Sanofi Pasteur to pay $20 million for overcharging Dept. of Veteran Affairs

 

PARIS, FRANCE - Sanofi, the parent company of Sanofi Pasteur based in Swiftwater, PA, reported increases in sales and earnings for the third quarter of 2020, largely due to strong performances by Vaccines and DUPIXENT, used to treat several types of allergic diseases.

Of course, the world’s eyes are focused on the development of a vaccine for COVID-19 and Sanofi reported several advancements in that area.

Sanofi and GSK (Glaxo Smith Kline) initiated a Phase 1/2 clinical trial to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of a COVID-19 vaccine candidate. A total of 440 healthy adults were enrolled in the trial across 11 investigational sites in the United States. First results are anticipated for early December 2020 to support the initiation of a Phase 3 trial. Permitting data sufficient for licensure application, regulatory approval would be requested in the first half of 2021.

Sanofi and GSK also finalized and signed an advanced purchase agreement with the European Community for the supply of up to 300 million doses of a recombinant protein-based COVID-19 vaccine, subject to vaccine approval.

Sanofi Chief Executive Officer, Paul Hudson, commented: “We achieved a strong quarter supported by solid sales from both DUPIXENT and Vaccines which allows us to upgrade our full year guidance. We remain focused on executing on our strategic priorities that will deliver promising medicines to address significant patient needs.”

Hudson noted that Sanofi strengthened its R&D pipeline with the successful completion of the Principia acquisition, adding multiple BTK (Bruton Tyrosine Kinase) inhibitors to address a variety of serious illnesses. COVID-19 vaccines development efforts continue on a fast track, Hudson said, along with ensuring global access with pre-orders signed with major countries, regions, and non-profit organizations.

Sanofi now expects 2020 EPS (Earnings Per Share) to grow between 7% and 8%, barring unforeseen major adverse events.

Sanofi Pasteur (Vaccines) Highlights

Third-quarter vaccines sales increased 13.6% to €2.077 billion reflecting the strong influenza vaccines performance across all geographies and PPH (Polio/Pertussis/HIB) recovery. These gains were partly offset by lower sales of MENACTRA, adult booster and travel vaccines due to the COVID-19 pandemic.

Influenza vaccines sales increased by 53.1% in the third quarter to €1.065 billion, reflecting strong demand in the northern hemisphere. In the U.S. sales increased 52.8% to €833 million. In Europe, sales grew 52.3% to €131 million. Rest of the World sales of €101 million reflected more substantial sales in China.

Sanofi expects to deliver a total of about 80 million doses to the U.S. market in 2020. Third quarter global influenza vaccines sales represent about half of influenza vaccines sales expected in the second half of 2020.

MENACTRA sales in the third quarter of 2020 were down 26.5% to €214 million, due to lower immunizations as a result of fewer students attending schools and universities in the U.S. due to COVID-19 as well as inventory fluctuation.

Adult Booster vaccines sales decreased 13.2% in the third quarter to €151 million, mainly reflecting the COVID-19 impact on ADACEL in the U.S. and REPAVAX in Europe. Third-quarter Travel and other endemic vaccines sales decreased 53.5%, due to extensive travel restrictions.

Vaccines gross margin ratio increased from 67.4% to 68.1%, driven by the influenza vaccines sales growth in the U.S., combined with industrial productivity gains.

Sanofi Corporate Highlights

Sanofi generated net sales of €9.479 billion in the third quarter of 2020, an increase of 5.7% at CER (constant exchange rate). Third-quarter other revenues decreased 5.2% to €400 million, reflecting VaxServe sales of non-Sanofi products (€357 million, up 0.8%).

Third-quarter gross profit increased 4.8% to €6.720 billion. Research and Development (R&D) expenses increased 0.4% reflecting reallocation of resources towards priority assets as well as a low basis for comparison.

Third-quarter operating expenses were €3.503 billion, a decrease of 0.4%.

Third-quarter business operating income (BOI) increased to €3.027 billion. At CER, BOI increased 9.2%.

Third-quarter effective tax rate was stable at 22.0% versus the prior period. Sanofi continues to expect its effective tax rate to be around 22% in 2020.

Business net income in the third quarter increased 9.4% to €2.299 billion. Business earnings per share (EPS) increased 8.8%.

Third-quarter 2020 Pharmaceutical sales increased 4.5% to €6.361 billion, with double-digit growth of the Specialty Care portfolio mainly driven by the strong performance of eczema treatment DUPIXENT.

In the third quarter, business operating income (BOI) of Pharmaceuticals increased 4.8% to €2.253 billion.

In the third quarter, Consumer Healthcare (CHC) sales decreased 1.1% to €1.041 billion mainly reflecting lower in-person pharmacy traffic due to the COVID-19 pandemic in Rest of the World and a lower demand for cough and cold products outside the U.S. Sales were also impacted by the voluntary recall of ZANTAC in October 2019, divestments of non-core products and product suspensions due to changing regulatory requirements.

Third quarter, business operating income (BOI) of CHC decreased 6.7% to €325 million.

Sanofi SA (NYSE: SNY) is a multinational pharmaceutical company headquartered in Gentilly, France. It has more than 100,00 employees in 100 countries around the globe with 81 manufacturing sites in 36 countries. Sanofi Pasteur, the vaccine division of Sanofi, is headquartered in Swiftwater, PA.

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