REG - AstraZeneca PLC - AZN: FY16 and Q4 2016 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 4
02/02/2017 07:06
- Part 4: For the preceding part double click ID:nRSB8083Vc
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 31 December 2016,
Acerta Pharma had no revenues and its loss after tax was $212m.
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 of $15m, a decrease in deferred
tax liabilities of $50m, and a decrease in goodwill of $65m.
Fair value$m
Intangible assets 7,307
Other assets including cash and cash equivalents 253
Deferred tax liabilities (1,777)
Other liabilities (90)
Total net assets acquired 5,693
Non-controlling interests (1,903)
Goodwill 19
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 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 $1,611m of other investments, $1,719m of loans, and $235m of derivatives as at 31 December 2016. The total fair
value of interest-bearing loans and borrowings at 31 December 2016 which have a carrying value of $16,808m in the Condensed
Consolidated Statement of Financial Position, was $18,174m. 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 (242) (51) (293) (579)
Revaluations (999) (159) (1,158) (432)
Discount unwind 389 108 497 524
Foreign exchange - - - (1)
At 31 December 4,240 1,217 5,457 6,411
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 and the Third Quarter and Nine-Month Results 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 fourth quarter of 2016 and to 2 February 2017.
Patent litigation
Faslodex (fulvestrant)
US patent proceedings
As previously disclosed, AstraZeneca has filed patent infringement lawsuits in the US District Court in New Jersey (the
District Court) relating to four patents listed in the FDA Orange Book with reference to Faslodex after AstraZeneca
received Paragraph IV notices relating to six Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market
generic versions of Faslodex prior to the expiration of AstraZeneca's patents. In December 2016, AstraZeneca settled the
lawsuit against one of the ANDA filers, and the District Court entered a consent judgment in January 2017 which ended that
particular lawsuit. AstraZeneca continues to litigate in the District Court against two other ANDA filers.
As previously disclosed, in July 2016, AstraZeneca was served with four petitions for inter partes review by the Patent
Trial and Appeal Board (PTAB) relating to each of the four Orange Book-listed patents. In December 2016, the PTAB issued an
order denying institution of the first of the four petitions. In January 2017, the PTAB terminated the remaining petitions
at the request of the parties.
Patent proceedings outside the US
As previously disclosed, in Germany, in July 2015, AstraZeneca was served with complaints filed by Hexal AG (Hexal) and
ratiopharm GmbH (ratiopharm) requesting the revocation of the German part of European Patent No. EP 1250138 (the '138
Patent). Following an oral hearing in January 2017, the German Federal Patent Court declared the patent invalid.
AstraZeneca intends to appeal. In January 2017, the Regional Court of Düsseldorf suspended the effects of a provisional
injunction based on the '138 patent which had been in place against Hexal since February 2016. Hexal is also seeking to
lift a provisional injunction based on European Patent No. EP 2266573. In January 2017, the Higher Regional Court of
Düsseldorf lifted a provisional injunction based on the '138 patent which had been in place against ratiopharm since
September 2016.
As previously disclosed, in China, in March 2014, AstraZeneca received a request for invalidation of the Faslodex
formulation patent, CN01803546.9, filed by Jiangsu Hansoh Pharmaceutical Co. Ltd. at the Chinese Patent Office. In
September 2014, the Patent Re-examination Board of the Chinese Patent Board declared the patent invalid. AstraZeneca
appealed to the Beijing IP Court and the appeal was rejected in April 2016. AstraZeneca appealed this decision to the
Beijing Higher People's Court and the appeal was rejected in December 2016. AstraZeneca is considering its options.
Onglyza (saxagliptin) and Kombiglyze (saxagliptin and metformin)
US patent proceedings
As previously disclosed, in June 2016, the US Court of Appeals for the Federal Circuit denied Mylan Pharmaceuticals Inc.'s
(Mylan) 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 and, in January 2017, the writ was denied.
As previously disclosed, in May 2016, the US Patent and Trademark Office (USPTO) instituted an inter partes review brought
by Mylan Pharmaceuticals Inc. challenging the validity of US Patent No. RE44,186 (the '186 Patent) (the Mylan IPR).
Subsequently, Wockhardt Bio AG, Teva Pharmaceuticals USA Inc., Sun Pharmaceutical Industries Ltd., Sun Pharma Global FZE,
and Amneal Pharmaceuticals LLC also filed petitions for inter partes review challenging the validity of the '186 Patent and
joined the Mylan IPR. A hearing in the Mylan IPR was held in January 2017. A decision is awaited.
Crestor (rosuvastatin)
US patent proceedings
As previously disclosed, in December 2015, the US District Court for the District of South Carolina (the District Court)
dismissed and entered judgment in AstraZeneca's favour in a patent infringement lawsuit filed by plaintiff Palmetto
Pharmaceuticals, LLC (Palmetto), which, among other things, claimed that AstraZeneca's Crestor sales induced infringement
of Palmetto's patent. Palmetto subsequently appealed. In December 2016, the Federal Circuit Court of Appeals affirmed the
District Court's order dismissing the lawsuit.
Patent proceedings outside the US
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. In July 2016, the JPO dismissed the request. The
individual has appealed to the Intellectual Property High Court of Japan (the High Court) with the intervention of Nippon
Chemiphar Co. Ltd (Nippon). In addition, Nippon commenced a separate patent invalidation request with the JPO in relation
to the Crestor substance patent. In November 2016, the JPO denied the request. Nippon has appealed to the High Court.
Synagis (palivizumab)
US patent proceedings
In December 2016, UCB BioPharma SPRL (UCB) filed a complaint against MedImmune LLC in the US District Court for the
District of Delaware alleging infringement of US Patent No. 7,566,771. The complaint relates to a royalty-bearing license
between Celltech R&D LTD and MedImmune which was terminated by MedImmune in 2010.
Losec/Prilosec (omeprazole)
Patent proceedings outside the US
As previously disclosed, in Canada, in 2004, AstraZeneca brought proceedings against Apotex Inc. (Apotex) for infringement
of several patents related to Losec. In February 2015, the Federal Court of Canada (the Federal Court) found that Apotex
had infringed AstraZeneca's Losec formulation patent (Canadian Patent No. 1,292,693). Apotex appealed. In January 2017, the
Federal Court of Appeal upheld the trial court's findings of infringement and validity. However, the Federal Court upheld
one aspect of Apotex's appeal relating to a limitation period defence, which may lower the amount of damages owed by
Apotex. A reference to determine patent infringement damages is scheduled to commence in February 2017.
Product liability litigation
Farxiga (dapagliflozin)
As previously disclosed, in the US, AstraZeneca has been named as a defendant in lawsuits involving plaintiffs claiming
physical injury, including diabetic ketoacidosis and kidney failure, from treatment with Farxiga and/or Xigduo XR. Cases
with these allegations have been filed in several jurisdictions. As previously disclosed, in October 2016 one of these
cases was dismissed with prejudice in favour of AstraZeneca. Since then, several other cases have been dismissed either
voluntarily or by the courts. Motions to dismiss are pending in many of the jurisdictions where AstraZeneca has been
served.
As previously disclosed, in the US, 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 (JPML) seeking transfer of
any currently pending cases as well as any similar, subsequently filed cases to a coordinated and consolidated pre-trial
multidistrict litigation (MDL) proceeding on a class-wide basis. In December 2016, the JPML granted an MDL to only those
plaintiffs alleging injury from Invokana.
Onglyza/Kombiglyze (saxagliptin)
As previously disclosed, in the US, AstraZeneca is defending various lawsuits filed in state and federal courts involving
multiple plaintiffs claiming heart failure, cardiac failure and/or death from treatment with either Onglyza or Kombiglyze.
In December 2016, plaintiffs in the California Superior Court filed a Petition for Coordination with the Judicial Council
of California, requesting that all similar, currently pending or subsequently filed cases in California be coordinated for
pre-trial purposes.
Nexium (esomeprazole)
As previously disclosed, in the US, AstraZeneca has been defending product liability lawsuits brought in US federal and
state courts by approximately 1,900 plaintiffs who alleged that Nexium caused osteoporotic injuries, such as bone
deterioration, loss of bone density and/or bone fractures, but all such claims have now been dismissed with judgment
entered in AstraZeneca's favour. Approximately 270 plaintiffs appealed the dismissal of their claims to the US Court of
Appeals for the Ninth Circuit, and fewer than 40 plaintiffs appealed the dismissal of their claims to the California Second
Appellate Division. In October 2016, the US Court of Appeals for the Ninth Circuit affirmed the dismissal of the
approximately 270 claims in federal court. In January 2017, the California Second Appellate Division affirmed the dismissal
of the less than 40 cases in California state court.
Commercial litigation
Crestor (rosuvastatin calcium)
As previously disclosed, in Israel, in November 2012, a Motion to Certify a Claim as a Class Action and Statement of Claim
(together, a Motion to Certify) were filed in the District Court in Tel Aviv, Jaffa, (the District Court) against
AstraZeneca and four other pharmaceutical companies for alleged deception and failure to disclose material facts to
consumers regarding potential adverse events associated with certain drugs, including Crestor. In July 2013, an amended
Motion to Certify containing similar allegations to those in the first action were filed in the same District Court against
the same defendants. In November 2016, the plaintiff filed a motion to withdraw from the action, which the District Court
granted in December 2016. This matter has now concluded.
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 (the District Court)
commenced in October 2014 and, in December 2014, a jury returned a verdict in favour of AstraZeneca and entered judgment in
favour of AstraZeneca in September 2015. The plaintiffs appealed that judgment and, in November 2016, the US Court of
Appeals for the First Circuit affirmed the District Court's decision. The plaintiffs petitioned for rehearing and rehearing
en banc, both of which were denied in January 2017.
Telephone Consumer Protection Act litigation
In December 2016, in the US, AstraZeneca and several other entities were served with a complaint filed in the US District
Court for the Southern District of Florida (the District Court) that alleges, among other things, violations of the
Telephone Consumer Protection Act caused by the sending of unsolicited advertisements by facsimile. AstraZeneca's motion to
dismiss is pending. The plaintiff also made a motion for class certification, which, in January 2017, was denied without
prejudice by the District Court.
8 product analysis - FY 2016
World US Europe Established ROW Emerging Markets
FY 2016$m CER% FY 2016$m CER% FY 2016$m CER% FY 2016$m CER% FY 2016$m CER%
Oncology:
Iressa 513 (5) 23 n/m 120 (5) 137 (8) 233 (10)
Tagrisso 423 n/m 254 n/m 76 n/m 83 100 10 100
Lynparza 218 n/m 127 81 81 n/m 3 n/m 7 n/m
Legacy:
Faslodex 830 19 438 23 228 11 68 15 96 25
Zoladex 816 - 35 25 156 (4) 270 (7) 355 6
Casodex 247 (9) 2 100 27 (7) 111 (23) 107 8
Arimidex 232 (6) 14 (26) 37 (24) 71 (18) 110 15
Others 104 (26) - n/m 8 (65) 71 7 25 (13)
Total Oncology 3,383 20 893 74 733 18 814 2 943 6
Cardiovascular & Metabolic Diseases:
Brilinta 839 39 348 45 258 15 44 22 189 80
Farxiga 835 72 457 75 187 52 58 72 133 96
Onglyza 720 (6) 376 (10) 132 (5) 70 11 142 (4)
Bydureon 578 - 463 (4) 100 23 11 25 4 (25)
Byetta 254 (19) 164 (22) 45 (25) 21 (9) 24 13
Legacy:
Crestor 3,401 (32) 1,223 (57) 866 (4) 591 (5) 721 12
Seloken/Toprol-XL 737 9 95 7 90 (5) 16 25 536 12
Atacand 315 (8) 36 6 97 (8) 20 (20) 162 (9)
Others 437 (26) 40 (27) 119 (17) 50 (21) 228 (30)
Total Cardiovascular & Metabolic Diseases 8,116 (13) 3,202 (31) 1,894 1 881 (1) 2,139 8
Respiratory:
Symbicort 2,989 (10) 1,242 (18) 909 (12) 436 5 402 10
Pulmicort 1,061 8 174 (13) 99 (14) 90 (3) 698 21
Tudorza/Eklira 170 (9) 77 (25) 83 9 9 - 1 n/m
Daliresp/Daxas 154 48 134 29 15 100 1 n/m 4 n/m
Duaklir 63 n/m - - 60 n/m 2 n/m 1 n/m
Others 316 27 11 (39) 118 38 50 108 137 13
Total Respiratory 4,753 (3) 1,638 (16) 1,284 (4) 588 8 1,243 17
Other:
Nexium 2,032 (18) 554 (39) 251 (11) 537 (10) 690 (3)
Seroquel XR 735 (27) 515 (28) 134 (32) 17 (32) 69 (7)
Synagis 677 2 325 14 352 (7) - - - -
Losec/Prilosec 276 (17) 10 (44) 83 (13) 55 (31) 128 (9)
FluMist/Fluenz 104 (59) 33 (84) 64 3 6 (14) 1 n/m
Movantik/Moventig 91 n/m 90 n/m - - - - 1 -
Others 1,152 (20) 105 (54) 269 (21) 198 (27) 580 (4)
Total Other 5,067 (19) 1,632 (31) 1,153 (15) 813 (17) 1,469 (4)
Total Product Sales 21,319 (8) 7,365 (22) 5,064 (3) 3,096 (4) 5,794 6
9 product analysis - Q4 2016
World US Europe Established ROW Emerging Markets
Q4 2016$m CER% Q4 2016$m CER Q4 2016$m CER% Q4 2016$m CER% Q4 2016$m CER%
%
Oncology:
Iressa 118 (11) 7 75 29 (6) 36 (6) 46 (22)
Tagrisso 147 n/m 74 n/m 27 n/m 40 100 6 n/m
Lynparza 62 72 31 29 25 127 3 n/m 3 n/m
Legacy:
Faslodex 222 19 117 23 59 11 20 20 26 23
Zoladex 235 13 8 33 39 2 71 (9) 117 36
Casodex 60 (8) - - 8 14 27 (27) 25 13
Arimidex 57 (7) 2 (50) 10 (17) 18 (24) 27 22
Others 29 - - - 4 33 20 6 5 (29)
Total Oncology 930 26 239 61 201 26 235 11 255 16
Cardiovascular & Metabolic Diseases:
Brilinta 236 37 105 50 66 13 12 10 53 62
Farxiga 239 57 130 69 51 37 17 50 41 56
Onglyza 149 (21) 72 (27) 30 (6) 15 (17) 32 (23)
Bydureon 142 (8) 114 (7) 25 (7) 3 50 - n/m
Byetta 55 (22) 37 (14) 8 (43) 5 (29) 5 (25)
Legacy:
Crestor 631 (53) 95 (88) 209 (6) 146 (16) 181 14
Seloken/Toprol-XL 178 14 14 (26) 23 (4) 6 67 135 23
Atacand 81 (5) 8 14 23 (12) 5 25 45 (6)
Others 100 (31) 13 (7) 30 (21) 12 (29) 45 (41)
Total Cardiovascular & Metabolic Diseases 1,811 (26) 588 (52) 465 (3) 221 (11) 537 6
Respiratory:
Symbicort 740 (13) 284 (31) 230 (3) 126 15 100 5
Pulmicort 288 8 36 (31) 26 (10) 29 - 197 25
Tudorza/Eklira 36 (23) 16 (36) 18 (5) 2 - - n/m
Daliresp/Daxas 41 28 33 3 5 100 - - 3 n/m
Duaklir 19 58 - - 18 46 1 n/m - -
Others 86 37 4 (33) 35 85 17 143 30 (3)
Total Respiratory 1,210 (5) 373 (29) 332 5 175 19 330 16
Other:
Nexium 491 (15) 135 (23) 61 (19) 148 (5) 147 (12)
Seroquel XR 118 (51) 71 (60) 28 (32) 3 (40) 16 (16)
Synagis 302 10 154 20 148 1 - - - -
Losec/Prilosec 59 (23) 3 100 20 (19) 13 (33) 23 (30)
FluMist/Fluenz 67 (60) 20 (83) 43 (21) 4 (43) - -
Movantik/Moventig 26 73 26 73 - - - - - -
Others 246 (34) 9 (84) 34 (57) 25 (69) 178 8
Total Other 1,309 (25) 418 (38) 334 (21) 193 (28) 364 (5)
Total Product Sales 5,260 (15) 1,618 (37) 1,332 (3) 824 (6) 1,486 7
Shareholder Information
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.; Toprol-XL, a trademark of Aralez Pharmaceuticals Inc.; Epanova, a
trademark of Chrysalis Pharma AG; Rhinocort Aqua, a trademark of Cilag GmbH International (outside the US); Zinforo, a
trademark of Forest Laboratories; Invokana, a trademark of Johnson & Johnson/Janssen Pharmaceutica NV; and Zavicefta, a
trademark of Pfizer Inc.
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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