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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:
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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

Rosmah’s trial : Najib asked to leave court room

KUALA LUMPUR, Former Prime Minister Datuk Seri Najib Tun Razak was today ordered to leave the court during the hearing of his wife, Datin Seri Rosmah Mansor’s case for corruption.

Najib, 67, in a short-sleeved red shirt was sitting at the public gallery behind Rosmah, when he was asked to leave the court room at about 10.45 am, about 15 minutes after the fourth prosecution witness was called to testify.

Najib’s presence was noticed by deputy public prosecutor Ahmad Akram Gharib, who then informed presiding judge Mohamed Zaini Mazlan.

During the course of investigations, MACC (Malaysian Anti-Corruption Commission) had recorded Datuk Seri Najib’s statement. There is a possibility that he may be a witness and I don’t think it is appropriate for him to be here, Ahmad Akram said.

Rosmah’s lawyer Datuk Jagjit Singh told that Najib came to court to support his wife.

His name (Najib) is not in the witness list that the prosecution will call, he added.

Justice Mohamed Zaini then faced Najib and said as a matter of caution, could I ask you to leave the court, please?

Najib nodded, before walking out of the courtroom.

Rosmah, 68, claimed trial to a charge of soliciting RM187.5 million and two counts of receiving a bribe of RM6.5 million from Jepak Holdings Sdn Bhd managing director Saidi Abang Samsudin, through her former aide, Datuk Rizal Mansor , for projects to provide solar energy to 369 rural schools in Sarawak.

She allegedly committed the offences at three places in Lygon Cafe, Sunway Putra Mall in Jalan Putra, at her house in Jalan Langgak Duta, Taman Duta and at Seri Perdana Residence, Persiaran Seri Perdana, Precinct 10, Putrajaya between Jan 2016 and Sept 7, 2017.

Source: BERNAMA (News Agency)

Enforcement of Malaysia’s Smoking Ban Sparks Controversy

KUALA LUMPUR – At a popular Kuala Lumpur open-air food court, Eiswary Thirumalai enjoys a meal with her family. She says in the past, secondhand smoke would sometimes ruin the atmosphere. Actually, it’s really discomfortable for us because while we are eating we smell the smoke, she says. So it’s not healthy for us while we are eating.

A year ago, a new law prohibited smoking at all eateries in Malaysia. Previously, smoking was banned inside all air-conditioned restaurants. But the new law bans smoking within three meters of any table or chair at any indoor or outdoor eatery.

There was a one-year phase-in period in which offenders were given warnings, but since January, violators have faced fines ranging from $35 to $85. During January, more than 5,000 tickets were issued nationwide. If they come out with this penalty, maybe it will give the person a lesson, says Thirumalai.

Alex Lee runs a wonton stall in the same food court. Lee has been smoking for two decades, but he supports the ban. People should have clean air while they eat, so I think it’s good that they’re enforcing this smoking ban, he says.

It’s a point of view echoed by health advocates. Twenty-thousand people die of smoking-related illness each year in Malaysia, says Mandy Thoo of the National Cancer Society of Malaysia, while explaining why the society supports strict enforcement of the law. Smoking as well as passive smoking, which is secondhand smoke, causes 15 kinds of cancer, heart disease, and it worsens diabetes as well as mental illnesses.

The broadened smoking ban directly impacts the semi-enclosed open-air food courts that are common across Malaysia.Several eatery trade associations say some members have seen a drop in business by almost 20% since the ban started. We request to have a small smoking zone for the convenience of the smokers, says Chris Lee of the Malaysia Singapore Coffee Shop Proprietors General Association.

Henry Wong doesn’t smoke but says he thinks the government is overreaching. People choose to smoke, he says. It’s their life, it’s their health, so I don’t really agree with banning people from smoking.

Steven Wong, no relation to Henry Wong, openly smoked at an outdoor table at a food court one afternoon until other customers yelled at him. A lot of people complain about secondhand smoking, he says. “I have friends, ladies who are in their 80s who’ve been inhaling secondhand smoke for 50 years, maybe 60 years, and they’re still alive.

The National Cancer Society of Malaysia points to studies that show secondhand smoke is very unhealthy. For nonsmokers who are exposed to secondhand smoke in homes as well as offices, they increase their risk of smoking-related diseases by 20 to 30 percent, says the society’s Mandy Thoo. So it may be your choice to smoke but it’s not someone else’s choice to be exposed to secondhand smoke.

Source: Voice of America

Demand for Ukrainian sunflower oil in Malaysia to grow this year — Ambassador

KUALA LUMPUR, There will be a stronger demand for sunflower oil imported from Ukraine as edible oil consumers in various Asian countries, including Malaysia, are moving toward healthier food choices, said Ukraine Ambassador to Malaysia Olexander Nechytaylo.

Nechytaylo said the promotion of healthy lifestyle and nutrition is one of the main reasons why consumers of edible oil, especially sunflower oil, are increasing in Malaysia.

There is a growing demand for healthy vegetable oils and sunflower oil is one of them. Moreover, Ukrainian producers can offer for Malaysian consumers very competitive high-oleic sunflower oil.

According to the State Statistics Service of Ukraine in January-November 2019, Ukraine exported to Malaysia 72.4 thousand tonnes of sunflower oil with a total cost of US$54.5 million. This is 36 per cent of our total export to Malaysia.

As compared to the same period of 2018, the growth of export of sunflower oil to Malaysia has reached 105.4 per cent. We expect it to grow in 2020 and upcoming years as well, he told Bernama.

Commenting on the health benefits of sunflower oil, the envoy said it strengthens the immune system, rich in antioxidants, and also contains protein that is necessary for healthy functioning.

Sunflower oil contains 12 times more amount of vitamin E than olive oil. It also contains vitamin D that helps the body to better absorb important elements such as calcium, he added.

Ukraine is the world leader in the supply of sunflower oil, and Ukrainian sunflower oil is a popular product with annual growth in exports.

Nechytaylo said Ukrainian sunflower oil is exported to more than 90 countries and it has sufficient potential to increase production by increasing the yield of oilseeds in its own fields.

Despite that, more than 50 per cent of our sunflower oil is exported to the Asian market, (and) the main consumer is still India.

According to the State Statistics Service of Ukraine in January-November 2019, Ukraine exported 5,523.5 thousand (5.5 million) tonnes of sunflower oil where 34 per cent of it was exported to India, followed by the European Union (29 per cent), China (16 per cent) and Iraq (five per cent), he said.

Source: BERNAMA (News Agency)