-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Ho4nnsRVTbTgcyU3QASz750pQU3m3VUdkzZROIJ3QJZ0FzwPSAp7vYPNTCVd4xyf zpKNt1qcQGSXuT+KzDNYeg== 0000950103-03-002133.txt : 20031105 0000950103-03-002133.hdr.sgml : 20031105 20031105132534 ACCESSION NUMBER: 0000950103-03-002133 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20031105 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031105 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP PLC CENTRAL INDEX KEY: 0000936402 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29630 FILM NUMBER: 03978645 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 BUSINESS PHONE: 1264333455 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 8-K 1 nov0403_8k.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (date of earliest event reported): November 5, 2003

Shire Pharmaceuticals Group plc
(Exact name of registrant as specified in its charter)

England and Wales
(State or other jurisdiction of incorporation)

0-29630 98-0359573
(Commission File Number) (I.R.S. Employer Identification No.)

Hampshire International Business Park
Chineham, Basingstoke,
Hampshire RG24 8EP England

(Address of principal executive offices)(Zip Code)

Registrant’s telephone number, including area code: 44 1256 894 000

Not Applicable
(Former name or former address, if changed since last report)






Item 7. Financial Statements and Exhibits
   
  (c) Exhibit. The following exhibits are filed herewith:
   
99 Press Release of Shire Pharmaceuticals Group plc dated November 5, 2003, reporting Shire’s financial results for the third quarter of 2003.
   
Item 12. Results of Operations and Financial Condition

On November 5, 2003, Shire Pharmaceuticals Group plc issued a press release announcing its financial results for the third quarter of 2003. A copy of the press release is furnished as Exhibit 99 to this report and is incorporated herein by reference.



SIGNATURE

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: November 5, 2003 SHIRE PHARMACEUTICALS GROUP PLC


  By: /s/ A C Russell  
    Name:
Title:
Angus Russell
Group Finance Director





EXHIBIT INDEX

Number   Description
     
99.1  

Press Release dated November 5, 2003



EX-99 3 nov0403_ex99.htm item1

Exhibit 99

Strong third quarter results support confidence in year-end guidance
Positive outlook for 2004

Basingstoke, UK – 5 November 2003 – Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces results for the third quarter ended 30 September 2003.

Third Quarter 2003 Unaudited US GAAP Results Highlights

    Q3 2003   Q3 2002   % Growth 
    $M   $M    

             
  Total revenues 289.4   249.7   +16% 
  Operating income 88.8   81.0   +10% 
  Income from continuing operations before          
  income taxes and equity in (losses) / earnings          
  of equity method investees 89.8   84.1   +7% 
  Net income 64.6   63.6   +2% 
  Diluted Earnings Per Share (EPS):          
  Per ordinary share 12.8 c 12.4 c +3% 
  Per American Depository Share (ADS) 38.3 c 37.2 c +3% 
(1) The 2002 US GAAP results have been restated to reflect the disposal of our ‘Over-The-Counter’ (OTC) business, which has been accounted for as a discontinued operation. All 2002 figures down to income from continuing operations exclude the OTC business, while 2002 net income and EPS figures include the OTC results.
   
(2) Average exchange rates for Q3 2003 and 2002 were $1.62: £1.00 and $1.56: £1.00 respectively.

Matthew Emmens, Chief Executive, said:

“Shire’s robust performance continued in the third quarter and we remain on track to meet our year-end guidance. Our underlying business is very solid. Most notable is the fact that we recently achieved record prescription levels for ADDERALL XR.

“Our franchise was further strengthened with the receipt of an approvable letter from the US Food and Drug Administration (FDA) for the use of ADDERALL XR in adults with Attention Deficit and Hyperactivity Disorder (ADHD). With the most prescribed ADHD brand in the US and four other ADHD compounds in development, our intention is to remain the leading company in this rapidly growing market.

“Our recently announced strategic initiatives are moving forward. The first step, announced last quarter, was to redefine our focus. The resulting ‘search and development’ strategy implies honing our drug development capabilities and also enhancing our business development efforts. To accomplish this, we have exited early stage research and will spin out the vaccine business so that we can focus resources on later stage projects. Concurrently, we have been concentrating our business development efforts on a small number of highly attractive targets. Additionally, we are finalising our plan for organisational restructuring and US site consolidation. An update on this will be provided at the year-end.

“In summary, we expect to achieve our guidance of mid to high teens revenue growth, operating margins of around 30% and high single to low double digit earnings per share (EPS) growth (including the approximate 3 cents per share cost impact associated with the closure of early stage research). Given our positive momentum, we are confident of delivering sustained growth in 2004”

1


Third Quarter 2003 and Recent Events Highlights

  • Q3 2003 revenues up 16% to $289.4 million, driven by ADDERALL XR’s excellent performance.

  • Diluted earnings per ADS up 3% at 38.3c after charging costs of $12.1 million associated with early stage research and other intangible asset write-downs of $11.2 million.

  • Total ADHD prescriptions up 23% quarter on quarter.

  • ADDERALL XR sales up 55% on the same period last year, totalling $121.3 million; ADDERALL XR outperformed the market with prescription demand of 1.51 million up 34% compared with Q3 2002; the ADDERALL® franchise is the leading ADHD brand in the US with 25%1prescription share in Q3 2003.

  • Shire receives approvable letter from the US Food and Drug Administration (FDA) for ADDERALL XR adult indication.

  • Royalties up 14% to $49.7 million; 3TC™ royalties up 9% to $35.3 million and other royalties (mainly REMINYL™) up 51% to $8.2 million.

  • FOSRENOL® responses submitted to the EU Reference Member State; US approvable letter responses to be delivered to the FDA before year-end.

  • SPD476, a novel formulation of mesalamine for the treatment of Ulcerative Colitis, enters Phase III development.

Strategy update

Shire’s new strategy, which is to position itself as the leading company in meeting the needs of the specialist physician with a focus on fewer and later stage projects was announced at Q2 2003. Implementation of this new strategy is progressing well:

  • Plans to spin off the vaccine business are advancing and in parallel the Company is examining a number of expressions of interest from potential purchasers.
  • SPD754 (for HIV) and TROXATYL (for the treatment of acute myeloid leukaemia and pancreatic cancer), both of which are in Phase II, have attracted a number of potential partners and the Company expects to complete the out-licensing and partnering process by mid 2004.
  • The early stage research centre in Laval, Quebec was closed in the quarter. An additional US manufacturing and distribution site has been closed in the past few months.
  • M&A has been significantly enhanced with the establishment of a global focus team targeting acquisitions in the US including large scale transactions – a small number of highly attractive targets have been identified.
  • The Company will provide an update on the organisational restructuring and US site consolidation at the year-end.

– Ends –

For further information please contact:    
     
Cléa Rosenfeld – Investor Relations Global +44 1256 894 160
Jessica Mann – Media Europe +1 859 669 8905
Michele Roy – Media US & Canada +1 450 978 7938

Notes to editors
Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world’s key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

For further information on Shire, please visit the Company’s website: www.shire.com

2


THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialise, Shire’s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialisation, the impact of competitive products, including, but not limited to, the impact on Shire’s Attention Deficit Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire’s ADHD franchise, government regulation and approval, including but not limited to the expected product approval date of lanthanum carbonate (FOSRENOL®), METHYPATCH®, XAGRID® and the adult indication for ADDERALL XR® and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K/A by Shire with the Securities and Exchange Commission.

The following are trade marks of Shire or companies within the Shire Group, which are the subject of trade mark registrations in certain territories.

ADDERALL XR® (mixed amphetamine salts)
ADDERALL® (mixed amphetamine salts)
AGRYLIN® (anagrelide hydrochloride)
CARBATROL® (carbamazepine)
FLUVIRAL® S/F (split-virion influenza vaccine)
FOSRENOL® (lanthanum carbonate)
METHYPATCH® (methylphenidate)

PROAMATINE® (midodrine hydrochloride)
TROXATYL® (troxacitabine)
XAGRID® (anagrelide hydrochloride)

The following are trade marks of third parties.

3TC (lamivudine) (trade mark of GlaxoSmithKline (GSK))
NEISVAC-C (trade mark of Baxter International Inc.)
PENTASA (mesalamine) (trade mark of Ferring)

REMINYL (galantamine hydrobromide) (trade mark of Johnson & Johnson)
ZEFFIX (lamivudine) (trade mark of GSK)

Data sources.

1 IMS Prescription Data – Product specific
2
GlaxoSmithKline (GSK)

3


OVERVIEW OF US GAAP FINANCIAL RESULTS

Introduction

The results for the third quarter ended 30 September 2002 have been restated to reflect the disposal of the OTC business, which is accounted for as a discontinued operation in accordance with generally accepted accounting principles in the US (US GAAP). In accordance with US GAAP, 2002 figures from revenues down to income from continuing operations exclude the results of the OTC business, while 2002 net income and earnings per share include the results of the OTC business.

Revenues from continuing operations for the third quarter ended 30 September 2003 increased by 16% to $289.4 million (Q3 2002: $249.7 million).

The Company recorded net income of $64.6million, an increase of 2% compared to the three months ended 30 September 2002. Diluted earnings per ordinary share were 12.8 cents, or 38.3 cents per ADS, an increase of 3% over Q3 2002. This result was achieved after charging $12.1 million of closure costs in respect of Lead Optimisation and other intangible write-downs of $11.2 million.

Operations generated cash inflows from operating activities of $109.2 million.

Cash, cash equivalents and marketable securities at 30 September 2003 amounted to $1,274.7 million (31 December 2002: $1,213.8 million). After deduction of borrowings, this translates to a net cash position of $896.2 million (31 December 2002: $805.7 million). The primary use of cash will be to enhance further the Shire portfolio through product and project acquisitions.

Product sales

For the quarter ended 30 September 2003, product sales increased $32.8 million to $238.3 million (Q3 2002: $205.5 million) and represented 82% of total revenues. The Company estimates that Q3 2003 product sales were broadly in line with prescription-based demand for the quarter, however, reported sales of ADDERALL, AGRYLIN, PENTASA and PROAMATINE were lower, as predicted, as wholesalers reduced inventories. These movements were offset by the expected seasonal stocking of ADDERALL XR during the quarter.

Third Quarter 2003 Product Highlights
    Sales US Rx1 Q3 20031
   Product Sales Growth Growth US Market Share
  $M % % %

   ADDERALL XR 121.3 +55% + 34% 22%
   ADDERALL 9.0 - 51% - 48%   3%

   Total ADDERALL 130.3 +35% + 13% 25%

   AGRYLIN 25.9 - 10% + 5% 27%
   PENTASA 19.8 - 8% - 11%
   PROAMATINE 8.1 - 44% + 11% 27%
   CARBATROL 11.6 + 6% + 8% 40%

CNS Franchise

ADDERALL XR and ADDERALL for the treatment of attention deficit hyperactivity disorder (ADHD)

Total ADDERALL franchise sales in Q3 2003 were $130.3 million, an increase of 35% over Q3 2002 ($96.1 million). Over the same period, total ADDERALL franchise prescriptions grew by approximately 13%1, despite the entry of generic versions of ADDERALL last year and new competition within the ADHD market.

Increased competitive activities have had a positive impact on US ADHD market growth, which grew by 23%1 for Q3 2003. Despite competition, ADHD physicians have continued to recognise the strengths of the ADDERALL brand, which maintained its leading position in the ADHD market with a 25%1 prescription share during Q3 2003 following a strong performance during the ‘back to school’ season.

Sales of ADDERALL XR in Q3 2003 were $121.3 million, an increase of 55% over Q3 2002 ($78.0 million). ADDERALL XR prescriptions increased 34%1 between periods driven by significant US ADHD market growth and an increased share of that larger market. The difference between reported growth and prescription growth is largely due to the expected seasonal stocking of ADDERALL XR during the quarter. Wholesaler inventories at quarter-end were close to normal levels.

4


Sales of ADDERALL were $9.0 million in Q3 2003, down 51% from Q3 2002 ($18.1 million). Overall prescriptions were down approximately 48%1 between periods, reflecting the switch to ADDERALL XR and generic competition

In August 2003 Shire was granted a new US patent, No 6,605,300, which covers ADDERALL XR. In September 2003, Shire filed a lawsuit against Barr Laboratories Inc for infringement of this '300 patent. The lawsuit results from an Abbreviated New Drug Application (ANDA) filed by Barr for a generic version of ADDERALL XR.

CARBATROL for the treatment of epilepsy

CARBATROL sales increased by $0.7 million or 6%, compared to Q3 2002, versus an 8%1 increase in prescriptions.

Following the recommencement of promotional efforts, Shire has grown CARBATROL’s share of the extended release carbamazepine market from 36%1 in Q3 2002 to 40%1 in Q3 2003.

In August 2003 Shire received a Paragraph IV letter confirming that a generic company has filed an ANDA for CARBATROL 300 mg. This dose strength represents half of Shire’s current sales in epilepsy. Shire is currently evaluating this Paragraph IV notice and is still planning to file for a bipolar indication in 2004.

Other Franchises

AGRYLIN for the treatment of thrombocythaemia

AGRYLIN sales decreased by 10% in Q3 2003 however, US prescription growth increased by 5%1. The decrease in sales in Q3 2003 was expected as wholesalers reduced stocking from Q2 2003 levels. Shire anticipates further de-stocking in Q4 if wholesalers return to normalised inventory levels by year-end

AGRYLIN remains the only product specifically approved for essential thrombocythaemia in the US. Shire is seeking a paediatric extension for AGRYLIN which would extend its orphan drug exclusivity from March 2004 to September 2004, after which time it is expected to face generic competition. The expected launch of XAGRID in the EU (the trade name of AGRYLIN used in the EU) will continue to drive growth from markets outside the US.

PENTASA for the treatment of ulcerative colitis

PENTASA sales decreased by 8% compared to Q3 2002, despite no change1 in prescription demand for the same period. The decrease in sales in Q3 2003 was expected as wholesalers reduced stocking from Q2 2003 levels. Shire anticipates further de-stocking in Q4 if wholesalers return to normalised inventory levels by year-end.

Although its formal indication is for mild to moderately active ulcerative colitis, PENTASA is used mainly in Crohn’s Disease.

PROAMATINE for the treatment of hypotension

Prescription growth for PROAMATINE increased by 11%1compared to Q3 2002, while sales decreased by 44% during the quarter. The decrease in sales in Q3 2003 was expected as wholesalers reduced stocking from Q2 2003 levels. Shire anticipates additional de-stocking in Q4.

PROAMATINE’s Orphan Drug Status expired in September 2003. Since then several generic copies have entered the market.

Royalties

Royalty revenue increased 14% to $49.7 million for Q3 2003 (Q3 2002: $43.5 million) as a result of strong sales and positive foreign exchange movements.

Third Quarter 2003 Royalty Highlights
Product Royalties
to Shire
$M
Royalty
growth
%
Worldwide in-market sales by
licensee in Q3 2003
2
$M
3TC 35.3 + 9%* 272
ZEFFIX 6.2 + 12%** 52
Other 8.2 + 51% n/a
*The impact of foreign exchange movements has contributed 3% to the reported growth
**The impact of foreign exchange movements has contributed 5% to the reported growth

5


 

For the products 3TC and ZEFFIX, treatments for HIV infection and chronic hepatitis B respectively, Shire receives royalties from GlaxoSmithKline (GSK) on worldwide sales, with the exception of Canada, where a commercialisation partnership with GSK exists.

The nucleoside analogue market for HIV has continued to exhibit solid growth in recent months. This growth is supported by increases in the number of individuals living with HIV, as well as reduced mortality due to more effective treatment regimens.

Royalty revenue is also received in respect of REMINYL from Johnson & Johnson, and in respect of a number of hormone replacement therapy products from various licensees.

REMINYL, for the treatment of mild to moderately severe dementia of the Alzheimer’s type is growing well in the Alzheimer’s market. Progress continues with other indications and formulations.

Cost of product sales

For the third quarter ended 30 September 2003, cost of product sales amounted to 15.9% of product sales (Q3 2002: 15.5%).

Research and development (R&D)

R&D expenditure increased to $53.3 million in Q3 2003 from $42.0 million in Q3 2002. Expressed as a percentage of total revenues, R&D expenditure for the quarter was 18% (Q3 2002: 17%). Included within the expenditure for Q3 2003 is $6.6 million in respect of costs resulting from the closure of early stage research.

Selling, general and administrative (SG&A)

SG&A expenses decreased from $82.4 million in Q3 2002 to $82.3 million in Q3 2003. As a percentage of product sales, these expenses were 35% (2002: 40%).

The decrease, as a percentage of product sales, was the result of heavy investment in the ADDERALL XR brand in 2002 during its initial US ‘back to school’ season.

Depreciation and amortisation

The depreciation and amortisation charge for Q3 2003 was $27.1 million, an increase of $14.5 million compared to Q3 2002. Included within the Q3 2003 charge are $11.2 million of intangible asset write-downs (Q3 2002 $3.0 million) and $5.5 million of tangible fixed asset write-downs.

Interest income and expense

For the three months ended 30 September 2003, the Company received interest income of $3.7 million (Q3 2002: $5.1 million). Interest expense decreased from $2.3 million in Q3 2002 to $2.0 million in Q3 2003, primarily due to the partial buy back of the convertible notes in Q2 2003 at a discount to their par value.

Other (expense)/income, net

For the three months ended 30 September 2003, other expense totalled $0.7 million (Q3 2002: other income of $0.2 million). The quarter on quarter change is due to foreign exchange movements.

Taxation

For Q3 2003 income taxes increased $2.1 million to $25.1 million, from $23.0 million for Q3 2002. The effective tax rate was 28% for Q3 2003 (2002: 27%). Net deferred tax assets totalled $58.4 million at 30 September 2003. Realisation is dependent upon generating sufficient taxable income to utilise such assets. Although realisation of these assets is not assured, management believe it is more likely than not that the deferred tax assets will be realised.

Equity in (losses)/earnings of equity method investees

The Company received $0.9 million, representing a 50% share of earnings from the antiviral commercialisation partnership with GSK in Canada (Q3 2002: $0.7 million). A loss of $0.9 million was incurred representing a 50% share of the losses in Qualia Computing Inc (Q3 2002: $nil).

6


Closure costs

Included within operating expenses is a charge of $12.1 million in relation to the closure of early stage research. This includes severance payments to employees and the write-off of tangible fixed assets.

Discontinued operations

The Company completed the divestment of its OTC portfolio on 27 December 2002. These products were originally acquired in 1999 as a result of the Company’s merger with Roberts Pharmaceutical Corporation. In accordance with US GAAP the 2002 results have been restated to present the results of these products as a discontinued operation.

The OTC business contributed net income of $1.8 million for the three months ended 30 September 2002, which is included in the reported net income number for 2002.

R&D OVERVIEW

As part of its strategic review Shire will re-focus its portfolio onto lower risk, later stage opportunities and to build its franchise in CNS, GI and in renal. The re-focus and prioritisation will enable Shire to alter the risk-balance profile of the portfolio to improve the likely return on this investment.

R&D activities from July to October 2003

CENTRAL NERVOUS SYSTEM (CNS)

ADDERALL XR for the treatment of attention deficit hyperactivity disorder (ADHD)

Shire received an ‘approvable’ letter from the US Food and Drug Administration (FDA) for ADDERALL XR® once daily treatment for adult Attention Deficit Hyperactivity Disorder (ADHD) on 17 October 2003. Shire is working with the FDA to answer the questions raised in the approvable letter.

GASTROINTESTINAL

SPD476 for the treatment of ulcerative colitis

This project is progressing well and has now entered Phase III development.

RENAL

FOSRENOL for the treatment of hyperphosphataemia

Shire’s clinical package now includes data from four years of use of FOSRENOL in patients. Questions from the European Reference Member State have now been answered and data was submitted in October. Following the receipt of the US approvable letter Shire is analysing current data to provide answers to the questions raised in the letter from the US FDA; these will be submitted by year-end.

7


US GAAP Results
Unaudited Condensed Consolidated Balance Sheets

          (Audited)  
    30 September   31 December  
    2003   2002  
  $’000 $’000  
   
 
 
ASSETS            
Current assets:              
Cash and cash equivalents   1,061,523   897,718  
Marketable securities   213,186   316,126  
Accounts receivable, net   181,526   138,397  
Inventories   56,201   49,216  
Deferred tax asset   44,955   34,849  
Prepaid expenses and other current assets   42,173   30,790  
   
 
 
Total current assets   1,599,564   1,467,096  
           
Investments   76,589   71,962  
Property, plant and equipment, net   167,611   135,234  
Goodwill, net   210,485   203,767  
Other intangible assets, net   308,372   301,084  
Deferred tax asset   13,422   6,216  
Other non-current assets   20,691   23,264  
   
 
 
Total assets   2,396,734   2,208,623  
   
 
 
LIABILITIES AND SHAREHOLDERS’ EQUITY              
Current liabilities:              
Current instalments of long-term debt   1,008     888  
Accounts payable and accrued expenses   198,355   184,107  
Other current liabilities   23,458   15,492  
   
 
 
Total current liabilities from continuing operations   222,821   200,487  
Current liabilities from discontinued operations     -   12,784  
   
 
 
Total current liabilities   222,821   213,271  
               
Long-term debt, excluding current instalments   377,545   407,302  
Other long-term liabilities   13,134   14,884  
   
 
 
Total liabilities   613,500   635,457  
   
 
 
Shareholders’ equity:              
Common stock of 5p par value; 800,000,000 shares              
authorised; and 477,335,061 (December 31, 2002:              
484,344,412) shares issued and outstanding   39,473   40,051  
Exchangeable shares; 5,840,110 (December 31, 2002:              
5,874,112) shares issued and outstanding   270,698   272,523  
Additional paid-in capital   979,868   1,027,499  
Accumulated other comprehensive income/(loss)   25,501   (41,431 )
Retained earnings   467,694   274,524  
   
 
 
Total shareholders’ equity   1,783,234   1,573,166  
   
 
 
Total liabilities and shareholders’ equity   2,396,734   2,208,623  
   
 
 

8


US GAAP Results
Unaudited Condensed Consolidated Statements of Operations

  3 months to   3 months to   9 months to   9 months to  
  30   30   30   30  
  September   September   September   September  
  2003   2002   2003   2002  
  $’000   $’000   $’000   $’000  
 
 
 
 
 
Total revenues 289,442   249,720   892,947   734,786  
Cost of revenues (37,986 ) (31,768 ) (115,624 ) (86,509 )
 
 
 
 
 
Gross profit 251,456   217,952   777,323   648,277  
Operating expenses (162,644 ) (136,962 ) (505,102 ) (421,885 )
 
 
 
 
 
Operating income 88,812   80,990   272,221   226,392  
                 
Interest income 3,688   5,142   13,099   14,693  
Interest expense (1,995 ) (2,280 ) (7,332 ) (6,053 )
Other (expense)/income, net (702 ) 200   (7,997 ) 431  
 
 
 
 
 
Total other income/(expense), net 991   3,062   (2,230 ) 9,071  
 
 
 
 
 
Income from continuing operations before income taxes and equity in (losses)/earnings of equity method investees 89,803   84,052   269,991   235,463  
                 
Income taxes (25,139 ) (22,954 ) (75,122 ) (64,034 )
                 
Equity in (losses)/earnings of equity method investees (45 ) 704   (1,699 ) 3,303  
 
 
 
 
 
Income from continuing operations 64,619   61,802   193,170   174,732  
                 
Income from discontinued operations (net of income tax expense of $nil, $1,047,000, $nil and $2,915,000 respectively) -   1,783   -   4,962  
 
 
 
 
 
Net income 64,619   63,585   193,170   179,694  
 
 
 
 
 
                 
Earnings per share:                
Basic                
Continuing operations 13.1c   12.3c   38.7c   34.9c  
Discontinued operations -   0.4c   -   1.0c  
 
 
 
 
 
Net income 13.1c   12.7c   38.7c   35.9c  
 
 
 
 
 
Diluted                
Continuing operations 12.8c   12.0c   37.9c   34.1c  
Discontinued operations -   0.4c   -   1.0c  
 
 
 
 
 
Net income 12.8c   12.4c   37.9c   35.1c  
 
 
 
 
 
Weighted average number of shares:                
Basic 494,827,334   501,026,581   499,414,490   500,394,452  
Diluted 515,826,822   524,130,078   520,530,702   524,058,558  

The results for the 3 and 9 months ended 30 September 2002 have been restated to reflect the disposal of our OTC business that has been accounted for as a discontinued operation.

9


US GAAP Results
Unaudited Condensed Consolidated Statements of Cash Flows

  3 months to   3 months to   9 months to   9 months to  
  30   30   30   30  
  September   September   September   September  
  2003   2002   2003   2002  
  $’000
  $’000
  $’000
  $’000
 
CASH FLOWS FROM OPERATING                
ACTIVITIES:                
Net income from continuing operations 64,619   61,802   193,170   174,732  
Adjustments to reconcile net income to net cash provided by operating activities:                
      Depreciation and amortisation 10,390   9,548   31,851   27,360  
      Stock option compensation -   (16 ) (24 ) (166 )
      Tax benefit of stock option compensation,                
      charged directly to equity -   (2 ) -   687  
      Decrease/(increase) in deferred tax asset 483   9,634   (17,312 ) 4,939  
      Non cash exchange gains and losses 1,855   1,263   7,792   2,935  
      Equity in losses/(earnings) of equity method investees 45   (704 ) 1,699   (3,303 )
      Write-down of long term investments -   3,000   8,472   5,500  
      Write-down of intangible assets 11,150   3,000   14,437   7,500  
      Write-down of tangible assets 5,521   -   5,521   -  
      (Gain)/loss on sale of fixed assets (104 ) 37   (104 ) 153  
Changes in operating assets and liabilities, net of acquisitions:                
      Decrease/(increase) in accounts receivable 13,382   (28,372 ) (43,129 ) 25,032  
      Increase in inventory (1,796 ) (5,709 ) (6,985 ) (15,118 )
      Increase in prepayments and other current assets (6,818 ) (13,874 ) (11,383 ) (9,546 )
      Decrease in other assets 1,939   2,069   2,573   2,638  
   Increase/(decrease) in accounts and                
      notes payable and other liabilities 6,249   6,136   7,680   (46,281 )
      Decrease in unearned income -   -   -   (17,409 )
Dividend received from equity method investees 2,289   -   2,289   -  
 
 
 
 
 
Net cash provided by operating activities 109,204   47,812   196,547   159,653  
 
 
 
 
 
CASH FLOWS FROM INVESTING ACTIVITIES                
Decrease (increase) in short-term deposits 4,491   (42,907 ) 102,940   455,114  
Purchase of long-term investments -   (3,131 ) (1,475 ) (4,148 )
Purchase of subsidiary undertakings -   (17,000 ) -   (17,000 )
Purchase of intangible assets (10,608 ) (187 ) (36,108 ) (18,697 )
Proceeds from sale of fixed assets 852   -   852   -  
Purchase of property, plant and equipment (10,475 ) (3,965 ) (38,076 ) (11,613 )
 
 
 
 
 
Net cash (used in)/provided by investing activities (15,740 ) (67,190 ) 28,133   403,656  
 
 
 
 
 
CASH FLOWS FROM FINANCING ACTIVITIES:                
Repurchase/payments on long-term debt,                
capital leases and notes (63 ) (145 ) (29,942 ) (2,728 )
Proceeds from exercise of options 127   903   2,381   4,455  
Payment for the redemption of stock -   -   (52,392 ) -  
 
 
 
 
 
Net cash provided by/(used in) financing activities 64   758   (79,953 ) 1,727  
 
 
 
 
 

10


US GAAP Results
Unaudited Condensed Consolidated Statements of Cash Flows (continued)

    3 months to   3 months to     9 months to   9 months to  
    30   30     30   30  
    September   September     September   September  
    2003   2002     2003   2002  
  $’000   $’000     $’000   $’000  
Effect of foreign exchange rate changes on                    
cash and cash equivalents   515   (3,797 )   19,078   5,692  
   
 
   
 
 
Net increase/(decrease) in cash and cash                    
equivalents   94,043   (22,417 )   163,805   570,728  
Cash flows provided by discontinued                    
operations   -   2,509     -   5,847  
   
 
   
 
 
Net increase/(decrease) in cash and cash                    
equivalents   94,043   (19,908 )   163,805   576,575  
Cash and cash equivalents at beginning of                    
period   967,480   714,523     897,718   118,040  
   
 
   
 
 
Cash and cash equivalents at end of period   1,061,523   694,615     1,061,523   694,615  
   
 
   
 
 

11


Selected Notes to the Unaudited US GAAP Financial Statements

(1) Analysis of revenues, operating income and reportable segments

The Company has disclosed segment information for the individual operating areas of the business, based on the way in which the business is managed and controlled. The Company evaluates performance based on operating income or loss before interest and income taxes.

For 2003 our reporting has been expanded as set out below to provide more information on the Corporate and International segments. The 2002 reportable segments have been restated on this basis.

3 months to 30 September US   International   Biologics   Corporate   R&D   Total  
2003 $’000   $’000   $’000   $’000   $’000   $’000  
 
 
 
 
 
 
 
Product sales 190,530   39,096   8,720   -   -   238,346  
Licensing and development 1,355   -   -   -   -   1,355  
Royalties -   2,282   -   47,453   -   49,735  
Other 6   -   -   -   -   6  
 
 
 
 
 
 
 
Total revenues 191,891   41,378   8,720   47,453   -   289,442  
 
 
 
 
 
 
 
                         
Cost of product sales 18,401   12,504   7,081   -   -   37,986  
Research and development -   -   -   -   53,309   53,309  
Selling, general and administrative 49,440   18,559   2,194   12,081   -   82,274  
                         
Depreciation and amortisation 9,083   *16,102   1,142   734   -   27,061  
 
 
 
 
 
 
 
Total operating expenses 76,924   47,165   10,417   12,815   53,309   200,630  
 
 
 
 
 
 
 
Operating income/(loss) 114,967   (5,787 ) (1,697 ) 34,638   (53,309 ) 88,812  
 
 
 
 
 
 
 
                         
                         
3 months to 30 September US   International   Biologics   Corporate   R&D   Total  
2002 $’000   $’000   $’000   $’000   $’000   $’000  
 
 
 
 
 
 
 
Product sales 166,995   34,920   3,589   -   -   205,504  
Licensing and development 726   -   -   -   -   726  
Royalties -   2,132   -   41,353   -   43,485  
Other revenues -   5   -   -   -   5  
 
 
 
 
 
 
 
Total revenues 167,721   37,057   3,589   41,353   -   249,720  
 
 
 
 
 
 
 
                         
Cost of product sales 11,556   17,152   3,060   -   -   31,768  
Research and development -   -   -   -   42,026   42,026  
Selling, general and administrative 45,254   19,462   2,054   15,618   -   82,388  
Depreciation and amortisation 7,548   2,951   915   1,134   -   12,548  
 
 
 
 
 
 
 
Total operating expenses 64,358   39,565   6,029   16,752   42,026   168,730  
 
 
 
 
 
 
 
Operating income/(loss) 103,363   (2,508 ) (2,440 ) 24,601   (42,026 ) 80,990  
 
 
 
 
 
 
 

*Included within depreciation and amortisation costs in the International segment for the 3 months to 30 September 2003 are $5.5 million of tangible asset write-downs in respect of the closure of Lead Optimisation and intangible asset write-downs of $7.8 million.

12


Selected Notes to the Unaudited US GAAP Financial Statements (continued)

(1) Analysis of revenues, operating income and reportable segments (continued)

9 months to 30 September US   International   Biologics   Corporate   R&D   Total
2003 $’000   $’000   $’000   $’000   $’000   $’000
 
 
 
 
 
 
Product sales 620,100   110,843   10,206   -   -   741,149
Licensing and development 2,451   -   -   -   -   2,451
Royalties 14   7,206   -   142,114   -   149,334
Other revenues 13   -   -   -   -   13
 
 
 
 
 
 
Total revenues 622,578   118,049   10,206   142,114   -   892,947
 
 
 
 
 
 
                       
Cost of product sales 71,660   35,600   8,364   -   -   115,624
Research and development -   -   -   -   158,004   158,004
Selling, general and administrative 185,066   56,800   6,810   46,613   -   295,289
Depreciation and amortisation 25,136   *20,846   3,412   2,415   -   51,809
 
 
 
 
 
 
Total operating expenses 281,862   113,246   18,586   49,028   158,004   620,726
 
 
 
 
 
 
Operating income/(loss) 340,716   4,803   (8,380 ) 93,086   (158,004 ) 272,221
 
 
 
 
 
 
                       
                       
9 months to 30 September US   International   Biologics   Corporate   R&D   Total
2002 $’000   $’000   $’000   $’000   $’000   $’000
 
 
 
 
 
 
Product sales 508,203   96,483   4,186   -   -   608,872
Licensing and development 1,929   402   -   -   -   2,331
Royalties 221   5,172   -   118,180   -   123,573
Other revenues -   10   -   -   -   10
 
 
 
 
 
 
Total revenues 510,353   102,067   4,186   118,180   -   734,786
 
 
 
 
 
 
                       
Cost of product sales 41,531   41,159   3,819   -   -   86,509
Research and development -   -   -   -   138,557   138,557
Selling, general and administrative 154,837   51,580   6,023   36,028   -   248,468
Depreciation and amortisation 21,027   7,649   3,100   3,084   -   34,860
 
 
 
 
 
 
Total operating expenses 217,395   100,388   12,942   39,112   138,557   508,394
 
 
 
 
 
 
Operating income/(loss) 292,958   1,679   (8,756 ) 79,068   (138,557 ) 226,392
 
 
 
 
 
 

*Included within depreciation and amortisation costs in the International segment for the 9 months to 30 September 2003 are $5.5 million of tangible asset write-downs in respect of the closure of Lead Optimisation and intangible asset write-downs of $7.8 million.

**Included within the selling, general and administrative costs in the Corporate segment for the 9 months to 30 September 2003 is $7.2 million in respect of the former Chief Executive’s departure.

13


Selected Notes to the Unaudited US GAAP Financial Statements (continued)

(2) Earnings per share

Basic earnings per share is based upon the net income available to common stockholders divided by the weighted-average number of common shares outstanding during the period.

Diluted earnings per share is based upon net income available to common stockholders divided by the weighted-average number of common shares outstanding during the period and adjusted for the effect of all dilutive potential common shares that were outstanding during the period.

  3 months to   3 months to   9 months to   9 months to
  30   30   30   30
  September   September   September   September
  2003   2002   2003   2002
  $’000   $’000   $’000   $’000
 
 
 
 
Numerator for basic earnings per share 64,619   63,585   193,170   179,694
Interest charged on convertible debt, net of tax 1,200   1,380   3,923   4,188
 
 
 
 
Numerator for diluted earnings per share 65,819   64,965   197,093   183,882
 
 
 
 
               
  Number of   Number of   Number of   Number of
  shares   shares   shares   shares
 
 
 
 
Weighted-average number of shares:              
Basic 494,827,334   501,026,581   499,414,490   500,394,452
Effect of dilutive shares:              
Stock options 2,628,923   1,993,136   2,043,820   2,553,745
Warrants -   1,263,184   -   1,263,184
Convertible debt 18,370,565   19,847,177   19,072,392   19,847,177
 
 
 
 
Diluted 515,826,822   524,130,078   520,530,702   524,058,558
 
 
 
 
               
Basic earnings per share 13.1c   12.7c   38.7c   35.9c
 
 
 
 
Diluted earnings per share 12.8c   12.4c   37.9c   35.1c
 
 
 
 

Warrants to purchase approximately 1.4 million common shares for the three and nine months ended 30 September 2003 were anti-dilutive and were therefore excluded from the computation of diluted earnings per share.

Stock options to purchase approximately 17.5 million and 17.7 million common shares for the three months and nine months ended September 30, 2003 respectively, were anti-dilutive and were therefore excluded from the computation of diluted earnings per share.

14


Selected Notes to the Unaudited US GAAP Financial Statements (continued)

(3) Analysis of revenues

  3 months to
 
3 months to   3 months to   3 months to  
  30 September   30 September   30 September   30 September  
  2003   2002   2003   2003  
  $’000   $’000   % change   % of total  
 
 
 
 
 
Net product sales:                
ADDERALL XR 121,255   78,000   +55 % 42 %
ADDERALL 8,961   18,128   -51 % 3 %
AGRYLIN 25,907   28,725   -10 % 9 %
PENTASA 19,838   21,619   -8 % 7 %
PROAMATINE 8,102   14,398   -44 % 3 %
CARBATROL 11,619   10,944   +6 % 4 %
Calciums 7,009   6,126   +14 % 2 %
Others 35,655   27,564   +29 % 12 %
 
 
 
 
 
  238,346   205,504   +16 % 82 %
 
 
 
 
 
Royalty income:                
3TC 35,300   32,501   +9 % 12 %
ZEFFIX 6,217   5,547   +12 % 2 %
Others 8,218   5,437   +51 % 3 %
 
 
 
 
 
  49,735   43,485   +14 % 17 %
 
 
 
 
 
Licensing 1,355   726   +87 % 1 %
Other 6   5   +20 % -  
 
 
 
 
 
Total revenues 289,442   249,720   +16 % 100 %
 
 
 
 
 
                 
  9 months to   9 months to   9 months to   9 months to  
  30 September   30 September   30 September   30 September  
  2003   2002   2003   2003  
  $’000   $’000   % change   % of total  
 
 
 
 
 
Net product sales:                
ADDERALL XR 338,847   215,696   +57 % 38 %
ADDERALL 47,051   92,619   -49 % 5 %
AGRYLIN 102,132   81,596   +25 % 12 %
PENTASA 74,311   60,645   +23 % 8 %
PROAMATINE 40,238   34,839   +15 % 5 %
CARBATROL 34,955   35,090   -   4 %
Calciums 19,476   16,528   +18 % 2 %
Others 84,139   71,859   +17 % 9 %
 
 
 
 
 
  741,149   608,872   +22 % 83 %
 
 
 
 
 
Royalty income:                
3TC 106,979   93,857   +14 % 12 %
ZEFFIX 18,337   15,350   +19 % 2 %
Others 24,018   14,366   +67 % 3 %
 
 
 
 
 
  149,334   123,573   +21 % 17 %
 
 
 
 
 
Licensing 2,451   2,331   +5 % -  
Other 13   10   +30 % -  
 
 
 
 
 
Total revenues 892,947   734,786   +22 % 100 %
 
 
 
 
 

15


UK GAAP Results
Unaudited and Unreviewed Consolidated Profit and Loss Account

                  (Audited)  
  3 months to   3 months to   9 months to   9 months to   Year to  
  30   30   30   30   31  
  September   September   September   September   December  
  2003   2002   2003   2002   2002  
  £’000   £’000   £’000   £’000   £’000  
 
 
 
 
 
 
   Turnover: group and share of joint venture 181,046   161,837   559,684   502,907   697,314  
   Less: share of joint venture’s turnover (790 ) -   (2,326 ) -   (762 )
 
 
 
 
 
 
   Group turnover on continuing operations 180,256   161,837   557,358   502,907   696,552  
   Discontinued operations -   4,196   -   12,716   15,975  
 
 
 
 
 
 
   Group turnover 180,256   166,033   557,358   515,623   712,527  
   Cost of sales (24,213 ) (22,087 ) (73,709 ) (63,502 ) (95,042 )
 
 
 
 
 
 
   Gross profit 156,043   143,946   483,649   452,121   617,485  
   Net operating expenses (123,663 ) (124,524 ) (397,677 ) (395,608 ) (1,150,630 )
 
 
 
 
 
 
   Operating profit/(loss): 32,380   19,422   85,972   56,513   (533,145 )
                     
   Continuing operations - Group 32,380   17,604   85,972   51,189   (541,603 )
   Discontinued operations -   1,818   -   5,324   8,458  
 
 
 
 
 
 
  32,380   19,422   85,972   56,513   (533,145 )
                     
   Share of joint venture’s operating  loss (580 ) -   (2,571 ) -   (559 )
   Finance charges, net 380   (75 ) 3,557   720   6,931  
 
 
 
 
 
 
   Profit/(loss) on ordinary activities                    
   before taxation 32,180   19,347   86,958   57,233   (526,773 )
   Tax on profit/(loss) on ordinary activities (15,514 ) (15,412 ) (46,329 ) (44,784 ) (61,626 )
 
 
 
 
 
 
   Retained profit/(loss) for the                    
   period transferred to/(from) reserves 16,666   3,935   40,629   12,449   (588,399 )
 
 
 
 
 
 
   Earnings/(loss) per share                    
   Basic 3.4 p 0.8 p 8.1 p 2.5 p (117.5 p)
   Diluted 3.4 p 0.8 p 8.1 p 2.5 p (117.5 p)
                     
Unaudited and Unreviewed Consolidated Statement of Total Recognised Gains and Losses  
                     
                  (Audited)  
  3 months to   3 months to   9 months to   9 months to   Year to  
  30   30   30   30   31  
  September   September   September   September   December  
  2003   2002   2003   2002   2002  
  £’000   £’000   £’000   £’000   £’000  
 
 
 
 
 
 
   Profit/(loss) for the period 16,666   3,935   40,629   12,449   (588,399 )
   Translation of the financial                    
   statements of overseas subsidiaries (4,365 ) (27,989 ) 4,469   (43,746 ) (62,739 )
 
 
 
 
 
 
   Total recognised gains and losses                    
   relating to the period 12,301   (24,054 ) 45,098   (31,297 ) (651,138 )
 
 
 
 
 
 

16


UK GAAP Results
Unaudited and Unreviewed Consolidated Balance Sheet

      (Audited)  
  30   31  
  September   December  
  2003   2002  
  £’000   £’000  
 
 
 
Fixed assets        
Intangible assets – intellectual property 185,701   183,404  
Intangible assets – goodwill 1,820,048   1,900,896  
Tangible assets 100,885   84,001  
Fixed asset investments 37,387   37,345  
Investment in joint ventures        
   Share of gross assets 3,623   5,082  
   Share of gross liabilities (938 ) (342 )
 
 
 
  2,146,706   2,210,386  
 
 
 
Current assets        
Stocks 33,828   30,571  
Debtors        
-   due within one year excluding deferred tax 135,557   106,125  
-   due within one year – deferred tax 27,058   21,646  
-   due after more than one year excluding deferred tax 8,432   9,535  
-   due after more than one year – deferred tax 8,079   3,861  
Current asset investments 128,216   196,364  
Cash at bank and in hand 640,104   558,432  
 
 
 
  981,274   926,534  
Creditors: amounts falling due within one year        
   Convertible debt -   -  
   Other creditors (134,984 ) (131,885 )
 
 
 
  (134,984 ) (131,885 )
 
 
 
Net current assets 846,290   794,649  
 
 
 
Total assets less current liabilities 2,992,996   3,005,035  
Creditors: amounts falling due after more than one year        
   Convertible debt (218,214 ) (243,547 )
   Other creditors (12,311 ) (13,782 )
 
 
 
  (230,525 ) (257,329 )
 
 
 
Net assets 2,762,471   2,747,706  
 
 
 
Capital and reserves        
Called-up share capital 23,869   24,217  
Share premium 3,217,080   3,214,512  
Exchangeable shares 190,442   191,552  
Capital reserve 2,755   2,755  
Capital redemption reserve 380   -  
Other reserves 24,247   24,247  
Profit and loss account (696,302 ) (709,577 )
 
 
 
Equity shareholders’ funds 2,762,471   2,747,706  
 
 
 

17


Selected Notes to the Unaudited and Unreviewed UK GAAP Financial Statements

(1) Earnings per share

Earnings per share has been calculated by dividing the profit on ordinary activities after taxation for each period by the weighted-average number of shares in issue during those periods.

The weighted-average number of shares used in calculating fully diluted earnings per share has been adjusted for the effects of all dilutive potential ordinary shares.

The $370 million convertible loan note is excluded from the calculation of weighted average number of shares for fully diluted earnings per share in 2003 and 2002 as it was not dilutive. The zero coupon convertible loan note included in 2002 has no impact on the numerator for fully diluted earnings per share.

The warrants to purchase approximately 1.4 million common shares for the 3 and 9 months ended 30 September 2003 were anti-dilutive and were therefore excluded from the computation of diluted earnings per share.

                  (Audited)  
  3 months to   3 months to   9 months to   9 months to   Year to  
  30   30   30   30   31  
  September   September   September   September   December  
  2003   2002   2003   2002   2002  
  £’000   £’000   £’000   £’000   £’000  
 
 
 
 
 
 
Profit for the period (for basic and diluted EPS) 16,666   3,935   40,629   12,449   (588,399 )
 
 
 
 
 
 
                     
                     
  Number of   Number of   Number of   Number of   Number of  
  shares   shares   shares   shares   shares  
 
 
 
 
 
 
Weighted-average number of shares:                    
Basic 494,827,334   501,026,581   499,414,490   500,394,452   500,687,594  
Conversion of convertible debt -   -   -   -   -  
Exercise of share options 2,628,923   1,993,136   2,043,820   2,553,745   -  
Exercise of warrants -   1,263,184   -   1,263,184   -  
 
 
 
 
 
 
Fully diluted 497,456,257   504,282,901   501,458,310   504,211,381   500,687,594  
 
 
 
 
 
 

(2) Basis of preparation

The Group has applied consistent accounting policies throughout both periods.

The results for the 3 and 9 months ended 30 September 2003 have not been audited or reviewed and do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985.

The figures for the 12 months ended 31 December 2002 do not constitute the Group’s statutory accounts, which have been filed with the Registrar of Companies. The auditors have reported on these accounts and that report was unqualified and did not contain a statement under Section 237 (2) of the Companies Act 1985.

18


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