Monthly Archives: October 2019

SunGen Pharma Receives Eighth ANDA Approval from US FDA

PRINCETON, N.J., Oct. 31, 2019 (GLOBE NEWSWIRE) — SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its eighth ANDA approval from the US Food and Drug Administration (FDA).

The eighth approved ANDA is for Lidocaine Ointment USP, 5%, Package size: 1 ½ oz tube (35.44 g). This drug product is used for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. This drug has annual sales of about 60 million US dollars.

“These approvals represent one of many products being developed or co-developed by our company and with our partners globally. Today, we have more than forty active products in our pipeline and over twenty co-development, licensing, CMO and sales and marketing partnerships around the world,” said Dr. Isaac Liu, Co-Founder and Co-CEO of the company.  “Our high-quality development expertise and capability is now expanded to topical dosage forms and is further demonstrated by the short approval timeline. We will continue to focus on development of highly selective products that are niche and high barrier to entry with high value added to US and Asian markets,” said Dr. Jim Huang, Co-Founder and Co-CEO of the company.

About SunGen Pharma LLC
SunGen Pharma, LLC is a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products. SunGen specializes in the development of oral solid extended release, topical and complex injectable products. SunGen has business partnerships with many North American, European and Asian-based generic pharmaceutical companies to develop, manufacture, and sell several pharmaceutical products around the world.

Contact:

SunGen Pharma LLC
Shanshan Li, Ph.D.
Tel: (732) 410-5467
support@sungenpharm.com

British American Tobacco Selects Synchronoss Digital Experience Platform to Speed Delivery of Highly Optimized Customer Journeys

New pilot project spans three European countries to support in-store sales team members

BRIDGEWATER, N.J., Oct. 31, 2019 (GLOBE NEWSWIRE) — Synchronoss Technologies, Inc. (NASDAQ:SNCR), a global leader and innovator of cloud, messaging, digital and IoT products, today announced that it is launching a multi-country pilot of the Synchronoss Digital Experience Platform (DXP) for British American Tobacco (BAT), a leading, multi-category consumer goods company providing tobacco and nicotine products to millions of adult consumers around the world.

The Synchronoss DXP solution will provide BAT with a toolkit of capabilities that vastly simplifies IT delivery, giving BAT the capacity to quickly design, deploy, manage and optimize customer journeys while providing a unified experience across all its owned retail locations.

“Synchronoss’ DXP will give us the insights, flexibility and speed required to create highly optimized guided customer journeys that will not only deliver additional value for our customers but also maximize our revenue,” said Jean-Francois Parent, Global Head of Own Retail & New Channels at British American Tobacco. “At the same time, DXP will help ensure that our global adult customers can count on a consistent experience as they explore our products – including when they are interacting with an in-store tablet and one of our sales team members.”

The pilot will be deployed for three months across 25 BAT retail locations in Europe: 10 stores in Poland, 9 stores in the UK and 6 stores in Germany.

Chris Hill, SVP Digital Transformation, Synchronoss, said, “Our Synchronoss Digital Experience Platform provides BAT with both the intelligence and the technical capabilities it needs to put in place a best-in-class customer retail experience that delivers exceptional value to both its customers and the company’s bottom line.”

To learn more about the Synchronoss Digital Experience Platform, visit the Synchronoss website.

About Synchronoss
Synchronoss (NASDAQ:SNCR) transforms the way companies create new revenue, reduce costs and delight their subscribers with cloud, messaging, digital and IoT products, supporting hundreds of millions of subscribers across the globe. Synchronoss’ secure, scalable and groundbreaking new technologies, trusted partnerships and talented people change the way Technology-Media-Telecommunications customers grow their business. For more information, visit us at www.synchronoss.com

Contact:

Media:
North America:
Diane Rose
CCgroup
M: +1 202-350-2469
E: synchronoss@ccgrouppr.com

International:
Anais Merlin
CCgroup
T: +44 (0)203 824 9219
E: synchronoss@ccgrouppr.com

Investor:
Joe Crivelli
Synchronoss
908-566-3131
investor@synchronoss.com

K2 Expands Footprint in Asia-Pacific Region with Acquisition of Australian Distributor

Low-code application development company to expand presence in Australia to meet increasing demand for cloud-based process automation solutions

BELLEVUE, Wash., Oct. 31, 2019 (GLOBE NEWSWIRE) — SourceCode Technology Holdings, Inc. (“K2”), a leader in enterprise low-code application development, today announced the acquisition of its distributor SourceCode ANZ Pty Ltd. (“K2 Australia”). K2 and K2 Australia share a long history of collaboration and joint innovation. With this acquisition, K2 establishes a direct presence in Australia, further investing in growth across the region to meet the increasing demand for cloud-based process automation solutions.

“The acquisition of K2 Australia immediately provides us with a strong and established foothold in Australia,” said Evan Ellis, CEO at K2. “As part of our ongoing growth strategy, we are confident we can leverage our common vision to strengthen and expand the adoption of our cloud-based process automation platform.”

Combining the expertise of the talented K2 Australia team with the global resources and market strength of K2 will create a collaboration that can accelerate the delivery of innovative process automation solutions across the region.

“K2 is an ideal match for our team and the work we aspire to do in helping enterprises digitally transform,” said Hennie Laubscher, managing director of K2 Australia, who will join K2 as the vice president of Asia-Pacific. “By joining the K2 family, we can accelerate our growth in the region and deliver low-code applications on a broader scale.”

About K2
K2, a leader in enterprise low-code application development, enables companies to speed time-to-market and simplify the creation of modern process applications, automate workflows and transform their businesses. More than 4 million users in over 84 countries, including 30 percent of Fortune 100 are using K2 to take control of their business processes, increase visibility and improve operational efficiency. Discover what you can accomplish when you connect your people, processes and data at K2.com.
 
Contact
Andrea Mocherman
K2
+1 (425) 883-4200
press@k2.com

Bombardier Reports Third Quarter 2019 Results

  • Consolidated revenues of $3.7 billion, representing 8% organic growth(1)
  • Consolidated adjusted EBITDA(2) and adjusted EBIT(2) of $255 million and $159 million, respectively; $143 million of reported EBIT
  • Free cash flow usage(2) of $682 million, supporting Global 7500 and Transportation ramp-up; $557 million operating cash flow usage
  • Clear roadmap to full year revenues, earnings(4) and free cash flow guidance supported by planned fourth quarter delivery schedules at Aviation and Transportation(3)

All amounts in this press release are in U.S. dollars unless otherwise indicated. Amounts in tables are in millions except per share amounts, unless otherwise indicated.

MONTRÉAL, Oct. 31, 2019 (GLOBE NEWSWIRE) — Bombardier (TSX: BBD.B) today reported its third quarter 2019 financial results, highlighting continued progress on its turnaround.

Among its achievements in the third quarter, Bombardier obtained Transport Canada and European Aviation Safety Agency (EASA) certification for its new Global 5500 and Global 6500 aircraft, with the Global 6500 also entering service. Bombardier Transportation made steady progress addressing its challenging projects, while also growing and improving the quality of its backlog.

Bombardier’s consolidated revenues for the quarter were $3.7 billion, representing 8% organic growth year-over-year, driven mainly by a favourable delivery mix of large business aircraft and progress on rail projects. Order activity remained solid in the quarter, and the Company reported strong backlogs at Transportation and for business aircraft of $35.1 billion and $15.3 billion, respectively.

Consolidated adjusted EBITDA and adjusted EBIT for the quarter were $255 million and $159 million, respectively. Adjusted EBIT margin in Aviation was 6.0%, in line with expectations and driven by Global 7500 aircraft ramp-up and the dilutive effect of commercial aircraft activities. Adjusted EBIT margin in Transportation was 5.1%, reflecting a concentration of large, late-stage projects and planned investments in manufacturing and engineering capacity announced earlier this year. On a reported basis, EBIT for the quarter was $143 million.

Free cash flow usage was $682 million for the quarter, reflecting the intense ramp-up of the Global 7500 production and lower cash inflows associated with train deliveries and milestones payments that have moved into the fourth quarter. Cash flows usage from operating activities during the quarter was $557 million.

The Company continues to expect full-year free cash flow usage to be approximately $500 million, driven by seasonally strong fourth quarter cash flows, the acceleration of Global 7500 deliveries and the partial release of excess working capital at Transportation.(3) As we move beyond short-term challenges, Bombardier is positioned for 2020 earnings(3) growth and positive cash flow generation.(3)(5)

“We continue to make progress driving our turnaround,” said Alain Bellemare, President and Chief Executive Officer, Bombardier Inc. “At Aviation, the recent certification of our new Global 5500 and Global 6500 aircraft, and the outstanding in-service performance of our new Global 7500, highlight the strength of our business jet franchise. At Transportation, we are turning the corner. We are making steady progress working through our legacy projects, giving us confidence in our ability to deliver stronger financial performance.”

SELECTED RESULTS

RESULTS OF THE QUARTER
Three-month periods ended September 30 2019 (6) 2018 Variance
Revenues $ 3,722 $ 3,643 2 %
Adjusted EBITDA $ 255 $ 333 (23 )%
Adjusted EBITDA margin(2) 6.9 % 9.1 % (220) bps
Adjusted EBIT $ 159 $ 271 (41 )%
Adjusted EBIT margin 4.3 % 7.4 % (310) bps
EBIT $ 143 $ 267 (46 )%
EBIT margin 3.8 % 7.3 % (350) bps
Net income (loss) $ (91 ) $ 149 nmf
Diluted EPS (in dollars) $ (0.06 ) $ 0.04 $ (0.10 )
Adjusted net income (loss)(2) $ (55 ) $ 167 nmf
Adjusted EPS (in dollars)(2) $ (0.04 ) $ 0.04 $ (0.08 )
Net additions to PP&E and intangible assets $ 125 $ 229 (45 )%
Cash flows from operating activities $ (557 ) $ (141 ) (295 )%
Free cash flow usage $ (682 ) $ (370 ) (84 )%
As at September 30, 2019
December 31, 2018 Variance
Available short-term capital resources(7) $ 3,010 $ 4,373 (31 )%
Order backlog (in billions of dollars)
Aviation
Business aircraft $ 15.3 $ 14.3 7 %
Other aviation(8) $ 2.6 $ 4.3 (40 )%
Transportation $ 35.1 $ 34.5 2 %
RESULTS OF THE NINE-MONTH PERIOD
Nine-month periods ended September 30 2019 (6) 2018 Variance
Revenues $ 11,552 $ 11,933 (3 )%
EBIT $ 1,198 $ 659 82 %
EBIT margin 10.4 % 5.5 % 490 bps
Adjusted EBIT $ 536 $ 743 (28 )%
Adjusted EBIT margin 4.6 % 6.2 % (160) bps
Adjusted EBITDA $ 833 $ 934 (11 )%
Adjusted EBITDA margin 7.2 % 7.8 % (60) bps
Net income $ 112 $ 263 (57 )%
Diluted EPS (in dollars) $ (0.02 ) $ 0.08 $ (0.10 )
Adjusted net income (loss) $ (224 ) $ 289 nmf
Adjusted EPS (in dollars) $ (0.16 ) $ 0.09 $ (0.25 )
Net additions to PP&E and intangible assets $ 402 $ 167 141 %
Cash flows from operating activities $ (1,753 ) $ (692 ) (153 )%
Free cash flow usage $ (2,155 ) $ (859 ) (151 )%

SEGMENTED RESULTS AND HIGHLIGHTS

Following the strategic formation of Bombardier Aviation, effective July 1, 2019, Business Aircraft, Commercial Aircraft and Aerostructures and Engineering Services are reported under Aviation. Prior periods have been restated to reflect this new reporting structure. The Corporation’s interest in Airbus Canada Limited Partnership (ACLP) is treated as a corporately held investment and therefore is not included in Aviation.

Aviation

Results of the quarter
Three-month periods ended September 30 2019 (6) 2018 Variance
Revenues $ 1,558 $ 1,504 4 %
Aircraft deliveries (in units)
Business aircraft 31 31
Commercial aircraft (9) 6 5 1
Adjusted EBITDA $ 154 $ 166 (7 )%
Adjusted EBITDA margin 9.9 % 11.0 % (110) bps
Adjusted EBIT $ 93 $ 129 (28 )%
Adjusted EBIT margin 6.0 % 8.6 % (260) bps
EBIT $ 96 $ 132 (27 )%
EBIT margin 6.2 % 8.8 % (260) bps
Net additions to PP&E and intangible assets $ 87 $ 191 (54 )%
As at September 30, 2019
December 31, 2018
Order backlog (in billions of dollars)
Business aircraft $ 15.3 $ 14.3 7 %
Other aviation $ 2.6 $ 4.3 (40 )%
  • Revenues of $1.6 billion during the quarter reflect double-digit organic growth year-over-year (excluding the Q400 and training activities divestitures completed earlier this year), driven by the Global 7500, external aerostructures revenues and stronger aftermarket services.
  • Deliveries during the quarter totalled 37 aircraft, including 6 CRJ and 31 business aircraft. Revenue grew mainly because of a favourable mix of large business aircraft sales led by 2 Global 7500 deliveries and the entry into service of the first Global 6500 aircraft.
  • On September 24, 2019, the Global 5500 and Global 6500 aircraft were awarded Transport Canada Type Certification, followed by EASA certification. The Global 5500 and Global 6500 aircraft showcase the ingenuity of innovation by bringing value to customers with segment-leading ranges and reduced operating costs.
  • As the pace of deliveries accelerates into the fourth quarter, Aviation is on track to reach 175 to 180 aircraft deliveries for the full-year on revenues of approximately $8.0 billion(3). Production ramp-up of the Global 7500 continues to make steady progress with an estimated 10 to 15 aircraft deliveries in the fourth quarter(3).
  • Order momentum remained healthy during the quarter for business aircraft, with backlog stable at an  industry-leading $15.3 billion. For the first nine months, business aircraft backlog increased by $1.0 billion.
  • Adjusted EBIT margin for the third quarter was 6.0% (6.2% EBIT margin), in line with expectations as the ramp-up of the Global 7500 aircraft and the dilutive effect of commercial aircraft activities weigh on Aviation margins. Year-to-date, adjusted EBIT margin was 7.6% (21.6% reported EBIT margin), tracking to full year margin guidance of 7.0%.(3)

Transportation

Results of the quarter
Three-month periods ended September 30 2019 (6) 2018 Variance
Revenues $ 2,175 $ 2,140 2 %
Order intake (in billions of dollars) $ 4.5 $ 1.9 137 %
Book-to-bill ratio(10) 2.1 0.9 1.2
Adjusted EBITDA (11) $ 144 $ 212 (32 )%
Adjusted EBITDA margin (11) 6.6 % 9.9 % (330) bps
Adjusted EBIT(11) $ 110 $ 187 (41 )%
Adjusted EBIT margin(11) 5.1 % 8.7 % (360) bps
EBIT(11) $ 88 $ 184 (52 )%
EBIT margin(11) 4.0 % 8.6 % (460) bps
Net additions to PP&E and intangible assets $ 48 $ 36 33 %
As at September 30, 2019
December 31, 2018
Order backlog (in billions of dollars) $ 35.1 $ 34.5 2 %
  • Transportation is gradually turning the corner on large, legacy projects as it makes progress against key project milestones.
    °  With deliveries increasing approximately 15% over the previous quarter, this progress positions the business to further accelerate the release of excess working capital starting in the fourth quarter and into 2020 and 2021.(3)
    °  To achieve this result, we are nearing completion of software testing and homologation for U.K. projects while completing production and we continue driving stronger in-service reliability in Switzerland and Germany to trigger customer acceptance of trains in operation.
    °  Longer term, the turnaround at Transportation is supported by the recent redeployment of resources, investments in additional capacity, and a strengthened management team, resting on a solid backlog and quality order intake. This drives our confidence in the long-term prospects of the business.
  • Revenues during the quarter totalled $2.2 billion, delivering 5% growth year-over-year, excluding currency translation, mainly coming from services. Transportation remains on track to the full year revenue guidance of approximately $8.75 billion,(3) assuming a 1.12 Euro to U.S. exchange rate.
  • Adjusted EBIT margin(3) for the quarter of 5.1% is in line with full year guidance of approximately 5.0%, reflecting a concentration of large, late-stage projects and includes the costs associated with planned investments in manufacturing and engineering capacity announced earlier this year. Reported EBIT margin for the quarter is 4.0%.
  • Backlog grew to $35.1 billion during the quarter, supported by $4.5 billion of order intake driving a book-to-bill ratio of 2.1. For the first nine months of the year, Transportation’s order intake was $8.1 billion, with a strong mix of high re-use projects, services and signalling orders as well as significant call-offs. Improving the backlog mix by replacing legacy projects with lower-risk projects is key to return to stronger financial performance.
    °  Highlighting the quarters’ order activity, Transportation is part of a consortium that was awarded a contract to supply and operate two monorail lines in Cairo, Egypt with its share valued at $2.64 billion. This award leverages Transportation’s INNOVIA monorail platform through an integrated offering of rolling stock and systems, signalling and services solutions. This project re-uses the platform operating in Sao Paulo, Brazil, since 2014 and currently under construction in Bangkok, Thailand and Wuhu, China.

About Bombardier
With over 68,000 employees, Bombardier is a global leader in the transportation industry, creating innovative and game-changing planes and trains. Our products and services provide world-class transportation experiences that set new standards in passenger comfort, energy efficiency, reliability and safety.

Headquartered in Montreal, Canada, Bombardier has production and engineering sites in 28 countries as well as a broad portfolio of products and services for the business aviation, commercial aviation and rail transportation markets. Bombardier shares are traded on the Toronto Stock Exchange (BBD). In the fiscal year ended December 31, 2018, Bombardier posted revenues of $16.2 billion US. The company is recognized on the 2019 Global 100 Most Sustainable Corporations in the World Index. News and information are available at bombardier.com or follow us on Twitter @Bombardier.

Bombardier, Challenger, CRJ, CRJ900, Global, Global 5500, Global 6500, Global 7500, INNOVIA and Learjet are trademarks of Bombardier Inc. or its subsidiaries.

 For information

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

The Management’s Discussion and Analysis and the Interim Consolidated Financial Statements are available at ir.bombardier.com.

bps: basis points
nmf: information not meaningful
(1) Excluding divestitures and currency translation impact.
(2) Non-GAAP financial measures. Refer to the Caution regarding Non-GAAP financial measures below for definitions of these metrics and reconciliations to the most comparable IFRS measures.
(3) See the forward-looking statements disclaimer at the end of this press release as well as the forward-looking statements section in Overview and the Guidance and forward-looking statements section in each reportable segment in the Corporation’s 2018 Financial Report for details regarding the assumptions on which the guidance is based.
(4) Defined as adjusted EBITDA and adjusted EBIT.
(5) Free cash flow target for 2020 excludes cash flow from the CRJ program, as well as payments associated with CRJ retained liabilities such as credit and residual value guarantees.
(6) Refer to Note 2 – Changes in accounting policies, to our interim consolidated financial statements, for the impact of the adoption of IFRS 16, Leases. Under the modified retrospective approach adopted by the Corporation, 2018 figures are not restated.
(7) Defined as cash and cash equivalents plus the amount available under our revolving credit facilities.
(8) Including 32 firm orders for CRJ900 as of September 30, 2019 and 45 firm orders and 4 options for CRJ900 as of December 31, 2018.
(9) On May 31, 2019, the Corporation completed the previously announced sale of the Q Series aircraft program assets, including aftermarket operations and assets, to De Havilland Aircraft of Canada Limited (formerly Longview Aircraft Company of Canada Limited). 2 Q Series aircraft deliveries are included in comparative period of 2018.
(10) Ratio of new orders over revenues.
(11) Including share of income from joint ventures and associates amounting to $20 million for the three-month period ended September 30, 2019 ($22 million for the three-month period ended September 30, 2018).

CAUTION REGARDING NON-GAAP FINANCIAL MEASURES

This press release is based on reported earnings in accordance with IFRS and on the following non-GAAP financial measures:

Non-GAAP financial measures
Adjusted EBIT EBIT excluding special items. Special items comprise items which do not reflect the Corporation’s core performance or where their separate presentation will assist users of the consolidated financial statements in understanding the Corporation’s results for the period. Such items include, among others, the impact of restructuring charges and significant impairment charges and reversals.
Adjusted EBITDA Adjusted EBIT plus amortization and impairment charges on PP&E and intangible assets.
Adjusted net income (loss) Net income (loss) excluding special items, accretion on net retirement benefit obligations, certain net gains and losses arising from changes in measurement of provisions and of financial instruments carried at FVTP&L and the related tax impacts of these items.
Adjusted EPS EPS calculated based on adjusted net income attributable to equity holders of Bombardier Inc., using the treasury stock method, giving effect to the exercise of all dilutive elements.
Free cash flow (usage) Cash flows from operating activities less net additions to PP&E and intangible assets.

Non-GAAP financial measures are mainly derived from the consolidated financial statements but do not have standardized meanings prescribed by IFRS. The exclusion of certain items from non-GAAP performance measures does not imply that these items are necessarily non-recurring. Other entities in our industry may define the above measures differently than we do. In those cases, it may be difficult to compare the performance of those entities to ours based on these similarly-named non-GAAP measures.

Prior to the first quarter of fiscal year 2019, the Corporation reported non-GAAP measures labelled “EBIT before special items” and “EBITDA before special items”. Beginning in the first quarter of fiscal year 2019, the Corporation changed the label of these non-GAAP measures to “adjusted EBIT” and “adjusted EBITDA”, respectively, without making any change to the composition of these non-GAAP measures. The Corporation believes that this new label aligns better with broad market practice in its industry and better distinguishes these measures from the IFRS measurement “EBIT”.

Adjusted EBIT, adjusted EBITDA, adjusted net income (loss) and adjusted EPS
Management uses adjusted EBIT, adjusted EBITDA, adjusted net income (loss) and adjusted EPS for purposes of evaluating underlying business performance. Management believes these non-GAAP earnings measures in addition to IFRS measures provide users of our Financial Report with enhanced understanding of our results and related trends and increases the transparency and clarity of the core results of our business. Adjusted EBIT, adjusted EBITDA, adjusted net income (loss) and adjusted EPS exclude items that do not reflect our core performance or where their exclusion will assist users in understanding our results for the period. For these reasons, a significant number of users of the MD&A analyze our results based on these financial measures. Management believes these measures help users of MD&A to better analyze results, enabling better comparability of our results from one period to another and with peers.

Free cash flow (usage)
Free cash flow is defined as cash flows from operating activities less net additions to PP&E and intangible assets. Management believes that this non-GAAP cash flow measure provides investors with an important perspective on the Corporation’s generation of cash available for shareholders, debt repayment, and acquisitions after making the capital investments required to support ongoing business operations and long-term value creation. This non-GAAP cash flow measure does not represent the residual cash flow available for discretionary expenditures as it excludes certain mandatory expenditures such as repayment of maturing debt. Management uses free cash flow as a measure to assess both business performance and overall liquidity generation.

Reconciliations of non-GAAP financial measures to the most comparable IFRS financial measures are provided in the tables hereafter, except for the following reconciliations:

  • adjusted EBIT to EBIT – see the Results of operations tables in the reporting segments and Consolidated results of operations section of the Corporation’s MD&A for the quarter ended September 30, 2019.
Reconciliation of segment to consolidated results
Three-month periods
ended September 30

Nine-month periods
ended September 30

2019
(1) 2018
2019
(1) 2018
Revenues
Aviation $ 1,558 $ 1,504 $ 5,088 $ 5,182
Transportation 2,175 2,140 6,476 6,754
Corporate and Others (11 ) (1 ) (12 ) (3 )
$ 3,722 $ 3,643 $ 11,552 $ 11,933
Adjusted EBIT
Aviation $ 93 $ 129 $ 388 $ 288
Transportation 110 187 304 583

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Bombardier Announces Definitive Agreement to Sell Aerostructures Business to Spirit AeroSystems Holding, Inc.

  • Sale of aerostructures business supports Aviation transformation, refocuses on business aviation and strengthens liquidity
  • Expected cash proceeds of $500 million (1) plus the assumptions of liabilities
  • Transaction implies enterprise value to 2019E EBITDA multiple of approximately 10x  All amounts in this press release are in U.S. dollars unless otherwise indicated.

MONTREAL, Oct. 31, 2019 (GLOBE NEWSWIRE) — Bombardier (TSX: BBD.B) today announced a definitive agreement to sell its aerostructures business to Spirit AeroSystems Holding, Inc. (Spirit), supporting Bombardier’s strategic decision to focus on its two strong growth pillars, trains and business aircraft.

With this transaction, Spirit will acquire Bombardier’s aerostructures activities and aftermarket services operations in Belfast, U.K.; Casablanca, Morocco; and its aerostructures maintenance, repair and overhaul (MRO) facility in Dallas, U.S. for a cash consideration of $500 million and the assumption of liabilities with a total carrying value in excess of $700(2)  million, including government refundable advances and pension obligations. Following the transaction, Spirit will continue to supply structural aircraft components and spare parts to support the production and in-service fleet of Bombardier Aviation’s Learjet, Challenger and Global families of aircraft.

2019 revenues for these activities are expected to be approximately $1.0 billion(3) , while generating adjusted EBITDA margin of approximately 12%. On this basis, the transaction implies an enterprise value to EBITDA multiple of approximately 10x.

The transaction follows the formation of Bombardier Aviation earlier this year and streamlines Bombardier’s aerostructures footprint to focus on core capabilities in Montreal, Mexico and its Global 7500 wing operations in Texas. The transaction also further strengthens Bombardier’s liquidity as it moves toward the deleveraging phase of the turnaround. The transaction is expected to close in the first half of 2020 and remains subject to regulatory approvals and customary closing conditions.

“This transaction represents another strategic milestone in the reshaping of our portfolio to focus on our strong business aircraft and rail franchises,” said Alain Bellemare, President and Chief Executive Officer, Bombardier Inc.  “We are confident that Spirit’s acquisition of these aerostructures assets is the best outcome for customers, employees and shareholders, and we are committed to ensuring a smooth and orderly transition.”

About Bombardier

With over 68,000 employees, Bombardier is a global leader in the transportation industry, creating innovative and game-changing planes and trains. Our products and services provide world-class transportation experiences that set new standards in passenger comfort, energy efficiency, reliability and safety.

Headquartered in Montreal, Canada, Bombardier has production and engineering sites in 28 countries as well as a broad portfolio of products and services for the business aviation, commercial aviation and rail transportation markets. Bombardier shares are traded on the Toronto Stock Exchange (BBD). In the fiscal year ended December 31, 2018, Bombardier posted revenues of $16.2 billion US. The company is recognized on the 2019 Global 100 Most Sustainable Corporations in the World Index. News and information are available at bombardier.com or follow us on Twitter @Bombardier.

Bombardier, Challenger, Global, Global 7500, and Learjet are trademarks of Bombardier Inc. or its subsidiaries.

 For information

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

 

(1) See the forward-looking statements disclaimer at the end of this press release as well as the forward-looking statements section in Overview and the Guidance and forward-looking statements section in each reportable segment in the Corporation’s 2018 Financial Report for details regarding the assumptions on which the guidance is based.
(2) Represents the carrying values of liabilities for Bombardier as of September 30, 2019. This value may differ under Spirit ownership.
(3) Including approximately one third from internal sales to Bombardier Aviation.


FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements, which may involve, but are not limited to: statements with respect to the Corporation’s, anticipations and guidance in respect of various financial and global metrics and sources of contribution thereto, targets, goals, priorities, market and strategies, financial position, market position, capabilities, competitive strengths, credit ratings, beliefs, prospects, plans, expectations, anticipations, estimates and intentions; general economic and business outlook, prospects and trends of an industry; expected growth in demand for products and services; growth strategy, including in the business aircraft aftermarket business; product development, including projected design, characteristics, capacity or performance; expected or scheduled entry-into-service of products and services, orders, deliveries, testing, lead times, certifications and project execution in general; competitive position; expectations regarding working capital recovery across late-stage Transportation projects; expectations regarding revenue and backlog mix; the expected impact of the legislative and regulatory environment and legal proceedings on the Corporation’s business and operations; strength of capital profile and balance sheet, creditworthiness, available liquidities and capital resources, expected financial requirements and ongoing review of strategic and financial alternatives; the introduction of productivity enhancements, operational efficiencies and restructuring initiatives and anticipated costs, intended benefits and timing thereof; the expected objectives and financial targets underlying our transformation plan and the timing and progress in execution thereof, including the anticipated business transition to growth cycle and cash generation; expectations and objectives regarding debt repayments, expectations and timing regarding an opportunistic redemption of CDPQ’s investment in BT Holdco; intentions and objectives for the Corporation’s programs, assets and operations; the pursuit of a divestiture of the Corporation’s operations in Belfast and Morocco, the anticipated benefits of any divestiture or other transaction resulting therefrom and their expected impact on the Corporation’s operations, infrastructure, opportunities, financial condition, business plan and overall strategy; the funding and liquidity of Airbus Canada Limited Partnership (ACLP); and the expected impact and intended benefits of the Corporation’s partnership with Airbus and investment in ACLP. As it relates to the sale of the CRJ aircraft program (the Pending Transaction), this press release also contains forward-looking statements with respect to: the expected terms, conditions, and timing for completion thereof; the respective anticipated proceeds and use thereof and/or consideration therefor, related costs and expenses, as well as the anticipated benefits of such actions and transactions and their expected impact on the Corporation’s guidance and targets; and the fact that closing of these transactions will be conditioned on certain events occurring, including the receipt of necessary regulatory approval.

Forward-looking statements can generally be identified by the use of forward-looking terminology such as “may”, “will”, “shall”, “can”, “expect”, “estimate”, “intend”, “anticipate”, “plan”, “foresee”, “believe”, “continue”, “maintain” or “align”, the negative of these terms, variations of them or similar terminology. Forward-looking statements are presented for the purpose of assisting investors and others in understanding certain key elements of the Corporation’s current objectives, strategic priorities, expectations and plans, and in obtaining a better understanding of our business and anticipated operating environment. Readers are cautioned that such information may not be appropriate for other purposes.

By their nature, forward-looking statements require management to make assumptions and are subject to important known and unknown risks and uncertainties, which may cause our actual results in future periods to differ materially from forecast results set forth in forward-looking statements. While management considers these assumptions to be reasonable and appropriate based on information currently available, there is risk that they may not be accurate. The assumptions underlying the forward-looking statements made in this press release in relation to the pursuit of a divestiture of the Corporation’s operations in Belfast and Morocco include the following material assumptions: the identification and successful completion of one or more divestiture(s) or other transactions resulting therefrom on commercially satisfactory terms and the realization of the intended benefits therefrom within the anticipated timeframe. The assumptions underlying the forward-looking statements made in this press release in relation to the Pending Transaction discussed herein include the following material assumptions: the satisfaction of all conditions of closing and the successful completion of such strategic actions and transaction within the anticipated timeframe, including receipt of regulatory approvals. For additional information with respect to the assumptions underlying the forward-looking statements made in this press release, refer to the Strategic Priorities and Guidance and forward-looking statements sections in Overview, Business Aircraft, Commercial Aircraft, Aerostructures and Engineering Services and Transportation in the MD&A of the Corporation’s financial report for the fiscal year ended December 31, 2018.

Certain factors that could cause actual results to differ materially from those anticipated in the forward-looking statements include, but are not limited to, risks associated with general economic conditions, risks associated with our business environment (such as risks associated with “Brexit””[, the financial condition of the airline industry], business aircraft customers, and the rail industry; trade policy; increased competition; political instability and force majeure events or global climate change), operational risks (such as risks related to developing new products and services; development of new business and awarding of new contracts; book-to-bill ratio and order backlog; the certification and homologation of products and services; fixed-price and fixed-term commitments and production and project execution, including challenges associated with certain Transportation’s legacy projects and the release of working capital therefrom; pressures on cash flows and capital expenditures based on project-cycle fluctuations and seasonality; risks associated with our ability to successfully implement and execute our strategy, transformation plan, productivity enhancements, operational efficiencies and restructuring initiatives, including the formation of Bombardier Aviation; doing business with partners; risks associated with the Corporation’s partnership with Airbus and investment in ACLP; risks associated with the Corporation’s ability to continue with its funding plan of ACLP and to fund, if required, the cash shortfalls; inadequacy of cash planning and management and project funding; product performance warranty and casualty claim losses; regulatory and legal proceedings; environmental, health and safety risks; dependence on certain customers, contracts and suppliers; supply chain risks; human resources; reliance on information systems; reliance on and protection of intellectual property rights; reputation risks; risk management; tax matters; and adequacy of insurance coverage), financing risks (such as risks related to liquidity and access to capital markets; retirement benefit plan risk; exposure to credit risk; substantial existing debt and interest payment requirements; certain restrictive debt covenants and minimum cash levels; financing support provided for the benefit of certain customers; and reliance on government support), market risks (such as risks related to foreign currency fluctuations; changing interest rates; decreases in residual values; increases in commodity prices; and inflation rate fluctuations). For more details, see the Risks and uncertainties section in Other in the MD&A of the Corporation’s financial report for the fiscal year ended December 31, 2018.

With respect to the pursuit of a divestiture of the Corporation’s operations in Belfast and Morocco discussed herein specifically, certain factors that could cause actual results to differ materially from those anticipated in the forward-looking statements include, but are not limited to: the failure to identify and complete any divestiture or other transaction resulting therefrom within the expected time frame, on commercially satisfactory terms or at all; all or part of the intended benefits therefrom not being realized within the anticipated timeframe, or at all; and the incurrence of related costs and expenses; and negative effects of the announcement or pendency of any such divestiture or other transaction. With respect to the Pending Transaction discussed herein specifically, certain factors that could cause actual results to differ materially from those anticipated in the forward-looking statements include, but are not limited to: the failure to receive or delay in receiving regulatory approvals, or otherwise satisfy the conditions to the completion of the transaction or delay in completing and uncertainty regarding the length of time required to complete such transactions, and the funds and benefits thereof not being available to Bombardier in the time frame anticipated or at all; alternate sources of funding that would be used to replace the anticipated proceeds and savings from such strategic actions and transactions, as the case may be, may not be available when needed, or on desirable terms. Accordingly, there can be no assurance that any divestiture relating to the Corporation’s operations in Belfast and Morocco, or the Pending Transaction will be undertaken or occur, or of the timing or successful completion thereof, or the amount and use of proceeds therefrom, or that the anticipated benefits will be realized in their entirety, in part or at all. There can also be no assurance as to the completion, the form, or the timing of any BT Holdco buy-back. For more details, see the Risks and uncertainties section in Other in the MD&A of the Corporation’s financial report for the fiscal year ended December 31, 2018.

Readers are cautioned that the foregoing list of factors that may affect future growth, results and performance is not exhaustive and undue reliance should not be placed on forward-looking statements. Other risks and uncertainties not presently known to us or that we presently believe are not material could also cause actual results or events to differ materially from those expressed or implied in the Corporation’s forward-looking statements. The forward-looking statements set forth herein reflect management’s expectations as at the date of this press release and are subject to change after such date. Unless otherwise required by applicable securities laws, the Corporation expressly disclaims any intention, and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The forward-looking statements contained in this press release are expressly qualified by this cautionary statement.

Ingredion Incorporated Reports Third Quarter 2019 Results

  • Third quarter 2019 reported and adjusted EPS* were $1.47 and $1.82, respectively, compared with $1.32 and $1.70 in the third quarter 2018, respectively
  • Year-to-date 2019 reported and adjusted EPS were $4.51 and $5.03, respectively, down from $4.80 of reported EPS and down from $5.31 of adjusted EPS in the year-ago period
  • 2019 adjusted EPS expected to be in the range of $6.45-$6.65

WESTCHESTER, Ill., Oct. 31, 2019 (GLOBE NEWSWIRE) — Ingredion Incorporated (NYSE: INGR), a leading global provider of ingredient solutions to diversified industries, today reported results for the third quarter 2019. The results, reported in accordance with U.S. generally accepted accounting principles (“GAAP”) for 2019 and 2018, include items that are excluded from the non-GAAP financial measures that the Company presents.

“We are pleased to have delivered modest net sales and operating income growth despite the challenging environment. We advanced our specialties strategy, which delivered specialty volume growth across every region, while also managing pricing actions across our entire business to offset the impacts of currency and input cost inflation,” said Jim Zallie, Ingredion’s president and chief executive officer.

“We continued executing well against our Cost Smart savings program to drive additional operational efficiencies. Most recently, we made the decision to move to an import model and cease production at our Lane Cove facility in Australia to address persistent corn cost increases due to water scarcity. In addition, we initiated a significant restructuring of our South America business by streamlining operations to create a more agile business in the region.”

“Looking ahead, we expect ongoing macroeconomic pressures in the fourth quarter resulting from the impacts of trade disputes, uncertainty from the political transition in Argentina, and Brexit postponements, which is reflected in our revised full-year EPS guidance range of $6.45-$6.65. We are confident in our team’s ability to continue executing against our strategic initiatives to achieve our long-term profit growth outlook. We remain committed to returning capital to shareholders, as evidenced by the Board’s decision to increase the dividend for the fifth consecutive year,” Zallie concluded.

*Adjusted diluted earnings per share (“adjusted EPS”), adjusted operating income, adjusted effective income tax rate and adjusted cash flow from operations are non-GAAP financial measures. See section II of the Supplemental Financial Information entitled “Non-GAAP Information” following the Condensed Consolidated Financial Statements included in this press release for a reconciliation of these non-GAAP financial measures to the most directly comparable U.S. GAAP measures.

Diluted Earnings Per Share (EPS)

3Q18 3Q19 YTD18 YTD19
Reported EPS $1.32 $1.47 $4.80 $4.51
Income Tax Settlement $(0.03)
Income Tax Reform $0.03 $0.03
Impairment/Restructuring Costs $0.38 $0.32 $0.48 $0.47
Acquisition/Integration Costs $0.02
Other Tax Matters $0.03 $0.03
Adjusted EPS** $1.70 $1.82 $5.31 $5.03

**Totals may not foot due to rounding


Estimated factors affecting change in reported and adjusted EPS

3Q19 YTD19
Margin 0.06 (0.20)
Volume 0.10 0.08
Foreign exchange (0.11) (0.39)
Other income (0.02) (0.04)
Total operating items 0.03 (0.55)
Other non-operating income (0.02) (0.04)
Financing costs 0.01 0.04
Shares outstanding 0.12 0.37
Tax rate (0.02) (0.11)
Non-controlling interest 0.01
Total non-operating items 0.09 0.27
Total items affecting EPS 0.12 (0.28)

Financial Highlights

  • At September 30, 2019, total debt and cash and short-term investments were $2.1 billion and $446 million, respectively, versus $2.1 billion and $334 million, respectively, at December 31, 2018. The increase in cash and short-term investments was primarily due to the timing of short-term debt payments and stock repurchases in the prior year.
  • Net financing costs were $24 million, or flat to the third quarter from the year-ago period, as the impact of Argentina hyperinflationary accounting offset the benefit of lapping prior year foreign exchange losses.
  • Reported and adjusted effective tax rates for the quarter were 27.1 percent and 25.0 percent compared to reported and adjusted effective tax rates of 25.8 percent and 24.7 percent, respectively, from the year-ago period. The increase in reported and adjusted rates resulted from the relatively lower valuation of the Mexican peso impacting the U.S. dollar denominated balances in Mexico. This was partially offset by a change in earnings mix and other factors.
  • Third quarter capital expenditures were $75 million, up $1 million from the year-ago period.
  • Cost Smart is expected to deliver $30 million to $40 million of 2019 year-end cumulative run-rate savings. Cost Smart is achieving structural cost savings by aligning people and processes to improve effectiveness and efficiency across the organization.

Business Review

Total Ingredion

$ in millions 2018 Net sales FX Impact Volume Price/mix 2019 Net sales % change
Third quarter 1,450 -52 9 50 1,457 0%
Year-to-Date 4,415 -223 -48 167 4,311 -2%

Net Sales

  • Third quarter net sales were slightly up from the year-ago period. Improved price/mix and volume growth were partially offset by foreign currency impacts.
  • Year-to-date net sales were down from the year-ago period. The decrease in year-to-date net sales was driven by unfavorable foreign currency impacts and planned Stockton HFCS and industrial starch volume shed, partially offset by favorable price/mix due to pricing actions.

Operating income

  • Reported and adjusted operating income for the quarter were $165 million and $193 million, respectively, increases of 6 percent and 2 percent, respectively, from the year-ago period. The increases were largely attributable to improved price/mix and specialty volume growth, partially offset by foreign exchange impacts and higher raw material costs.
  • Third quarter reported operating income was lower than adjusted operating income by $28 million due to restructuring costs related to the Cost Smart savings program.
  • Year-to-date reported and adjusted operating income were $494 million and $537 million, respectively, decreases of 9 percent from the year-ago period. The decreases were largely attributable to foreign exchange impacts and higher raw material and production costs, partially offset by improved price/mix.

North America

$ in millions 2018 Net sales FX Impact Volume Price/mix 2019 Net sales % change
Third quarter 889 -1 -9 13 892 0%
Year-to-Date 2,679 -9 -51 18 2,637 -2%

Operating income

  • Third quarter operating income was $145 million, an increase of $7 million from the year-ago period. The increase was driven by improved price/mix and benefits from the Cost Smart savings program, partially offset by higher net corn costs.
  • Year-to-date operating income was $409 million, a decrease of $22 million from the year-ago period. The decrease was driven by higher inventory and production costs, higher net corn costs due to lower co-product values, and a modest impact from the extreme weather in the U.S. and Canada.

South America

$ in millions 2018 Net sales FX Impact Volume Price/mix 2019 Net sales % change
Third quarter 228 -34 11 29 234 3%
Year-to-Date 709 -143 -3 104 667 -6%

Operating income

  • Third quarter operating income was $27 million, an increase of $5 million from the year-ago period. Favorable pricing actions, volume, and the benefits of the Cost Smart program more than offset foreign exchange impacts.
  • Year-to-date operating income was $61 million, a decrease of $7 million from the year-ago period. Higher input costs and foreign exchange impacts and were partially offset by favorable pricing actions.

Asia-Pacific

$ in millions 2018 Net sales FX Impact Volume Price/mix 2019 Net sales % change
Third quarter 197 -1 5 -5 196 -1%
Year-to-Date 592 -16 -1 10 585 -1%

Operating income

  • Third quarter operating income was $22 million, down $3 million from the year-ago period. The decrease was driven by increased operating costs in Australia and the continuing impact of trade disputes, which have increased input costs and intensified competitive pressure on price/mix.
  • Year-to-date operating income was $65 million, a decrease of $10 million from the year-ago period. Specialty volume growth and improved price/mix were more than offset by higher regional input costs, foreign exchange impacts and increased operating costs in Australia.

Europe, Middle East, and Africa (EMEA)

$ in millions 2018 Net sales FX Impact Volume Price/mix 2019 Net sales % change
Third quarter 136 -16 2 13 135 -1%
Year-to-Date 435 -55 10 32 422 -3%

Operating income

  • Third quarter operating income was $24 million, down $2 million from the year-ago period. Higher corn costs and unfavorable foreign exchange impacts were partially offset by strong pricing actions.
  • Year-to-date operating income was $71 million, a decrease of $15 million from a year ago. Unfavorable foreign exchange impacts, driven primarily by the Pakistan rupee, and higher raw material costs were partially offset by improved price/mix and specialty volume growth.

Updated 2019 Outlook

The Company expects 2019 adjusted EPS to be in the range of $6.45-$6.65 compared to adjusted EPS of $6.92 in 2018. This expectation excludes acquisition-related, integration and restructuring costs, as well as any potential impairment costs. Compared with last year, we expect fourth quarter adjusted operating income to be flat to slightly down, higher financing costs driven by the impact of Argentina hyperinflation, and a higher effective tax rate due to the anticipated mix of earnings. Compared with last year, the 2019 full-year outlook is as follows: North America operating income is expected to be down assuming continuation of current market conditions for corn and co-products, which have been negatively impacted by late crop plantings and delayed harvest in the U.S. and continued crop inventory imbalances arising from the U.S./China trade dispute; South America operating income is expected to be down due to the impact of macroeconomic uncertainty; Asia-Pacific operating income is expected to be down driven increased input costs and anticipated slower customer demand, intensified competitive pressure on price and by foreign currency weakness; EMEA operating income is expected to be down due to foreign currency weakness, higher raw material costs and postponement of Brexit; higher-value specialty ingredients are expected to deliver continued growth; and our adjusted effective tax rate is expected to be in the range of approximately 27.0-28.0 percent. Cash from operations is expected to be in the range of $600 million to $640 million. Capital expenditures are anticipated to be between $335 million and $355 million including mechanical stores of $50 million to $60 million.

Conference Call and Webcast Details
Ingredion will conduct a conference call today at 7 a.m. Central Time hosted by Jim Zallie, president and chief executive officer, and James Gray, executive vice president and chief financial officer. The call will be webcast in real time and will include a presentation accessible through the Company’s website at www.ingredion.com. The presentation will be available to download a few hours prior to the start of the call. A replay of the webcast will be available for a limited time at www.ingredion.com.

ABOUT THE COMPANY
Ingredion Incorporated (NYSE: INGR), headquartered in the suburbs of Chicago, is a leading global ingredient solutions provider serving customers in more than 120 countries. With annual net sales of nearly $6 billion, the company turns grains, fruits, vegetables and other plant materials into value-added ingredients and biomaterial solutions for the food, beverage, paper and corrugating, brewing and other industries. With Ingredion Idea Labs® innovation centers around the world and more than 11,000 employees, the Company develops ingredient solutions to meet consumers’ evolving needs by making crackers crunchy, yogurt creamy, candy sweet, paper stronger, and adding fiber to nutrition bars. For more information, visit ingredion.com.

Forward-Looking Statements
This news release contains or may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company intends these forward-looking statements to be covered by the safe harbor provisions for such statements.

Forward-looking statements include, among other things, any statements regarding the Company’s future financial condition, earnings, revenues, tax rates, capital expenditures, cash flows, expenses or other financial items, including the Company’s expectations for 2019 adjusted EPS, operating income, adjusted effective tax rate, cash from operations and capital expenditures, any statements concerning the Company’s prospects or future operations, including management’s plans or strategies and objectives therefor, and any assumptions, expectations or beliefs underlying the foregoing.

These statements can sometimes be identified by the use of forward-looking words such as “may,” “will,” “should,” “anticipate,” “assume”, “believe,” “plan,” “project,” “estimate,” “expect,” “intend,” “continue,” “pro forma,” “forecast,” “outlook,” “propels,” “opportunities,” “potential,” “provisional” or other similar expressions or the negative thereof. All statements other than statements of historical facts in this release or referred to in this release are “forward-looking statements.”

These statements are based on current circumstances or expectations, but are subject to certain inherent risks and uncertainties, many of which are difficult to predict and are beyond our control. Although we believe our expectations reflected in these forward-looking statements are based on reasonable assumptions, investors are cautioned that no assurance can be given that our expectations will prove correct.

Actual results and developments may differ materially from the expectations expressed in or implied by these statements, based on various factors, including changing consumption preferences including those relating to high fructose corn syrup; the effects of global economic conditions, including, particularly, economic, currency and political conditions in South America, trade relations between the United States and China and economic and political conditions in Europe, and their impact on our sales volumes and pricing of our products; our ability to collect our receivables from customers and our ability to raise funds at reasonable rates; future financial performance of major industries which we serve, including, without limitation, the food, beverage, paper and corrugated, and brewing industries; fluctuations in worldwide markets for corn and other commodities, and the associated risks of hedging against such fluctuations; genetic and biotechnology issues; our ability to develop or acquire new products and services at rates or of qualities sufficient to meet expectations; availability of raw materials, including corn, including the impact of recent excess precipitation in the U.S. corn-planting season, potato starch, tapioca, gum Arabic and also the specific varieties of corn upon which some of our products are based; fluctuations in the markets and prices for our co-products, particularly corn oil; fluctuations in aggregate industry supply and market demand; the behavior of financial markets, including foreign currency fluctuations and fluctuations in interest and exchange rates; volatility and turmoil in the capital markets; the commercial and consumer credit environment; general political, economic, business, market and weather conditions in the various geographic regions and countries in which we buy our raw materials or manufacture or sell our products; energy costs and availability; freight and shipping costs; and changes in regulatory controls regarding quotas; tariffs, duties, taxes and income tax rates, particularly United States tax reform enacted in 2017; operating difficulties; energy issues in Pakistan; boiler reliability; our ability to effectively integrate and operate acquired businesses; our ability to achieve budgets and to realize expected synergies; our ability to achieve expected savings under our Cost Smart program; our ability to complete planned maintenance and investment projects successfully and on budget; labor disputes; ; increased competitive and/or customer pressure in the corn-refining industry; and the outbreak or continuation of serious communicable disease or hostilities, including acts of terrorism. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement as a result of new information or future events or developments. If we do update or correct one or more of these statements, investors and others should not conclude that we will make additional updates or corrections. For a further description of these and other risks, see “Risk Factors” and other information included in our Annual Report on Form 10-K for the year ended December 31, 2018 and subsequent reports on Forms 10-Q and 8-K.

CONTACTS:
Investors: Ryan Koller, 708-551-2592
Media: Becca Hary, 708-551-2602

Ingredion Incorporated (“Ingredion”)
Condensed Consolidated Statements of Income
(Unaudited)
(in millions, except per share amounts) Three Months Ended September 30, Change % Nine Months Ended September 30, Change %
2019 2018 2019 2018
Net sales before shipping and handling costs $ 1,574 $ 1,563 1 % $ 4,660 $ 4,752 (2 %)
Less: shipping and handling costs 117 113 349 337
Net sales 1,457 1,450 0 % 4,311 4,415 (2 %)
Cost of sales 1,113 1,116 3,322 3,367
Gross profit 344 334 3 % 989 1,048 (6 %)
Operating expenses 153 148 3 % 457 465 (2 %)
Other income, net (2 ) (3 ) (3 ) (7 )
Restructuring/impairment charges 28 34 41 45
Operating income 165 155 6 % 494 545 (9 %)
Financing costs, net 24 24 62 65
Other, non-operating expense (income), net 1 (1 ) 1 (3 )
Income before income taxes 140 132 6 % 431 483 (11 %)
Provision for income taxes 38 34 120 126
Net income 102

[Message clipped]  View entire message

Sanofi Q3 well on track

Paris, October 31, 2019

Sanofi Q3 well on track

  Q3 2019 Change Change
at CER
9M 2019 Change Change
at CER
IFRS net sales reported €9,499m +1.1% -1.1% €26,518m +4.1% +2.2%
IFRS net income reported €1,766m -22.3% €2,816m -30.5%(2)
IFRS EPS reported €1.49 -18.6% €2.33 -28.3%(2)
Business net income(1) €2,399m +4.3% +0.2% €5,805m +6.4% +4.1%
Business EPS(1) €1.92 +4.3% 0.0% €4.65 +6.4% +4.1%
Third-quarter 2019 sales performance(3) led by Sanofi Genzyme and Emerging Markets

  • Net sales were €9,499 million, up 1.1% on a reported basis, down 1.1%(3) at CER and up 0.5% at CER/CS(4).
  • Sanofi Genzyme sales increased 19.5% driven by continued strong uptake of Dupixent®.
  • Vaccines sales decreased 9.8% reflecting anticipated weighting of U.S. flu vaccines supply towards fourth quarter.
  • CHC sales up 0.4%, impacted by Zantac® voluntary recall, non-core divestments and increased regulatory requirements.
  • Primary Care sales declined 12.7% at CER/CS due to lower sales in Diabetes and Established Products.
  • Emerging Markets(5) sales grew 9.7% due to strong performance in most regions.

Full-year business EPS guidance confirmed

  • Q3 2019 business net income increased 4.3% to €2,399 million and 0.2% at CER.
  • Q3 2019 business EPS(1) was stable at CER at €1.92.
  • Q3 2019 IFRS EPS was €1.49, down 18.6% reflecting the capital gain on the European generics divestment in Q3 2018.
  • Sanofi expects 2019 business EPS(1) to grow approximately 5% at CER(6) barring unforeseen major adverse events. Applying the average October 2019 exchange rates, the currency impact on 2019 business EPS is estimated to be around +3%.

Key R&D and regulatory milestones achieved

  • Dupixent® approved by European Commission for severe chronic rhinosinusitis with nasal polyposis.
  • Dupixent® approved by European Commission for adolescents with moderate-to-severe atopic dermatitis.
  • Dupixent® demonstrated positive topline phase 3 results in children aged 6 to 11 years with severe atopic dermatitis.
  • MenQuadfiTM, a meningococcal vaccine candidate, submitted in EU.
  • Flublok®, a quadrivalent influenza vaccine, submitted in EU.
Sanofi Chief Executive Officer, Paul Hudson, commented:

“Since joining Sanofi only two months ago, I am increasingly excited about the strength of our businesses, our ability to develop transformative medicines and the diverse talent of our teams across the organization. Building on this foundation, Sanofi delivered a resilient underlying performance in the third quarter with strong sales in Specialty Care, largely driven by the continued outstanding performance of Dupixent®. I am encouraged by the organization’s early achievements in our efficiency initiatives, which will allow us to further drive innovation in our business. I’m looking forward to discussing Sanofi‘s strategic priorities at our Capital Markets Day in Cambridge, MA on December 10”.

(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 8 for definitions). The consolidated income statement for Q3 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) including in Q2 2019 a €1.8 billion impairment charge mainly related to Eloctate®; (3) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8); (4) Constant Structure: Adjusted for divestment of European generics business and sales of Bioverativ products to SOBI; (5) See definition page 9; (6) 2018 business EPS was €5.47.

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  Mobile app: SANOFI IR available on the App Store and Google Play

2019 third-quarter and first nine months Sanofi sales

Unless otherwise indicated, all percentage changes in sales in this press release are stated at CER(7).

In the third quarter of 2019, Company sales were €9,499 million, up 1.1% on a reported basis. Exchange rate movements had a positive effect of 2.2 percentage points mainly driven by the strength of the U.S. dollar which was partially offset by the negative impact from the Argentine Peso. At CER, Company sales decreased 1.1%.

First nine months Company sales reached €26,518 million, up 4.1% on a reported basis. Exchange rate movements had a favorable effect of 1.9 percentage points. At CER, Company sales were up 2.2%.

Global Business Units

The table below presents sales by Global Business Unit (GBU). Please note that Emerging Markets sales for Specialty Care and Primary Care are included in the China & Emerging Markets GBU.

Net Sales by GBU
(€ million)
Q3 2019 Change
at CER
9M 2019 Change
at CER
Sanofi Genzyme (Specialty Care)(a)   2,359   +19.5% 6,670 +23.5%(c)
Primary Care(a) 2,185   -17.5%(d) 6,751 -16.7%(e)
China & Emerging Markets(b) 1,890   +10.0% 5,739 +9.1%
Total Pharmaceuticals   6,434   +1.5% 19,160 +2.1%
Consumer Healthcare (CHC)   1,136   +0.4% 3,535 +0.7%
Sanofi Pasteur (Vaccines)   1,929   -9.8% 3,823 +3.9%
Total net sales   9,499   -1.1% 26,518 +2.2%(f)

(a) Does not include China & Emerging Markets sales – see definition page 10; (b) Includes Emerging Markets sales for Primary Care and Specialty Care; (c) +19.2% at CS -Adjusted for Bioverativ acquisition and sales of Bioverativ products to SOBI – see page 5; (d) -12.7% at CS; (e) -11.6% at CS; (f) +3.2% at CS – Adjusted for Bioverativ and sales of Bioverativ products to SOBI and European Generics.

Global Franchises

The tables below present third-quarter and first nine months 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)
Q3 2019 Change
at CER
Developed
Markets
Change
at CER
Emerging
Markets
Change
at CER
Specialty Care franchises 2,654 +19.8% 2,359 +19.5% 295 +21.9%
Rare Disease 774 +6.5% 637 +2.8% 137 +24.2%
Multiple Sclerosis 551 +2.1% 534 +2.2% 17 0.0%
Oncology 424 +9.2% 297 +7.4% 127 +13.5%
Immunology 619 +140.1% 610 +138.8% 9 ns
Rare Blood Disorder 286 -3.9%(1) 281 -5.7%(2) 5 ns
Primary Care franchises 3,780 -8.3%(3) 2,185 -17.5%(4) 1,595 +7.9%
Established Rx Products(5) 2,371 -7.3%(6) 1,207 -17.9%(7) 1,164 +6.9%
Diabetes 1,261 -9.9% 837 -17.7% 424 +10.1%
Cardiovascular 148 -10.6% 141 -12.2% 7 +40.0%
Consumer Healthcare 1,136 +0.4%  722 -3.3% 414 +7.3%
Vaccines 1,929 -9.8% 1,448 -15.2% 481 +10.7%
Total net sales 9,499 -1.1%(8) 6,714 -5.1%(9) 2,785 +9.7%

(1) +1.1% at CS- see page 5; (2) -0.7% at CS- see page 5; (3) -5.0% at CS; (4 )-12.7% at CS; (5) including Generics; (6) -1.8% at CS; (7) -8.9% at CS; (8) +0.5% at CS;
(9) -2.9% at CS

(7) See Appendix 8 for definitions of financial indicators.

Net sales by Franchise
(€ million)
9M 2019 Change
at CER
Developed
Markets
Change
at CER
Emerging
Markets
Change
at CER
Specialty Care franchises 7,601 +24.2%(1) 6,670 +23.5% 931 +28.5%
Rare Disease 2,350 +8.3% 1,890 +3.2% 460 +31.1%
Multiple Sclerosis 1,620 +3.5% 1,563 +3.2% 57 +12.5%
Oncology 1,254 +10.4% 872 +6.7% 382 +19.5%
Immunology 1,526 +158.9% 1,507 +157.1% 19 ns
Rare Blood Disorder 851 +33.0%(2) 838 +30.8%(3) 13 ns
Primary Care franchises 11,559 -8.4%(4) 6,751 -16.7%(5) 4,808 +5.8%
Established Rx Products(6) 7,283 -8.9%(7) 3,789 -18.3%(8) 3,494 +3.7%
Diabetes 3,845 -7.9% 2,551 -15.6% 1,294 +11.2%
Cardiovascular 431 -4.6% 411 -6.6% 20 +66.7%
Consumer Healthcare 3,535 +0.7% 2,308 -1.7% 1,227 +5.2%
Vaccines 3,823 +3.9% 2,550 -5.6% 1,273 +28.7%
Total net sales 26,518 +2.2%(9) 18,279 -1.6%(10) 8,239 +11.1%

(1) +20.4 % at CS- Adjusted for Bioverativ and sales of products to SOBI – see page 5; (2) +1.5% at CS- see page 5; (3) -0.1% at CS -see page 5; (4) -5.0% at CS;
(5) -11.6% at CS; (6) including Generics; (7) -3.4% at CS; (8) -9.2% at CS; (9) +3.2% at CS- Adjusted for Bioverativ and sales of Bioverativ products to SOBI and European Generics;(10) -0.1% at CS –
Adjusted for Bioverativ and sales of Bioverativ products to SOBI and European Generics

Pharmaceuticals

Third-quarter Pharmaceutical sales were up 1.5% (up 4.1% at CS) to €6,434 million mainly driven by Dupixent® which was partially offset by Diabetes and Established Rx Products including the disposal of the European generics business at the end of third-quarter 2018. First nine months sales for Pharmaceuticals increased 2.1% (up 3.6% at CS) to €19,160 million.

Specialty Care franchises

Immunology franchise

Net sales (€ million) Q3 2019 Change
at CER
9M 2019 Change
at CER
Dupixent® 570 +142.2% 1,395 +160.6%
Kevzara® 49 +118.2% 131 +142.3%
Total Immunology 619 +140.1% 1,526 +158.9%

Dupixent® (collaboration with Regeneron) generated sales of €570 million in the third quarter (up 142%). In the U.S., Dupixent® sales of €455 million (up 130%) were driven by continued growth in atopic dermatitis which benefited from launch in the adolescent age group (12 to 17 years of age) in mid-March, rapid uptake in asthma and launch in chronic rhinosinusitis with nasal polyposis (approved in the U.S. in June). Dupixent® U.S. NBRx and TRx were respectively up 15% and 21% sequentially. In Europe, third-quarter sales were €54 million (up 170%). In Rest of the World region, Dupixent® sales were €52 million (up 243%) mainly generated in Japan. Dupixent® is now launched in 30 countries, 7 of which have multiple indications launched. First nine months Dupixent® sales increased 161% to €1,395 million. Long term 76 week data was recently published in the Journal of the American Academy of Dermatology with a safety profile that was consistent with previous clinical trials and sustained efficacy. This data is supportive of continuous long term use of Dupixent®.

Kevzara® (collaboration with Regeneron) sales were €49 million (up 118%) in the third quarter, of which €33 million was in the U.S. (up 78%) reflecting increased adoption and category share. First nine months Kevzara® sales increased 142% to €131 million.

Multiple Sclerosis franchise

Net sales (€ million) Q3 2019 Change
at CER
9M 2019 Change
at CER
Aubagio® 494 +12.4% 1,397 +11.7%
Lemtrada® 57 -42.4% 223 -28.4%
Total Multiple Sclerosis 551 +2.1% 1,620 +3.5%

Third-quarter Multiple Sclerosis (MS) sales increased 2.1% to €551 million, driven by double-digit growth of Aubagio® in the U.S. and Europe, partially offset by lower Lemtrada® sales. First nine months MS sales increased 3.5% to €1,620 million.

Third-quarter Aubagio® sales increased 12.4% to €494 million, supported by the U.S. performance (up 13.8% to €363 million) and Europe (up 10.8% to €103 million). First nine months Aubagio® sales increased 11.7% to €1,397 million.
Beginning January 1, 2020, Aubagio® will be excluded from the ESI National Preferred Formulary.

In the third quarter, Lemtrada® sales decreased 42.4% to €57 million due to lower U.S. sales (down 33.3% to €34 million) and European sales (down 60.5% to €15 million), reflecting increased global competition and the update to the EU label. First nine months Lemtrada® sales decreased 28.4% to €223 million.

On October 30, 2019, Sanofi entered into an agreement to settle, without any admission of liability or wrongdoing, the previously disclosed action initiated against Sanofi by the Trustee relating to Sanofi’s publicly-traded Contingent Value Rights. As part of the settlement agreement, Sanofi will pay a total of $315 million. The settlement agreement is subject to, among other things, final court approval

Oncology franchise

Net sales (€ million) Q3 2019 Change
at CER
9M 2019 Change
at CER
Jevtana® 119 +8.5% 356 +11.7%
Thymoglobulin® 90 +18.7% 265 +17.8%
Eloxatin® 52 +6.1% 161 +15.1%
Mozobil® 50 +14.3% 143 +11.3%
Taxotere® 42 -4.5% 131 +0.8%
Zaltrap® 26 +13.6% 71 +2.9%
Others 45 +4.8% 127 +1.7%
Total Oncology 424 +9.2% 1,254 +10.4%

Third-quarter Oncology sales increased 9.2% to €424 million driven by Emerging Markets (up 13.5% to €127 million) and the U.S. (up 9.7% to €152 million). First nine months Oncology sales increased 10.4% to €1,254 million.

Third-quarter Jevtana® sales increased 8.5% to €119 million driven by the U.S. and Japan. First nine months Jevtana® sales were up 11.7% to €356 million. In the third quarter, Thymoglobulin® sales increased 18.7% to €90 million, reflecting the performance in Emerging Markets. Over the period, Eloxatin® sales grew 6.1% to €52 million driven by China. First nine months sales of Thymoglobulin® and Eloxatin® increased 17.8% (to €265 million) and 15.1% (to €161 million), respectively.

Libtayo® (collaboration with Regeneron) was approved in the U.S. in September 2018 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. U.S. Libtayo® sales are reported by Regeneron. Libtayo® was approved in Brazil at the end of March and in Canada in April. In late June, Libtayo® was approved in the European Union for adult patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or curative radiation and launched in July in the UK, Germany, and Austria. Ex-U.S. Libtayo® sales were €4 million in the third quarter.

Rare Disease franchise

Net sales (€ million) Q3 2019 Change
at CER
9M 2019 Change
at CER
Myozyme® / Lumizyme® 226 +7.7% 680 +9.8%
Fabrazyme® 202 +3.7% 598 +6.4%
Cerezyme® 168 +6.7% 531 +6.1%
Aldurazyme® 49 0.0% 170 +12.5%
Cerdelga® 53 +26.8% 151 +27.8%
Others Rare Disease 76 +2.8% 220 +0.5%
Total Rare Disease 774 +6.5% 2,350 +8.3%

In the third quarter, Rare Disease sales increased 6.5% to €774 million, driven by Emerging Markets (up 24.2% to €137 million). In the U.S., third-quarter Rare Disease sales grew 4.8% to €298 million. In Europe, over the period, sales increased 4.1% to €253 million. First nine months Rare Disease sales increased 8.3% to €2,350 million.

Third-quarter Gaucher (Cerezyme® and Cerdelga®) sales were up 10.7% to €221 million, supported by the increasing penetration of Cerdelga® in Europe and the U.S. and the sustained growth of Cerezyme® in Emerging Markets. Third-quarter Cerdelga® sales increased 26.8% to €53 million, with sales up 53.8% in Europe (to €19 million) and up 12.0% in the U.S. (to €30 million). First nine months Gaucher sales were €682 million, up 10.1%.

Third-quarter Pompe (Myozyme®/Lumizyme®) sales grew 7.7% to €226 million, supported by positive trends in naïve patient accruals. This performance was driven by the U.S. (up 8.3% to €81 million) and Emerging Markets (up 18.8% to €34 million). First nine months Myozyme®/Lumizyme® sales increased 9.8% to €680 million.

Third-quarter Fabry (Fabrazyme®) sales grew 3.7% to €202 million, driven by Emerging Markets (up 33.3% to €22 million) and Europe (up 7.0% to €46 million). Over the period, U.S. sales were stable at €105 million. First nine months Fabrazyme® sales were up 6.4% to €598 million.

Rare Blood Disorder franchise

Net sales (€ million) Q3 2019 Change
at CER
9M 2019 Change
at CER
Eloctate® 162 -20.2%* 507 +15.8%*
Alprolix® 104 +12.5%** 304 +51.1%**
Cablivi® 20 40
Total Rare Blood Disorder 286 -3.9%*** 851 +33.0%***

*-17.6% at CS in Q3 2019 and -11.2% in 9M 2019 at CS – see footnotes 8 and 9; **+23.8% at CS in Q3 2019 and +13.9% at CS in 9M 2019 – see footnotes 8 and 9;
*** +1.1% at CS in Q3 2019 and +1.5% in 9M 2019 at CS – see footnotes 8 and 9

Bioverativ was consolidated in Sanofi’s Financial Statements from March 9, 2018. Third-quarter sales of the Rare Blood Disorder franchise were €286 million, up 1.1% at CS(8). Third-quarter U.S. sales were €214 million, down 5.6%. Non U.S. sales were €72 million with Japan as the primary contributor. First nine months sales of the Rare Blood Disorder franchise were €851 million, up 1.5% at CS(9).

Eloctate® sales were €162 million in the third quarter, down 17.6% at CS(8). In the U.S., sales of the product decreased 23.5% to €122 million, reflecting ongoing competitive pressure. In the Rest of the World region, third-quarter Eloctate® sales decreased 8.6% at CS(8) to €35 million. First nine months Eloctate® sales were €507 million, down 11.2% at CS(9).

Alprolix® sales were €104 million in the third quarter, up 23.8% at CS(8). In the U.S., sales of the product increased 17.5%  to €79 million. In the Rest of the World region, Alprolix® sales increased 47.1% at CS(8) to €25 million due to growth in product sales to SOBI and Japan. First nine months Alprolix® sales were €304 million, up 13.9% at CS(9).

Cablivi® for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) generated third-quarter sales of €20 million. In the U.S., where Cablivi® was launched in April, sales were €13 million. In Europe, where the product is commercially available in Germany, Denmark, Austria, Belgium and the Netherlands, sales were €6 million. Cablivi® has a temporary license to be sold in France. First nine months Cablivi® sales were €40 million.

Primary Care franchises

Cardiovascular franchise

Net sales (€ million) Q3 2019 Change
at CER
9M 2019 Change
at CER
Praluent® 61 -11.8% 183 -0.6%
Multaq® 87 -9.7% 248 -7.5%
Total cardiovascular franchise 148 -10.6% 431 -4.6%

Third-quarter Praluent® (collaboration with Regeneron) sales decreased 11.8% to €61 million, reflecting lower sales in the U.S. (down 31.7% to €29 million) which were impacted by significantly higher rebates. In Europe, Praluent® sales increased 4.5% to €22 million despite the suspension of sales in Germany in August following the Regional Court of Dusseldorf ruling in the ongoing patent litigation. First nine months Praluent® sales decreased 0.6% to €183 million. In August, the U.S. District Court for the District of Delaware ruled in favor of Sanofi and Regeneron in the ongoing Praluent® (alirocumab) patent litigation. The Court found as a matter of law that Amgen’s asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are invalid based on lack of enablement. U.S. payer coverage for Praluent® in 2020 is expected to be lower for insured lives across Medicare plans.

(8) 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.
(9) Growth comparing first nine months 2019 sales versus full first nine months 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) Q3 2019 Change
at CER
9M 2019 Change
at CER
Lantus® 751 -17.5% 2,283 -17.0%
Toujeo® 218 0.0% 649 +1.4%
Total glargine 969 -14.1% 2,932 -13.5%
Amaryl® 84 -8.0% 255 -2.7%
Apidra® 83 -2.4% 256 -4.1%
Admelog® 51 +84.6% 194 ns
Soliqua® 33 +55.0% 83 +71.7%
Insuman® 19 -4.8% 62 -5.9%
Total Diabetes 1,261 -9.9% 3,845 -7.9%

In the third quarter, global Diabetes sales decreased 9.9% to €1,261 million, due to lower glargine (Lantus® and Toujeo®) sales in the U.S. Third-quarter U.S. Diabetes sales were down 24.7% to €451 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. Third-quarter sales in Emerging Markets increased 10.1% to €424 million. Third-quarter sales in Europe decreased 3.0% to €295 million despite Toujeo® growth (up 18.3% to €84 million). First nine months global Diabetes sales decreased 7.9% to €3,845 million. Broad U.S. payer coverage for key Diabetes brands is expected to be largely maintained in 2020.

In the third quarter, Lantus® sales were €751 million, down 17.5%. In the U.S., Lantus® sales decreased 32.5% to €295 million, mainly reflecting lower average net price and the increased contribution to the coverage gap related to Medicare Part D. In Europe, third-quarter Lantus® sales were €140 million, down 13.0% due to biosimilar glargine competition and patients switching to Toujeo®. In Emerging Markets, third-quarter Lantus® sales were up 9.5% to €264 million. First nine months Lantus® sales decreased 17.0% to €2,283 million.

Third-quarter Toujeo® sales were stable at €218 million. In the U.S., third-quarter Toujeo® sales were €73 million, down 25.0% mainly reflecting lower average net price and the increased contribution to the coverage gap related to Medicare Part D. In Europe and Emerging Markets, third-quarter Toujeo® sales were €84 million (up 18.3%) and €43 million (up 26.5%), respectively. First nine months Toujeo® sales increased 1.4% to €649 million.

Third-quarter and first nine months Amaryl® sales were €84 million (down 8.0%) and €255 million (down 2.7%), respectively.

Third-quarter Apidra® sales decreased 2.4% to €83 million. Lower sales in the U.S. (down 35.3% to €11 million) offset growth in Emerging Markets (up 23.1% to €32 million). First nine months Apidra® sales were €256 million, down 4.1%.

Admelog® (insulin lispro injection) generated sales of €51 million (up 85%) in the third quarter. Admelog® sales in the U.S. were €47 million, up 80% versus the third quarter of 2018, but down 34% versus the second quarter of 2019 due to the WAC price adjustment of -44% which took effect on July 1. First nine months Admelog® sales were €194 million versus €36 million in the same period of 2018.

Third-quarter and first nine months Soliqua® 100/33 (insulin glargine 100 Units/mL & lixisenatide 33 mcg/mL injection) and Suliqua™ sales increased 55% (to €33 million) and 72% (to €83 million), respectively.

Established Rx Products

Net sales (€ million) Q3 2019 Change
at CER
9M 2019 Change
at CER
Lovenox® 334 -5.4% 1,024 -8.5%
Plavix® 356 -0.6% 1,122 -0.4%
Aprovel®/Avapro® 169 +5.7% 543 +7.2%
Synvisc® /Synvisc-One® 73 -2.8% 228 -6.5%
Renvela®/Renagel® 84 -28.9% 229 -29.8%
Myslee®/Ambien®/Stilnox® 56 -1.8% 163 -8.1%
Allegra® 18 -5.6% 100 -3.1%
Generics 268 -32.1% 804 -33.9%
Other 1,013 -1.2% 3,070 -3.3%
Total Established Rx Products 2,371 -7.3% 7,283 -8.9%

In the third quarter, Established Rx Products sales decreased 7.3% to €2,371 million, primarily reflecting the divestment of the European generics business Zentiva at the end of the third quarter of 2018. Excluding the generics divestment, Established Rx Products sales decreased 1.8% in the third quarter, reflecting generic competition to Renvela®/Renagel® (sevelamer) in the U.S. and lower Lovenox sales in Europe®. First nine months Established Rx Products sales decreased 8.9% to €7,283 million (down 3.4% at CS).

Third-quarter Lovenox® sales decreased 5.4% to €334 million, reflecting lower Mature Markets sales (down 16.2% to €191 million) due to biosimilar competition in several countries in Europe. In Emerging Markets, Lovenox® sales grew 14.6% to €143 million. First nine months Lovenox® sales were down 8.5% to €1,024 million.

In the third quarter, Plavix® sales decreased 0.6% to €356 million due to generic competition in Japan (sales down 23.1% to €32 million). In China, Plavix® sales increased 3.5% to €209 million despite the implementation of the volume based procurement program (VBP) in key cities in China at the beginning of the second quarter. First nine months Plavix® sales decreased 0.4% to €1,122 million.

Third-quarter Aprovel®/Avapro® sales increased 5.7% to €169 million driven by Emerging Markets sales (up 3.6% to €117 million). In China, Aprovel®/Avapro® sales were up 1.4% to €74 million despite the implementation of the VBP in key cities in China at the beginning of the second quarter. First nine months Aprovel®/Avapro® sales increased 7.2% to €543 million.

In September 2019, Plavix® and Co-Aprovel® were among the bidding winners of the nationwide VBP program. Sanofi expects the nationwide implementation of the VBP p

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