REG - AstraZeneca PLC - AZN: 1st Quarter Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 4
29/04/2016 07:06
- Part 4: For the preceding part double click ID:nRSc7470Wc
in state and federal courts in the US involving multiple plaintiffs
claiming physical injury from treatment with Onglyza. The lawsuits allege injuries including pancreatic cancer. AstraZeneca
has been served with lawsuits filed in California state court on behalf of approximately 35 plaintiffs alleging heart
failure, congestive heart failure, cardiac failure and/or death resulting from treatment with Onglyza/Kombiglyze.
Commercial litigation
Nexium/Prilosec trademark litigation
As previously disclosed, AstraZeneca filed separate complaints in the US District Court for the District of Delaware
against Camber Pharmaceuticals, Inc. (Camber) and Dr. Reddy's Laboratories, Inc. (Dr. Reddy's) to enforce certain
AstraZeneca trademark rights related to Nexium and Prilosec. The Delaware District Court issued preliminary injunctions
against Camber's and Dr. Reddy's sales of generic esomeprazole magnesium in purple capsules. The Camber action has been
settled through negotiation and as part of the settlement, the Delaware District Court entered a Consented Judgment of
Permanent Injunction and Other Relief on 31 March 2016 in favour of AstraZeneca. Dr. Reddy's filed its own separate claims
against AstraZeneca in both the Delaware District Court and the US District Court for the District of New Jersey. Dr.
Reddy's also appealed the preliminary injunction decision of the Delaware District Court to the US Court of Appeals for the
Third Circuit and in April 2016, voluntarily withdrew its appeal. All District Court cases involving Dr. Reddy's related to
this matter had been stayed pending the appeal, and have now resumed.
Nexium Consumer litigation
As previously disclosed, in July 2015, the Delaware Superior Court granted AstraZeneca's motion to dismiss and entered
judgment in a putative class action alleging that AstraZeneca's promotion, advertising and pricing of Nexium to physicians,
consumers and third party payers was unfair, unlawful and deceptive. In April 2016, the Delaware Supreme Court affirmed the
dismissal.
Toprol-XL (metoprolol succinate)
As previously disclosed, in March 2015, AstraZeneca was served with a state court complaint filed by the Attorney General
for the State of Louisiana alleging that, in connection with enforcement of its patents for Toprol-XL, it had engaged in
unlawful monopolisation and unfair trade practices, causing the state government to pay increased prices for Toprol-XL. In
February 2016, the Louisiana state court heard oral argument on AstraZeneca's motion to dismiss and ordered the dismissal
of the complaint with prejudice and judgment in AstraZeneca's favour.
7 product analysis - Q1 2016
World US Europe Established ROW Emerging Markets
Q1 2016$m CER% Q1 2016$m CER Q1 2016$m CER% Q1 2016$m CER% Q1 2016$m CER%
%
Respiratory, Inflammation & Autoimmunity:
Symbicort 749 (7) 322 (6) 231 (19) 91 (2) 105 18
Pulmicort 310 14 56 8 29 (19) 18 (5) 207 24
Tudorza/Eklira 39 33 17 89 21 17 1 (50) - -
Daliresp 31 n/m 31 n/m - - - - - -
Duaklir 13 n/m - - 12 n/m - - 1 n/m
Others 65 (4) 4 (20) 19 (10) 3 (40) 39 5
Total Respiratory, Inflammation & Autoimmunity 1,207 2 430 4 312 (14) 113 (5) 352 20
Cardiovascular & Metabolic disease:
Brilinta/Brilique 181 46 70 52 60 19 10 22 41 109
Onglyza 211 20 124 27 33 (6) 18 43 36 20
Farxiga/Forxiga 165 128 94 154 41 72 9 200 21 145
Bydureon 135 11 108 2 23 44 2 100 2 100
Byetta 62 (30) 42 (38) 10 (38) 5 25 5 200
Legacy:
Crestor 1,156 2 636 4 212 (7) 125 (5) 183 12
Seloken/Toprol-XL 185 5 21 (22) 22 (8) 2 (33) 140 14
Atacand 71 (17) 9 (18) 24 (17) 4 (43) 34 (13)
Others 126 (21) 5 (75) 30 (21) 9 (40) 82 (7)
Total Cardiovascular & Metabolic Disease 2,292 7 1,109 8 455 (1) 184 (1) 544 16
Oncology:
Iressa 135 (1) 4 n/m 34 3 30 (6) 67 (6)
Tagrisso 51 n/m 45 n/m 6 n/m - - - -
Lynparza 44 n/m 28 n/m 14 n/m - - 2 n/m
Legacy:
Faslodex 190 24 99 19 56 18 14 17 21 69
Zoladex 178 (1) 10 67 39 (9) 62 - 67 (3)
Casodex 62 (9) - - 7 (13) 26 (22) 29 7
Arimidex 57 (3) 4 33 8 (38) 16 (16) 29 19
Others 21 (37) - n/m 2 (88) 13 - 6 -
Total Oncology 738 15 190 79 166 8 161 (6) 221 5
Infection, Neuroscience & Gastrointestinal:
Nexium 463 (24) 131 (42) 60 (16) 95 (23) 177 (9)
Synagis 244 20 160 (1) 84 102 - - - -
Seroquel XR 202 (21) 144 (15) 35 (41) 5 (29) 18 (4)
Losec/Prilosec 75 (18) 2 (71) 21 (15) 13 (32) 39 (5)
Movantik/Moventig 17 n/m 17 n/m - - - - - -
FluMist/Fluenz 5 (29) 5 (29) - - - - - -
Others 322 (9) 58 21 85 1 65 9 114 (32)
Total Infection, Neuroscience & Gastrointestinal 1,328 (13) 517 (17) 285 1 178 (14) 348 (17)
TOTAL PRODUCT SALES 5,565 1 2,246 4 1,218 (4) 636 (7) 1,465 6
Shareholder Information
Announcements and Meetings
Announcement of half year and second quarter 2016 results 28 July 2016
Announcement of nine months and third quarter 2016 results 10 November 2016
Dividends
Future dividends will normally be paid as follows:
First interim Announced with half year and second quarter results and paid in September
Second interim Announced with full year and fourth quarter results and paid in March
The record date for the first interim dividend for 2016, payable on 12 September 2016, will be 12 August 2016. Ordinary
Shares listed in London and Stockholm will trade ex-dividend from 11 August 2016. American Depositary Shares listed in New
York will trade ex-dividend from 10 August 2016.
Trademarks
Trademarks of the AstraZeneca group of companies and of companies other than AstraZeneca appear throughout this document in
italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of
companies. Trademarks of companies other than AstraZeneca that appear in this document include Daliresp, a trademark of
Takeda GmbH; Duaklir Genuair, Duaklir, Eklira, and Tudorza, trademarks of Almirall, S.A.; Epanova, a trademark of Chrysalis
Pharma AG; and Zinforo, a trademark of Forest Laboratories.
Addresses for Correspondence
Registrar andTransfer OfficeEquiniti LimitedAspect HouseSpencer RoadLancingWest SussexBN99 6DAUK US DepositaryCitibank Shareholder ServicesPO Box 43077ProvidenceRI 02940-3077USA Registered Office2 Kingdom StreetLondonW2 6BDUK Swedish Central Securities DepositoryEuroclear Sweden ABPO Box 191SE-101 23 StockholmSweden
Tel (freephone in UK): 0800 389 1580 Tel (outside UK): Tel: (toll free in the US) +1 (888) 697 8018 Tel: (outside the US) +1 (781) 575 4555 citibank@shareholders-online.com Tel: +44 (0)20 7604 8000 Tel: +46 (0)8 402 9000
+44 (0)121 415 7033
Cautionary Statements Regarding Forward-Looking Statements
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act
1995, we are providing the following cautionary statement: This document contains certain forward-looking statements with
respect to the operations, performance and financial condition of the Group, including, among other things, statements
about expected revenues, margins, earnings per share or other financial or other measures. Although we believe our
expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from
those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of
this document and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the
forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in
such statements. Important factors that could cause actual results to differ materially from those contained in
forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration
of, or limitations to, patents, marketing exclusivity or trademarks, or the risk of failure to obtain and enforce patent
protection; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage;
effects of patent litigation in respect of IP rights; exchange rate fluctuations; the risk that R&D will not yield new
products that achieve commercial success; the risk that strategic alliances and acquisitions, including licensing and
collaborations, will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the
risk of substantial product liability claims; the impact of any delays in the manufacturing, distribution and sale of any
of our products; the impact of any failure by third parties to supply materials or services; the risk of failure of
outsourcing; the risks associated with manufacturing biologics; the risk of delay to new product launches; the difficulties
of obtaining and maintaining regulatory approvals for products; the risk of failure to adhere to applicable laws, rules and
regulations; the risk of failure to adhere to applicable laws, rules and regulations relating to anti-competitive
behaviour; the risk that new products do not perform as we expect; failure to achieve strategic priorities or to meet
targets or expectations; the risk of an adverse impact of a sustained economic downturn; political and socio-economic
conditions; the risk of environmental liabilities; the risk of occupational health and safety liabilities; the risk
associated with pensions liabilities; the risk of misuse of social medial platforms and new technology; the risks
associated with developing our business in emerging markets; the risk of illegal trade in our products; the risks from
pressures resulting from generic competition; the risk of failure to successfully implement planned cost reduction measures
through productivity initiatives and restructuring programmes; economic, regulatory and political pressures to limit or
reduce the cost of our products; the risk that regulatory approval processes for biosimilars could have an adverse effect
on future commercial prospects; the impact of failing to attract and retain key personnel and to successfully engage with
our employees; the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption
legislation; and the risk of failure of information technology and cybercrime. Nothing in this
document/presentation/webcast should be construed as a profit forecast.
This information is provided by RNS
The company news service from the London Stock ExchangeRecent news on AstraZeneca
See all newsRCS - LHH - LHH, EZRA's AI Leadership Transformation Program
AnnouncementREG - AstraZeneca PLC - Baxdrostat met primary endpoint in Bax24 Ph3 trial
AnnouncementREG - AstraZeneca PLC - Datroway improved OS and PFS in TROPION-Breast02
AnnouncementREG - AstraZeneca PLC - Total Voting Rights
AnnouncementREG - AstraZeneca PLC - Enhertu improved IDFS in early BC in DB-05
Announcement