease was mainly due to lower positive impact from hedging activity, as well as lower sales in Japan resulting from regulatory price reductions and generic competition to off-patented products, partially offset by lower S&M expenses.

Other Activities

We have other sources of revenues, primarily the sale of active pharmaceutical ingredients ("APIs") to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our North America, Europe or International Markets segments described above.

Our revenues from other activities in the first quarter of 2021 were $289 million, a decrease of 6% compared to the first quarter of 2020. In local currency terms, revenues decreased by 9%.

API sales to third parties in the first quarter of 2021 were $178 million, flat in both U.S. dollar and local currency terms, compared to the first quarter of 2020.

Conference Call

Teva will host a conference call and live webcast including a slide presentation on Wednesday, April 28, 2021 at 8:00 a.m. ET to discuss its first quarter of 2021 results and overall business environment. A question & answer session will follow.

In order to participate, please dial the following numbers:

A live webcast of the call will be available on Teva’s website at: ir.tevapharm.com.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website or by calling United States 1-866-331-1332; International +44 (0) 3333 009785; passcode: 8347148

On April 28, 2021 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported that data that it has received during its collaboration with Professor Paul Timpson of the Garvan Institute of Medical Research, Sydney ("Garvan") (Press release, Amplia Therapeutics, APR 28, 2021, View Source;[email protected] [SID1234578670]).

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In March, Amplia announced that it had agreed terms for a collaboration with the Garvan. This collaboration has brought together Amplia’s clinical-stage FAK inhibitors with the Garvan’s unique insights into FAK biology and its clinical research network.

Amplia has now received data from work conducted under this collaboration in which AMP945 was tested in a range of different in vitro and in vivo experimental systems that have been established over many years in Professor Paul Timpson’s laboratory at the Garvan. These data have demonstrated that AMP945 impacts several key markers of disease, including the level of fibrosis and collagen maturity in the tumour environment in a mouse model of pancreatic cancer. Furthermore, when combined with gemcitabine/Abraxane, which is a standard of care in pancreatic cancer, AMP945 enhances the activity of the chemotherapy as determined by key indicators of cell death and of cancer cell proliferation. Specifically, after a single round of treatment, AMP945, in combination with gemcitabine/Abraxane, caused a significant increase in levels of cleaved Caspase-3 which is a marker of cancer cell death. In addition, Ki67, a marker of cancer cell proliferation, was significantly decreased after dosing with both AMP945 and gemcitabine/Abraxane.

John Lambert, CEO of Amplia Therapeutics commented that "We are extremely happy to see such positive results coming out of the Timpson Lab with AMP945. These data provide further validation of our approach of using our proprietary FAK inhibitors to enhance the effectiveness of the current therapies for this difficult to treat disease. It is very encouraging to see that AMP945 is able to directly reduce the levels of fibrosis is these tumour models, as well as enhance the activity of gemcitabine/Abraxane, which is currently standard treatment for many pancreatic cancer patients."

In light of the positive data received from the Timpson Laboratory and the emerging clinical data from the Company’s Phase 1 trial in healthy volunteers, Amplia has now started planning a Phase 2 clinical trial of AMP945 in pancreatic cancer patients. Amplia is currently working closely with a range of clinical advisors, clinical pharmacologists, statisticians and potential vendors to finalise the required regulatory applications and refine the study protocol. This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On April 28, 2021 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, reported that it will hold its upcoming first quarter 2021 earnings call and webcast, reporting financial results for the quarter ended March 31, 2021 and providing a review of recent accomplishments and anticipated upcoming milestones, on Monday May 10, 2021 at 8:30 a.m. ET. (Press release, Biohaven Pharmaceutical, APR 28, 2021, View Source [SID1234578692])

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To access the call, please dial 877-407-9120 (domestic) or 412-902-1009 (international). The conference call webcast and accompanying slide presentation can be accessed through the "Investors" section of Biohaven’s website at www.biohavenpharma.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the call will be made available for two weeks following the conference call. To hear a replay of the call, dial 877-660-6853 (domestic) or 201-612-7415 (international) with conference ID 13718062. An archived webcast will be available on Biohaven’s website.