REG - AstraZeneca PLC - AstraZeneca Full-Year and Q4 2015 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 4
04/02/2016 07:10
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without qualifying their report, and (iii) did not contain a statement
under section 498(2) or (3) of the Companies Act 2006. The quarterly information for the three month period to 31 December
2015 and to 31 December 2014 has not been subject to audit.
2 restructuring costs
Profit before tax for the year ended 31 December 2015 is stated after charging restructuring costs of $1,034m ($372m for
the fourth quarter of 2015). These have been charged to profit as follows:
FY 2015 FY 2014 Q4 2015 Q4 2014
$m $m $m $m
Cost of sales 158 107 34 35
Research and development expense 258 497 78 97
Selling, general and administrative costs 618 662 260 259
Other operating income and expense - 292 - -
Total 1,034 1,558 372 391
3 Net DEBT
The table below provides an analysis of net debt and a reconciliation of net cash flow to the movement in net debt.
At 1 Jan 2015 $m Cash Flow $m Non-cash& Other$m Exchange Movements$m At 31 Dec 2015 $m
Loans due after one year (8,337) (5,928) 40 116 (14,109)
Finance leases due after one year (60) - 31 1 (28)
Total long-term debt (8,397) (5,928) 71 117 (14,137)
Current instalments of loans (912) 884 - 28 -
Current instalments of finance leases (48) 42 (63) 2 (67)
Total current debt (960) 926 (63) 30 (67)
Other investments - current 795 (244) 103 (41) 613
Net derivative financial instruments 465 12 (39) - 438
Cash and cash equivalents 6,360 (39) - (81) 6,240
Overdrafts (196) 2 - 5 (189)
Short-term borrowings (1,290) 630 - - (660)
6,134 361 64 (117) 6,442
Net debt (3,223) (4,641) 72 30 (7,762)
Non-cash movements in the period include fair value adjustments under IAS 39.
4 ACQUISITION OF ZS Pharma
On 17 December 2015, AstraZeneca completed the acquisition of ZS Pharma, a biopharmaceutical company based in San Mateo,
California. ZS Pharma uses its proprietary ion-trap technology to develop novel treatments for hyperkalaemia, a serious
condition of elevated potassium in the bloodstream, typically associated with CKD and CHF.
The acquisition gives AstraZeneca access to the potassium-binding compound ZS-9, a potential best-in-class treatment for
hyperkalaemia, which is under regulatory review by the US Food and Drug Administration with a Prescription Drug User Fee
Act goal date of 26 May 2016. A submission for European Marketing Application Authorisation was made late in 2015.
ZS Pharma represents a strong fit with AstraZeneca's pipeline and portfolio in Cardiovascular and Metabolic Disease, one of
the Company's three main therapy areas. AstraZeneca's strategy focuses on reducing morbidity, mortality and organ damage by
addressing multiple risk factors across cardiovascular disease, diabetes and chronic kidney disease. ZS-9 complements the
Company's increasing focus on CKD and CHF, including the investigational medicine roxadustat, which is currently in Phase
III development for patients with anaemia associated with CKD, as well as its leading diabetes portfolio.
Under the terms of the agreement, AstraZeneca has acquired 100% of the share capital of ZS Pharma for $90 per share in an
all-cash transaction, or approximately $2.7bn in aggregate transaction value.
ZS Pharma has around 200 employees across three sites in California, Texas and Colorado. The combination of intangible
product rights with an established workforce and their associated operating processes, principally those related to
research and development and manufacturing, requires that the transaction is accounted for as a business combination in
accordance with IFRS 3.
Goodwill is principally attributable to the commercial synergies AstraZeneca expects to be able to realise upon launch of
ZS-9, the value of the specialist know-how inherent in the acquired workforce and the accounting for deferred taxes.
Goodwill of nil is expected to be deductible for tax purposes.
ZS Pharma's results have been consolidated into the Company's results from 17 December 2015. From the period from
acquisition to 31 December 2015, ZS Pharma's revenue and loss were immaterial.
Given the proximity of the completion of the transaction to the date the Financial Statements were approved, the
finalisation of the accounting entries for this transaction has yet to be completed. Our provisional assessment of the fair
values of the assets and liabilities acquired is detailed below. Our assessment will be completed in 2016.
Fair value$m
Non-current assets
Intangible assets 3,162
Property, plant and equipment 21
3,183
Current assets 169
Current liabilities (50)
Non-current liabilities
Deferred tax liabilities (1,045)
Other liabilities (13)
(1,058)
Total net assets acquired 2,244
Goodwill 456
Total upfront consideration 2,700
Less: cash and cash equivalents acquired (73)
Less: deferred upfront consideration (181)
Net cash outflow 2,446
5 Agreement with ACERTA PHARMA
On 2 February 2016, AstraZeneca completed an agreement to invest in a majority equity stake in Acerta Pharma, a
privately-owned biopharmaceutical company based in the Netherlands and US. The transaction provides AstraZeneca with a
potential best-in-class irreversible oral Bruton's tyrosine kinase (BTK) inhibitor, acalabrutinib (ACP-196), currently in
Phase II/III development for B-cell blood cancers and in Phase I/II clinical trials in multiple solid tumours.
Under the terms of the agreement, AstraZeneca has acquired 55% of the issued share capital of Acerta for an upfront payment
of $2.5bn. A further payment of $1.5bn will be paid either on receipt of the first regulatory approval for acalabrutinib in
the US, or the end of 2018, depending on whichever is sooner. The agreement also includes options which, if exercised,
provide the opportunity for Acerta shareholders to sell, and AstraZeneca to buy, the remaining 45% of shares in Acerta. The
options can be exercised at various points in time, conditional on the first approval of acalabrutinib in both the US and
Europe and when the extent of the commercial opportunity has been fully established, at a price of approximately $3bn net
of certain costs and payments incurred by AstraZeneca and net of agreed future adjusting items, using a pre-agreed pricing
mechanism. Acerta has approximately 150 employees.
AstraZeneca's 55% holding is a controlling interest and Acerta's combination of intangible product rights with an
established workforce and their operating processes requires that the transaction is accounted for as a business
combination in accordance with IFRS 3. Acerta's results and net assets will be consolidated into the Company's results from
2 February 2016.
Given the close proximity of the completion of the transaction to the date the Financial Statements were approved, the
accounting entries for this transaction have not yet been determined. Our provisional assessment of the fair values of the
assets and liabilities acquired will be completed in 2016.
6 FINANCIAL INSTRUMENTS
As detailed in the Group's most recent annual financial statements, our principal financial instruments consist of
derivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, trade and
other payables, and interest-bearing loans and borrowings. As indicated in Note 1, there have been no changes to the
accounting policies for financial instruments, including fair value measurement, from those disclosed on pages 140 and 141
of the Company's Annual Report and Form 20-F Information 2014. In addition, there have been no changes of significance to
the categorisation or fair value hierarchy of our financial instruments. Financial instruments measured at fair value
include $1,071m of other investments, $1,753m of loans, and $438m of derivatives as at 31 December 2015. The total fair
value of interest-bearing loans and borrowings at 31 December 2015, which have a carrying value of $15,053m in the
Condensed Consolidated Statement of Financial Position, was $16,277m. Contingent consideration liabilities arising on
business combinations have been classified under Level 3 in the fair value hierarchy and movements in fair value are shown
below:
DiabetesAlliance2015 Other 2015 Total 2015 Total 2014
$m $m $m $m
At 1 January 5,386 1,513 6,899 514
Additions through business combinations - - - 6,138
Settlements (325) (254) (579) (657)
Revaluations (378) (54) (432) 512
Discount unwind 409 115 524 391
Foreign exchange - (1) (1) 1
At 31 December 5,092 1,319 6,411 6,899
7 legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and
investigations relating to product liability, commercial disputes, infringement of intellectual property rights, the
validity of certain patents, anti-trust law and sales and marketing practices. The matters discussed below constitute the
more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual
Report and Form 20-F Information 2014, the Company's Half-Yearly Financial Report for the six-month period to 30 June 2015,
and the Third Quarter and Nine-Month Results 2015 (the Disclosures). Unless noted otherwise below or in the Disclosures, no
provisions have been established in respect of the claims discussed below.
As discussed in the Disclosures, for the majority of claims in which AstraZeneca is involved it is not possible to make a
reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings.
In these cases, AstraZeneca discloses information with respect only to the nature and facts of the cases but no provision
is made.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are
not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, we record the
loss absorbed or make a provision for our best estimate of the expected loss.
The position could change over time and the estimates that we have made and upon which we have relied in calculating these
provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of
any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors
causing this uncertainty are described more fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property.
Matters disclosed in respect of the fourth quarter of 2015 to 4 February 2016.
Patent litigation
Byetta (exenatide)
Patent proceedings in the US
In November 2015, Sanofi-Aventis U.S. LLC and Sanofi-Aventis Deutschland GmbH (together, Sanofi) served AstraZeneca with a
complaint for declaratory judgment that Sanofi's proposed lixisenatide product would not infringe three AstraZeneca
patents. Sanofi also alleges invalidity of the patents. In December 2015, AstraZeneca filed an answer including
counterclaims that Sanofi's proposed lixisenatide product would infringe several AstraZeneca patents. Certain
patents-at-issue are listed in the FDA Orange Book with reference to Byetta. Proceedings are in early stages in the US
District Court for the District of Delaware. No trial date has been set.
Separately, in December 2015, Sanofi filed petitions in the US Patent Trial and Appeals Board for inter partes review of
certain patents that are also at issue in the above-referenced District Court litigation. Proceedings are in early stages.
In December 2015, AstraZeneca commenced patent litigation in response to a Paragraph IV notice from Amneal Pharmaceuticals
LLC (Amneal) in the US District Court for the District of Delaware. The Amneal proceedings are at an early stage and no
trial date has been set.
Crestor (rosuvastatin)
Patent proceedings in the US
As previously disclosed, AstraZeneca has been defending three patent infringement lawsuits in the US District Court for the
District of South Carolina which, among other things, claim that AstraZeneca's Crestor sales induce infringement of the
plaintiffs' patents. In December 2015, the court issued an order dismissing the first of these cases, which was filed by
Palmetto Pharmaceuticals, LLC (Palmetto), and entered judgment in AstraZeneca's favour. In January 2015, Palmetto filed a
notice of appeal.
Patent proceedings outside the US
As previously disclosed, in the UK, in October 2015, Resolution Chemicals Ltd. commenced an action alleging partial
invalidity and non-infringement of the supplementary protection certificate related to the Crestor substance patent.
AstraZeneca has responded.
As previously disclosed, in Australia, AstraZeneca was unsuccessful in defending the validity of Crestor-related patents,
at trial and on appeal. This patent litigation concluded in September 2015 when the High Court of Australia dismissed an
appeal filed by AstraZeneca. Relevant parties could pursue damages claims against AstraZeneca. A provision has been taken
in respect of generic entities which were prevented by court order from launching their products in Australia before
AstraZeneca's patents were subsequently found invalid.
Faslodex (fulvestrant)
Patent proceedings in the US
As previously disclosed, AstraZeneca is engaged in patent litigation against several companies that are seeking to market
generic versions of Faslodex prior to the expiry of AstraZeneca's relevant FDA Orange Book listed patents. In November 2015
and February 2016, AstraZeneca filed patent infringement lawsuits against two additional companies that sent Paragraph IV
notices relating to Faslodex to AstraZeneca.
Patent proceedings outside the US
As previously disclosed, in Brazil, in February 2013, Eurofarma Laboratorios S.A. (Eurofarma) filed a nullity action
against a formulation patent for Faslodex in the 31st Specialized Intellectual Property Federal Court of Rio de Janeiro
(the Court). In October 2015, the Court ruled in Eurofarma's favour and invalidated AstraZeneca's patent. In November 2015,
AstraZeneca appealed the decision.
As previously disclosed, in Germany, in July 2015, AstraZeneca was served with a nullity complaint by Hexal AG (Hexal),
commencing invalidity proceedings before the Federal Patent Court, and requesting revocation of the German part of a
Faslodex formulation use patent, European Patent No. 1,250,138. In September 2015, AstraZeneca filed a request for a
provisional injunction against Hexal in the Regional Court of Düsseldorf after Hexal threatened to launch a generic
Faslodex product in the fourth quarter of 2015. The provisional injunction request was denied and AstraZeneca filed an
appeal against this decision in November 2015. In December 2015, AstraZeneca filed an infringement suit against Hexal in
the Regional Court of Mannheim referring to their threatened launch of a generic Faslodex product.
In October 2015, Hexal filed a notice of opposition against European Patent No. 2,266,573, a patent granted in June 2015.
European Patent No. 2,266,573 is related to European Patent No. 1,250,138 referred to above.
Onglyza (saxagliptin) and Kombiglyze (saxagliptin and metformin)
Patent proceedings in the US
As previously disclosed, in June 2015, Mylan Pharmaceuticals, Inc. (Mylan) filed a petition for an inter partes review
(IPR) with the US Patent and Trademark Office (USPTO) challenging the validity of US Patent No. RE44,186. In December 2015
the USPTO declined to institute the IPR (the December Decision). In January 2016, Mylan filed a Request for Rehearing with
the USPTO seeking reconsideration of the December Decision.
Seroquel XR (quetiapine fumarate)
Patent proceedings outside the US
As previously disclosed, in France, in the third quarter of 2015, Mylan SAS (Mylan) launched its generic Seroquel XR
product at-risk. In November 2015, AstraZeneca obtained a preliminary injunction against Mylan, which was overturned on
appeal in December 2015.
As previously disclosed, Accord Healthcare France SAS and Accord Healthcare Limited (together, Accord) and AstraZeneca were
involved in patent litigation in France regarding the French designation of the Seroquel XR formulation patent, European
Patent No. 0,907,364. In January 2016, AstraZeneca settled the litigation with Accord.
In Germany, generic entities have claimed, or could claim, damages relating to the preliminary injunction issued in April
2012 that prevented generic Seroquel XR sales by those entities until the injunction was lifted following a November 2012
Federal Patent Court decision that held that the Seroquel XR patent was invalid. A provision has been taken.
Product liability litigation
Byetta/Bydureon (exenatide)
As previously disclosed, Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of AstraZeneca, and/or AstraZeneca are
among multiple defendants in various lawsuits filed in federal and state courts in the US involving approximately 2,500
claims of physical injury from treatment with Byetta and/or Bydureon. The lawsuits allege multiple types of injuries
including pancreatitis, pancreatic cancer, thyroid cancer, and kidney cancer. A multi-district litigation has been
established in the US District Court for the Southern District of California (the District Court) in regard to the alleged
pancreatic cancer cases in federal courts. Further, a co-ordinated proceeding has been established in Los Angeles,
California in regard to the various lawsuits in California state courts.
In November 2015, the District Court granted the defendants' motion for summary judgment and dismissed all claims alleging
pancreatic cancer that accrued prior to 11 September 2015. The plaintiffs have appealed that ruling. A similar motion was
granted in favour of the defendants in the California state co-ordinated proceeding, and judgment has not yet been
entered.
A single case pending in Alabama state court has been set for trial on 21 June 2016. A motion for summary judgment is
pending.
Farxiga (dapagliflozin)
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.
Onglyza (saxagliptin)
As previously disclosed, Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of AstraZeneca, and/or AstraZeneca are
among multiple defendants in various lawsuits filed in federal and state courts in the US involving multiple plaintiffs
claiming physical injury from treatment with Onglyza. The lawsuits allege injuries including pancreatic cancer. The lawsuit
that was pending, and was previously disclosed, claiming congestive heart failure from treatment with Onglyza has been
dismissed.
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. Dr. Reddy's has filed its own separate claims against
AstraZeneca in both the US District Court for the District of Delaware (the Delaware District Court) as well as the US
District Court for the District of New Jersey. The Delaware District Court has issued preliminary injunctions against
Camber's and Dr. Reddy's sales of generic esomeprazole magnesium in purple capsules. Dr. Reddy's has appealed the decision
of the Delaware District Court to the US Court of Appeals for the Third Circuit, and the appeal is pending. All cases
related to this matter have been stayed pending this appeal.
Synagis (palivizumab)
As previously disclosed, in September 2011, MedImmune filed an action against AbbVie, Inc. (AbbVie) (formerly Abbott
International, LLC) in the Circuit Court of Montgomery County, Maryland, seeking a declaratory judgment in a contract
dispute. AbbVie's motion to dismiss was granted. In September 2011, AbbVie filed a parallel action against MedImmune in
Illinois State Court and, as previously disclosed, trial began in August 2015. In September 2015, a jury returned a verdict
in favour of AbbVie and awarded AbbVie damages in the amount of approximately $94m. In December 2015, MedImmune and AbbVie
reached a settlement of this matter bringing this litigation to a conclusion.
Ocimum Lawsuit
In December 2015, AstraZeneca was served with a complaint filed by Ocimum Biosciences, Ltd. (Ocimum) in the Superior Court
for the State of Delaware that alleges, among other things, breaches of contractual obligations and misappropriation of
trade secrets, relating to a now terminated 2001 licensing agreement between AstraZeneca and Gene Logic, Inc. (Gene Logic),
the rights to which Ocimum purports to have acquired from Gene Logic.
Government investigations/proceedings
Good Manufacturing Practices subpoena
As previously disclosed, in March 2013, AstraZeneca received a subpoena duces tecum from the US Attorney's Office in Boston
seeking documents and information relating to products manufactured or packaged at AstraZeneca's Macclesfield facility in
the UK. AstraZeneca co-operated with this inquiry which is now closed.
8 product analysis - FY 2015
World US Europe Established ROW Emerging Markets
FY 2015$m CER% FY 2015$m CER FY 2015$m CER% FY 2015$m CER% FY 2015$m CER%
%
Respiratory, Inflammation & Autoimmunity:
Symbicort 3,394 (3) 1,520 1 1,076 (14) 404 2 394 22
Pulmicort 1,014 15 200 (5) 117 (13) 88 4 609 35
Tudorza/Eklira 190 n/m 103 n/m 76 n/m 9 n/m 2 n/m
Daliresp 104 n/m 104 n/m - - - - - -
Duaklir 27 n/m - - 26 n/m 1 n/m - -
Others 258 (5) 18 (31) 88 (6) 25 4 127 (1)
Total Respiratory, Inflammation & Autoimmunity 4,987 7 1,945 11 1,383 (7) 527 5 1,132 25
Cardiovascular & Metabolic disease:
Brilinta/Brilique 619 44 240 64 230 18 37 33 112 91
Onglyza 786 2 420 (13) 141 8 66 27 159 41
Bydureon 580 35 482 29 81 65 8 80 9 150
Farxiga/Forxiga 492 137 261 114 126 126 32 124 73 n/m
Byetta 316 2 209 5 62 (11) 22 (7) 23 30
Legacy:
Crestor 5,017 (3) 2,844 (3) 916 (9) 571 (1) 686 2
Seloken/Toprol-XL 710 4 89 (2) 97 (6) 12 (26) 512 9
Atacand 358 (15) 34 (23) 105 (26) 26 (30) 193 (4)
Others 611 (10) 55 (28) 143 (15) 60 (15) 353 (3)
Total Cardiovascular & Metabolic Disease 9,489 4 4,634 4 1,901 (1) 834 1 2,120 11
Oncology:
Iressa 543 (2) 6 n/m 128 (8) 137 (10) 272 4
Lynparza 94 n/m 70 n/m 23 n/m - - 1 n/m
Tagrisso 19 n/m 15 n/m 4 n/m - - - -
Legacy:
Zoladex 816 7 28 8 171 (12) 272 (2) 345 27
Faslodex 704 9 356 5 207 2 54 5 87 49
Casodex 267 (6) 1 (80) 30 (14) 131 (11) 105 9
Arimidex 250 (5) 19 27 49 (24) 79 (17) 103 16
Others 132 6 19 (24) 23 (18) 60 44 30 -
Total Oncology 2,825 7 514 25 635 (4) 733 (4) 943 18
Infection, Neuroscience & Gastrointestinal:
Nexium 2,496 (26) 902 (52) 284 (7) 549 5 761 3
Seroquel XR 1,025 (12) 716 (3) 202 (30) 25 (34) 82 (1)
Synagis 662 (26) 285 (43) 377 (6) - - - -
Losec/Prilosec 340 (10) 18 (32) 97 (10) 74 (19) 151 (1)
FluMist/Fluenz 288 - 206 (6) 76 16 7 14 (1) (100)
Movantik/Moventig 29 n/m 28 n/m 1 n/m - - - -
Others 1,500 - 226 50 367 (15) 273 (3) 634 1
Total Infection, Neuroscience & Gastrointestinal 6,340 (16) 2,381 (32) 1,404 (13) 928 (1) 1,627 2
TOTAL PRODUCT SALES 23,641 (1) 9,474 (6) 5,323 (6) 3,022 - 5,822 12
9 product Sales analysis - Q4 2015
World US Europe Established ROW Emerging Markets
Q4 2015$m CER% Q4 2015$m CER Q4 2015$m CER% Q4 2015$m CER% Q4 2015$m CER%
%
Respiratory, Inflammation & Autoimmunity:
Symbicort 859 (6) 410 4 251 (18) 100 (5) 98 (3)
Pulmicort 274 9 52 (7) 29 (20) 27 7 166 24
Tudorza/Eklira 47 n/m 26 n/m 19 n/m 2 n/m - n/m
Daliresp 32 n/m 32 n/m - - - - - -
Duaklir 12 n/m - - 12 n/m - - - -
Others 65 (4) 6 50 22 (8) 7 33 30 (13)
Total Respiratory, Inflammation & Autoimmunity 1,289 4 526 15 333 (12) 136 - 294 9
Cardiovascular & Metabolic disease:
Brilinta/Brilique 174 43 70 63 60 15 10 33 34 86
Onglyza 192 3 98 (3) 33 (14) 18 24 43 29
Bydureon 155 28 122 18 25 56 2 100 6 n/m
Farxiga/Forxiga 152 76 77 45 37 72 10 71 28 n/m
Byetta 72 10 43 10 17 - 7 14 5 67
Legacy:
Crestor 1,322 - 777 2 225 (9) 154 5 166 2
Seloken/Toprol-XL 160 5 19 27 24 (10) 3 (25) 114 6
Atacand 86 (15) 7 (36) 25 (19) 5 (33) 49 (7)
Others 147 (9) 14 (7) 35 (13) 16 - 82 (9)
Total Cardiovascular & Metabolic Disease 2,460 6 1,227 8 481 (2) 225 8 527 11
Oncology:
Iressa 129 (5) 4 n/m 32 (12) 35 (7) 58 (5)
Lynparza 36 n/m 24 n/m 11 n/m - - 1 n/m
Tagrisso 18 n/m 15 n/m 3 n/m - - - -
Legacy:
Zoladex 198 4 6 (25) 43 (8) 70 (4) 79 21
Faslodex 185 12 95 6 53 7 15 7 22 60
Casodex 63 (7) - - 7 (20) 33 (10) 23 4
Arimidex 60 (1) 4 33 12 (13) 20 (22) 24 27
Others 27 (26) - (100) 2 (75) 16 13 9 (10)
Total Oncology 716 9 148 40 163 1 189 (6) 216 15
Infection, Neuroscience & Gastrointestinal:
Nexium 564 (26) 175 (63) 75 1 138 47 176 14
Seroquel XR 241 (18) 176 (10) 42 (38) 5 (40) 18 (12)
Synagis 275 (32) 128 (45) 147 (14) - - - -
Losec/Prilosec 77 (23) - 100 26 - 19 (19) 32 (26)
FluMist/Fluenz 191 46 118 57 67 31 7 60 (1) (100)
Movantik/Moventig 15 n/m 15 n/m - - - - - -
Others 379 25 59 (238) 87 (15) 67 (19) 166 11
Total Infection, Neuroscience & Gastrointestinal 1,742 (13) 671 (29) 444 (10) 236 11 391 7
TOTAL PRODUCT SALES 6,207 - 2,572 (3) 1,421 (7) 786 4 1,428 10
Shareholder Information
Announcements and Meetings
Announcement of first quarter 2016 results 29 April 2016
Annual General Meeting 29 April 2016
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 second interim dividend for 2015, payable on 21 March 2016, will be 19 February 2016. Ordinary
Shares listed in London and Stockholm will trade ex-dividend from 18 February 2016. American Depositary Shares listed in
New York will trade ex-dividend from 17 February 2016.
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 Caprelsa, a trademark of
Genzyme Corporation; Daliresp and Daxas, trademarks of Takeda GmbH; Duaklir Genuair, Duaklir, Eklira, and Tudorza,
trademarks of Almirall, S.A.; Epanova, a trademark of Chrysalis Pharma AG; Ibrance, a trademark of Pfizer Inc.; Myalept, a
trademark of Aegerion Pharmaceuticals, Inc.; 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): Tel: +44 (0)207 500 2030or +1 877 248 4237 (1 877-CITI-ADR)/E-mail: citiadr@citi.com Tel: +44 (0)20 7604 8000 Tel: +46 (0)8 402 9000
0800 389 1580Tel (outside UK):
+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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