UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 20-F

 

(Mark One)

 

 

Date of event requiring this shell company report . . . . . . . . . . . . . . . . . . .

 

For the transition period from                       to                        .

 

Commission file number: 001-11960

 

ASTRAZENECA PLC

(Exact name of Registrant as specified in its charter)

England and Wales

(Jurisdiction of incorporation or organization)

1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA England

(Address of principal executive offices)

Adrian Kemp AstraZeneca PLC 1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA England Telephone: +44 20 3749 5000 Facsimile number: +44 1223 352 858

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

 

Securities registered or to be registered pursuant to Section 12(b) of the Act:

 

 

* Not for trading, but only in connection with the registration of American Depositary Shares representing such Ordinary Shares pursuant to the requirements of the Securities and Exchange Commission.

 

Securities registered or to be registered pursuant to Section 12(g) of the Act:

 

None

(Title of Class)

 

 

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:

 

None

(Title of Class)

 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

 

The number of outstanding shares of each class of stock of AstraZeneca PLC as of December 31, 2018 was:

 

Ordinary Shares of 25¢ each: 1,267,039,436
Redeemable Preference Shares of £1 each: 50,000

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes x  No o

 

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Yes o  No x

 

Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes x  No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes x  No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

 

 

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. o

 

†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

 

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

 

 

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

o Item 17   o Item 18

 

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes o  No x

 

(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)

 

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.

 

Yes o   No o

 

 

Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the information for the 2018 Form 20-F of AstraZeneca PLC (the “Company”) set out below is being incorporated by reference from AstraZeneca’s “Annual Report and Form 20-F Information 2018” included as exhibit 15.1 to this Form 20-F dated and submitted on March 5, 2019.

 

References below to major headings include all information under such major headings, including subheadings, unless such reference is a reference to a subheading, in which case such reference includes only the information contained under such subheading. Unless the context otherwise requires, “AstraZeneca” or “Group” refers to the Company and its consolidated entities. Other information contained within AstraZeneca’s “Annual Report and Form 20-F Information 2018” included as exhibit 15.1 to this Form 20-F, including graphs and tabular data, is not included in this Form 20-F unless specifically identified below. Photographs are also not included.

 

In addition to the information set out below, the information (including tabular data) set forth under the headings “Use of terms” on the inside front cover, “Strategic Report—Financial Review—Measuring performance” on pages 76 and 77, and the tables on page 77, “Additional Information —Trade Marks” on page 238, “—Glossary” on pages 239 to 242 and “—Important information for readers of this Annual Report—Cautionary statement regarding forward-looking statements”, “—Inclusion of Reported performance, Core financial measures and constant exchange rate growth rates”, “—Statements of competitive position, growth rates and sales”, “—AstraZeneca websites”, “—External/third party websites” and “—Figures” on page 244, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2018” included as exhibit 15.1 to this Form 20-F dated March 5, 2019 is incorporated by reference. References herein to AstraZeneca websites are textual references only and information on or accessible through such websites does not form part of and is not incorporated into this Form 20-F dated March 5, 2019.

 

PART 1

 

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

 

Not applicable.

 

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE

 

Not applicable.

 

ITEM 3. KEY INFORMATION

 

A. Selected Financial Data

 

The information (including graphs and tabular data) set forth under the headings “Financial Statements—Group Financial Record” on page 210, “Additional Information—Shareholder Information—Issued share capital, shareholdings and share prices”  and the first table that appears under “—Ordinary Shares in issue” on page 233, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2018” included as exhibit 15.1 to this Form 20-F dated March 5, 2019 is incorporated by reference. The selected financial data incorporated by reference herein is derived from audited financial statements of the Company and its consolidated entities, prepared in accordance with International Financial Reporting Standards (“IFRS”) as adopted by the European Union and as issued by the International Accounting Standards Board, included in AstraZeneca’s “Annual Report and Form 20-F Information 2018” included as exhibit 15.1 to this Form 20-F dated March 5, 2019.

 

B. Capitalization and Indebtedness

 

Not applicable.

 

C. Reason for the Offer and Use of Proceeds

 

Not applicable.

 

1

 

D. Risk Factors

 

The information (including tabular data) set forth or referenced under the heading “Additional Information—Risk” on pages 220 to 230 of AstraZeneca’s “Annual Report and Form 20-F Information 2018” included as exhibit 15.1 to this Form 20-F dated March 5, 2019 is incorporated by reference.

 

ITEM 4. INFORMATION ON THE COMPANY

 

A. History and Development of the Company

 

The information (including tabular data) set forth under the headings “Additional Information—Shareholder Information—History and development of the Company” on page 233, “Strategic Report—Financial Review— Externalisation Revenue” on pages 79 to 80, “Strategic Report—Financial Review—Financial position—December 31, 2018— Business combinations” on page 83, “—Investments, divestments and capital expenditure” on pages 85 and 86, “Financial Statements—Notes to the Group Financial Statements—Note 26—Acquisitions of business operations” on page 186, “Corporate Governance—Corporate Governance Report—Relations with shareholders” on page 104 and “Additional Information—Important information for readers of this Annual Report—AstraZeneca websites” in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2018” included as exhibit 15.1 to this Form 20-F dated March 5, 2019 is incorporated by reference.

 

The United States Securities and Exchange Commission (the “SEC”) maintains a website at www.sec.gov which contains in electronic form each of the reports and other information that we have filed electronically with the SEC.

 

B. Business Overview

 

The information (including graphs and tabular data) set forth under the headings “Strategic Report—AstraZeneca at a glance” on pages 2 to 3, “—Chairman’s Statement” on page 4, “—Chief Executive Officer’s Review” on pages 5 to 7, “—Strategy” on pages 18 to 19,  “—Key Performance Indicators” on pages 20 to 23, “—Business Review” on pages 24 to 49, “—Therapy Area Review” on pages 50 to 69, “— Risk Overview—Managing Risk”, “— Risk Overview —Risk management embedded in business processes” and “— Risk Overview—Brexit” on pages 70 to 71, “Corporate Governance—Corporate Governance Report—Other Governance information—Business organisation—Global Compliance and Internal Audit Services (IA)” on page 105, “Additional Information—Development Pipeline” on pages 212 to 216, “—Patent Expiries of Key Marketed Products” on pages 217 to 219, “—Sustainability: supplementary information” on page 231, “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161, “—Note 6—Segment information” on pages 165 to 167, and “Additional Information— Important information for readers of this Annual Report—Statements of competitive position, growth rates and sales” on page 244, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2018” included as exhibit 15.1 to this Form 20-F dated March 5, 2019 is incorporated by reference.

 

On February 25, 2019, AstraZeneca announced that Brilinta’s Phase III THEMIS trial met its primary endpoint and demonstrated that Brilinta (ticagrelor), taken in conjunction with aspirin, showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE) compared to aspirin alone.

 

On February 26, 2019, AstraZeneca and MSD announced positive results from the Phase III POLO trial showing a statistically significant and clinically-meaningful improvement in progression free survival with Lynparza (olaparib) compared to placebo.

 

On March 1, 2019, AstraZeneca and MSD announced that the CHMP of the European Medicines agency adopted a positive opinion, which recommended the use of Lynparza (olaparib) tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.

 

Geographical Review

 

This section Item 4—“Information on the Company— Business Overview—Geographical Review” should be read in conjunction with Item 5—“Operating and Financial Review and Prospects—Operating Results” below.

 

2

 

		World						Emerging Markets						U.S.				Europe						Established ROW
2018		Sales $m		Actual %		CER %		Sales $m		Actual %		CER %		Sales $m		Actual %		Sales $m		Actual %		CER %		Sales $m		Actual %		CER %
Oncology:
Tagrisso		1,860		95		93		347		n/m		n/m		869		n/m		314		68		61		330		45		43
Faslodex		1,028		9		9		154		34		41		537		9		221		(14	)	(19	)	116		49		46
Zoladex		752		2		2		409		16		18		8		(47	)	133		(6	)	(10	)	202		(11	)	(12	)
Lynparza		647		n/m		n/m		51		n/m		n/m		345		n/m		190		46		41		61		n/m		n/m
Imfinzi		633		n/m		n/m		6		n/m		n/m		564		n/m		27		n/m		n/m		36		n/m		n/m
Iressa		518		(2	)	(4	)	286		14		12		26		(33	)	109		(3	)	(8	)	97		(23	)	(25	)
Arimidex		212		(2	)	(3	)	132		12		11		—		n/m		31		(9	)	(9	)	49		(16	)	(17	)
Casodex		201		(7	)	(8	)	113		5		2		1		n/m		20		(9	)	(9	)	67		(22	)	(23	)
Calquence		62		n/m		n/m		—		—		—		62		n/m		—		—		—		—		—		—
Others		115		1		(1	)	30		29		30		—		—		8		20		20		77		(7	)	(8	)
Total Oncology		6,028		50		49		1,528		36		37		2,412		n/m		1,053		19		14		1,035		16		14
CVRM:
Crestor		1,433		(39	)	(40	)	841		7		7		170		(54	)	203		(70	)	(71	)	219		(60	)	(60	)
Farxiga/Forxiga		1,391		30		30		336		45		52		591		21		315		30		24		149		34		34
Brilinta		1,321		22		21		326		46		48		588		16		348		18		13		59		16		16
Seloken/Toprol-XL		712		2		4		641		8		10		39		5		19		(63	)	(63	)	13		—		—
Bydureon		584		2		1		8		(11	)	(11	)	475		4		81		(8	)	(13	)	20		5		5
Onglyza		543		(11	)	(11	)	172		32		34		223		(30	)	89		(14	)	(18	)	59		4		4
Atacand		260		(13	)	(12	)	157		(12	)	(7	)	13		(32	)	70		(19	)	(20	)	20		18		18
Byetta		126		(28	)	(28	)	8		(33	)	(33	)	74		(35	)	29		(15	)	(15	)	15		(6	)	(6	)
Symlin		34		(29	)	(29	)	—		—		—		34		(29	)	—		—		—		—		—		—
Others		306		(11	)	(12	)	206		—		—		(1	)	n/m		76		(17	)	(20	)	25		(42	)	(42	)
Total CVRM		6,710		(8	)	(8	)	2,695		14		15		2,206		(7	)	1,230		(26	)	(29	)	579		(33	)	(34	)
Respiratory:
Symbicort		2,561		(9	)	(10	)	495		13		14		862		(22	)	773		(6	)	(10	)	431		(3	)	(4	)
Pulmicort		1,286		9		8		995		18		17		116		(26	)	90		(2	)	(8	)	85		(3	)	(5	)
Fasenra		297		n/m		n/m		1		n/m		n/m		218		n/m		32		n/m		n/m		46		n/m		n/m
Daliresp/Daxas		189		(5	)	(5	)	5		25		25		155		(7	)	28		8		4		1		—		—
Tudorza/Eklira		110		(27	)	(29	)	1		(50	)	n/m		25		(62	)	74		1		(3	)	10		11		11
Duaklir		95		20		14		1		n/m		n/m		—		—		91		18		12		3		50		50
Bevespi		33		n/m		n/m		—		—		—		33		n/m		—		—		—		—		—		—
Others		340		20		18		146		42		41		7		40		141		9		6		46		(2	)	(2	)
Total Respiratory		4,911		4		3		1,644		18		18		1,416		(6	)	1,229		1		(4	)	622		5		4
Other:
Nexium		1,702		(13	)	(14	)	690		1		1		306		(39	)	235		(6	)	(11	)	471		(10	)	(11	)
Synagis		665		(3	)	(3	)	1		n/m		n/m		287		(9	)	377		2		2		—		—		—
Seroquel XR / IR		361		(29	)	(31	)	118		(22	)	(23	)	108		(44	)	107		(16	)	(20	)	28		(26	)	(26	)
Losec/Prilosec		272		—		(2	)	161		15		11		7		(36	)	70		(9	)	(12	)	34		(21	)	(21	)
FluMist/Fluenz		110		41		44		1		n/m		n/m		15		n/m		91		20		22		3		—		—
Movantik/Moventig		109		(11	)	(11	)	—		—		—		108		(10	)	—		n/m		n/m		1		n/m		n/m
Others		181		(66	)	(67	)	53		(82	)	(79	)	11		(59	)	67		(27	)	(41	)	50		(59	)	(60	)
Total Other		3,400		(18	)	(19	)	1,024		(19	)	(19	)	842		(28	)	947		(5	)	(8	)	587		(19	)	(20	)
Total Product Sales		21,049		4		4		6,891		12		13		6,876		11		4,459		(6	)	(10	)	2,823		(8	)	(9	)

 

3

 

		World						Emerging Markets						U.S.				Europe						Established ROW
2017		Sales $m		Actual %		CER %		Sales $m		Actual %		CER %		Sales $m		Actual %		Sales $m		Actual %		CER %		Sales $m		Actual %		CER %
Oncology:
Tagrisso		955		126		126		135		n/m		n/m		405		59		187		146		142		228		175		183
Faslodex		941		13		13		115		20		18		492		12		256		12		11		78		15		18
Zoladex		735		(10	)	(10	)	353		(1	)	(1	)	15		(57	)	141		(10	)	(8	)	226		(16	)	(15	)
Lynparza		297		36		35		18		n/m		n/m		141		11		130		60		58		8		n/m		n/m
Imfinzi		19		n/m		n/m		—		—		—		19		n/m		—		—		—		—		—		—
Iressa		528		3		3		251		8		8		39		70		112		(7	)	(8	)	126		(8	)	(6	)
Arimidex		217		(6	)	(4	)	118		7		10		7		(50	)	34		(8	)	(8	)	58		(18	)	(15	)
Casodex		215		(13	)	(11	)	108		1		4		(1	)	n/m		22		(19	)	(19	)	86		(23	)	(21	)
Calquence		3		n/m		n/m		—		—		—		3		n/m		—		—		—		—		—		—
Others		114		10		13		28		12		16		—		—		3		(63	)	(63	)	83		17		20
Total Oncology		4,024		19		19		1,126		19		20		1,120		25		885		21		20		893		10		12
CVRM:
Crestor		2,365		(30	)	(30	)	784		9		11		373		(70	)	666		(23	)	(23	)	542		(8	)	(6	)
Farxiga/Forxiga		1,074		29		28		232		74		73		489		7		242		29		28		111		91		90
Brilinta		1,079		29		29		224		19		21		509		46		295		14		13		51		16		11
Seloken/Toprol-XL		695		(6	)	(4	)	593		11		12		37		(61	)	52		(42	)	(41	)	13		(19	)	(19	)
Bydureon		574		(1	)	(1	)	9		125		75		458		(1	)	88		(12	)	(11	)	19		73		73
Onglyza		611		(15	)	(16	)	130		(8	)	(10	)	320		(15	)	104		(21	)	(21	)	57		(19	)	(20	)
Atacand		300		(5	)	(3	)	178		10		12		19		(47	)	86		(11	)	(11	)	17		(15	)	(15	)
Byetta		176		(31	)	(30	)	12		(50	)	(50	)	114		(30	)	34		(24	)	(22	)	16		(24	)	(24	)
Symlin		48		20		20		—		—		—		48		20		—		—		—		—		—		—
Others		344		(13	)	(12	)	205		(10	)	(7	)	4		n/m		92		(23	)	(24	)	43		(14	)	(12	)
Total CVRM		7,266		(10	)	(10	)	2,367		11		12		2,371		(26	)	1,659		(12	)	(13	)	869		(1	)	—
Respiratory:
Symbicort		2,803		(6	)	(6	)	439		9		10		1,099		(12	)	819		(10	)	(10	)	446		2		2
Pulmicort		1,176		11		12		840		20		23		156		(10	)	92		(7	)	(8	)	88		(2	)	(1	)
Fasenra		1		n/m		n/m		—		—		—		1		n/m		—		—		—		—		—		—
Daliresp/Daxas		198		29		28		4		—		—		167		25		26		73		73		1		—		—
Tudorza/Eklira		150		(12	)	(12	)	2		n/m		n/m		66		(14	)	73		(12	)	(11	)	9		—		—
Duaklir		79		25		25		—		n/m		n/m		—		—		77		24		24		2		—		—
Bevespi		16		n/m		n/m		—		—		—		16		n/m		—		—		—		—		—		—
Others		283		(10	)	(9	)	103		(25	)	(24	)	4		(44	)	129		10		10		47		(6	)	(6	)
Total Respiratory		4,706		(1	)	(1	)	1,388		12		13		1,509		(8	)	1,216		(5	)	(5	)	593		1		1
Other:
Nexium		1,952		(4	)	(3	)	684		(1	)	2		499		(10	)	248		(1	)	(3	)	521		(3	)	(1	)
Synagis		687		1		1		—		—		—		317		(2	)	370		5		5		—		—		—
Seroquel XR / IR		508		(47	)	(47	)	151		(5	)	(4	)	193		(66	)	128		(32	)	(32	)	37		(17	)	(17	)
Losec/Prilosec		271		(2	)	(1	)	140		9		10		11		10		77		(7	)	(7	)	43		(22	)	(20	)
FluMist/Fluenz		78		(25	)	(28	)	(1	)	n/m		n/m		—		(100	)	76		17		12		3		(50	)	(50	)
Movantik/Moventig		122		34		34		—		n/m		n/m		120		33		2		n/m		n/m		—		—		—
Others		538		(42	)	(42	)	294		(39	)	(39	)	29		(42	)	92		(57	)	(60	)	122		(28	)	(28	)
Total Other		4,156		(18	)	(17	)	1,268		(14	)	(12	)	1,169		(28	)	993		(14	)	(15	)	726		(11	)	(9	)
Total Product Sales		20,152		(5	)	(5	)	6,149		6		8		6,169		(16	)	4,753		(6	)	(7	)	3,081		—		1

 

4