US prescriptions for ADDERALL XR for the year to December 31, 2005 were up 12%. ADDERALL XR, further strengthened its position as the leading brand in the US ADHD market with a 1% increase in market share to an all time high of 26% in December 2005 (December 2004: 25%). In addition, the US ADHD market grew 5% overall compared to the same period in 2004.
Product sales growth was higher than prescription growth for the year due mainly to the impact of price increases in December 2004 and August 2005, partially offset by a decrease in pipeline inventory and higher sales deductions.
During 2005, Shire negotiated ‘fee for service’ agreements with two of its three major US wholesalers. These industry-wide agreements change the way significant wholesale distributors are compensated by pharmaceutical manufacturers and should allow for more efficient management of inventory levels held by wholesale distributors.
FDA approval of the adolescent indication for ADDERALL XR was received on July 22, 2005.
On February 12, 2005, Shire announced that it had suspended sales of ADDERALL XR in Canada at the request of Health Canada. On August 24, 2005, Shire announced that Health Canada would reinstate the marketing authorization of ADDERALL XR in Canada effective August 26, 2005. This reinstatement follows the acceptance by Health Canada of the recommendations from the New Drug Committee, which was appointed by Health Canada at Shire’s request to review the suspension of ADDERALL XR in Canada.
During October 2005 Shire filed a Citizen Petition with the FDA requesting that the FDA require more rigorous bioequivalence testing or additional clinical testing for generic or follow-on drug products that reference ADDERALL XR before they can be approved. Shire believes that these requested criteria will ensure that generic formulations of ADDERALL XR or follow-on drug products will be clinically effective and safe. In January 2006, Shire chose to file a supplemental amendment to its original Citizen Petition, which included additional clinical data in support of the original filing. The FDA has six months to respond to Shire’s petition and while this petition is under review it will not grant final approval of generic or follow-on drug products referencing ADDERALL XR.
On February 9, 2006, an FDA Advisory Committee recommended to the FDA that risk information about cardiovascular events be included in a "black box warning" for all stimulant medicines used to treat ADHD. In making its recommendation, the Advisory Committee recognized that the reported incidence rates of the rare serious cardiovascular adverse events that were discussed by the Committee are generally within the rates that would be expected from the untreated general population. ADDERALL XR and ADDERALL already include a "black box warning" in their labels for safety concerns related to amphetamine abuse or misuse and also warn of the risk of sudden death in patients with structural cardiac abnormalities. Shire stands behind the current labeling and believes that further action is unwarranted.
In January 2006, Shire settled its ADDERALL XR patent infringement lawsuits with Impax. The litigations involved Shire’s US patents, Nos. 6,322,819 (“the ‘819 Patent”), 6,605,300 (“the ‘300 Patent”) and 6,913,768 (“the ‘768 Patent”). As part of the settlement, Impax has confirmed that its proposed generic ADDERALL XR product infringes Shire’s ‘819, ‘300 and ‘768 Patents and that the three patents are valid and enforceable. Under the terms of the settlement, Impax will be permitted to market generic versions of ADDERALL XR in the US no later than January 1, 2010 and will pay Shire a royalty from those sales. In certain situations, such as the launch of another generic version of ADDERALL XR, Impax may be permitted to enter the market as Shire’s authorized generic.
Shire’s ADDERALL XR patent infringement lawsuits with Barr continue. Shire is seeking a ruling that Barr’s Abbreviated New Drug Application (ANDA) seeking permission to market its generic versions of ADDERALL XR infringes the ‘819, ‘300 and ‘768 Patents. Barr’s 30-month stay under the Hatch-Waxman Act expired on February 18, 2006. Following the expiry of the 30-month stay, the FDA may approve Barr’s ANDA. A final pre-trial conference in the ‘819 and ‘300 patent cases is set for March 10, 2006. No trial date has been set. Shire is continuing its discussions with Barr in connection with these lawsuits and the discussions are progressing. Further information can be found in our filings with the US Securities and Exchange Commission, including our Annual Report on Form 10-K for the year to December 31, 2004 and our most recent quarterly report on Form 10-Q for the period ended September 30, 2005.
CARBATROL for the treatment of Epilepsy
US prescriptions for the year to December 31, 2005 were down 8% compared to the previous year. This was due primarily to supply constraints, a 4% decrease in Shire’s market share of the total US extended release carbamazepine prescription market to 42% in December 2005 (December 2004: 46%) and a 5% decrease in that market as a whole. The supply constraints have now been resolved.
Product sales for the year to December 31, 2005 were up 33% compared to the previous year. The difference between sales growth and the lower level of prescriptions is due to price increases in August 2004 and October 2005 and to lower sales deductions than in 2004.
Patent litigation proceedings with Nostrum Pharmaceuticals, Inc. (Nostrum) relating to CARBATROL are ongoing. No trial date has been set. Nostrum’s 30-month stay under the Hatch-Waxman Act expired on February 6, 2006. Accordingly, the FDA may approve Nostrum’s ANDA. Further information can be found in our filings with the US Securities and Exchange Commission, including our Annual Report on Form 10-K for the year to December 31, 2004 and our most recent quarterly report on Form 10-Q for the period ended September 30, 2005.
PENTASA for the treatment of Ulcerative Colitis
US prescriptions for the year to December 31, 2005 were up 6% compared to the previous year. The increase was due to the success of the co-promotional agreement with Solvay Pharmaceuticals Inc., the impact of the 500mg dosage form launched in the third quarter of 2004 and a 2% increase in the total US oral mesalamine prescription market.
Product sales for the year to December 31, 2005 were up 18%, compared to the previous year. The difference between sales growth and prescription growth is due to the impact of the September 2004 price increase and a normalization of pipeline inventories compared to lower levels in 2004.
PENTASA had an 18% share of the total US oral mesalamine prescription market in December 2005 (December 2004: 18%).
AGRYLIN/XAGRID for the treatment of Thrombocythemia
AGRYLIN/XAGRID sales worldwide for the year to December 31, 2005 were $92.8 million, down 39% compared to the previous year (2004: $152.5 million).
North American sales were $46.0 million, down 61% compared to the previous year (2004: $119.1 million). This reduction was expected following the approval of generic versions of AGRYLIN in the US market in April 2005.
Rest of the World sales (all sales outside North America) were $46.8 million, up 40%, compared to the previous year (2004: $33.4 million). This was primarily due to the successful launch of XAGRID in the UK, Germany and France in the first quarter of 2005 and Spain in the third quarter of 2005. In accordance with current orphan drug legislation in the EU, XAGRID will have up to 10 years of marketing exclusivity in the EU.
FOSRENOL for the treatment of Hyperphosphatemia
FOSRENOL was launched in the US in January 2005. Product sales for the year to December 31, 2005 were $53.5 million, with US prescriptions for the year totaling 137,000.
FOSRENOL had an 8% share of the total US phosphate binding market in December 2005.
On November 28, 2005 the FDA approved new, higher dose formulations of FOSRENOL. New, higher dose strengths of 750 milligrams and 1,000 milligrams were shipped to wholesalers in the US in December 2005. Higher dose strengths should help to reduce the number of pills that end-stage renal disease patients need to take to achieve target phosphorus levels.
Product sales in Q4 2005 were $29.0 million compared with $9.7 million in Q3 2005. The variance relates primarily to increased pipeline inventory sales to wholesalers of the new higher dose formulation during December.
FOSRENOL was launched in Austria in December 2005. Shire continues its discussions relating to FOSRENOL with regulatory authorities and reimbursement agencies across Europe and other regions and further launches are expected in European markets over the next few months, subject to obtaining national approvals and concluding pricing and reimbursement negotiations.
REPLAGAL for the treatment of Fabry Disease
REPLAGAL was acquired by Shire as part of the TKT acquisition, which completed on July 27, 2005. Product sales for the period since acquisition were $41.3 million. The majority of REPLAGAL sales are in Europe. Total sales for the full year, including pre-acquisition sales, were $94.6 million (2004: $77.4 million). The increase in sales (including pre-acquisition sales) is primarily due to greater European coverage by an increased number of sales representatives.
3. Royalties
Royalty revenue increased 5% to $242.9 million for the year to December 31, 2005 (2004: $230.4 million) as a result of growth in sales.
Royalty Highlights
Product | Royalties to Shire $M | Royalty(4) Growth % | Worldwide in-market sales by licensee(3)in 2005 $M |
3TC | 159.8 | +3%(1) | 1,211 |
ZEFFIX | 30.5 | +11%(2) | 266 |
Other | 52.6 | +11% | n/a |
(1) | The impact of foreign exchange movements has contributed +1% to the reported growth. |
(2) | The impact of foreign exchange movements has contributed +2% to the reported growth. |
(3) | GSK. |
(4) | Compared with 2004. |
3TC
Royalties from sales of 3TC for the year to December 31, 2005 were $159.8 million, an increase of 3% compared to 2004 ($155.8 million). This was due to the continued growth in the nucleoside analog market for HIV and the positive impact of foreign exchange movements.
Shire receives royalties from GSK on worldwide 3TC sales. GSK’s worldwide sales of 3TC for the year to December 31, 2005 were $1,211 million, an increase of 2% compared to prior year (2004: $1,184 million).
ZEFFIX
Royalties from sales of ZEFFIX for the year to December 31, 2005 were $30.5 million, an increase of 11% compared to 2004 ($27.4 million), due to strong growth in the Japanese market and the positive impact of foreign exchange movements.
Shire receives royalties from GSK on worldwide ZEFFIX sales. GSK’s worldwide sales of ZEFFIX for the year to December 31, 2005 were $266 million, an increase of 11% compared to prior year (2004: $240 million).
OTHER
Other royalties are primarily in respect of REMINYL and REMINYL XL (now marketed as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide by Janssen Pharmaceutica N.V. (Janssen), an affiliate of Johnson and Johnson, with the exception of the United Kingdom and the Republic of Ireland where Shire acquired the exclusive marketing rights from May 2004.
Sales of the REMINYL/RAZADYNE range, for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer’s type, are growing well in the Alzheimer’s market.
On March 1, 2005, the National Institute for Health and Clinical Excellence (NICE) in England and Wales issued an Appraisal Consultation Document (ACD). This document included a recommendation that all existing approved products for the symptomatic treatment of mild to moderate Alzheimer's disease in England and Wales should no longer be reimbursed by the National Health Service (NHS) when used in the treatment of new patients. The recommendation potentially affected sales of REMINYL and of REMINYL XL in England and Wales. An amended ACD was issued by NICE on January 23, 2006. The new ACD recommends that REMINYL and REMINYL XL, together with other drugs in the same class, be reimbursed on the NHS when used for the treatment of either (i) patients with existing Alzheimer's disease already being treated with one of these drugs; or (ii) newly diagnosed patients once their disease has progressed to a moderate stage. Therefore the current recommendation excludes the reimbursement of treatment for patients presenting with mild symptoms of Alzheimer’s disease for which REMINYL and REMINYL XL are approved. A final appraisal document is expected from NICE in July 2006.
On April 11, 2005, Ortho-McNeil Neurologics Inc. (Janssen's US affiliate company) announced that REMINYL would be marketed in the US under the new product name of RAZADYNE. Subsequently, in the US, REMINYL XL was launched as RAZADYNE ER. Ortho-McNeil Neurologics Inc. worked closely with the FDA on a name change following dispensing errors in the US, between REMINYL and the Type 2 diabetes mellitus drug known as AMARYL. Shire is only aware of one similar dispensing error outside the US.
4. Financial details
Cost of product sales
For the year to December 31, 2005 the cost of product sales amounted to 16% of product sales (2004: 13%). The decrease in gross margin is primarily due to the addition of REPLAGAL to Shire’s product portfolio following the acquisition of TKT. REPLAGAL’s cost of product sales relates entirely to the acquired inventories, which in accordance with US GAAP, have been accounted for at fair value, estimated to be 97% of the expected sales price of REPLAGAL. Accordingly, little or no margin will be reflected for REPLAGAL sales until all acquired finished goods have been sold (anticipated Q3 2006). For the year to December 31, 2005 the cost of product sales for REPLAGAL includes a $41.9 million adjustment in respect of the acquired inventory, of which $39.8 million related to sales of acquired finished goods and $2.1 million was a write-off of damaged work-in-progress. In 2005, this fair value adjustment increased Shire’s cost of product sales by 3%.
Research and development (R&D)
R&D expenditure increased from $196.3 million in the year to December 31, 2004 to $336.2 million in 2005. Expressed as a percentage of total revenues, R&D expenditure was 21% for the year to December 31, 2005 (2004: 14%). The increase was primarily due to:
- The initial payment to New River of $50 million for in-licensing NRP104, which has beenexpensed in accordance with the Company’s accounting policy; and
- The addition of two significant R&D projects following the acquisition of TKT (ELAPRASE andGA-GCB).
The New River payment and the R&D expenditure on ELAPRASE and GA-GCB represented 5% of total revenues.
Shire’s pipeline is now well advanced with seven projects in late stage development or registration.
Selling, general and administrative (SG&A)
SG&A expenses increased from $458.1 million in the year to December 31, 2004 to $631.1 million in 2005, an increase of 38%. As a percentage of product sales, these expenses were 48% (2004: 41%).
This increase was expected, with additional costs attributable to four product launches during 2005, together with incremental costs in 2005 associated with the new FOSRENOL and EQUETRO sales forces, patent litigation and infrastructure, $24.5 million of SG&A costs related to the acquired TKT business and $4.5 million related to the set up of the new listed holding company for the Shire group.
Depreciation and amortization
The depreciation charge for the year to December 31, 2005 was $29.2 million (2004: $19.8 million), which in 2005 included property, plant and equipment write-downs of $6.5 million (2004: $nil). Amortization charges, including the amortization on acquired products, were $45.2 million for the year to December 31, 2005 (2004: $38.7 million).
Intangible asset impairment
The charge for intangible asset impairments for the year to December 31, 2005 was $5.6 million (2004: $13.5 million).
The approval of generic versions of AGRYLIN in April 2005 and the decision not to support and promote certain non-core products going forward resulted in changes to the estimate of Shire’s future cash flows and, as a result, impairments were required in both 2005 and 2004.
Reorganization costs
During the year to December 31, 2005 Shire incurred reorganization costs of $9.3 million (2004: $48.5 million). These costs related to Shire’s North American site consolidation, which commenced in 2004. The site consolidation is now complete and no further reorganization costs are expected.
During the year to December 31, 2005 the reorganization costs were for employee severance ($1.6 million), operating duplicate facilities ($7.2 million) and other costs ($0.5 million).
During the year to December 31, 2004 the reorganization costs were for employee severance ($20.0 million), relocation ($13.8 million) and other costs ($14.7 million).
Integration costs
For the year to December 31, 2005, the Company incurred $9.7 million of costs associated with the integration of the TKT business into the Shire group (2004: $nil). This included retention payments for key staff of $7.0 million, IT costs of $1.0 million and other costs of $1.7 million.
In-process R&D write-off
During the year to December 31, 2005, as required under US GAAP, Shire wrote off the portion of the TKT purchase price allocated to in-process R&D of $673.0 million. This amount represents the value of those intangible assets acquired as part of the TKT acquisition, which at the time of acquisition had not been approved by the FDA or other regulatory authorities, including ELAPRASE and GA-GCB.
Interest income
For the year to December 31, 2005 the Company received interest income of $35.3 million (2004: $21.9 million). The increase compared to 2004 is due to higher interest rates on Shire’s US cash deposits, which were partially offset by the interest foregone by Shire on the net payments of $1.2 billion made to date in respect of the acquisition of TKT.
Interest expense
For the year to December 31, 2005 the Company incurred interest expense of $12.0 million (2004: $12.3 million).
In 2005, this expense included a $7.7 million provision for interest, which may be awarded by the court in respect of amounts due to those ex-TKT shareholders who have requested appraisal of the acquisition consideration payable for their TKT shares. In addition, interest expense includes $1.2 million, relating to the costs of a bridging loan to finance the TKT acquisition and other interest related expenses of $3.1 million.
In 2004, interest expense included the write-off of $8.0 million of deferred debt acquisition costs arising on the issue of convertible loan notes in August 2001. The write-off was required as a significant portion of the convertible loan notes were redeemed. The $8.0 million represented the balance of these fees at the date of redemption in August 2004. In addition, interest expense included a $4.2 million interest charge incurred prior to the redemption and $0.1 million of other interest related expenses.
Other income/(expense), net
For the year to December 31, 2005 other income totaled $9.9 million (2004: $3.8 million).
Other income for 2005 included a $3.9 million realized gain on the sale of a portfolio investment, $4.3 million in respect of other investment income, a $3.6 million gain on the sale of Shire’s drug formulation business and other net income of $ 0.1 million, offset by a write-down of certain portfolio investments ($2.0 million).
Other income for 2004 consisted of a $14.8 million realized gain on the sale of a portfolio investment, $4.1 million of other investment income and other net income of $0.4 million. This income was offset by the write-down of certain portfolio investments ($15.5 million).
Taxation
The effective tax rate for 2005 on US GAAP losses was negative 29% (a tax charge of $92.1 million on US GAAP losses from continuing operations before income taxes and equity method investees of $320.9 million). The significant difference from the prior year effective tax rate of 28% is due to the in-process R&D write-off of $673 million which is not tax deductible. Excluding the impact of this in-process R&D charge, the effective tax rate for 2005 was 26%.
At December 31, 2005 net deferred tax assets of $116.2 million were recognized (December 31, 2004: $78.1 million).
Equity in (losses)/earnings of equity method investees
Net losses of $1.0 million were recorded for the year to December 31, 2005: (2004: net earnings of $2.5 million). This comprised earnings of $5.3 million from the 50% share of the antiviral commercialization partnership with GSK in Canada (2004: $4.4 million), offset by the Company’s share of losses in the GeneChem and EGS Healthcare Funds of $6.3 million (2004: $1.9 million).
Discontinued operations
During the year to December 31, 2005 gains on disposition of the discontinued operations totaled $3.1 million. This resulted from the finalization of the working capital agreement with IDB, which was part of the sale of Shire’s vaccines business to IDB in 2004. As a result, a disputed amount, which had previously been provided for, was received and the corresponding provision was released.
Financial Information Table of Contents | |
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Unaudited US GAAP Consolidated Balance Sheets | 16 |
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Unaudited US GAAP Consolidated Statements of Operations | 18 |
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Unaudited US GAAP Consolidated Statements of Cash Flows | 20 |
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Selected Notes to the Unaudited US GAAP Financial Statements | |
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(1) Earnings per share | 23 |
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(2) Analysis of revenues | 25 |
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Non GAAP reconciliation of numerator for diluted EPS | 27 |
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Non GAAP reconciliation of reported EPS | 28 |
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US GAAP and Non GAAP Unaudited Consolidated Statements of Operations | 29 |
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Unaudited IFRS Consolidated Balance Sheets | 31 |
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Unaudited IFRS Consolidated Income Statements | 33 |
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Unaudited IFRS Consolidated Cash Flow Statement | 34 |
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Selected Notes to the Unaudited IFRS Financial Statements | |
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(1) Earnings per share | 35 |
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(2) Condensed statement of changes in shareholders’ equity | 36 |
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(3) Basis of preparation | 36 |
Unaudited US GAAP results for the year to December 31, 2005 Consolidated Balance Sheets | | | | |
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| | December 31, 2005 $'000 | | December 31, 2004 $'000 |
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ASSETS | | | | |
Current assets: | | | | |
Cash and cash equivalents | | 656,456 | | 1,111,477 |
Restricted cash | | 30,568 | | 21,627 |
Short-term investments | | 6,947 | | 324,411 |
Accounts receivable, net | | 329,924 | | 222,546 |
Inventories | | 136,057 | | 41,230 |
Deferred tax asset | | 54,186 | | 70,387 |
Prepaid expenses and other current assets | | 98,084 | | 137,271 |
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Total current assets | | 1,312,222 | | 1,928,949 |
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Investments | | 50,162 | | 63,267 |
Property, plant and equipment, net | | 233,999 | | 131,351 |
Goodwill | | 367,652 | | 235,396 |
Other intangible assets, net | | 729,304 | | 309,297 |
Deferred tax asset | | 61,994 | | 7,724 |
Other non-current assets | | 42,907 | | 38,895 |
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Total assets | | 2,798,240 | | 2,714,879 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | |
Current liabilities: | | | | |
Loan facility to IDB | | - | | 43,162 |
Accounts payable and accrued expenses | | 431,819 | | 311,231 |
Liability to dissenting shareholders | | 427,609 | | - |
Other current liabilities | | 105,993 | | 77,558 |
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Total current liabilities | | 965,421 | | 431,951 |
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Long-term debt, excluding current installments | | 116 | | 116 |
Other non-current liabilities | | 43,437 | | 32,159 |
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Total liabilities | | 1,008,974 | | 464,226 |
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Unaudited US GAAP results for the year to December 31, 2005 Consolidated Balance Sheets (continued) | | | | | |
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| December 31, 2005 $'000 | | | December 31, 2004 $'000 | |
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Shareholders’ equity: | | | | | |
Common stock of 5p par value; 600,000,000 shares | | | | | |
authorized; and 495,733,782 shares issued and | | | | | |
outstanding (2004: 800,000,000 shares authorized; and | | | | | |
484,916,034 shares issued and outstanding) | 42,728 | | | 41,796 | |
Exchangeable shares: 2,187,793 shares issued and | | | | | |
outstanding (2004: 4,226,476) | 101,248 | | | 195,830 | |
Treasury stock | (2,813 | ) | | (264 | ) |
Additional paid-in capital | 1,205,257 | | | 1,070,675 | |
Accumulated other comprehensive income | 71,472 | | | 131,939 | |
Retained earnings | 371,374 | | | 810,677 | |
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Total shareholders’ equity | 1,789,266 | | | 2,250,653 | |
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Total liabilities and shareholders’ equity | 2,798,240 | | | 2,714,879 | |
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Unaudited US GAAP results for the 3 months and year to December 31, 2005 Consolidated Statements of Operations |
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| | 3 months to December 31, 2005 $'000 | | 3 months to December 31, 2004 $'000 | | 12 months to December 31, 2005 $'000 | | 12 months to December 31, 2004 $'000 | |
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Revenues: | | | | | | | | | |
Product sales | | 397,511 | | 308,860 | | 1,327,660 | | 1,112,457 | |
Royalties | | 61,837 | | 60,363 | | 242,910 | | 230,364 | |
Licensing and development | | 3,833 | | 3,262 | | 15,002 | | 13,479 | |
Other revenues | | 1,769 | | 1,253 | | 13,744 | | 6,907 | |
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Total revenues | | 464,950 | | 373,738 | | 1,599,316 | | 1,363,207 | |
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Costs and expenses: | | | | | | | | | |
Cost of product sales | | 78,605 | | 41,899 | | 213,964 | | 141,909 | |
Research and development | | 84,917 | | 52,505 | | 336,217 | | 196,265 | |
Selling, general and administrative | | 165,164 | | 127,902 | | 631,124 | | 458,132 | |
Depreciation and amortization | | 24,300 | | 18,039 | | 74,435 | | 58,513 | |
Intangible asset impairment | | 2,632 | | 8,021 | | 5,632 | | 13,477 | |
Reorganization costs | | - | | 16,428 | | 9,335 | | 48,469 | |
Integration costs | | 6,196 | | - | | 9,716 | | - | |
In-process R&D write-off | | - | | - | | 673,000 | | - | |
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Total operating expenses | | 361,814 | | 264,794 | | 1,953,423 | | 916,765 | |
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Operating income/(loss) | | 103,136 | | 108,944 | | (354,107 | ) | 446,442 | |
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Interest income | | 7,432 | | 7,800 | | 35,300 | | 21,901 | |
Interest expense | | (7,305 | ) | (35 | ) | (12,023 | ) | (12,294 | ) |
Other income/(expense), net | | 6,007 | | (558 | ) | 9,945 | | 3,845 | |
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Total other income, net | | 6,134 | | 7,207 | | 33,222 | | 13,452 | |
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Income/(loss) from continuing | | | | | | | | | |
operations before income taxes | | | | | | | | | |
and equity in (losses)/earnings of | | | | | | | | | |
equity method investees | | 109,270 | | 116,151 | | (320,885 | ) | 459,894 | |
Income taxes | | (30,376 | ) | (31,915 | ) | (92,083 | ) | (129,103 | ) |
Equity in (losses)/earnings of | | | | | | | | | |
equity method investees | | (1,150 | ) | (850 | ) | (1,000 | ) | 2,508 | |
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Income/(loss) from continuing | | | | | | | | | |
operations | | 77,744 | | 83,386 | | (413,968 | ) | 333,299 | |
Loss from discontinued operations | | - | | - | | - | | (20,135 | ) |
(Loss)/gain on disposition of | | | | | | | | | |
discontinued operations | | (1,049 | ) | - | | 3,125 | | (44,157 | ) |
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Net income/(loss) | | 76,695 | | 83,386 | | (410,843 | ) | 269,007 | |
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Unaudited US GAAP results for the 3 months and year to December 31, 2005
Consolidated Statements of Operations (continued)
| | 3 months to December 31, 2005
| | | 3 months to December 31, 2004
| | 12 months to December 31, 2005
| | | 12 months to December 31, 2004
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Earnings per share - basic | | | | | | | | | | | |
Income/(loss) from continuing | | | | | | | | | | | |
operations | | 15.5c | | | 16.8c | | (82.7c | ) | | 67.2c | |
Loss from discontinued operations | | - | | | - | | - | | | (4.1c | ) |
(Loss)/gain on disposition of | | | | | | | | | | | |
discontinued operations | | (0.2c | ) | | - | | 0.6c | | | (8.9c | ) |
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Earning per ordinary share - | | | | | | | | | | | |
basic | | 15.3c | | | 16.8c | | (82.1c | ) | | 54.2c | |
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Earnings per share – diluted | | | | | | | | | | | |
Income/(loss) from continuing | | | | | | | | | | | |
operations | | 15.3c | | | 16.7c | | (82.7c | ) | | 65.9c | |
Loss from discontinued operations | | - | | | - | | - | | | (4.0c | ) |
(Loss)/gain on disposition of | | | | | | | | | | | |
discontinued operations | | (0.2c | ) | | - | | 0.6c | | | (8.6c | ) |
| |
| | |
| |
| | |
| |
| | | | | | | | | | | |
Earning per ordinary share - | | | | | | | | | | | |
diluted | | 15.1c | | | 16.7c | | (82.1c | ) | | 53.3c | |
| |
| | |
| |
| | |
| |
| | | | | | | | | | | |
Earnings per ADS - diluted | | 45.2c | | | 49.8c | | (246.4c | ) | | 159.9c | |
| |
| | |
| |
| | |
| |
| | | | | | | | | | | |
Weighted average number of | | | | | | | | | | | |
shares: | | | | | | | | | | | |
Basic | | 501,675,141 | | | 497,063,870 | | 500,243,137 | | | 496,306,604 | |
Diluted | | 508,702,513 | | | 500,227,937 | | 500,243,137 | | | 511,267,432 | |
| |
| | |
| |
| | |
| |
Unaudited US GAAP results for the 3 months and year to December 31, 2005
Consolidated Statements of Cash Flows
| | 3 months to | | 3 months to | | 12 months to | | 12 months to | |
| | December 31, | | December 31, | | December 31, | | December 31, | |
| | 2005 | | 2004 | | 2005 | | 2004 | |
| | $’000 | | $’000 | | $’000 | | $’000 | |
| |
| |
| |
| |
| |
CASH FLOWS FROM OPERATING | | | | | | | | | |
ACTIVITIES: | | | | | | | | | |
| | | | | | | | | |
Net income/(loss) from continuing | | | | | | | | | |
operations | | 77,744 | | 83,386 | | (413,968 | ) | 333,299 | |
Adjustments to reconcile net income/(loss) | | | | | | | | | |
to net cash provided by operating | | | | | | | | | |
activities: | | | | | | | | | |
Depreciation and amortization: | | | | | | | | | |
- cost of product sales | | 801 | | 775 | | 3,483 | | 2,740 | |
- SG&A | | 23,892 | | 18,039 | | 67,977 | | 58,513 | |
Stock option compensation | | 205 | | 51 | | 392 | | 216 | |
In-process R&D write-off | | - | | - | | 673,000 | | - | |
Write-down of long-term assets | | 3,059 | | 9,925 | | 14,064 | | 29,317 | |
Loss/(gain) on sale of long-term assets | | 12 | | (796 | ) | (3,854 | ) | (15,268 | ) |
Gain on sale of drug formulation | | | | | | | | | |
business | | (3,561 | ) | - | | (3,561 | ) | - | |
Movement in deferred taxes | | (12,012 | ) | 8,631 | | 22,295 | | (14,979 | ) |
Equity in losses/(earnings) of equity | | | | | | | | | |
method investees | | 1,150 | | 850 | | 1,000 | | (2,508 | ) |
Changes in operating assets and | | | | | | | | | |
liabilities, net of acquisitions: | | | | | | | | | |
(Increase)/decrease in accounts | | | | | | | | | |
receivable | | (45,992 | ) | 21,195 | | (79,885 | ) | (28,066 | ) |
Increase in sales deduction accrual | | 4,192 | | 11,195 | | 18,616 | | 50,746 | |
Decrease in inventory | | 9,855 | | 5,049 | | 8,582 | | 2,185 | |
(Increase)/decrease in prepayments | | | | | | | | | |
and other current assets | | (15,708 | ) | 310 | | (40,111 | ) | 2,509 | |
Decrease/(increase) in other assets | | 48 | | 11,497 | | (731 | ) | 13,520 | |
Increase in accounts and notes | | | | | | | | | |
payable and other liabilities | | 114,814 | | 29,471 | | 122,949 | | 76,793 | |
(Decrease)/increase in deferred | | | | | | | | | |
revenue | | (2,989 | ) | 6,439 | | (13,520 | ) | 6,151 | |
Returns on investments | | - | | - | | 4,710 | | 4,043 | |
Cash flows used in discontinued | | | | | | | | | |
operations | | (1,049 | ) | (4,912 | ) | (362 | ) | (30,525 | ) |
| |
| |
| |
| |
| |
Net cash provided by operating | | | | | | | | | |
activities(A) | | 154,461 | | 201,105 | | 381,076 | | 488,686 | |
| |
| |
| |
| |
| |
Unaudited US GAAP results for the 3 months and year to December 31, 2005
Consolidated Statements of Cash Flows
| | 3 months to | | 3 months to | | 12 months to | | 12 months to | |
| | December 31, | | December 31, | | December 31, | | December 31, | |
| | 2005 | | 2004 | | 2005 | | 2004 | |
| | $’000 | | $’000 | | $’000 | | $’000 | |
| |
| |
| |
| |
| |
CASH FLOWS FROM INVESTING | | | | | | | | | |
ACTIVITIES: | | | | | | | | | |
Movements in short-term investments | | 15,485 | | (41,321 | ) | 366,731 | | (20,282 | ) |
Movements in restricted cash | | (483 | ) | 9,274 | | (768 | ) | 24,847 | |
Purchase of subsidiary undertaking, | | | | | | | | | |
net of cash and cash equivalents | | (14,398 | ) | - | | (1,114,048 | ) | - | |
Expenses of acquisition | | (13,379 | ) | - | | (37,491 | ) | - | |
Purchase of long-term investments | | (22 | ) | (404 | ) | (7,700 | ) | (6,124 | ) |
Purchase of property, plant and | | | | | | | | | |
equipment | | (28,601 | ) | (32,763 | ) | (86,239 | ) | (57,603 | ) |
Purchase of intangible assets | | (427 | ) | (17,824 | ) | (20,491 | ) | (30,209 | ) |
Proceeds from sale of long-term | | | | | | | | | |
investments | | - | | - | | 10,135 | | 26,733 | |
Proceeds from sale of property, plant | | | | | | | | | |
and equipment | | 8 | | 3,083 | | 116 | | 3,527 | |
Proceeds from sale of intangible | | | | | | | | | |
assets | | - | | 3,701 | | - | | 3,701 | |
Proceeds from sale of assets held for | | | | | | | | | |
sale | | - | | - | | - | | 11,289 | |
Proceeds from sale of drug | | | | | | | | | |
formulation business | | 557 | | - | | 557 | | - | |
Returns of investments | | - | | 248 | | 3,774 | | 1,450 | |
Loans made to IDB | | - | | (33,018 | ) | (43,162 | ) | (56,838 | ) |
Proceeds from sale of the vaccines | | | | | | | | | |
business | | - | | 4,912 | | 92,236 | | 34,912 | |
Cash flows used in discontinued | | | | | | | | | |
operations | | - | | - | | - | | (12,715 | ) |
| |
| |
| |
| |
| |
| | | | | | | | | |
Net cash used in investing activities(B) | | (41,260 | ) | (104,112 | ) | (836,350 | ) | (77,312 | ) |
| |
| |
| |
| |
| |
Unaudited US GAAP results for the 3 months and year to December 31, 2005
Consolidated Statements of Cash Flows (continued)
| | 3 months to | | 3 months to | | 12 months to | | 12 months to | |
| | December 31, | | December 31, | | December 31, | | December 31, | |
| | 2005 | | 2004 | | 2005 | | 2004 | |
| | $’000 | | $’000 | | $’000 | | $’000 | |
| |
| |
| |
| |
| |
| | | | | | | | | |
CASH FLOWS FROM FINANCING | | | | | | | | | |
ACTIVITIES: | | | | | | | | | |
Redemption of 2% convertible loan | | | | | | | | | |
notes | | - | | - | | - | | (370,109 | ) |
Repayment of long-term debt, capital | | | | | | | | | |
leases and notes | | - | | (5,908 | ) | - | | (6,079 | ) |
Proceeds from exercise of options | | 6,666 | | 5,885 | | 37,113 | | 13,416 | |
Proceeds from issue of common | | | | | | | | | |
stock, net | | - | | 160 | | - | | 771 | |
Tax benefit of stock option | | | | | | | | | |
compensation, charged directly to | | | | | | | | | |
reserves | | 949 | | 354 | | 3,427 | | 354 | |
Payments to acquire treasury stock | | (2,480 | ) | (264 | ) | (2,480 | ) | (264 | ) |
Payment of dividend | | (9,403 | ) | (8,905 | ) | (28,460 | ) | (8,905 | ) |
| |
| |
| |
| |
| |
Net cash (used in)/provided by | | | | | | | | | |
financing activities(C) | | (4,268 | ) | (8,678 | ) | 9,600 | | (370,816 | ) |
| |
| |
| |
| |
| |
Effect of foreign exchange rate | | | | | | | | | |
changes on cash and cash | | | | | | | | | |
equivalents | | (2,297 | ) | 5,272 | | (9,347 | ) | 7,567 | |
Effect of foreign exchange rate | | | | | | | | | |
changes on discontinued operations | | - | | - | | - | | (10 | ) |
| |
| |
| |
| |
| |
Net effect of foreign exchange rate | | | | | | | | | |
changes(D) | | (2,297 | ) | 5,272 | | (9,347 | ) | 7,557 | |
| |
| |
| |
| |
| |
Net increase/(decrease) in cash and | | | | | | | | | |
cash equivalents(A)+(B)+(C)+(D) | | 106,636 | | 93,587 | | (455,021 | ) | 48,115 | |
Cash and cash equivalents at | | | | | | | | | |
beginning of period | | 549,820 | | 1,017,890 | | 1,111,477 | | 1,063,362 | |
| |
| |
| |
| |
| |
Cash and cash equivalents at end of | | | | | | | | | |
period | | 656,456 | | 1,111,477 | | 656,456 | | 1,111,477 | |
| |
| |
| |
| |
| |
US GAAP results for the 3 months and year to December 31, 2005
Selected Notes to the Unaudited US GAAP Financial Statements (continued)
(1) Earnings per share
| | 3 months to | | 3 months to | | 12 months to | | 12 months to | |
| | December 31, | | December 31, | | December 31, | | December 31, | |
| | 2005 | | 2004 | | 2005 | | 2004 | |
| | $’000 | | $’000 | | $’000 | | $’000 | |
| |
| |
| |
| |
| |
Income/(loss) from continuing | | | | | | | | | |
operations | | 77,744 | | 83,386 | | (413,968 | ) | 333,299 | |
Loss from discontinued operations, | | | | | | | | | |
net of tax | | - | | - | | - | | (20,135 | ) |
(Loss)/gain on disposition of | | | | | | | | | |
discontinued operations | | (1,049 | ) | - | | 3,125 | | (44,157 | ) |
| |
| |
| |
| |
| |
Numerator for basic EPS | | 76,695 | | 83,386 | | (410,843 | ) | 269,007 | |
Interest on convertible | | | | | | | | | |
debt, net of tax | | - | | (3 | ) | - | | 3,421 | |
| |
| |
| |
| |
| |
Numerator for diluted EPS | | 76,695 | | 83,383 | | (410,843 | ) | 272,428 | |
| |
| |
| |
| |
| |
| | | | | | | | | |
Weighted average number of | | | | | | | | | |
shares: | | No.of shares | | No. of shares | | No.of shares | | No. of shares | |
| |
| |
| |
| |
| |
| | | | | | | | | |
Basic | | 501,675,141 | | 497,063,870 | | 500,243,137 | | 496,306,604 | |
Effect of dilutive shares: | | | | | | | | | |
Stock options | | 6,615,836 | | 3,059,348 | | - | | 3,035,620 | |
Warrants | | 405,780 | | 98,963 | | - | | 66,792 | |
Convertible debt | | 5,756 | | 5,756 | | - | | 11,858,416 | |
| |
| |
| |
| |
| |
Diluted | | 508,702,513 | | 500,227,937 | | 500,243,137 | | 511,267,432 | |
| |
| |
| |
| |
| |
US GAAP results for the 3 months and year to December 31, 2005
Selected Notes to the Unaudited US GAAP Financial Statements (continued)
The share options, warrants and convertible debt not included in the calculation of the diluted weighted average number of shares are shown below:
| | (1)3 months to | | (1)3 months to | | (2)12 months to | | (1)12 months to |
| | December 31, | | December 31, | | December 31, | | December 31, |
| | 2005 | | 2004 | | 2005 | | 2004 |
| | | | | | | | |
| | | | | | | | |
| | No. of shares | | No. of shares | | No. of shares | | No. of shares |
| |
| |
| |
| |
|
Stock options | | 10,085,752 | | 9,163,492 | | 20,680,407 | | 16,640,724 |
Warrants | | - | | - | | 1,346,407 | | - |
Convertible debt | | - | | - | | 5,756 | | - |
| |
| |
| |
| |
|
| | | | | | | | |
| | 10,085,752 | | 9,163,492 | | 22,032,570 | | 16,640,724 |
| |
| |
| |
| |
|
| (1) | Not included as the exercise price exceeded the Company’s average share price during the calculation period. |
| (2) | Not included as the Company made a loss during the calculation period. |
Unaudited US GAAP results for the 3 months to December 31, 2005
Selected Notes to the US GAAP Financial Statements (continued)
(2) Analysis of revenues
| | 3 months to | | 3 months to | | 3 months to | | 3 months to | |
| | December 31, | | December 31, | | December 31, | | December 31, | |
| | 2005 | | 2004 | | 2005 | | 2005 | |
| | $’000 | | $’000 | | % change | | % of total | |
| | | | | | | | revenue | |
| |
| |
| |
| |
| |
Net product sales: | | | | | | | | | |
CNS | | | | | | | | | |
ADDERALL XR | | 214,010 | | 183,660 | | +17% | | 46% | |
ADDERALL | | 12,078 | | 12,074 | | 0% | | 2% | |
CARBATROL | | 17,275 | | 15,468 | | 12% | | 4% | |
| |
| |
| |
| |
| |
| | 243,363 | | 211,202 | | +15% | | 52% | |
| |
| |
| |
| |
| |
GI | | | | | | | | | |
PENTASA | | 42,306 | | 28,290 | | +50% | | 9% | |
COLAZIDE | | 2,099 | | 2,268 | | -7% | | 1% | |
| |
| |
| |
| |
| |
| | 44,405 | | 30,558 | | +45% | | 10% | |
| |
| |
| |
| |
| |
GP | | | | | | | | | |
AGRYLIN/XAGRID | | | | | | | | | |
NORTH AMERICA | | 4,031 | | 22,259 | | -82% | | 1% | |
ROW | | 10,381 | | 8,276 | | +25% | | 2% | |
FOSRENOL | | 29,032 | | - | | N/A | | 6% | |
CALCICHEW | | 10,359 | | 10,727 | | -3% | | 2% | |
REMINYL/REMINYL XL | | 4,136 | | 2,865 | | +44% | | 1% | |
SOLARAZE | | 3,754 | | 3,244 | | +16% | | 1% | |
LODINE | | 3,114 | | 2,663 | | +17% | | 1% | |
| |
| |
| |
| |
| |
| | 64,807 | | 50,034 | | +30% | | 14% | |
| |
| |
| |
| |
| |
HGT | | | | | | | | | |
REPLAGAL | | 25,358 | | - | | N/A | | 5% | |
| |
| |
| |
| |
| |
| | 25,358 | | - | | N/A | | 5% | |
| |
| |
| |
| |
| |
| | | | | | | | | |
Other product sales | | 19,578 | | 17,066 | | +15% | | 4% | |
| |
| |
| |
| |
| |
Total product sales | | 397,511 | | 308,860 | | +29% | | 85% | |
| |
| |
| |
| |
| |
Royalty income: | | | | | | | | | |
3TC | | 40,372 | | 40,118 | | +1% | | 8% | |
ZEFFIX | | 8,499 | | 7,219 | | +18% | | 2% | |
Others | | 12,966 | | 13,026 | | 0% | | 3% | |
| |
| |
| |
| |
| |
| | 61,837 | | 60,363 | | 2% | | 13% | |
| |
| |
| |
| |
| |
Licensing and development | | 3,833 | | 3,262 | | 18% | | 1% | |
Other | | 1,769 | | 1,253 | | 41% | | 1% | |
| |
| |
| |
| |
| |
Total revenues | | 464,950 | | 373,738 | | 24% | | 100% | |
| |
| |
| |
| |
| |
Unaudited US GAAP results for the year to December 31, 2005
Selected Notes to the US GAAP Financial Statements (continued)
(2) Analysis of revenues (continued)
| | 12 months to | | 12 months to | | 12 months to | | 12 months to | |
| | December 31, | | December 31, | | December 31, | | December 31, | |
| | 2005 | | 2004 | | 2005 | | 2005 | |
| | $’000 | | $’000 | | % change | | % of total | |
| | | | | | | | revenue | |
| |
| |
| |
| |
| |
Net product sales: | | | | | | | | | |
CNS | | | | | | | | | |
ADDERALL XR | | 730,833 | | 606,657 | | +20% | | 46% | |
ADDERALL | | 43,111 | | 34,485 | | +25% | | 3% | |
CARBATROL | | 72,098 | | 54,341 | | +33% | | 4% | |
| |
| |
| |
| |
| |
| | 846,042 | | 695,483 | | +22% | | 53% | |
| |
| |
| |
| |
| |
GI | | | | | | | | | |
PENTASA | | 136,083 | | 114,995 | | +18% | | 8% | |
COLAZIDE | | 8,619 | | 8,212 | | +5% | | 1% | |
| |
| |
| |
| |
| |
| | 144,702 | | 123,207 | | +17% | | 9% | |
| |
| |
| |
| |
| |
GP | | | | | | | | | |
AGRYLIN/XAGRID | | | | | | | | | |
N AMERICA | | 45,981 | | 119,099 | | -61% | | 3% | |
ROW | | 46,809 | | 33,431 | | +40% | | 3% | |
FOSRENOL | | 53,516 | | - | | N/A | | 3% | |
CALCICHEW | | 38,712 | | 38,252 | | +1% | | 2% | |
REMINYL/REMINYL XL | | 13,520 | | 10,848 | | +25% | | 1% | |
SOLARAZE | | 12,530 | | 9,458 | | +32% | | 1% | |
LODINE | | 12,589 | | 7,582 | | +66% | | 1% | |
| |
| |
| |
| |
| |
| | 223,657 | | 218,670 | | +2% | | 14% | |
| |
| |
| |
| |
| |
HGT | | | | | | | | | |
REPLAGAL | | 41,314 | | - | | N/A | | 3% | |
| |
| |
| |
| |
| |
| | 41,314 | | - | | N/A | | 3% | |
| |
| |
| |
| |
| |
| | | | | | | | | |
Other product sales | | 71,945 | | 75,097 | | -4% | | 4% | |
| |
| |
| |
| |
| |
Total product sales | | 1,327,660 | | 1,112,457 | | +19% | | 83% | |
| |
| |
| |
| |
| |
Royalty income: | | | | | | | | | |
3TC | | 159,839 | | 155,791 | | +3% | | 10% | |
ZEFFIX | | 30,468 | | 27,393 | | +11% | | 2% | |
Others | | 52,603 | | 47,180 | | +11% | | 3% | |
| |
| |
| |
| |
| |
| | | | | | | | | |
| | 242,910 | | 230,364 | | +5% | | 15% | |
| |
| |
| |
| |
| |
Licensing and development | | 15,002 | | 13,479 | | +11% | | 1% | |
Other | | 13,744 | | 6,907 | | +99% | | 1% | |
| |
| |
| |
| |
| |
Total revenues | | 1,599,316 | | 1,363,207 | | +17% | | 100% | |
| |
| |
| |
| |
| |
Non GAAP reconciliation of numerator for diluted EPS for the 3 months and year to December 31, 2005
| | 3 months to | | 3 months to | | 12 months to | | 12 months to | |
| | December 31, | | December 31, | | December 31, | | December 31, | |
| | 2005 | | 2004 | | 2005 | | 2004 | |
| | $’000 | | $’000 | | $’000 | | $’000 | |
| |
| |
| |
| |
| |
Net income/(loss) for basic EPS | | 76,695 | | 83,386 | | (410,843 | ) | 269,007 | |
Add back: | | | | | | | | | |
Loss/(gain) from discontinued | | | | | | | | | |
operations | | 1,049 | | - | | (3,125 | ) | 20,135 | |
Loss on disposition of discontinued | | | | | | | | | |
operations | | - | | - | | - | | 44,157 | |
TKT in-process R&D write-off | | - | | - | | 673,000 | | - | |
TKT cost of product sales fair | | | | | | | | | |
value adjustment | | 24,683 | | - | | 41,885 | | - | |
New River upfront payment | | - | | - | | 50,000 | | - | |
New listed holding company costs | | - | | - | | 4,527 | | - | |
Reorganization costs | | - | | 16,428 | | 9,335 | | 48,469 | |
TKT integration costs | | 6,196 | | - | | 9,716 | | - | |
Gain on disposal of drug | | | | | | | | | |
formulation business | | (3,561 | ) | - | | (3,561 | ) | - | |
Gain on sale of investment | | - | | - | | - | | (14,805 | ) |
Taxes on above adjustments | | (7,649 | ) | (4,600 | ) | (31,333 | ) | (9,426 | ) |
| |
| |
| |
| |
| |
| | | | | | | | | |
Total non GAAP adjustment | | 20,718 | | 11,828 | | 750,444 | | 88,530 | |
| |
| |
| |
| |
| |
| | | | | | | | | |
Net income for non GAAP | | 97,413 | | 95,214 | | 339,601 | | 357,537 | |
Interest on convertible | | | | | | | | | |
debt | | - | | (3 | ) | 1 | | 3,421 | |
| |
| |
| |
| |
| |
Numerator for non GAAP - Diluted | | | | | | | | | |
EPS | | 97,413 | | 95,211 | | 339,602 | | 360,958 | |
| |
| |
| |
| |
| |
(1) | An analysis of the results for the three months and year to December 31, 2005 between Shire (excluding TKT) and TKT is shown on pages 29 and 30. |
Non GAAP reconciliation of reported EPS for the 3 months and 12 months to December 31, 2005
| | 3 months to | | 3 months to | | 12 months to | | 12 months to | |
| | December 31, | | December 31, | | December 31, | | December 31, | |
| | 2005 | | 2004 | | 2005 | | 2004 | |
| |
| |
| |
| |
| |
Diluted EPS per ordinary share | | 15.1c | | 16.7c | | (82.1c) | | 53.3c | |
Add back: | | | | | | | | | |
Loss/(gain) from discontinued | | | | | | | | | |
operations, net of tax | | 0.2c | | - | | (0.6c) | | 4.0c | |
Loss on disposition of discontinued | | | | | | | | | |
operations | | - | | - | | - | | 8.6c | |
| |
| |
| |
| |
| |
Diluted EPS from continuing | | | | | | | | | |
operations | | 15.3c | | 16.7c | | (82.7c) | | 65.9c | |
Change in denominator due to | | | | | | | | | |
effect on dilution of non GAAP | | | | | | | | | |
adjustments(1) | | - | | - | | 0.9c | | - | |
| |
| |
| |
| |
| |
| | 15.3c | | 16.7c | | (81.8c) | | 65.9c | |
Add back: | | | | | | | | | |
TKT in-process R&D write-off | | - | | - | | 133.0c | | - | |
TKT cost of product sales fair | | | | | | | | | |
value adjustment | | 4.9c | | - | | 8.3c | | - | |
New River upfront payment | | - | | - | | 9.9c | | - | |
New listed holding company costs | | - | | - | | 0.9c | | - | |
Reorganization costs | | - | | 3.3c | | 1.8c | | 9.5c | |
TKT integration costs | | 1.2c | | - | | 1.9c | | - | |
Gain on disposal of drug | | | | | | | | | |
formulation business | | (0.7c) | | - | | (0.7c) | | - | |
Gain on sale of investment | | - | | - | | - | | (2.9c) | |
| | | | | | | | | |
Taxes on above adjustments | | (1.6c) | | (1.0c) | | (6.2c) | | (1.9c) | |
| |
| |
| |
| |
| |
Non GAAP – diluted EPS per | | | | | | | | | |
ordinary share | | 19.1c | | 19.0c | | 67.1c | | 70.6c | |
| |
| |
| |
| |
| |
| | | | | | | | | |
Non GAAP – diluted EPS per ADS | | 57.4c | | 57.0c | | 201.4c | | 211.8c | |
| |
| |
| |
| |
| |
Total non GAAP adjustments – | | | | | | | | | |
diluted EPS per ordinary share | | 4.0c | | 2.3c | | 149.2c | | 17.3c | |
| |
| |
| |
| |
| |
(1) | Since the items added back result in positive non GAAP net income for the year to December 31, 2005, the options, warrants and convertible debt become dilutive under this measure and are therefore included in the calculation of the denominator for non GAAP EPS. |
US GAAP and Non GAAP results for the 3 months to December 31, 2005 | | | | |
Unaudited Consolidated Statements of Operations | | | | | | | |
| | Non GAAP | | | | | | | |
| |
| | | | | | | |
| | (1) Shire | | | (2) TKT | | | Combined | | | Adjustments | | | US GAAP | |
| | $’000 | | | $’000 | | | $’000 | | | $’000 | | | $’000 | |
| |
| | |
| | |
| | |
| | |
| |
Revenues: | | | | | | | | | | | | | | | |
Product sales | | 372,153 | | | 25,358 | | | 397,511 | | | - | | | 397,511 | |
Royalties | | 61,837 | | | - | | | 61,837 | | | - | | | 61,837 | |
Licensing and development | | 3,833 | | | - | | | 3,833 | | | - | | | 3,833 | |
Other revenues | | 1,305 | | | 464 | | | 1,769 | | | - | | | 1,769 | |
| |
| | |
| | |
| | |
| | |
| |
Total revenues | | 439,128 | | | 25,822 | | | 464,950 | | | - | | | 464,950 | |
| |
| | |
| | |
| | |
| | |
| |
Costs and expenses: | | | | | | | | | | | | | | | |
Cost of product sales (3) | | 51,844 | | | 2,078 | | | 53,922 | | | 24,683 | | | 78,605 | |
Research and development | | 61,095 | | | 23,822 | | | 84,917 | | | - | | | 84,917 | |
Selling, general and | | | | | | | | | | | | | | | |
administrative | | 147,618 | | | 17,546 | | | 165,164 | | | - | | | 165,164 | |
Depreciation and amortization | | 17,053 | | | 9,879 | | | 26,932 | | | - | | | 26,932 | |
Reorganization costs | | - | | | - | | | - | | | - | | | - | |
Integration costs | | - | | | - | | | - | | | 6,196 | | | 6,196 | |
In-process R&D write-off | | - | | | - | | | - | | | - | | | - | |
| |
| | |
| | |
| | |
| | |
| |
Total operating expenses | | 277,610 | | | 53,325 | | | 330,935 | | | 30,879 | | | 361,814 | |
| |
| | |
| | |
| | |
| | |
| |
Operating income/(loss) | | 161,518 | | | (27,503 | ) | | 134,015 | | | (30,879 | ) | | 103,136 | |
Interest income | | 6,907 | | | 525 | | | 7,432 | | | - | | | 7,432 | |
Interest expense | | (2,050 | ) | | (5,255 | ) | | (7,305 | ) | | - | | | (7,305 | ) |
Other income, net (4) | | 1,896 | | | 550 | | | 2,446 | | | 3,561 | | | 6,007 | |
| |
| | |
| | |
| | |
| | |
| |
Total other income/(expense), | | | | | | | | | | | | | | | |
net | | 6,753 | | | (4,180 | ) | | 2,573 | | | 3,561 | | | 6,134 | |
| |
| | |
| | |
| | |
| | |
| |
Income/(loss) from continuing | | | | | | | | | | | | | | | |
operations before income | | | | | | | | | | | | | | | |
taxes and equity in losses of | | | | | | | | | | | | | | | |
equity method investees | | 168,271 | | | (31,683 | ) | | 136,588 | | | (27,318 | ) | | 109,270 | |
Income taxes | | (46,790 | ) | | 8,765 | | | (38,025 | ) | | 7,649 | | | (30,376 | ) |
Equity in losses of equity | | | | | | | | | | | | | | | |
method investees | | (1,150 | ) | | - | | | (1,150 | ) | | - | | | (1,150 | ) |
| |
| | |
| | |
| | |
| | |
| |
Income/(loss) from continuing | | | | | | | | | | | | | | | |
operations | | 120,331 | | | (22,918 | ) | | 97,413 | | | (19,669 | ) | | 77,744 | |
Gain on disposition of | | | | | | | | | | | | | | | |
discontinued operations | | - | | | - | | | - | | | (1,049 | ) | | (1,049 | ) |
| |
| | |
| | |
| | |
| | |
| |
Net income/(loss) | | 120,331 | | | (22,918 | ) | | 97,413 | | | (20,718 | ) | | 76,695 | |
| |
| | |
| | |
| | |
| | |
| |
Diluted EPS | | | | | | | | | | | | | | | |
Ordinary share | | 23.6c | | | (4.5c | ) | | 19.1c | | | (4.0c | ) | | 15.1c | |
ADS | | 70.9c | | | (13.5c | ) | | 57.4c | | | (12.2c | ) | | 45.2c | |
| |
| | |
| | |
| | |
| | |
| |
(1) | Defined as the ongoing Shire business excluding TKT and other non GAAP adjustments. |
| |
(2) | Defined as the acquired TKT business excluding fair value adjustments and integration costs. |
| |
(3) | The GAAP adjustment of $24.7m is the difference between fair value and cost of REPLAGAL inventory acquired with the TKT business and used during the period. |
| |
(4) | The GAAP adjustment of $3.6 million is the gain on sale of the drug formulation business. |
| |
US GAAP and Non GAAP results for the year to December 31, 2005 | | | | | | | |
Unaudited Consolidated Statements of Operations | | | | | | | | | | | | | | | |
| | Non GAAP | | | | | | | |
| |
| | | | | | | |
| | (1)Shire | | | (2)TKT | | | Combined | | | Adjustments | | | US GAAP | |
| | $’000 | | | $’000 | | | $’000 | | | $’000 | | | $’000 | |
| |
| | |
| | |
| | |
| | |
| |
Revenues: | | | | | | | | | | | | | | | |
Product sales | | 1,286,346 | | | 41,314 | | | 1,327,660 | | | - | | | 1,327,660 | |
Royalties | | 242,910 | | | - | | | 242,910 | | | - | | | 242,910 | |
Licensing and development | | 15,002 | | | - | | | 15,002 | | | - | | | 15,002 | |
Other revenues | | 13,066 | | | 678 | | | 13,744 | | | - | | | 13,744 | |
| |
| | |
| | |
| | |
| | |
| |
Total revenues | | 1,557,324 | | | 41,992 | | | 1,599,316 | | | - | | | 1,599,316 | |
| |
| | |
| | |
| | |
| | |
| |
Costs and expenses: | | | | | | | | | | | | | | | |
Cost of product sales(3) | | 167,818 | | | 4,261 | | | 172,079 | | | 41,885 | | | 213,964 | |
Research and development | | 248,197 | | | 38,020 | | | 286,217 | | | 50,000 | | | 336,217 | |
Selling, general and | | | | | | | | | | | | | | | |
administrative(4) | | 602,088 | | | 24,509 | | | 626,597 | | | 4,527 | | | 631,124 | |
Depreciation and amortization | | 63,678 | | | 16,389 | | | 80,067 | | | - | | | 80,067 | |
Reorganization costs | | - | | | - | | | - | | | 9,335 | | | 9,335 | |
Integration costs | | - | | | - | | | - | | | 9,716 | | | 9,716 | |
In-process R&D write-off | | - | | | - | | | - | | | 673,000 | | | 673,000 | |
| |
| | |
| | |
| | |
| | |
| |
Total operating expenses | | 1,081,781 | | | 83,179 | | | 1,164,960 | | | 788,463 | | | 1,953,423 | |
| |
| | |
| | |
| | |
| | |
| |
Operating income/(loss) | | 475,543 | | | (41,187 | ) | | 434,356 | | | (788,463 | ) | | (354,107 | ) |
Interest income | | 34,346 | | | 954 | | | 35,300 | | | - | | | 35,300 | |
Interest expense | | (4,331 | ) | | (7,692 | ) | | (12,023 | ) | | - | | | (12,023 | ) |
Other income, net(5) | | 5,695 | | | 689 | | | 6,384 | | | 3,561 | | | 9,945 | |
| |
| | |
| | |
| | |
| | |
| |
Total other income/(expense), | | | | | | | | | | | | | | | |
net | | 35,710 | | | (6,049 | ) | | 29,661 | | | 3,561 | | | 33,222 | |
| |
| | |
| | |
| | |
| | |
| |
Income/(loss) from continuing | | | | | | | | | | | | | | | |
operations before income | | | | | | | | | | | | | | | |
taxes and equity in losses of | | | | | | | | | | | | | | | |
equity method investees | | 511,253 | | | (47,236 | ) | | 464,017 | | | (784,902 | ) | | (320,885 | ) |
Income taxes | | (136,463 | ) | | 13,047 | | | (123,416 | ) | | 31,333 | | | (92,083 | ) |
Equity in losses of equity | | | | | | | | | | | | | | | |
method investees | | (1,000 | ) | | - | | | (1,000 | ) | | - | | | (1,000 | ) |
| |
| | |
| | |
| | |
| | |
| |
Income/(loss) from continuing | | | | | | | | | | | | | | | |
operations | | 373,790 | | | (34,189 | ) | | 339,601 | | | (753,569 | ) | | (413,968 | ) |
Gain on disposition of | | | | | | | | | | | | | | | |
discontinued operations | | - | | | - | | | - | | | 3,125 | | | 3,125 | |
| |
| | |
| | |
| | |
| | |
| |
Net income/(loss) | | 373,790 | | | (34,189 | ) | | 339,601 | | | (750,444 | ) | | (410,843 | ) |
| |
| | |
| | |
| | |
| | |
| |
Diluted EPS | | | | | | | | | | | | | | | |
Ordinary share | | 73.9c | | | (6.8c | ) | | 67.1c | | | (149.2c | ) | | (82.1c | ) |
ADS | | 221.7c | | | (20.3c | ) | | 201.4c | | | (447.8c | ) | | (246.4c | ) |
| |
| | |
| | |
| | |
| | |
| |
(1) | Defined as the ongoing Shire business excluding TKT and other non GAAP adjustments. |
| |
(2) | Defined as the acquired TKT business excluding fair value adjustments and integration costs. |
| |
(3) | The GAAP adjustment of $41.9m is the difference between fair value and cost of REPLAGAL inventory acquired with the TKT business and used or written off during the period. |
| |
(4) | The GAAP adjustment of $4.5 million relates to the costs of setting up the new holding company. |
| |
(5) | The GAAP adjustment of $3.6 million is the gain on sale of the drug formulation business. |
| |
Unaudited IFRS results for the year to December 31, 2005 | | | | |
| | | | |
Consolidated Balance Sheet | | | | |
| | December 31, | | December 31, |
| | 2005 | | 2004 |
| | $’000 | | $’000 |
| |
| |
|
ASSETS | | | | |
Non-current assets: | | | | |
Goodwill | | 2,209,460 | | 2,246,220 |
Other intangible assets | | 1,394,677 | | 322,258 |
Property, plant and equipment | | 218,199 | | 128,202 |
Deferred tax assets | | 67,283 | | 85,041 |
Investments accounted for using equity method | | 23,023 | | 30,848 |
Available for sale investments | | 27,139 | | 76,550 |
Other receivables | | 42,907 | | 38,895 |
| |
| |
|
| | 3,982,688 | | 2,928,014 |
| |
| |
|
Current assets: | | | | |
Inventories | | 136,057 | | 41,230 |
Trade and other receivables | | 415,189 | | 299,817 |
Trading investments | | 6,947 | | 324,845 |
Cash and cash equivalents | | 656,456 | | 1,111,477 |
Restricted cash | | 30,568 | | 21,627 |
| |
| |
|
| | 1,245,217 | | 1,798,996 |
| |
| |
|
Total assets | | 5,227,905 | | 4,727,010 |
| |
| |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY | | | | |
Non-current liabilities: | | | | |
Borrowings | | 4,704 | | 4,242 |
Trade and other payables | | 18,036 | | 12,963 |
Deferred tax liabilities | | 127,691 | | - |
Long-term provisions | | 25,401 | | 26,232 |
| |
| |
|
| | 175,832 | | 43,437 |
| |
| |
|
Current liabilities: | | | | |
Borrowings | | 2,667 | | 2,420 |
Trade and other payables | | 518,051 | | 344,367 |
Liability to dissenting shareholders | | 427,609 | | - |
Current tax liabilities | | 12,090 | | 46,757 |
Provisions | | 8,523 | | 45,097 |
| |
| |
|
| | 968,940 | | 438,641 |
| |
| |
|
Total liabilities | | 1,144,772 | | 482,078 |
| |
| |
|
Unaudited IFRS results for the year to December 31, 2005 | | | | | | |
| | | | | | |
Consolidated Balance Sheet (continued) | | | | | | |
| | | | | | |
| | December 31, 2005 | | | December 31, 2004 | |
| | $’000 | | | $’000 | |
| |
|
| |
|
|
Shareholders’ equity: | | | | | | |
Share capital | | 42,728 | | | 36,083 | |
Share premium | | 2,977 | | | 4,883,219 | |
Treasury shares | | (2,813 | ) | | (264 | ) |
Exchangeable shares: 2,187,793 shares issued and | | | | | | |
outstanding (2004: 4,226,476) | | 101,248 | | | 195,830 | |
Capital reduction reserve | | 2,946,490 | | | - | |
Capital reserve | | - | | | 4,729 | |
Other reserve | | 2,099,652 | | | 36,121 | |
Retained earnings | | (1,107,149 | ) | | (910,786 | ) |
| |
| | |
| |
Total shareholders’ equity | | 4,083,133 | | | 4,244,932 | |
| |
| | |
| |
Total liabilities and shareholders’ equity | | 5,227,905 | | | 4,727,010 | |
| |
| | |
| |
Unaudited IFRS results for the year to December 31, 2005 | | | | | | |
| | | | | | |
Consolidated Income Statement | | | | | | |
| | | | | | |
Year to December 31, | | 2005 | | | 2004 | |
| | $’000 | | | $’000 | |
| |
| | |
| |
Continuing operations: | | | | | | |
Revenue | | 1,599,316 | | | 1,363,207 | |
Cost of sales | | (215,336 | ) | | (142,557 | ) |
| |
| | |
| |
Gross profit | | 1,383,980 | | | 1,220,650 | |
Research and development | | (287,146 | ) | | (210,974 | ) |
Selling, general and administrative (including $526,956,000 | | | | | | |
goodwill impairment (2004: $132,576,000)) | | (1,255,707 | ) | | (718,890 | ) |
| |
| | |
| |
Operating (loss)/profit | | (158,873 | ) | | 290,786 | |
Investment revenues | | 35,300 | | | 21,901 | |
Finance costs | | (17,420 | ) | | (14,771 | ) |
Share of post tax profit from associates and joint ventures | | (1,000 | ) | | 4,508 | |
| |
| | |
| |
(Loss)/profit before tax | | (141,993 | ) | | 302,424 | |
Taxation | | (38,510 | ) | | (141,623 | ) |
| |
| | |
| |
(Loss)/profit for the year from continuing operations | | (180,503 | ) | | 160,801 | |
| | | | | | |
Discontinued operations: | | | | | | |
Profit/(loss) for the year from discontinued operations | | 3,125 | | | (64,292 | ) |
| |
| | |
| |
(Loss)/profit for the year | | (177,378 | ) | | 96,509 | |
| |
| | |
| |
Earnings per share (expressed in cents per share) | | | | | | |
- Basic | | (35.5c | ) | | 19.4c | |
- Diluted | | (35.5c | ) | | 19.3c | |
| |
| | |
| |
Earnings per share from continuing operations (expressed in cents per share) | | | | | | |
- Basic | | (36.1c | ) | | 32.4c | |
- Diluted | | (36.1c | ) | | 32.2c | |
| |
| | |
| |
Unaudited IFRS results for the year to December 31, 2005 | | | | | | |
| | | | | | |
Consolidated Cash Flow Statement | | | | | | |
| | | | | | |
Year to December 31, | | 2005 | | | 2004 | |
| | $’000 | | | $’000 | |
| |
| | |
| |
Net cash flows from operating activities | | 401,187 | | | 465,762 | |
| | | | | | |
Cash flow from investing activities | | | | | | |
Movement in restricted cash | | (768 | ) | | 24,847 | |
Purchase of subsidiary undertaking, net of cash and cash | | | | | | |
equivalents | | (1,114,048 | ) | | - | |
Expense of acquisition | | (37,491 | ) | | - | |
Loan made to IDB | | (43,162 | ) | | (56,838 | ) |
Purchase of property, plant and equipment | | (71,946 | ) | | (49,746 | ) |
Purchase of intangible assets | | (92,139 | ) | | (42,293 | ) |
Purchases of financial assets | | (7,700 | ) | | (6,124 | ) |
Net decrease/(increase) in current financial assets | | 366,731 | | | (20,282 | ) |
Proceeds from sale of property, plant and equipment (PP&E) | | 1,169 | | | 4,360 | |
Proceeds from sale of intangible assets | | - | | | 3,701 | |
Proceeds from sale of financial assets | | 10,135 | | | 26,733 | |
Proceeds from PP&E held for sale | | - | | | 11,289 | |
Proceeds from sale of drug formulation business | | 557 | | | - | |
Proceeds from sale of discontinued business | | 92,236 | | | 34,912 | |
Interest received | | 34,203 | | | 21,901 | |
Dividend received from associates | | 3,774 | | | 1,450 | |
Dividend from joint venture | | 4,710 | | | 4,043 | |
Investing activities of discontinued business | | - | | | (12,715 | ) |
| |
| | |
| |
Net cash used in investing activities | | (853,739 | ) | | (54,762 | ) |
| |
| | |
| |
Cash flow from financing activities | | | | | | |
| | | | | | |
Proceeds from issuance of ordinary shares, net | | - | | | 771 | |
Proceeds from exercise of share options | | 37,113 | | | 13,416 | |
Purchase of treasury shares | | (2,480 | ) | | (264 | ) |
Redemption of 2% guaranteed convertible loan notes 2011 | | - | | | (370,109 | ) |
Increase in/(repayment of) finance lease obligations | | 708 | | | (5,351 | ) |
Dividends paid | | (28,460 | ) | | (8,905 | ) |
| |
| | |
| |
Net cash from/(used in) financing activities | | 6,881 | | | (370,442 | ) |
| |
| | |
| |
Net (decrease)/increase in cash and cash equivalents | | (445,671 | ) | | 40,558 | |
Cash and cash equivalents at beginning of year | | 1,111,477 | | | 1,063,362 | |
Effect of foreign currency translation | | (9,350 | ) | | 7,557 | |
| |
| | |
| |
Cash and cash equivalents at end of year | | 656,456 | | | 1,111,477 | |
| |
| | |
| |
Unaudited IFRS results for the year to December 31, 2005
Selected Notes to the IFRS Financial Statements
(1) Earnings per share | | | | | | | |
| | | | Weighted | | Per-share | |
Year to December 31, 2005 | | Earnings | | average no of | | amount | |
| | $’000 | | shares | | | |
| |
| |
| |
| |
Basic EPS | | | | | | | |
Loss attributable to ordinary shareholders | | (177,378 | ) | 500,243,137 | | (35.5c | ) |
Effect of dilutive securities | | | | | | | |
Share options | | - | | - | | - | |
Warrants | | - | | - | | - | |
Convertible debt | | - | | - | | - | |
| |
| |
| |
| |
Diluted EPS | | (177,378 | ) | 500,243,137 | | (35.5c | ) |
| |
| |
| |
| |
| | | | | | | |
| | | | | | | |
Earnings per share from continuing and | | | | Weighted | | Per-share | |
discontinued operations: | | Earnings | | average no of | | amount | |
| | $’000 | | shares | | | |
| |
| |
| |
| |
Basic and diluted EPS | | | | | | | |
(Loss) from continuing operations | | (180,503 | ) | 500,243,137 | | (36.1c | ) |
Gain from discontinued operations | | 3,125 | | - | | 0.6c | |
| |
| |
| |
| |
| | | | | | | |
| | | | Weighted | | Per-share | |
Year to December 31, 2004 | | Earnings | | average no of | | amount | |
| | $’000 | | shares | | | |
| |
| |
| |
| |
Basic EPS | | | | | | | |
Earnings attributable to ordinary shareholders | | 96,509 | | 496,306,604 | | 19.4c | |
| | | | | | | |
Effect of dilutive securities | | | | | | | |
Share options | | - | | 3,035,620 | | (0.1c | ) |
Warrants | | - | | 66,792 | | - | |
| |
| |
| |
| |
Diluted EPS | | 96,509 | | 499,409,016 | | 19.3c | |
| |
| |
| |
| |
| | | | | | | |
| | | | | | | |
Earnings per share from continuing and | | | | Weighted | | Per-share | |
discontinued operations: | | Earnings | | average no of | | amount | |
| | $’000 | | shares | | | |
| |
| |
| |
| |
Basic EPS | | | | | | | |
Profit from continuing operations | | 160,801 | | 496,306,604 | | 32.4c | |
Loss from discontinued operations | | (64,292 | ) | - | | (13.0c | ) |
Diluted EPS | | | | | | | |
Profit from continuing operations | | 160,801 | | 499,409,016 | | 32.2c | |
Loss from discontinued operations | | (64,292 | ) | - | | (12.9c | ) |
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Unaudited IFRS results for the year to December 31, 2005
Selected Notes to the IFRS Financial Statements (continued)
(2) Condensed statement of changes in shareholders’ equity | | | | | |
| | | | | |
| | 2005 | | 2004 | |
| | $’000 | | $’000 | |
| |
| |
| |
Shareholders' equity at January 1, | | 4,244,932 | | 4,093,875 | |
Foreign currency translation differences | | (28,855 | ) | 34,066 | |
Employee share option scheme: | | | | | |
- value of employee services | | 27,383 | | 15,464 | |
- proceeds from shares issued | | 37,113 | | 13,416 | |
Issue of share capital | | - | | 771 | |
Purchase of treasury shares | | (2,549 | ) | (264 | ) |
Dividends | | (28,460 | ) | (8,905 | ) |
Tax benefit associated with the exercise of stock options | | 1,721 | | - | |
Unrealized holding gain on available for sale investments | | 9,226 | | - | |
(Loss)/profit for the year | | (177,378 | ) | 96,509 | |
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| | | | | |
Balance at December 31, | | 4,083,133 | | 4,244,932 | |
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(3) Basis of preparation
The financial information set out in the announcement does not constitute the Company's statutory accounts for the years ended December 31, 2005 or 2004. The financial information presented above under IFRS for the comparative period has been derived from the statutory accounts for the year ended December 31, 2004. It has been restated from that which was contained in those statutory financial statements, which were prepared under UK GAAP and have been delivered to the Registrar of Companies. The auditors reported on those accounts; their report was unqualified and did not contain a statement under s. 237(2) or (3) Companies Act 1985. The statutory accounts for the year ended December 31, 2005 will be finalized on the basis of the financial information presented by the directors in this preliminary announcement and will be delivered to the Registrar of Companies following the Company's annual general meeting. This preliminary announcement was approved by the Board on February 22, 2006.
- ENDS -