REG - AstraZeneca PLC - Year-To-Date and Q3 2016 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 4
10/11/2016 07:10
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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 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
for any indication in the US, or the end of 2018, depending on which is first. 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.
Goodwill is principally attributable to the value of the specialist knowhow inherent in the acquired workforce and the
accounting for deferred taxes. Goodwill is not expected to be deductible for tax purposes. Acerta Pharma's results have
been consolidated into the Group's results from 2 February 2016. From the period from acquisition to 30 September 2016,
Acerta Pharma had no revenues and its loss after tax was $157m.
In the period since 2 February 2016, the acquisition accounting has been adjusted to reflect new information regarding the
value of net assets acquired with Acerta. This has resulted in an increase in other assets and a decrease in goodwill of
$15m.
Fair value$m
Intangible assets 7,307
Other assets including cash and cash equivalents 253
Deferred tax liabilities (1,827)
Other liabilities (90)
Total net assets acquired 5,643
Non-controlling interests (1,903)
Goodwill 69
Fair value of total consideration 3,809
Less: fair value of deferred consideration (1,332)
Total upfront consideration 2,477
Less: cash and cash equivalents acquired (94)
Net cash outflow 2,383
5 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 Chronic Heart Failure.
During 2016, we have revised our assessment of the fair values of the assets and liabilities acquired as a result of new
information obtained about facts and circumstances that existed at the date of acquisition that impact the value of
deferred tax. This has resulted in a reduction to both deferred tax liabilities and goodwill of $68m.
Fair value$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 (977)
Other liabilities (13)
(990)
Total net assets acquired 2,312
Goodwill 388
Total upfront consideration 2,700
Less: cash and cash equivalents acquired (73)
Less: deferred upfront consideration (181)
Net cash outflow 2,446
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 146 and 147
of the Company's Annual Report and Form 20-F Information 2015. 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 $1,624m of other investments, $1,749m of loans, and $267m of derivatives as at 30 September 2016. The total fair
value of interest-bearing loans and borrowings at 30 September 2016 which have a carrying value of $17,683m in the
Condensed Consolidated Statement of Financial Position, was $19,559m. 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:
DiabetesAlliance2016 Other 2016 Total 2016 Total 2015
$m $m $m $m
At 1 January 5,092 1,319 6,411 6,899
Settlements (197) - (197) (553)
Revaluations 32 100 132 58
Discount unwind 292 80 372 395
Foreign exchange - 2 2 2
At 30 September 5,219 1,501 6,720 6,801
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 2015 and as part of the Company's Half-Yearly Financial Report for the six-month period to
30 June 2016 (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 third quarter of 2016 and to 10 November 2016.
Patent litigation
Tagrisso (osimertinib)
Patent proceedings outside the US
In Europe, in October 2016, Stada Arzneimittel AG filed an opposition to the grant of European Patent No. 2,736,895.
Faslodex (fulvestrant)
US patent proceedings
As previously disclosed, AstraZeneca has filed patent infringement lawsuits in the US District Court in New Jersey relating
to four patents listed in the FDA Orange Book with reference to Faslodex. A trial against two of the defendants commenced
on 11 July 2016 and was scheduled to reconvene on 1 August 2016. AstraZeneca settled the lawsuits against both of these
defendants prior to trial reconvening and consequently those cases have since been dismissed. AstraZeneca continues to
litigate against several additional defendants with trial anticipated in 2017.
Patent proceedings outside the US
As previously disclosed, in Spain, in January 2016 the Barcelona Commercial Court ordered a preliminary injunction
preventing Sandoz Farmacéutica, S. A. from launching its generic version of Faslodex. The preliminary injunction was
maintained following an oral hearing in July 2016.
In Germany, in September 2016, a provisional injunction request based on European Patent No. 1,250,138 (the '138 Patent)
was granted by the Regional Court of Düsseldorf against ratiopharm GmbH (ratiopharm). As previously disclosed, in July
2015, AstraZeneca was served with complaints filed by Hexal AG (Hexal) and ratiopharm requesting the revocation of the '138
patent. The German Federal Patent Court has scheduled a hearing on this matter for 22 November 2016.
Also in Germany, as previously disclosed, in December 2015 AstraZeneca filed a patent infringement suit relating to
European Patent No. 2,255,573 against Hexal in the Regional Court of Mannheim referring to Hexal's threatened launch of a
generic Faslodex product. These proceedings were stayed at an oral hearing in August 2016.
Onglyza (saxagliptin) and Kombiglyze (saxagliptin and metformin)
US patent proceedings
As previously disclosed, AstraZeneca initiated patent infringement proceedings against Wockhardt Bio AG and Wockhardt USA
LLC, Sun Pharma Global FZE, Sun Pharmaceutical Industries Ltd. and Amneal Pharmaceuticals LLC (Wockhardt, Sun and Amneal)
in the US District Court for the District of Delaware (the District Court) after those entities had submitted ANDAs
containing a Paragraph IV Certification alleging that US Patent No. RE44,186 (the '186 Patent), listed in the FDA Orange
Book with reference to Onglyza and Kombiglyze XR, is invalid and/or will not be infringed by the products as described in
their ANDAs. In August and September 2016, AstraZeneca was informed that Wockhardt, Sun and Amneal had changed their
Paragraph IV Certifications to Paragraph III Certifications, seeking approval to market the products described in their
ANDAs following expiration of the '186 Patent. The patent infringement proceedings against these entities continues.
A trial was held in September 2016 against Wockhardt, Sun and Amneal, Mylan Pharmaceuticals Inc. (Mylan), Aurobindo Pharma
Ltd., Aurobindo Pharma U.S.A., Inc., Actavis Laboratories FL, Inc. and Watson Laboratories, Inc. in the District Court. A
decision on the validity of the '186 Patent is awaited. In September 2016, Apotex Corp. and Apotex, Inc. agreed to be bound
by the District Court's judgment.
As previously disclosed, in June 2016, the US Court of Appeals for the Federal Circuit denied Mylan's petition for
rehearing en banc of the decision affirming the denial of Mylan's motion to dismiss for lack of jurisdiction. In September
2016, Mylan filed a petition for writ of certiorari with the Supreme Court of the United States seeking an appeal of that
decision.
As previously disclosed, in May 2016, the US Patent and Trademark Office (USPTO) instituted an inter partes review brought
by Mylan challenging the validity of the '186 Patent (the Mylan IPR) and a number of generics companies also filed
petitions for inter partes review challenging the validity of the '186 Patent and sought to join the Mylan IPR. In August
and September 2016 respectively, Wockhardt Bio AG and Teva Pharmaceuticals USA, Inc. were joined with the Mylan IPR. A
decision as to whether the others will be permitted to join the Mylan IPR is awaited.
Crestor (rosuvastatin)
Patent proceedings outside the US
As previously disclosed, in France, in February 2016, Biogaran S.A.S. (Biogaran) obtained a marketing authorisation for its
rosuvastatin zinc product. In April 2016, AstraZeneca and Shionogi Seiyaku Kabushiki Kaisha (Shionogi) sought a preliminary
injunction to prevent Biogaran from launching its product. On 4 July 2016, the Paris Court of First Instance declined to
issue a preliminary injunction. AstraZeneca and Shionogi appealed; however, the parties settled the preliminary proceedings
before the appeal hearing. AstraZeneca and Shionogi have commenced patent infringement proceedings against Biogaran.
As previously disclosed, in Japan, in March 2015, an individual filed a patent invalidation request with the Japanese
Patent Office (JPO) in relation to the Crestor substance patent. On 13 July 2016, the JPO dismissed the request. The
individual has appealed to the Intellectual Property High Court of Japan with the intervention of Nippon Chemiphar Co. Ltd
(Nippon). In addition, Nippon has commenced a separate patent invalidation request with the JPO in relation to the Crestor
substance patent. A hearing was held on 30 September 2016.
As previously disclosed, in the UK, in October 2015, Resolution Chemicals Ltd. commenced an action in the UK Patent Court
alleging partial invalidity and non-infringement of the supplementary protection certificate related to the Crestor
substance patent. The case has been stayed.
In Switzerland, in May 2016, Mepha Pharma AG challenged the validity of the supplementary protection certificate related to
the Crestor substance patent. In September 2016, AstraZeneca responded.
Product liability litigation
Farxiga (dapagliflozin)
As previously disclosed, AstraZeneca has been named as a defendant in lawsuits filed in four jurisdictions involving
plaintiffs claiming physical injury, including diabetic ketoacidosis and kidney failure, from treatment with Farxiga. Since
then, additional cases with similar allegations have been filed in other jurisdictions. On 25 October 2016, one of these
cases was dismissed with prejudice in favour of AstraZeneca. Motions to dismiss are pending in other jurisdictions. In
October 2016, counsel for plaintiffs in a product liability action pertaining to Invokana (a product in the same class as
Farxiga) filed a motion with the Judicial Panel on Multidistrict Litigation seeking transfer of any currently pending cases
as well as any similar, subsequently filed cases to a coordinated and consolidated pre-trial Multidistrict Litigation
proceeding on a class-wide basis.
Onglyza/Kombiglyze (saxagliptin)
As previously disclosed, AstraZeneca is defending various lawsuits filed in state and federal courts in the US involving
multiple plaintiffs claiming heart failure, cardiac failure and/or death injuries from treatment with either Onglyza or
Kombiglyze. In October 2016, 14 of these claims were dismissed in response to motions filed by AstraZeneca. Approximately
80 plaintiffs claims currently remain in active litigation.
Synagis (palivizumab)
As previously disclosed, AstraZeneca and MedImmune were 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. In July
2016, the plaintiffs dismissed their claims voluntarily.
Nexium and Prilosec (esomeprazole and omeprazole)
As previously disclosed, all claims alleging that Nexium caused osteoporotic injuries, such as bone deterioration, loss of
bone density and/or bone fractures, have now been dismissed with judgment entered in AstraZeneca's favour. Approximately
270 plaintiffs have appealed the dismissal of their claims to the US Court of Appeals for the Ninth Circuit, and fewer than
40 plaintiffs have appealed the dismissal of their claims to the California Second Appellate Division. On 27 October 2016,
the US Court of Appeals for the Ninth Circuit affirmed the dismissal of the approximately 270 claims that were pending in
federal court.
AstraZeneca is defending various lawsuits in federal courts in the US involving multiple plaintiffs claiming that they have
been diagnosed with kidney injuries following treatment with proton pump inhibitors, including Nexium and Prilosec. In
October 2016, counsel for these plaintiffs filed a motion with the Judicial Panel on Multidistrict Litigation seeking
transfer of any currently pending cases as well as any similar, subsequently filed cases to a coordinated and consolidated
pre-trial Multidistrict Litigation proceeding.
Commercial litigation
Pearl Therapeutics
As previously disclosed, AstraZeneca was served with a complaint filed in Delaware State court by the former shareholders
of Pearl Therapeutics, Inc. (Pearl) that alleged, among other things, breaches of contractual obligations relating to a
2013 merger agreement between AstraZeneca and Pearl. This case has been resolved.
Crestor Citizen's Petition
As previously disclosed, in May 2016, AstraZeneca filed a Citizen's Petition with the FDA requesting that the FDA does not
approve any pending generic ANDAs for rosuvastatin until the expiration of the paediatric orphan exclusivity for Crestor.
In 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. The filings requested 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. In July 2016, the Court denied AstraZeneca's application for a TRO. On 19 August 2016, the
Court entered an order dismissing the case without prejudice.
Nexium settlement anti-trust litigation
As previously disclosed, AstraZeneca is a defendant in a multidistrict litigation class action and individual lawsuit
alleging that AstraZeneca's settlements of certain patent litigation in the US relating to Nexium violated US anti-trust
law and various state laws. A trial in the US District Court for the District of Massachusetts commenced in October 2014
and, in December 2014, a jury returned a verdict in favour of AstraZeneca. Following the Court's denial of the plaintiffs'
motion for a new trial and preliminary injunction, the Court entered judgment in favour of AstraZeneca in September 2015.
The plaintiffs have appealed that judgment and oral argument on the appeal was heard on 5 October 2016.
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. and Dr. Reddy's Laboratories, Inc. to enforce certain AstraZeneca trademark rights
related to Nexium and Prilosec. This matter is now resolved.
Government investigations/proceedings
Foreign Corrupt Practices Act
As previously disclosed, in connection with investigations into anti-bribery and corruption issues in the pharmaceutical
industry, AstraZeneca received inquiries from enforcement agencies, including the Department of Justice (DOJ) and the
Securities Exchange Commission (SEC), regarding, among other things, sales practices, internal controls, certain
distributors and interactions with healthcare providers and other government officials in several countries. In August
2016, AstraZeneca entered into a civil settlement with the SEC to resolve these inquiries. The DOJ has informed AstraZeneca
that it has closed its inquiry into this matter.
SeroquelIR (quetiapine fumarate) and Seroquel XR (quetiapine fumarate)
As previously disclosed, AstraZeneca was in litigation with the Attorney General of Mississippi in relation to the state
law claims brought by state Attorneys General which alleged that AstraZeneca had made false and/or misleading statements in
marketing and promoting Seroquel. This litigation has been resolved and the matter has been dismissed.
8 product analysis - YTD 2016
World US Europe Established ROW Emerging Markets
YTD 2016$m CER% YTD 2016$m CER% YTD 2016$m CER% YTD 2016$m CER% YTD 2016$m CER%
Oncology:
Iressa 395 (3) 16 n/m 91 (5) 101 (9) 187 (6)
Tagrisso 276 n/m 180 n/m 49 n/m 43 n/m 4 n/m
Lynparza 156 n/m 96 109 56 n/m - - 4 n/m
Legacy:
Faslodex 608 19 321 23 169 11 48 13 70 26
Zoladex 581 (4) 27 23 117 (5) 199 (6) 238 (3)
Casodex 187 (9) 2 n/m 19 (14) 84 (21) 82 6
Arimidex 175 (6) 12 (20) 27 (27) 53 (16) 83 13
Others 75 (32) - n/m 4 (80) 51 7 20 (9)
Total Oncology 2,453 17 654 79 532 14 579 (1) 688 3
Cardiovascular & Metabolic Diseases:
Brilinta 603 39 243 43 192 15 32 26 136 88
Farxiga 596 79 327 78 136 58 41 82 92 120
Onglyza 571 (2) 304 (6) 102 (5) 55 21 110 3
Bydureon 436 3 349 (3) 75 38 8 17 4 50
Byetta 199 (18) 127 (23) 37 (19) 16 - 19 31
Legacy:
Crestor 2,770 (24) 1,128 (45) 657 (3) 445 (1) 540 12
Seloken/Toprol-XL 559 8 81 16 67 (6) 10 11 401 9
Atacand 234 (9) 28 4 74 (6) 15 (29) 117 (10)
Others 337 (24) 27 (34) 89 (16) 38 (18) 183 (27)
Total Cardiovascular & Metabolic Diseases 6,305 (8) 2,614 (23) 1,429 3 660 3 1,602 9
Respiratory:
Symbicort 2,249 (10) 958 (14) 679 (15) 310 1 302 11
Pulmicort 773 8 138 (7) 73 (15) 61 (5) 501 20
Tudorza/Eklira 134 (5) 61 (22) 65 14 7 - 1 n/m
Daliresp/Daxas 113 57 101 40 10 n/m 1 n/m 1 n/m
Duaklir 44 n/m - - 42 n/m 1 n/m 1 n/m
Others 230 23 7 (42) 83 24 33 94 107 18
Total Respiratory 3,543 (2) 1,265 (11) 952 (7) 413 5 913 17
Other:
Nexium 1,541 (19) 419 (42) 190 (7) 389 (12) 543 -
Seroquel XR 617 (20) 444 (18) 106 (33) 14 (30) 53 (5)
Synagis 375 (3) 171 9 204 (11) - - - -
Losec/Prilosec 217 (15) 7 (61) 63 (11) 42 (30) 105 (3)
Movantik/Moventig 65 n/m 64 n/m - - - - 1 n/m
FluMist/Fluenz 37 (58) 13 (85) 21 n/m 2 n/m 1 n/m
Others 906 (15) 96 (43) 235 (11) 173 (14) 402 (9)
Total Other 3,758 (16) 1,214 (29) 819 (12) 620 (14) 1,105 (4)
Total Product Sales 16,059 (6) 5,747 (17) 3,732 (2) 2,272 (3) 4,308 6
9 product analysis - Q3 2016
World US Europe Established ROW Emerging Markets
Q3 2016$m CER% Q3 2016$m CER Q3 2016$m CER% Q3 2016$m CER% Q3 2016$m CER%
%
Oncology:
Iressa 125 (13) 6 n/m 30 - 36 (14) 53 (23)
Tagrisso 133 n/m 77 n/m 24 n/m 28 n/m 4 n/m
Lynparza 58 111 34 70 24 n/m - - - -
Legacy:
Faslodex 207 11 110 15 56 8 18 7 23 9
Zoladex 199 (5) 8 - 37 (9) 69 (12) 85 1
Casodex 62 (8) - - 6 (14) 28 (25) 28 15
Arimidex 56 (14) 2 (75) 9 (25) 18 (11) 27 8
Others 27 (29) - n/m 1 (86) 19 13 7 -
Total Oncology 867 17 237 69 187 19 216 2 227 (1)
Cardiovascular & Metabolic Diseases:
Brilinta 208 25 84 22 67 11 12 20 45 60
Farxiga 220 64 118 71 47 37 16 36 39 100
Onglyza 169 (16) 92 (17) 29 (22) 18 19 30 (21)
Bydureon 145 (10) 115 (17) 25 30 3 (33) 2 n/m
Byetta 61 (15) 38 (16) 12 (24) 6 - 5 -
Legacy:
Crestor 688 (44) 124 (82) 219 - 159 1 186 17
Seloken/Toprol-XL 185 12 28 27 23 (4) 5 150 129 10
Atacand 74 (3) 7 (22) 25 (7) 5 (29) 37 11
Others 95 (28) 11 83 25 (26) 13 (14) 46 (39)
Total Cardiovascular & Metabolic Disease 1,845 (21) 617 (47) 472 - 237 4 519 9
Respiratory:
Symbicort 697 (17) 277 (30) 213 (8) 114 4 93 (13)
Pulmicort 224 4 32 (20) 19 (5) 21 (10) 152 13
Tudorza/Eklira 47 (17) 20 (39) 24 9 3 - - n/m
Daliresp/Daxas 42 27 35 6 6 n/m 1 n/m - -
Duaklir 14 88 - - 14 88 - - - -
Others 86 46 - n/m 32 48 16 n/m 38 31
Total Respiratory 1,110 (8) 364 (27) 308 2 155 10 283 5
Other:
Nexium 516 (21) 125 (50) 63 (2) 152 (5) 176 (2)
Seroquel XR 190 (26) 138 (26) 30 (34) 4 (33) 18 6
Synagis 104 (11) 8 n/m 96 (20) - - - -
Losec/Prilosec 72 (11) 2 (67) 22 - 15 (28) 33 -
Movantik/Moventig 25 n/m 24 n/m - - - - 1 n/m
FluMist/Fluenz 26 (61) 2 (97) 21 n/m 2 n/m 1 n/m
Others 270 (25) 21 (66) 66 (24) 46 (37) 137 (4)
Total Other 1,203 (22) 320 (44) 298 (13) 219 (16) 366 (2)
Total Product Sales 5,025 (14) 1,538 (35) 1,265 (1) 827 (1) 1,395 3
Shareholder Information
Announcement of full year and fourth quarter 2016 results 2 February 2017
Announcement of first quarter 2017 results 27 April 2017
Annual General Meeting 27 April 2017
Announcement of half year and second quarter 2017 results 27 July 2017
Announcement of nine months and third quarter 2017 results 9 November 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 second interim dividend for 2016, payable on 20 March 2017, will be 17 February 2017. Ordinary
Shares listed in London and Stockholm will trade ex-dividend from 16 February 2017. American Depositary Shares listed in
New York will trade ex-dividend from 15 February 2017.
The record date for the first interim dividend for 2017, payable on 11 September 2017, will be 11 August 2017. Ordinary
Shares listed in London and Stockholm will trade ex-dividend from 10 August 2017. American Depositary Shares listed in New
York will trade ex-dividend from 9 August 2017.
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; Zinforo, a trademark of
Forest Laboratories; and Invokana, a trademark of Johnson & Johnson/ Janssen Pharmaceutica NV.
Addresses for Correspondence
Registered Office1 Francis Crick AvenueCambridge Biomedical Campus, CambridgeCB2 0AAUK Registrar andTransfer OfficeEquiniti LimitedAspect HouseSpencer RoadLancingWest SussexBN99 6DAUK Swedish Central Securities DepositoryEuroclear Sweden ABPO Box 191SE-101 23 StockholmSweden US DepositaryCitibank Shareholder ServicesPO Box 43077ProvidenceRI 02940-3077USA
Tel: +44 (0)20 3749 5000 Tel (freephone in UK): 0800 389 1580 Tel (outside UK): Tel: +46 (0)8 402 9000 Tel: (toll free in the US) +1 (888) 697 8018 Tel: (outside the US) +1 (781) 575 4555 citibank@shareholders-online.com
+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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