REG - AstraZeneca PLC - AZN: H1 2016 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 5
28/07/2016 07:07
- Part 5: For the preceding part double click ID:nRSb4551Fd
co-ordinated proceeding, and judgment was entered in May 2016. The plaintiffs have appealed both rulings.
As previously disclosed, a single case was pending in Alabama state court and is now resolved.
Crestor (rosuvastatin calcium)
AstraZeneca is defending a number of lawsuits alleging multiple types of injuries caused by the use of Crestor, including
diabetes mellitus, various cardiac injuries, rhabdomyolysis, and/or liver and kidney injuries. The claims of approximately
600 plaintiffs, comprising approximately 100 California residents and approximately 500 non-California residents, were
aggregated in one co-ordinated proceeding in Los Angeles, California. The claims of approximately 600 additional
non-California plaintiffs were also pending in California state court. In October 2014, the co-ordination judge dismissed
the claims of the non-California plaintiffs whose claims were in the co-ordinated proceeding. The plaintiffs appealed the
October 2014 order dismissing the non-California plaintiffs from the proceeding. In July 2016, the Court of Appeal in
California dismissed the plaintiffs' appeal, effectively dismissing the claims of all of the non-California residents from
California state court, leaving the option of re-filing in the plaintiffs' home states. The claims of approximately 80
plaintiffs remain pending in California state court.
Farxiga (dapagliflozin)
As previously disclosed, AstraZeneca has been named as one of multiple defendants in a lawsuit filed in the US District
Court for the Western District of Kentucky involving one plaintiff claiming physical injury, including diabetic
ketoacidosis and kidney failure, from treatment with Farxiga. Since then, cases with similar allegations have been filed in
three additional jurisdictions. Motions to dismiss are pending in the Western District of Kentucky and one other
jurisdiction.
Onglyza/Kombiglyze(saxagliptin)
AstraZeneca is defending various lawsuits filed in state and federal courts in the US involving multiple plaintiffs
claiming injury from the treatment with either Onglyza or Kombiglyze. In May 2016, a federal judge in California granted
AstraZeneca's motion for summary judgment and dismissed the claims of 14 of these plaintiffs who alleged injuries including
pancreatic cancer. The previously disclosed lawsuit, filed on behalf of approximately 50 plaintiffs alleging heart failure,
cardiac failure and/or death resulting from treatment with Onglyza/Kombiglyze remains pending.
Synagis (palivizumab)
AstraZeneca and MedImmune have been named as defendants in a lawsuit filed in the US District Court for the Middle District
of Louisiana involving two plaintiffs alleging wrongful death from treatment with Synagis. A motion to dismiss is pending.
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. The New
Jersey District Court has determined that the Delaware action should proceed first.
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 granted AstraZeneca's motion to dismiss the complaint with prejudice and judgment
in AstraZeneca's favour. The State of Louisiana has appealed this decision.
Pearl Therapeutics
AstraZeneca has been served with a complaint filed in Delaware State court by the former shareholders of Pearl
Therapeutics, Inc. (Pearl) that alleges, among other things, breaches of contractual obligations relating to a 2013 merger
agreement between AstraZeneca and Pearl.
Crestor Citizen's Petition
On 31 May 2016, AstraZeneca filed a Citizen's Petition with the FDA requesting that the Agency not approve any pending
generic ANDAs for rosuvastatin until the expiration of paediatric orphan exclusivity for Crestor. On 27 June 2016,
AstraZeneca filed its Complaint for Declaratory and Injunctive Relief and an Application for a Temporary Restraining Order
(TRO) with the US District Court for the District of Columbia requesting that the Court prohibit the FDA from granting
final approval to any pending ANDAs for generic versions of Crestor until the expiration of paediatric orphan exclusivity.
On 19 July 2016, the Court denied AstraZeneca's application for a TRO, but provided for FDA to produce to AstraZeneca a
copy of the administrative record.
8 product analysis - H1 2016
World US Europe Established ROW Emerging Markets
H1 2016$m CER% H1 2016$m CER H1 2016$m CER% H1 2016$m CER% H1 2016$m CER%
%
Respiratory & Autoimmunity:
Symbicort 1,552 (6) 681 (5) 466 (18) 196 - 209 25
Pulmicort 549 10 106 (2) 54 (18) 40 (2) 349 23
Tudorza/Eklira 87 4 41 (9) 41 17 4 n/m 1 n/m
Daliresp/Daxas 71 n/m 66 n/m 4 n/m - - 1 n/m
Duaklir 30 n/m - - 28 n/m 1 n/m 1 n/m
Others 144 13 7 (30) 51 13 17 55 69 12
Total Respiratory & Autoimmunity 2,433 1 901 (2) 644 (11) 258 2 630 23
Cardiovascular & Metabolic Diseases:
Onglyza 402 6 212 - 73 4 37 22 80 16
Brilinta 395 48 159 57 125 17 20 29 91 106
Farxiga 376 88 209 82 89 72 25 127 53 135
Bydureon 291 11 234 5 50 43 5 67 2 -
Byetta 138 (19) 89 (26) 25 (17) 10 - 14 45
Legacy:
Crestor 2,082 (15) 1,004 (27) 438 (4) 286 (2) 354 9
Seloken/Toprol-XL 374 7 53 10 44 (6) 5 (29) 272 9
Atacand 160 (11) 21 17 49 (6) 10 (29) 80 (16)
Others 242 (23) 16 (54) 64 (11) 25 (20) 137 (22)
Total Cardiovascular & Metabolic Diseases 4,460 (2) 1,997 (11) 957 4 423 2 1,083 9
Oncology:
Iressa 270 2 10 n/m 61 (8) 65 (6) 134 3
Tagrisso 143 n/m 103 n/m 25 n/m 15 n/m - -
Lynparza 98 n/m 62 n/m 32 n/m - - 4 n/m
Legacy:
Faslodex 401 23 211 28 113 13 30 16 47 36
Zoladex 382 (3) 19 36 80 (3) 130 (3) 153 (5)
Casodex 125 (9) 2 n/m 13 (13) 56 (20) 54 2
Arimidex 119 (2) 10 43 18 (28) 35 (18) 56 15
Others 48 (33) - - 3 (77) 32 3 13 (12)
Total Oncology 1,586 18 417 85 345 12 363 (3) 461 5
Infection & Neuroscience:
Nexium 1,025 (18) 294 (39) 127 (10) 237 (15) 367 1
Seroquel XR 427 (17) 306 (13) 76 (32) 10 (29) 35 (9)
Synagis 271 - 163 2 108 (2) - - - -
Losec/Prilosec 145 (17) 5 (58) 41 (16) 27 (32) 72 (5)
Movantik/Moventig 40 n/m 40 n/m - - - - - -
FluMist/Fluenz 11 (48) 11 (48) - - - - - -
Others 636 (11) 75 (29) 169 (6) 127 (3) 265 (11)
Total Infection & Neuroscience 2,555 (13) 894 (21) 521 (12) 401 (13) 739 (5)
Total Product Sales 11,034 (2) 4,209 (7) 2,467 (3) 1,445 (4) 2,913 7
9 product analysis - Q2 2016
World US Europe Established ROW Emerging Markets
Q2 2016$m CER% Q2 2016$m CER Q2 2016$m CER% Q2 2016$m CER% Q2 2016$m CER%
%
Respiratory & Autoimmunity:
Symbicort 803 (4) 359 (4) 235 (17) 105 2 104 33
Pulmicort 239 6 50 (11) 25 (17) 22 - 142 21
Tudorza/Eklira 48 (13) 24 (33) 20 18 3 50 1 n/m
Daliresp/Daxas 40 25 35 9 4 n/m - - 1 n/m
Duaklir 17 n/m - - 16 n/m 1 - - -
Others 79 34 3 40 32 33 14 n/m 30 25
Total Respiratory & Autoimmunity 1,226 1 471 (7) 332 (7) 145 8 278 26
Cardiovascular & Metabolic Diseases:
Onglyza 191 (7) 88 (22) 40 14 19 6 44 12
Brilinta 214 51 89 62 65 16 10 38 50 104
Farxiga 211 65 115 47 48 71 16 100 32 127
Bydureon 156 11 126 9 27 42 3 50 - (133)
Byetta 76 (6) 47 (11) 15 7 5 (17) 9 11
Legacy:
Crestor 926 (29) 368 (52) 226 (1) 161 1 171 5
Seloken/Toprol-XL 189 8 32 52 22 (4) 3 (25) 132 4
Atacand 89 (5) 12 71 25 9 6 (14) 46 (18)
Others 116 (25) 11 (27) 34 - 16 - 55 (38)
Total Cardiovascular & Metabolic Disease 2,168 (11) 888 (27) 502 9 239 5 539 3
Oncology:
Iressa 135 5 6 n/m 27 (19) 35 (6) 67 15
Tagrisso 92 n/m 58 n/m 19 n/m 15 n/m - -
Lynparza 54 n/m 34 89 18 n/m - - 2 n/m
Legacy:
Faslodex 211 23 112 37 57 8 16 15 26 15
Zoladex 204 (4) 9 13 41 2 68 (6) 86 (7)
Casodex 63 (10) 2 100 6 (14) 30 (18) 25 (4)
Arimidex 62 (2) 6 50 10 (17) 19 (19) 27 11
Others 27 (30) - n/m 1 (60) 19 6 7 (22)
Total Oncology 848 20 227 89 179 16 202 1 240 4
Infection & Neuroscience:
Nexium 562 (13) 163 (36) 67 (3) 142 (8) 190 13
Seroquel XR 225 (14) 162 (12) 41 (20) 5 (29) 17 (13)
Synagis 27 (59) 3 n/m 24 (66) - - - -
Losec/Prilosec 70 (16) 3 (40) 20 (17) 14 (32) 33 (5)
Movantik/Moventig 23 n/m 23 n/m - - - - - -
FluMist/Fluenz 6 (57) 6 (57) - - - - - -
Others 314 (12) 17 (71) 84 (13) 62 (13) 151 12
Total Infection & Neuroscience 1,227 (14) 377 (27) 236 (24) 223 (12) 391 9
Total Product Sales 5,469 (5) 1,963 (17) 1,249 (2) 809 (1) 1,448 9
Shareholder Information
Announcements
Announcement of nine months and third quarter 2016 results 10 November 2016
Announcement of full year and fourth quarter 2016 results 2 February 2017
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 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 Office1 Francis Crick AvenueCambridge Biomedical Campus, CambridgeCB2 0AAUK 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 3749 5000 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
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