Daily Archives: February 6, 2020

Bombardier to Report Fourth Quarter and Full Year 2019 Financial Results on February 13, 2020

MONTRÉAL, Feb. 06, 2020 (GLOBE NEWSWIRE) — Bombardier (TSX: BBD.B) will publish its financial results for the fourth quarter and full year 2019 on Thursday, February 13, 2020 and hold a live webcast/conference call to review the results starting at 8 a.m. Eastern Time (EDT).

Alain Bellemare, President and Chief Executive Officer; John Di Bert, Senior Vice President and Chief Financial Officer; and Patrick Ghoche, Vice President, Corporate Strategy and Investor Relations, will hold a conference call intended for investors and financial analysts to review the company’s financial results.

DATE: Thursday, February 13, 2020
TIME: 8:00 a.m., Eastern Time (ET)

A live webcast of the call and relevant financial charts will be available at www.bombardier.com

Stakeholders wishing to listen to the presentation and question and answer period by telephone may dial one of the following conference call numbers:

In English: +1 514 394 9320 or
+1 866 240 8954 (toll-free in North America)
+800 6578 9868 (overseas calls)
In French: +1 514 394 9316 or
(with translation) +1 888 791 1368 (toll-free in North America)
+800 6578 9868 (overseas calls)

The replay of this call will be available on Bombardier’s website shortly after the end of the webcast.

For Information
Jessica McDonald Patrick Ghoche
Advisor, Media Relations Vice President, Corporate Strategy
and Public Affairs and Investor Relations
Bombardier Inc. Bombardier Inc.
+1 514 861 9481 +1 514 861 5727

CNH Industrial brands IVECO and FPT together with Nikola Motor Company announce future Nikola TRE production in Ulm, Germany

CNH INDUSTRIAL N.V.

IVECO S-WAY NP (Natural Power)

CNH INDUSTRIAL N.V.

Nikola TRE

The IVECO manufacturing facility in Ulm, Germany, will host the production hub for the Nikola TRE battery electric and fuel-cell electric heavy-duty truck models.

London, February 6, 2020

IVECO and FPT Industrial, the commercial vehicle and powertrain brands of CNH Industrial N.V. (NYSE: CNHI/ MI: CNHI), and Nikola Motor Company will manufacture, through their European Joint Venture, the Nikola TRE in Ulm, Germany, at the IVECO manufacturing facility.

This strategic and exclusive Heavy-Duty Truck partnership saw CNH Industrial taking a $250 million stake in Nikola as the lead Series D investor. The partnership announcement at the CNH Industrial Capital Markets Day in September 2019, was quickly followed in December with the unveiling of the Nikola TRE, a battery electric vehicle (BEV) heavy duty truck, which is the first step towards the fuel-cell electric (FCEV) model.

Today, the site in Ulm is IVECO’s chassis engineering hub, ideally situated at the heart of the Baden-Württemberg region, which is striving to become a leading hub for fuel-cell mobility thanks also to its skilled workforce and research labs. The region has committed a substantial investment to fund research and development projects in the area which has a strong automotive industry, with strategic project partnerships, meaning the Ulm facility will benefit from close proximity to key suppliers.

Furthermore, the German Federal Government recently released its draft National Hydrogen Strategy, which has the aim of expanding the pioneering role of Companies in hydrogen technologies. In this strategy, it commits a total of two billion euro to fund the hydrogen innovation programme, incl. the development of the necessary distribution infrastructure.

“Our European joint-venture with NIKOLA and today’s announcement, is real proof that zero-emission long-haul transport is becoming a reality, resulting in tangible environmental benefits for Europe’s long distance hauliers and its citizens,” said Hubertus Mühlhäuser, Chief Executive Officer, CNH Industrial. “The decision to build the Nikola TRE in Ulm – a center of heavy-duty truck engineering excellence – underscores the site’s strategic location at the heart of Germany’s fuel cell technology cluster.”

In the first stage of the project, €40 million will be invested by the joint-venture Company to upgrade the manufacturing facility, which will focus on final assembly of the vehicle. Start of production is anticipated within the first quarter of 2021, with deliveries of the Nikola TRE beginning in the same year.

“The Nikola TRE is proving to be the most advanced articulated truck in the world and will continue to set the standard for zero-emission vehicles today and in the future” said Trevor Milton, Chief Executive Officer, Nikola Motor Company. “The decision to volume produce the TRE in the city of Ulm is a fitting example of how to create jobs, foster innovation, provide certainty to new zero-emission part suppliers and serve as an example to other OEM’s. The world is ready for zero-emission freight transportation, and the joint venture between Nikola and IVECO will be the first to deliver. I look forward to seeing the first production vehicles come off the line.”

The first models to enter production will be the battery-electric 4×2 and 6×2 articulated trucks with modular and scalable batteries with a capacity of up to 720 kWh and an electric powertrain that delivers up to 480 kW of continuous power output.

The Ulm facility will receive module supplies from IVECO´s manufacturing locations in Valladolid and Madrid, Spain, which will enable a rapid ramp up to meet expected customer demand. Fuel-cell electric versions, built on the same platform, will be tested under the EU-funded H2Haul project during 2021 for an expected market launch in 2023.

The Nikola TRE currently in development is based on the new IVECO S-WAY platform and integrates Nikola’s truck technology, controls and infotainment.  Testing is expected to begin in mid-2020 with prototypes showcased at the IAA 2020 commercial vehicle exhibition in Hannover, Germany this September.

“By drawing on our Gold standard World Class Manufacturing sites in Madrid and Valladolid, Spain, where the IVECO S-Way is produced, we are able to accelerate final assembly, powertrain integration and high-end customization of the Nikola TRE for a timely market introduction in 2021” said Gerrit Marx, President Commercial and Speciality Vehicles, CNH Industrial.

This Joint Venture forms part of a wider partnership established with Nikola to accelerate industry transformation towards emission neutrality of Class 8 heavy-duty trucks in North America and Europe through the adoption of fuel-cell technology. The primary focus of the collaboration is to leverage each partners’ respective expertise to successfully deploy zero-emission heavy-duty trucks and to disrupt the industry with an entirely new business model.

CNH Industrial N.V. (NYSE: CNHI / MI: CNHI) is a global leader in the capital goods sector with established industrial experience, a wide range of products and a worldwide presence. Each of the individual brands belonging to the Company is a major international force in its specific industrial sector: Case IH, New Holland Agriculture and Steyr for tractors and agricultural machinery; Case and New Holland Construction for earth moving equipment; Iveco for commercial vehicles; Iveco Bus and Heuliez Bus for buses and coaches; Iveco Astra for quarry and construction vehicles; Magirus for firefighting vehicles; Iveco Defence Vehicles for defence and civil protection; and FPT Industrial for engines and transmissions. More information can be found on the corporate website: www.cnhindustrial.com

Sign up for corporate news alerts from the CNH Industrial Newsroom:
bit.ly/media-cnhindustrial-subscribe

Media contact:

Laura Overall
Corporate Communications Manager
CNH Industrial
Tel. +44 (0)2077 660 338
E-mail: mediarelations@cnhind.com
www.cnhindustrial.com

Attachments

 

Euronet Worldwide to Provide Amazon India with New Transaction Processing Services Through Euronet’s REV™ Payments Cloud

LEAWOOD, Kan., Feb. 06, 2020 (GLOBE NEWSWIRE) — Euronet Worldwide (NASDAQ: EEFT), a leading global financial technology solutions and payments provider, today announced it will provide integration and content aggregation services through APIs from its REV™ Payments Cloud to add mobile recharges, bill payments, gift cards, consumer software, and other offerings to Amazon India.

In addition to the transaction processing services, Euronet will also provide technology integration and reconciliation services for onboarding new billers and merchants onto the platform. The integration has already created an LPG cylinder booking category on Amazon with several more categories scheduled to launch in the coming months.

“We are very excited to partner with a global integrator such as Euronet,” said Mahendra Nerurkar, Director of Amazon Pay. “Euronet’s experience will be important to the success of onboarding new services on the Amazon platform. We are constantly working towards delivering an awesome experience for our customers and this partnership is a key milestone in the journey.”

“Euronet has always been a leader for aggregating varied services through its local and global partnerships and also providing technology services to the leading ecommerce, fintech, and banking platforms in India,” said Pranay Jhaveri, Chief Business Officer, Euronet India and South Asia. “We are eager to enable Amazon to quickly and easily add new billers and services for its customers. We believe this partnership will empower millions of Amazon customers to securely pay and consume existing and new categories of services.”

About Amazon

Amazon is guided by four principles: customer obsession rather than competitor focus, passion for invention, commitment to operational excellence, and long-term thinking. Customer reviews, 1-Click shopping, personalized recommendations, Prime, Fulfillment by Amazon, AWS, Kindle Direct Publishing, Kindle, Fire tablets, Fire TV, Amazon Echo, and Alexa are some of the products and services pioneered by Amazon. For more information, visit www.amazon.com/about.

About Euronet Worldwide, Inc.

Euronet Worldwide is a leading global financial technology solutions and payments provider. Founded in 1994, the company offers payment and transaction processing solutions to financial institutions, retailers, service providers and individual consumers. These services include comprehensive ATM, POS and card outsourcing services, card issuing and merchant acquiring services, software solutions, cash-based and online-initiated consumer-to-consumer and business-to-business money transfer services, electronic distribution of digital media and prepaid mobile phone time and other cloud-based financial technology solutions.

Euronet’s global payment network is extensive – including 47,209 ATMs, approximately 305,000 EFT POS terminals and a growing portfolio of outsourced debit and credit card services which are under management in 54 countries; card software solutions; a prepaid processing network of approximately 710,000 POS terminals at approximately 329,000 retailer locations in 52 countries; and a global money transfer network of approximately 389,000 locations serving 161 countries. With corporate headquarters in Leawood, Kansas, USA, and 65 worldwide offices, Euronet serves clients in approximately 170 countries. For more information, please visit the Company’s website at www.euronetworldwide.com.

Contact
Stephanie Taylor
Director of Financial Planning
and Investor Relations
Euronet Worldwide, Inc.
+1-913-327-4200
staylor@euronetworldwide.com

 

Sanofi delivers strong 2019 business EPS growth of 6.8% at CER

Sanofi delivers strong 2019 business EPS growth of 6.8% at CER

  Q4 2019 Change Change
at CER
2019 Change Change
at CER
IFRS net sales reported €9,608m +6.8% +4.7% €36,126m +4.8% +2.8%
IFRS net income reported -€10m -103.9%(2) €2,806m -34.8%(2)
IFRS EPS reported -€0.01 -105.0%(2) €2.24 -35.1%(2)
Business net income(1) €1,684m +23.5% +18.4% €7,489m +9.8% +7.0%
Business EPS(1 €1.34 +21.8% +17.3% €5.99 +9.5% +6.8%
Fourth-quarter 2019 sales performance(3) driven by Dupixent® and Vaccines

  • Net sales were €9,608 million, up 6.8% on a reported basis and 4.7%(3) at CER.
  • Dupixent® (global sales €679 million, up 135%) the largest growth contributor, drove Sanofi Genzyme GBU sales up 19.7%.
  • Vaccines sales increased 22.0%, reflecting majority of U.S. influenza vaccine shipments in Q4.
  • CHC sales down 5.2%, mainly due to Zantac® voluntary recall, non-core divestments and changing regulatory requirements.
  • Primary Care GBU sales declined 8.7% due to lower sales in Diabetes and Established Products.
  • Lower China sales (down 21.0%) due to anticipated price and inventory adjustments on Plavix® and Avapro® in the channel.

Full-year 2019 sales growth of 3.6% at CER/CS(4) and business EPS growth of 6.8% at CER

  • Net sales were €36,126 million, up 4.8% on a reported basis and 2.8% at CER (up 3.6% at CER/CS(4)).
  • Dupixent® sales reached €2,074 million, on track with ambition to achieve more than €10 billion peak sales.
  • Vaccines sales increased 9.3% to €5,731 million, supporting expected mid-to-high single digit CAGR from 2018 to 2025.
  • Business operating income margin improved 1.2 percentage points to 27.0%, trending towards objective of 30% by 2022.
  • Q4 2019 business EPS(1) up 17.3% at CER to €1.34.
  • Full-year 2019 business EPS of €5.99 up 6.8% at CER.
  • Full-year 2019 IFRS EPS of €2.24 (down 35.1%(2)), reflecting a €3.6 billion impairment charge mainly related to Eloctate®.
  • Board proposes annual dividend of €3.15, the 26th consecutive increase in dividend.

Significant R&D advances and regulatory milestones

  • SAR442168, a BTK inhibitor, achieved proof of concept in relapsing multiple sclerosis; phase 3 program to be initiated mid-2020.
  • Dupixent® submitted to FDA (priority review) and EMA as first biologic for children aged 6-11 years with atopic dermatitis.
  • Dupixent® phase 3 pivotal studies initiated in bullous pemphigoid, chronic spontaneous urticaria and prurigo nodularis.
  • Dupixent® efficacy and safety further supported by 3-year data from OLE (Open Label Extension) study.
  • Fluzone® High-Dose Quadrivalent approved in the U.S.
  • Sutimlimab demonstrated positive phase 3 results in cold agglutinin disease.
  • SAR408701, an anti-CEACAM5 antibody-drug conjugate, entered into phase 3 in non-small cell lung cancer.
  • Olipudase demonstrated positive pivotal topline data in adult and pediatric patients with acid sphingomyelinase deficiency.
  • Successful completion of Synthorx acquisition enhances Sanofi’s position as an emerging leader in oncology and immunology.

2020 financial outlook
Sanofi expects 2020 business EPS(1) to grow around 5%(5) at CER, barring unforeseen major adverse events. Applying average January 2020 exchange rates, the positive currency impact on 2020 business EPS is estimated to be around 1%.

Sanofi Chief Executive Officer, Paul Hudson, commented:

“I am encouraged by the fourth quarter results which position Sanofi to deliver on our new strategic priorities. The acceleration in sales performance was mainly driven by the impressive growth of Dupixent®, our transformative medicine for type 2 inflammatory diseases and by our differentiated Vaccines portfolio. At the same time, our sharpened focus on operating and financial efficiencies helped us to deliver margin expansion and significant cash flow improvement. We are making great progress in our ambition to transform Sanofi R&D and I am particularly excited by the positive proof of concept data for our BTK inhibitor, a potentially practice changing therapy for multiple sclerosis, announced today. There is increasing momentum across the entire Sanofi organization and I am confident we will achieve the long-term growth aspirations and margin targets we set out at our Capital Markets Day”.

(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 (see Appendix 11 for definitions). The consolidated income statement for Q4 2019 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) Q4 2019 and full-year 2019 included impairment charge of €1,581 million and €3,604 million, respectively, mainly related to Eloctate®; (3) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 11); (4) Constant Structure: Adjusted for divestment of European generics business and sales of Bioverativ products to SOBI; (5) Base for business EPS growth is €5.97, reflecting 2 cents impact from IFRS 16 (see appendix 11).

Investor Relations: (+) 33 1 53 77 45 45 – E-mail: IR@sanofi.comMedia Relations: (+) 33 1 53 77 46 46 – E-mail: MR@sanofi.com
Website: www.sanofi.com

2019 fourth-quarter and full-year Sanofi sales

Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(6).

In the fourth quarter of 2019, Company sales were €9,608 million, up 6.8% on a reported basis. Exchange rate movements had a positive effect of 2.1 percentage points, mainly driven by the strength of the U.S. dollar and the Japanese yen. At CER, Company sales increased 4.7%. Full-year 2019 Company sales reached €36,126 million, up 4.8% on a reported basis. Exchange rate movements had a favorable effect of 2.0 percentage points. At CER, Company sales were up 2.8%.

Global Business Units

At its Capital Markets Day in December 2019, Sanofi announced plans for a new GBU organization(7) which will include three core GBUs, Specialty Care, General Medicines and Vaccines together with a standalone Consumer Healthcare business. The General Medicines GBU will be created from two existing GBUs, Primary Care and China & Emerging Markets. Each GBU will include its respective Emerging Markets sales contribution.
Olivier Charmeil has been appointed to lead the General Medicines GBU. Olivier is one of Sanofi’s most seasoned business leaders. He will draw on his recent experience leading the China & Emerging Markets GBU to engage with customers and markets and ensure that our combined Diabetes, Cardiovascular and Established Products business drives growth and deliver for patients around the world.
Alongside the GBU reorganization, Sanofi will implement changes in the configuration of its Executive Committee. This leadership committee will now include, in addition to the four GBU Heads, the global Heads of R&D, Industrial Affairs, Finance, Human Resources and Legal, together with the Chief Digital Officer. A leaner configuration will foster agility and speed in decision-making, in line with the fourth priority of the company’s new strategy (“Reinvent How We Work”).

The table below presents sales by Global Business Unit (GBU).

Net Sales by GBU
(€ million)
Q4 2019 Change
at CER
2019 Change
at CER
Sanofi Genzyme (Specialty Care)(a) 2,525   +19.7% 9,195 +22.4%(c)
Primary Care(a) 2,325   -8.7% 9,076 -14.8%(d)
China & Emerging Markets(b) 1,698   -1.9% 7,437 +6.4%
Total Pharmaceuticals 6,548 +2.4% 25,708 +2.2%
Consumer Healthcare (CHC) 1,152 -5.2% 4,687 -0.8%
Sanofi Pasteur (Vaccines) 1,908 +22.0% 5,731 +9.3%
Total net sales 9,608 +4.7% 36,126 +2.8%(e)

(a) Does not include China & Emerging Markets sales – see definition page 9; (b) Includes Emerging Markets sales for Primary Care and Specialty Care; (c) +19.3% at CS -Adjusted for Bioverativ acquisition and sales of Bioverativ products to SOBI – see page 5; (d) -10.9% at CS; (e) +3.6% at CS – Adjusted for Bioverativ and sales of Bioverativ products to SOBI and disposal of European Generics business.

Global Franchises

The tables below present fourth-quarter and full-year 2019 sales by global franchise, including Emerging Markets sales, to facilitate comparisons. Appendix 1 provides a reconciliation of sales by GBU and franchise.

Net sales by Franchise
(€ million)
Q4 2019 Change
at CER
Developed
Markets
Change
at CER
Emerging
Markets
Change
at CER
Specialty Care franchises 2,830 +18.9% 2,525 +19.7% 305 +12.8%
Rare Disease 815 +1.6% 661 +0.8% 154 +5.3%
Multiple Sclerosis 540 -3.0% 517 -3.8% 23 +21.1%
Oncology 441 +11.4% 333 +12.6% 108 +7.9%
Immunology 733 +128.6% 721 +126.2% 12 ns
Rare Blood Disorder 301 -0.7% 293 -2.4% 8 ns
Primary Care franchises 3,718 -7.2% 2,325 -8.7% 1,393 -4.7%
Established Rx Products 2,276 -6.3% 1,299 -4.0% 977 -9.3%
Diabetes 1,268 -9.2% 861 -15.5% 407 +7.4%
Cardiovascular 174 -4.5% 165 -5.8% 9 +33.3%
Consumer Healthcare 1,152 -5.2%  727 -9.4% 425 +3.0%
Vaccines 1,908 +22.0% 1,356 +25.5% 552 +14.2%
Total net sales 9,608 +4.7% 6,933 +5.9% 2,675 +1.8%

(6) See Appendix 11 for definitions of financial indicators. (7) subject to consultation with social partners and works councils.

Net sales by Franchise
(€ million)
2019 Change
at CER
Developed
Markets
Change
at CER
Emerging
Markets
Change
at CER
Specialty Care franchises 10,431 +22.7%(1) 9,195 +22.4% 1,236 +24.4%
Rare Disease 3,165 +6.5% 2,551 +2.6% 614 +24.0%
Multiple Sclerosis 2,160 +1.8% 2,080 +1.3% 80 +14.7%
Oncology 1,695 +10.6% 1,205 +8.3% 490 +16.7%
Immunology 2,259 +148.1% 2,228 +146.1% 31 ns
Rare Blood Disorder 1,152 +22.0%(2) 1,131 +20.0%(3) 21 ns
Primary Care franchises 15,277 -8.2%(4) 9,076 -14.8%(5) 6,201 +3.3%
Established Rx Products(6) 9,559 -8.3%(7) 5,088 -15.0%(8) 4,471 +0.6%
Diabetes 5,113 -8.2% 3,412 -15.6% 1,701 +10.3%
Cardiovascular 605 -4.6% 576 -6.4% 29 +55.6%
Consumer Healthcare 4,687 -0.8% 3,035 -3.6% 1,652 +4.7%
Vaccines 5,731 +9.3% 3,906 +3.4% 1,825 +24.0%
Total net sales 36,126 +2.8%(9) 25,212 +0.4%(10) 10,914 +8.7%

(1) +19.9 % at CS- Adjusted for Bioverativ and sales of products to SOBI – see page 5; (2) +0.8% at CS- see page 5; (3) -0.8% at CS -see page 5; (4) -5.5% at CS;
(5) -10.9% at CS; (6) including Generics; (7) -4.1% at CS; (8) -7.9% at CS; (9) +3.6% at CS- Adjusted for Bioverativ and sales of Bioverativ products to SOBI and disposal of European Generics business;(10) +1.5% at CS –
Adjusted for Bioverativ and sales of Bioverativ products to SOBI and disposal of European Generics business.

Pharmaceuticals

Fourth-quarter Pharmaceutical sales were up 2.4% to €6,548 million, mainly driven by Dupixent® which was partially offset by Diabetes and Established Rx Products. Full-year 2019 sales for Pharmaceuticals increased 2.2% (up 3.3% at CS) to €25,708 million, reflecting the disposal of the European generics business at the end of the third quarter of 2018.

Specialty Care franchises

Immunology franchise

Net sales (€ million) Q4 2019 Change
at CER
2019 Change
at CER
Dupixent® 679 +135.4% 2,074 +151.6%
Kevzara® 54 +67.7% 185 +114.5%
Total Immunology 733 +128.6% 2,259 +148.1%

Dupixent® (collaboration with Regeneron) generated sales of €679 million in the fourth quarter (up 135%). In the U.S., Dupixent® sales of €545 million (up 135%) were driven by continued growth in atopic dermatitis which benefited from increased penetration in adult patients and launch in the adolescent age group (12 to 17 years of age) in March, together with rapid uptake in asthma and launch in chronic rhinosinusitis with nasal polyposis (CRSwNP, approved in June). In the U.S., Dupixent® NBRx and TRx more than doubled in the quarter compared to the fourth quarter of 2018, growing at 108% and 117%, respectively. Fourth-quarter sales of Dupixent® in Europe rose to €64 million (up 117%) following additional launches while sales in Japan were €46 million (versus €13 million in the fourth quarter of 2018). Full-year 2019 Dupixent® sales increased 152% to €2,074 million. Dupixent® is now launched in 34 countries for adult atopic dermatitis; among these, Dupixent® is also launched in adolescent atopic dermatitis in 10 countries, in asthma in 8 countries and in CRSwNP in 4 countries. Potentially as many as 89 additional country launches are planned across these indications for 2020.

Kevzara® (collaboration with Regeneron) sales were €54 million (up 68%) in the fourth quarter, of which €34 million was generated in the U.S. (up 39%). Full-year 2019 Kevzara® sales increased 114% to €185 million.

Multiple Sclerosis franchise

Net sales (€ million) Q4 2019 Change
at CER
2019 Change
at CER
Aubagio® 482 +5.4% 1,879 +10.0%
Lemtrada® 58 -41.7% 281 -31.6%
Total Multiple Sclerosis 540 -3.0% 2,160 +1.8%

Fourth-quarter Multiple Sclerosis (MS) sales decreased 3.0% to €540 million. Over the period, Aubagio® sales growth in the U.S. was more than offset by lower Lemtrada® sales. Full-year 2019 MS sales increased 1.8% to €2,160 million.

Fourth-quarter Aubagio® sales increased 5.4% to €482 million, driven by the U.S. performance (up 7.1% to €343 million). Full-year 2019 Aubagio® sales increased 10.0% to €1,879 million. As of January 1, Aubagio® was excluded from the national formulary at ESI, which covers roughly 14% of total commercial lives in the US. Contracted access positions for Aubagio® remain strong for other national health plans and national PBMs.

In the fourth quarter, Lemtrada® sales decreased 42% to €58 million due to lower sales in the U.S. (down 29% to €34 million) and in Europe (down 57% to €16 million), reflecting increased global competition and the update to the EU label. Full-year 2019 Lemtrada® sales decreased 32% to €281 million.

Oncology franchise

Net sales (€ million) Q4 2019 Change
at CER
2019 Change
at CER
Jevtana® 128 +9.6% 484 +11.1%
Thymoglobulin® 89 +12.8% 354 +16.5%
Eloxatin® 42 -4.7% 203 +10.4%
Mozobil® 55 +12.8% 198 +11.7%
Taxotere® 42 +10.5% 173 +3.0%
Zaltrap® 26 +8.7% 97 +4.4%
Others 59 +29.5% 186 +9.1%
Total Oncology 441 +11.4% 1,695 +10.6%

Fourth-quarter Oncology sales increased 11.4% to €441 million driven by the U.S. (up 18.4% to €174 million) and Europe (up 15.7% to €102 million). Full-year 2019 Oncology sales increased 10.6% to €1,695 million.

Fourth-quarter Jevtana® sales increased 9.6% to €128 million driven by the U.S. and by publication of the results of the CARD study in metastatic castration-resistant prostate cancer at ESMO (European Society for Medical Oncology) in September 2019. Full-year 2019 Jevtana® sales were up 11.1% to €484 million. In the fourth quarter, Thymoglobulin® sales increased 12.8% to €89 million, driven by the U.S.  2019 sales of Thymoglobulin® increased 16.5% to €354 million.

Libtayo® (collaboration with Regeneron) approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation had ex-U.S. sales of €12 million and €16 million in the fourth quarter and full-year 2019, respectively. In 2019 Libtayo® was launched in 7 countries outside the U.S. and there are 13 additional country launches planned by the end of 2020. U.S. Libtayo® sales are reported by Regeneron.

Rare Disease franchise

Net sales (€ million) Q4 2019 Change
at CER
2019 Change
at CER
Myozyme® / Lumizyme® 238 +4.4% 918 +8.3%
Fabrazyme® 215 +2.4% 813 +5.3%
Cerezyme® 177 -6.8% 708 +2.7%
Aldurazyme® 54 0.0% 224 +9.2%
Cerdelga® 55 +22.7% 206 +26.4%
Others Rare Disease 76 +1.4% 296 +0.7%
Total Rare Disease 815 +1.6% 3,165 +6.5%

In the fourth quarter, Rare Disease sales increased 1.6% to €815 million against a high base for comparison. This performance was driven by Emerging Markets (up 5.3% to €154 million) and the U.S. (up 2.7% to €309 million). In Europe, over the period, sales were flat at €263 million. Full-year 2019 Rare Disease sales increased 6.5% to €3,165 million.

Fourth-quarter Gaucher (Cerezyme® and Cerdelga®) sales decreased 1.3% to €232 million, impacted by Cerezyme® sales phasing effects in Emerging Markets which offset strong Cerdelga® performance. Fourth-quarter Cerdelga® sales increased 22.7% to €55 million, with sales up 18.8% in Europe (to €20 million) and up 19.2% in the U.S. (to €31 million). Full-year 2019 Gaucher sales were €914 million, up 7.0%.
Fourth-quarter Pompe (Myozyme®/Lumizyme®) sales grew 4.4% to €238 million, driven by the U.S. (up 7.6% to €88 million) and Emerging Markets (up 16.7% to €41 million) and supported by positive trends in naïve patient accrual. Full-year 2019 Myozyme®/Lumizyme® sales increased 8.3% to €918 million.

Fourth-quarter Fabry (Fabrazyme®) sales grew 2.4% to €215 million, driven by Emerging Markets (up 15.4% to €29 million) and Europe (up 6.7% to €48 million). Over the period, U.S. sales decreased 1.0% to €106 million. Full-year 2019 Fabrazyme® sales were up 5.3% to €813 million.

Rare Blood Disorder franchise

Net sales (€ million) Q4 2019 Change
at CER
2019 Change
at CER
Eloctate® 177 -12.8% 684 +6.6%*
Alprolix® 108 +9.5% 412 +37.2%**
Cablivi® 16 ns 56 ns
Total Rare Blood Disorder 301 -0.7% 1,152 +22.0%***

* -11.6% at CS in 2019 – see footnote 8; **+12.4% at CS in 2019  – see footnote 8; *** +0.8% at CS in 2019 – see footnote 8

Bioverativ was consolidated in Sanofi’s Financial Statements from March 9, 2018. Fourth-quarter sales of the Rare Blood Disorder franchise were €301 million, down 0.7%. Fourth-quarter U.S. sales were €210 million, down 13.6%. Non U.S. sales were €91 million with Japan as the primary contributor. Full-year 2019 sales of the Rare Blood Disorder franchise were €1,152 million, up 0.8% at CS(8).

Eloctate® sales were €177 million in the fourth quarter, down 12.8%. In the U.S., sales of the product decreased 25.6% to €123 million, reflecting ongoing competitive pressure. In the Rest of the World region, fourth-quarter Eloctate® sales increased 35.3% to €47 million. Full-year 2019 Eloctate® sales were €684 million, down 11.6% at CS(8).

Alprolix® sales were €108 million in the fourth quarter, up 9.5%. In the U.S., sales of the product decreased 1.3%  to €77 million, related to shipment timing. In the Rest of the World region, Alprolix® sales increased 47.4% to €30 million due to growth in product sales to SOBI. Full-year 2019 Alprolix® sales were €412 million, up 12.4% at CS(8).

Cablivi® for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) generated fourth-quarter sales of €16 million. The number of patients treated with Cablivi increased over 30% compared to the third quarter to approximately 150 patients. Sales were sequentially lower primarily due to price adjustments in Europe and increased assistance program participations in the U.S. In the U.S., where Cablivi® was launched in April, sales were €10 million. In Europe, the product is commercially available in Germany, Denmark, Austria, Belgium and the Netherlands. Cablivi® has a temporary license to be sold in France. Full-year 2019 Cablivi® sales were €56 million.

Primary Care franchises

Cardiovascular franchise

Net sales (€ million) Q4 2019 Change
at CER
2019 Change
at CER
Praluent® 75 -11.0% 258 -3.8%
Multaq® 99 +1.1% 347 -5.1%
Total cardiovascular franchise 174 -4.5% 605 -4.6%

Fourth-quarter Praluent® (collaboration with Regeneron) sales decreased 11.0% to €75 million, reflecting lower sales in the U.S. (down 26.9% to €39 million) which were impacted by significantly higher rebates. In Europe, Praluent® sales increased 4.3% to €24 million despite the suspension of sales in Germany in August following the Regional Court of Dusseldorf ruling in the ongoing patent litigation. Full-year 2019 Praluent® sales decreased 3.8% to €258 million.

In December 2019, Sanofi and Regeneron announced their intent to simplify their antibody collaboration for Kevzara® and Praluent® by restructuring into a royalty-based agreement. Under the proposed restructuring, Sanofi is expected to gain sole global rights to Kevzara® and sole ex-U.S. rights to Praluent®. Regeneron is expected to gain sole U.S. rights to Praluent®. Under the proposed terms of the agreement, each party will be solely responsible for funding development and commercialization expenses in their respective territories. These changes are expected to increase efficiency and streamline operations for the products. Completion of the agreement is expected to be finalized in the first quarter of 2020.

(8) Growth comparing 2019 sales versus full 2018 sales at CER. Sales of products to SOBI were initially recorded in “other revenues” in H1 2018 and in sales from H2 2018; the H1 2018 reclassification was reflected in Q3 2018. H1 2018 and Q3 2018 sales were adjusted accordingly for calculation of CS. Unaudited data.
.
Diabetes franchise

Net sales (€ million) Q4 2019 Change
at CER
2019 Change
at CER
Lantus® 729 -17.2% 3,012 -17.0%
Toujeo® 234 +8.5% 883 +3.2%
Total glargine 963 -12.2% 3,895 -13.2%
Amaryl® 79 0.0% 334 -2.1%
Apidra® 88 -2.2% 344 -3.6%
Admelog® 56 -1.8% 250 +155.9%
Soliqua® 39 +40.7% 122 +60.3%
Insuman® 20 -13.0% 82 -7.7%
Total Diabetes 1,268 -9.2% 5,113 -8.2%

In the fourth quarter, global Diabetes sales decreased 9.2% to €1,268 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S.  Fourth-quarter U.S. Diabetes sales were down 20.5% to €454 million, reflecting the increased contribution to the coverage gap related to Medicare Part D and a continued decline in average U.S. glargine net prices. Fourth-quarter sales in Emerging Markets increased 7.4% to €407 million. Fourth-quarter sales in Europe decreased 4.4% to €305 million despite Toujeo® growth. Full-year 2019 global Diabetes sales decreased 8.2% to €5,113 million. Broad U.S. payer coverage for key Diabetes brands is expected to be largely maintained in 2020.

In the fourth quarter, Lantus® sales were €729 million, down 17.2%. In the U.S., Lantus® sales decreased 26.9% to €286 million, mainly reflecting lower average net price and the increased contribution to the coverage gap related to Medicare Part D. In Europe, fourth-quarter Lantus® sales were €146 million, down 13.1% due to biosimilar glargine competition and patients switching to Toujeo®. In Emerging Markets, fourth-quarter Lantus® sales were stable at €244 million reflecting lower sales in the Middle-East. Full-year 2019 Lantus® sales decreased 17.0% to €3,012 million.
On January 28, 2020, Sanofi’s petition for rehearing the Court of Appeals for the Federal Circuit decision affirming the December 2018 PTAB decisions invalidating the Lantus® formulation patents was denied. Mylan currently does not have FDA approval for either its vial or pen product.

Fourth-quarter Toujeo® sales increased 8.5% to €234 million. In the U.S., fourth-quarter Toujeo® sales were €77 million, down 7.4% mainly reflecting lower average net price and the increased contribution to the coverage gap related to Medicare Part D. In Europe and Emerging Markets, fourth-quarter Toujeo® sales were €87 million (up 14.3%) and €48 million (up 48.4%), respectively. Full-year 2019 Toujeo® sales increased 3.2% to €883 million.

Fourth-quarter and full-year 2019 Amaryl® sales were €79 million (stable) and €334 million (down 2.1%), respectively. In China, the second wave of the nationwide VBP (volume-based procurement) program includes glimepiride in 2020 and Sanofi has opted not to bid with Amaryl®. In China, Amaryl® sales were €136 million (up 3.1%) in 2019. Sanofi expects sales of Amaryl® in China to decline significantly in 2020 due to the extended VBP program.

Fourth-quarter Apidra® sales decreased 2.2% to €88 million. Lower sales in the U.S. (down 47.1% to €10 million) offset growth in Emerging Markets (up 20.7% to €34 million). Full-year 2019 Apidra® sales were €344 million, down 3.6%.

Admelog® (insulin lispro injection) generated sales of €56 million (down 1.8%) in the fourth quarter. Admelog® sales in the U.S. were €52 million, down 7.4% due to the WAC price adjustment of -44% which took effect on July 1, 2019. Full-year 2019 Admelog® sales were €250 million versus €93 million in 2018. Sanofi expects lower Admelog® sales in 2020 due to the full-year impact of the U.S. WAC price adjustment.

Fourth-quarter and full-year 2019 Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) and Suliqua™ sales increased 41% (to €39 million) and 60% (to €122 million), respectively.

Established Rx Products

Net sales (€ million) Q4 2019 Change
at CER
2019 Change
at CER
Lovenox® 335 -4.0% 1,359 -7.4%
Plavix® 212 -36.9% 1,334 -8.8%
Aprovel®/Avapro® 131 -15.2% 674 +2.0%
Synvisc® /Synvisc-One® 81

United States-Singapore Joint Statement on Financial Services Data Connectivity

U.S. Treasury Under Secretary for International Affairs Brent McIntosh and Monetary Authority of Singapore Deputy Managing Director Jacqueline Loh met in Singapore to discuss the importance of data connectivity in financial services. At the conclusion of their meeting, Under Secretary McIntosh and Deputy Managing Director Loh issued the following joint statement:

The United States and Singapore recognize that the ability to aggregate, store, process, and transmit data across borders is critical to financial sector development. The expanding use of data in financial services and the increasing use of technology to supply financial services offer a range of benefits, including greater consumer choice, enhanced risk management capabilities, and increased efficiency. These developments also pose new and complex risks for markets and challenges for policymakers and regulators. The United States and Singapore are committed to working together and with other countries to promote an environment in financial services that fosters the development of the global economy.

Consistent with these shared objectives, the United States and Singapore support allowing financial service suppliers to transfer data across borders and oppose generally applicable data localization requirements as long as financial regulators have access to data needed for regulatory and supervisory purposes. Data localization requirements can increase cybersecurity and other operational risks, hinder risk management and compliance, and inhibit financial regulatory and supervisory access to information. Data mobility in financial services supports economic growth and the development of innovative financial services and benefits risk management and compliance programs, including by making it easier to detect cross-border money laundering and terrorist financing patterns, defend against cyberattacks, and manage and assess risk on a global basis.

Based on this shared understanding, the United States and Singapore intend to seek to promote adoption and implementation of policies and rules in our bilateral and multilateral economic relationships to facilitate the following goals:

Ensuring that financial service suppliers can transfer data, including personal information, across borders by electronic means if this activity is for the conduct of the business of a financial service supplier.

Opposing measures that restrict where data can be stored and processed for financial service suppliers as long as financial regulators have full and timely access to data needed to fulfill their regulatory and supervisory mandate.

Ensuring that financial service suppliers have the opportunity to remediate the lack of access to such data before being required to use or locate computing facilities locally.

The United States and Singapore also intend to share information on developments related to these issues and, as appropriate, encourage third countries to adopt policies consistent with this joint statement.

The United States and Singapore issue this joint statement without prejudice to governments’ rights and obligations under the World Trade Organization (WTO), and to the exceptions contained in the WTO General Agreement on Trade in Services (GATS), such as the exceptions relating to protection of personal data privacy and confidentiality of individual records and accounts, and in related texts, such as the Annex on Financial Services and the prudential exception therein. In addition, relevant portions of this joint statement would not apply to the use and location of certain categories of financial service computing facilities. For greater certainty, this joint statement does not create binding obligations under domestic or international law.

Source: Monetary Authority of Singapore

TVET will be realigned to be industry-driven – Dr M

PUTRAJAYA, The Technical and Vocational Education and Teaching (TVET) programme will be reviewed and realigned to be industry-driven to produce graduates based on areas of economic focus by region or locality identified in the Shared Prosperity Vision (SPV) 2030.

Prime Minister Tun Dr Mahathir Mohamad who is also acting Education Minister said in line with the SPV, TVET would be made one of the enablers that contribute towards the development of a prosperous and inclusive developing country.

For the year 2020, he said the Education Ministry (MOE) and other TVET provider ministries would be focusing on the TVET Empowerment Strategies Map developed by the TVET Empowerment Cabinet Committee.

It is to produce balanced, holistic and entrepreneurial TVET graduates who will later become highly skilled workers contributing to the country’s productivity and economic growth, he said.

All relevant parties need to ensure the success of the industry-led TVET implementation to overcome skills mismatch issues, dependence on foreign workers, and eventually produce TVET graduates who meet the needs of the industry, he said at his mandate and aspiration-sharing programme with the MOE staff here today.

Meanwhile, Dr Mahathir said to prepare students to face the Fourth Industrial Revolution, the MOE would ensure science, technology, engineering and mathematics (STEM) education was enhanced in various aspects.

The enhancement includes the number of students taking STEM subjects, teachers teaching skills, collaboration with industries and parents’ involvement in fostering students’ interest in STEM, he said.

To attract more students into the STEM field, the ministry has provided more options for them to choose elective subjects under the STEM package besides literature and humanity, he said.

Dr Mahathir said the ministry’s digital learning platform, developed on July 1, 2019, would be strengthened further this year as a digital teaching and learning catalyst for teachers and students via easier and wider access to materials.

Curriculum content is also designed to include elements such as the Internet of Things (IoT), encoding, robotics and big data in primary and secondary school subjects to attract students and facilitate the mastery of knowledge, he said.

Source: Prime Minister’s Office of Malaysia

Decision on PPSMI will be based on cabinet’s majority opinion – Dr Mahathir

PUTRAJAYA, The government is still mulling the implementation of the Teaching and Learning of Science and Mathematics in English (PPSMI) and decision will be made based on the majority opinion of the Cabinet members, Prime Minister Tun Dr Mahathir Mohamad announced.

Clarifying his own opinion on the matter, Dr Mahathir, who is also acting Minister of Education said if one really loves his race, ensuring the success of the entire race should be his priority rather than only being able to speak well in his own language.

I am a Malay. I love the Malay race and the Malay language. But we need to give consideration to the development of the Malay race.

Love the (Malay) race, (but) give priority to success and ability to compete rather than only being able to speak well in the Malay language, he said at his mandate and aspiration-sharing programme with the MOE staff here today.

Elaborating further at a press conference later, the Prime Minister said a Cabinet Committee has been set up to look into the matter following protest from the public.

I found reports saying that the government has already decided to implement the teaching and learning of Science and Mathematics in English. There is no decision. I was just explaining the matter to the officers at the Education Ministry.

Somehow it leaked and was reported as if the government had already made its decision on that. We are still considering, he said.

While admitting that he was the one responsible of introducing the PPSMI before, Dr Mahathir said he still felt that the country would be left behind if it did not learn the two subjects in English.

He said this is because science is not static and is constantly evolving as various new terms are coined in from time to time.

In the past, we made everything by hand, then we moved to mass production, then mechanical, automation and robot, and now we are in the digital era. It does not stop, the science that we learned in the past cannot be put into use today, he said.

Asked if the government would get feedback from the public, he said everyone involved, including parents, teachers and students, could express their views to the government.

However, he said the government would not hold any engagement session with the stakeholders as it would be time-consuming.

Dr Mahathir said, at present, teachers are given the option to teach Science and Mathematics either in Malay or English, but the method does not produce good results.

As such, he said the method to teach English needs to be improved by using videos which are prepared by English language experts, shown to the students and coached by class teachers.

That way, the expertise of those who prepared the videos can really benefit the students, he added.

Source: Prime Minister’s Office of Malaysia