Business and Finance
On
Notes to Editors
Shire plc
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit and hyperactivity
disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and
renal diseases. The structure is sufficiently flexible to allow Shire to
target new therapeutic areas to the extent opportunities arise through
acquisitions. Shire's in-licensing, merger and acquisition efforts are
focused on products in niche markets with strong intellectual property
protection either in the US or
For further information on Shire, please visit the Company's website: http://www.shire.com
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 including, but not limited to, the successful
development of JUVISTA(R) (Human TGFbeta3) and velaglucerase alfa (GA-GCB);
manufacturing and commercialisation including, but not limited to, the
establishment in the market of VYVANSE(TM)(lisdexamfetamine dimesylate)
(Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of
competitive products including, but not limited to, the impact of those on
Shire's 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
INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure
new products for commercialisation and/or development; and other risks and
uncertainties detailed from time to time in Shire plc's filings with the
Securities and Exchange Commission, particularly Shire plc's Annual Report on
Form 10-K for the year ended
The following are trademarks of Shire or companies within the Shire Group which are the subject of trademark registrations in certain territories:
ADDERALL XR(R) (mixed salts of a single-entity amphetamine) ADDERALL(R) (mixed salts of a single-entity amphetamine) CALCICHEW(R) range (calcium carbonate with or without vitamin D3) CARBATROL(R) (carbamazepine) extended-release capsules DAYTRANA(TM) (methylphenidate transdermal system) ELAPRASE(R) (idursulfase) FOSRENOL(R) (lanthanum carbonate) INTUNIV(TM) (guanfacine) extended release LIALDA(TM) (mesalamine) MEZAVANT(R) (mesalazine) REMINYL(R) (galantamine hydrobromide) (UK and Republic of Ireland) REMINYL XL(TM) (galantamine hydrobromide) (UK and Republic of Ireland) REPLAGAL(R) (agalsidase alfa) VYVANSE(TM) (lisdexamfetamine dimesylate) XAGRID(R) (anagrelide hydrochloride)The following are trademarks of third parties referred to in this press release:
3TC (lamivudine) (trademarks of GlaxoSmithKline (GSK)) COMBIVIR (lamivudine) (trademark of GSK) DYNEPO (epoetin delta) (trademark of Sanofi Aventis) EPIVIR (lamivudine) (trademark of GSK) EPZICOM (lamivudine) (trademark of GSK) JUVISTA (trademark of Renovo) PENTASA (mesalamine) (trademark of Ferring) RAZADYNE (galantamine) (trademark of Johnson & Johnson) RAZADYNE ER (galantamine) (trademark of Johnson & Johnson) REMINYL (galantamine) (trademark of Johnson & Johnson, excluding UK and Republic of Ireland) REMINYL XL (galantamine) (trademark of Johnson & Johnson, excluding UK and Republic of Ireland) SOLARAZE (diclofenac sodium (3%w/w)) (trademark of Almirall) VANIQA (eflornithine hydrochloride) (trademark of Almirall) ZEFFIX (lamivudine) (trademark of GSK)Results of operations under IFRS
For the year to
Total revenues
The following table provides an analysis of the Group's total revenues by source: Year to December 31, 2007 2006 Change US$M US$M % __________ __________ ________ Product sales 2,170.2 1,535.8 +41 Royalties 247.2 242.9 +2 Other revenues 18.9 17.8 +6 __________ __________ ________ Total 2,436.3 1,796.5 +36 _________ _________ ________ Product sales Year to December 31, Product sales US prescription 2007 2006 growth growth US$M US$M % % ______________ __________ ______________ ________ Specialty Pharmaceuticals ADHD ADDERALL XR 1,030.9 863.6 +19 +3 VYVANSE 76.5 - N/A N/A DAYTRANA 64.2 25.1 +156 +166 ADDERALL - 23.6 N/A N/A GI PENTASA 176.4 137.8 +28 +3 LIALDA/MEZAVANT 50.5 - N/A N/A RENAL FOSRENOL 102.2 44.8 +128 +5 DYNEPO 14.2 - N/A N/A Other therapeutic areas CALCICHEW 54.2 45.5 +19 N/A CARBATROL 72.3 68.3 +6 -5 XAGRID 66.8 53.3 +25 N/A REMINYL/REMINYL XL 31.2 21.5 +45 N/A Other 105.1 111.0 -5 _____________ __________ ______________ 1,844.5 1,394.5 +32 _____________ __________ ______________ Human Genetic Therapies REPLAGAL 143.9 117.7 +22 N/A ELAPRASE 181.8 23.6 +670 N/A _____________ __________ _____________ 325.7 141.3 +131 _____________ __________ _____________ Total 2,170.2 1,535.8 +41 _____________ __________ _____________ The following discussion includes references to US prescription and US
market share data for key products. The source of this data is IMS Health,
Specialty Pharmaceuticals
ADDERALL XR - ADHD
As a result of the launch of VYVANSE in
Sales of ADDERALL XR for the year to
As previously disclosed, the
Patent litigation proceedings relating to ADDERALL XR are on-going.
Further information can be found in our filings with the SEC, including our
Annual Report on Form 10-K for the year to
VYVANSE - ADHD
VYVANSE was launched in the US market in
All initial launch stocks of VYVANSE totaling US$57.8 million were
recognised into revenue during the year to
DAYTRANA - ADHD
Product sales for the year to
On
The addition of VYVANSE combined with ADDERALL XR and DAYTRANA's market
share helped Shire grow its total share of the US ADHD market to 31.1% at
PENTASA - Ulcerative colitis
US prescriptions of PENTASA for the year to
Sales of PENTASA for the year to
LIALDA/MEZAVANT - Ulcerative colitis
Shire launched LIALDA in the US oral mesalamine market in
The product was launched in the UK in
Since the launch of LIALDA in
FOSRENOL - Hyperphosphatemia
FOSRENOL is now available in 25 countries and global sales totalled
US$102.2 million for the year to
US sales of FOSRENOL for the year to
DYNEPO - Anaemia associated with Chronic Kidney Disease ("CKD")
DYNEPO was launched in
CARBATROL - Epilepsy
US prescriptions for CARBATROL for the year to
Sales of CARBATROL for the year to
Patent litigation proceedings relating to CARBATROL are ongoing. Further
information can be found in our filings with the SEC, including our Annual
Report on Form 10-K for the year to
XAGRID - Thrombocythemia
Sales for the year to
Human Genetic Therapies
REPLAGAL - Fabry disease
Sales for the year to
ELAPRASE - Hunter syndrome
Sales for the year to
Royalties
Royalty revenue increased by 2% to US$247.2 million for the year to
3TC
Royalties from sales of 3TC for the year to
Shire receives royalties from GSK on worldwide 3TC sales. GSK's worldwide
sales of 3TC for the year to
In 2007 generic drug companies filed Abbreviated New Drug Applications
("ANDA") seeking approval for Epivir, Combivir, Zeffix and Epzicom in the US.
Pursuant to the GSK/Shire license for lamivudine products, GSK has the right
to enforce the licensed patents. In
ZEFFIX
Royalties from sales of ZEFFIX for the year to
Shire receives royalties from GSK on worldwide ZEFFIX sales. GSK's
worldwide sales of ZEFFIX for the year to
Other
Other royalties are primarily in respect of REMINYL and REMINYL XL (known
as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide
(excluding the UK and the Republic of
Barr and other companies have filed ANDA with the FDA for generic
versions of RAZADYNE. Janssen and Synaptech Inc. ("Synaptech") have filed
lawsuits against some of those ANDA filers. A trial was held during the week
of
Janssen and Synaptech filed lawsuits against Barr and Sandoz Inc. ("Sandoz") for infringement of their patent rights relating to RAZADYNE ER as a result of Barr and Sandoz filing ANDAs with the FDA for generic versions of RAZADYNE ER. No court dates have been set.
Cost of sales
For the year to
For the year to
Research and development (R&D)
R&D expenditure increased to US$775.2 million for the year to
The increase in R&D expenditure during the year to
(i) a non-cash charge of US$100.0 million recognised on the effective settlement of Shire's pre-existing relationship with New River Pharmaceuticals Inc. ("New River"). This charge represents the write-off of capitalised up-front and milestone payments made by Shire prior to the acquisition of New River. This charge is presented within R&D as at the time of the New River acquisition VYVANSE, although approved by the FDA, had not yet received the final scheduling classification from the Drug Enforcement Agency ("DEA") and was therefore not available for commercial sale. Further details in respect of this charge are included in Note 3 of the Financial Statements; and
(ii) an intangible asset impairment charge for the year to
Excluding these intangible impairment charges of US$256.4 million and the
US$100.0 million charge on the effective settlement of the pre-existing
relationship with New River, R&D expenditure in the year to
The increase in R&D expenditure in 2007 was due to Phase 3(b) and Phase 4 studies to support new product launches; the continuation of Phase 3 trials on velaglucerase alfa (GA-GCB); the development of the Women's Health franchise and JUVISTA; the pre-clinical development of three HGT projects and the newly in-licensed products from Amicus Therapeutics, Inc. ("Amicus") and Alba Therapeutics Corporation ("Alba").
For the year to
Selling, general and administrative (SG&A) expenses
SG&A expenses increased from US$1,219.9 million (79% of product sales) in the year to December 31, 2006 to US$1,381.1 million in 2007 (64% of product sales), an increase of 13%, which is less than the product sales increase of 41%. Year to December 31, 2007 2006 Change US$M US$M % _______ _______ _______ Sales costs 310.7 233.2 +33 Marketing costs 401.5 343.3 +17 Other SG&A costs 329.2 252.9 +30 _______ _______ _______ 1,041.4 829.4 +26 Depreciation, amortisation and impairment 339.7 390.5 -13 charges(1) _______ _______ _______ Total SG&A costs 1,381.1 1,219.9 +13 _______ _______ ______(1) Excludes (i) depreciation from manufacturing plants of US$5.0 million (2006: US$4.8 million) and amortisation of favourable supply contracts of US$1.2 million (2006: US$nil) which is included in cost of sales and (ii) other intangible assets impairment charges in respect of products under development of US$256.4 million (2006: US$nil) included in R&D.
Excluding depreciation, amortisation and impairment charges, SG&A costs increased by 26% to US$1,041.4 million (2006: US$829.4 million), and represented 48% of product sales (2006: 54%). The increase in SG&A expenses was expected, with additional expenditure required for:
- An increase in the ADHD sales force to promote VYVANSE;
- The cost of the new GI sales force in the US;
- The advertising, promotional and marketing spend to support the launches of VYVANSE, LIALDA and ELAPRASE; and
- A net charge of US$17.0 million in respect of legal settlements, being a charge of US$27.0 million for settlement of the TKT purported securities fraud class action shareholder suit relating to REPLAGAL, partially offset by a US$10.0 million release of existing legal provisions (1% of product sales).
The depreciation charge within SG&A for the year to
Intangible asset impairment charges within SG&A for the year to
For the year to
The catch-up charge relates to options issued by Shire in 2005 under the 2000 Executive Scheme. This charge arises as a result of the strong growth in revenue and profits (as determined under US GAAP) which the Group generated in the fourth quarter of 2007. This growth has in turn caused the Group to revise its original assumptions on which the IFRS 2 charge was based.
Gain on sale of product rights
For the year to
Shire received US$209.6 million (net of transaction costs of US$2.2
million) from Laboratorios Almirall S.A. ("Almirall") for a portfolio of non
core products comprising the dermatology products SOLARAZE and VANIQA and six
non-promoted products across a range of indications, which were sold by Shire
primarily in the UK,
Shire received US$24.8 million on the sale of other non-core products, realising a total gain of US$17.2 million, of which US$13.0 million was recognised during 2007. (The remaining deferred gain of US$4.2 million relating to these disposals is expected to be recognised in 2008 on the transfer of marketing authorisations.)
During the year to
Investment revenues
For the year to
Finance costs
For the year to
In the year to
Share of post tax profit from associates and joint ventures
The Group's share of profit from its associates and joint ventures
totalled US$1.8 million for the year to
Taxation
The effective tax rate for the year to
In 2007 and 2006 the Group recorded impairment charges in respect of goodwill relating to the acquisition of BioChem Pharma Inc. of US$133.7 million (2006: US$271.9 million): no tax deduction is available on this goodwill impairment. Excluding the goodwill impairment the effective tax rate is -31%, (2006: 28%).
This negative tax rate in the year to
Principal Differences: IFRS and US GAAP Net Income for the year to
The primary differences between net (loss) / income as reported under US
GAAP and net income as reported under IFRS for the years ended
(a) In-process research and development ("IPR&D")
IPR&D arising on the acquisition of New River relating to VYVANSE for non-paediatric patients in the US and VYVANSE in the rest of the world ("RoW"), which has been capitalised as an intangible asset under IFRS. As required under US GAAP the value ascribed to these IPR&D projects of US$1,866.4 million (2006: US$nil) has been expensed as research and development costs as of the acquisition date.
(b) Goodwill impairment
The impairment of goodwill of US$133.7 million (2006: US$271.9 million) under IFRS, not recorded under US GAAP. The impairment principally relates to the goodwill recognised under IFRS in respect of the acquisition of BioChem Pharma Inc: this goodwill was not recorded under US GAAP as the treatment of the combination as a pooling of interests under US GAAP resulted in no goodwill arising.
(c) Intangible asset impairment
An impairment charge of US$256.8 million (2006: US$1.1 million) was recorded under IFRS, primarily relating to the impairment of IPR&D in respect of the oncology indication of DYNEPO. These assets are not recognised on the US GAAP balance sheet as they were expensed as research and development costs at the time of their acquisition.
(d) Intangible assets capitalised
Up-front and milestone payments in respect of in-licensed technology of US$147.8 million (2006: US$80.5 million) have been capitalised under IFRS: these payments have been expensed as research and development costs as incurred under US GAAP.
(e) Effective settlement of the pre-existing relationship with New River
A non-cash charge under IFRS of US$100.0 million arose on effective settlement of the Group's pre-existing relationship with New River, in respect of the write-off of up-front and milestone payments capitalised under IFRS as intangible assets; no loss was recorded under US GAAP as these payments had been expensed as a research and development cost as incurred.
(f) Finance costs in respect of convertible bonds
Finance costs recognised in respect of the US$1,100.0 million 2.75% convertible bonds due 2014 are US$21.9 million (2006: US$nil) higher under IFRS compared to US GAAP.
Under both US GAAP and IFRS finance costs include the stated coupon on the bonds, together with amortisation of the direct costs of issue. However, under IFRS, finance costs also include amortisation of the discount arising from separately accounting for the equity conversion feature at inception; this equity conversion feature is not separately accounted for under US GAAP. Finance costs are higher under IFRS as compared to US GAAP as a result of the amortisation of this discount.
(g) Other differences
Other differences include goodwill allocated to the gain on disposal of product rights; adjustments to goodwill relating to prior years acquisitions; the amortisation of intangible assets capitalised under IFRS and not US GAAP; accruals for payroll taxes on share options; and share based payment charges.
Consolidated income statement Year to December 31, Notes 2007 2006 US$M US$M _______ _________ _________ Continuing operations: Revenue 2,436.3 1,796.5 Cost of sales (312.7) (252.9) __________ __________ Gross profit 2,123.6 1,543.6 Research and development (including other intangible asset impairments of US$256.4 million (2006: US$nil)) (775.2) (295.8) Selling, general and administrative (including goodwill and other intangible asset impairments of US$134.1 million (2006: (1,381.1) (1,219.9) US$273.0 million) Gain on sale of product rights 102.9 63.0 __________ __________ Operating profit 70.2 90.9 Investment revenues 50.6 50.5 Finance costs (93.1) (27.0) Other income/(expense), net 1.9 9.4 Share of post tax profit from associates and joint ventures 1.8 5.8 __________ __________ Profit before taxation 31.4 129.6 Taxation 4 51.0 (114.0) __________ __________ Profit for the year from continuing Operations 82.4 15.6 Discontinued operations: Gain on disposal of discontinued operation, net of tax - 40.6 __________ __________ Profit for the year 82.4 56.2 __________ __________ 5 Earnings per share (expressed in cents per share) - Basic 15.3c 11.2c - Diluted 15.0c 11.0c __________ __________ Earnings per share from continuing 5 operations (expressed in cents per share) - Basic 15.3c 3.1c - Diluted 15.0c 3.0c __________ __________The accompanying notes are an integral part of these consolidated financial statements.
The profit for the year is all attributable to the equity holders of the parent.
Consolidated statement of recognised income and expense 2007 2006 Year to December 31, Notes US$M US$M ________ __________ __________ Profit for the year 82.4 56.2 __________ __________ Exchange differences on translation of foreign operations 24.2 26.7 Unrealised holding loss on available-for-sale securities, net of taxes of US$5.2 million (2006: US$nil) (16.5) (1.8) Realised gain on available-for-sale securities (0.1) - __________ __________ Net income recognised directly in equity 7.6 24.9 __________ __________ Total recognised income for the year 90.0 81.1 __________ __________The accompanying notes are an integral part of these consolidated financial statements. The total recognised income for the year is attributable to equity holders of the parent.
Consolidated balance sheet December 31, December 31, Notes 2007 2006 US$M US$M ________ __________ __________ ASSETS Non-current assets Goodwill 6 2,254.0 1,805.9 Other intangible assets 7 4,501.2 1,747.8 Property, plant and equipment 297.9 259.1 Deferred tax assets 173.4 120.0 Investments accounted for using equity method 24.9 24.2 Available-for-sale investments 85.3 31.6 Other receivables 15.9 12.3 __________ __________ 7,352.6 4,000.9 __________ __________ Current assets Inventories 174.1 131.1 Trade and other receivables 543.3 396.1 Current tax assets 8.2 11.8 Cash and cash equivalents 762.5 1,126.9 Restricted cash 39.5 29.8 Assets held for sale 14.7 - __________ __________ 1,542.3 1,695.7 __________ __________ Total assets 8,894.9 5,696.6 __________ __________ LIABILITIES AND SHAREHOLDERS' EQUITY Non-current liabilities Convertible bonds 8 910.2 - Other borrowings 7.9 6.9 Trade and other payables 34.3 24.6 Deferred tax liabilities 1,093.9 147.2 Long-term provisions 20.5 27.6 __________ __________ 2,066.8 206.3 __________ __________ Current liabilities Other borrowings 4.7 3.5 Trade and other payables 678.2 585.5 Liability to dissenting shareholders 480.2 452.3 Current tax liabilities 390.2 295.3 Provisions 56.2 8.3 __________ __________ 1,609.5 1,344.9 __________ __________ Total liabilities 3,676.3 1,551.2 __________ __________ Consolidated balance sheet (continued) December 31, December 31, Notes 2007 2006 US$M US$M ________ __________ __________ Shareholders' equity Share capital 48.7 43.7 Share premium 194.1 125.7 Treasury shares (280.8) (94.8) Exchangeable shares 33.6 59.5 Equity component of convertible bonds 8 195.6 - Other reserve 2,099.7 2,099.7 Capital reduction reserve 2,914.5 2,946.5 Retained earnings 13.2 (1,034.9) __________ __________ Total shareholders' equity 9 5,218.6 4,145.4 __________ __________ Total liabilities and shareholders' equity 8,894.9 5,696.6 __________ __________The accompanying notes are an integral part of these consolidated financial statements.
Consolidated cash flow statement Year to December 31, Notes 2007 2006 US$M US$M ____ _________ __________ Net cash generated from operating activities 10 567.0 565.0 Investing activities Movement in restricted cash (9.7) 0.7 Purchase of subsidiary undertaking, net of cash and cash equivalents acquired (2,458.6) (0.8) Expenses relating to the New River acquisition (61.0) - Loan repaid by ID Biomedical Corporation (IDB) - 70.6 Purchase of property, plant and equipment (PP&E) (93.7) (68.7) Purchase of intangible assets (223.0) (173.6) Purchase of available-for-sale financial assets (63.2) (9.8) Net decrease in current financial assets 55.8 6.9 Proceeds/deposits received from sale of product rights 234.4 63.4 Proceeds from sale of PP&E 0.8 3.4 Proceeds from sale of available-for-sale financial assets 0.5 - Interest received 52.5 47.2 Dividend received from associates 2.3 0.4 Dividend from joint venture 6.8 5.8 __________ __________ Net cash used in investing activities (2,556.1) (54.5) __________ __________ Financing activities Proceeds from issue of Shire 2.75% convertible bonds due 2014 8 1,100.0 - Redemption of New River 3.75% convertible notes due 2013 (279.4) - Redemption of 2% guaranteed convertible loan notes 2011 - (0.1) Payment of debt issuance costs 8 (32.8) - Proceeds from drawings under bank facility 8 1,300.0 - Repayment of drawings under bank facility 8 (1,300.0) - Proceeds from exercise of New River purchased call option 141.8 - Proceeds from issue of ordinary shares, net of issue costs 877.3 - Proceeds from exercise of share options 30.4 82.0 Proceeds from exercise of warrants 13.0 - Payments to acquire shares by ESOT(1) (186.0) (92.0) Repayment of finance lease obligations (4.3) (5.5) Dividends paid (41.3) (32.4) __________ __________ Net cash provided by/(used in) financing activities 1,618.7 (48.0) __________ __________ Net (decrease)/increase in cash and cash equivalents (370.4) 462.5 Cash and cash equivalents at beginning of year 1,126.9 656.5 Effect of foreign currency translation 6.0 7.9 __________ __________ Cash and cash equivalents at end of year 762.5 1,126.9 __________ __________ (1) Employee Share Option Trust 1. General informationShire plc ("the Company") and its subsidiaries (collectively referred to as the "Group" or "Shire") develop and market products for specialty physicians. The Group focuses on four therapeutic areas: ADHD, gastro-intestinal, human genetic therapies and renal.
The Company is a public limited company incorporated under the Companies
Act 1985 and domiciled in the
The Company has its primary listing on the
These consolidated financial statements are presented in US Dollars as this is the currency of the primary economic environment in which the Group operates.
2. Accounting Presentation and Policies
While the financial information included in this preliminary announcement
has been prepared in accordance with the recognition and measurement criteria
of IFRS, this announcement does not itself contain sufficient disclosure and
other information to fully comply with IFRS. The Company's statutory accounts
for the year ended
The financial information set out above does not constitute the Company's
statutory accounts for the years ended
3. Business combinations
On
The acquisition of New River allows Shire to capture the full economic value of VYVANSE, and gain control of the future development and commercialisation of this product.
VYVANSE for ADHD in paediatric patients was approved by the FDA on
The acquisition of New River has been accounted for as a purchase
business combination in accordance with IFRS 3. Under the purchase method of
accounting, the assets and liabilities of New River are recorded at their
fair values at the acquisition date. The financial statements of Shire issued
after the completion of the acquisition reflect these fair values, with the
results of New River being included within the Consolidated Income Statement
from
Total consideration, including amounts payable in respect of stock options, share appreciation rights ("SARs"), warrants over New River's common stock and costs directly attributable to the business combination was approximately US$2.6 billion at the price of US$64 per share of New River's common stock, as analysed below:
US$M __________ Cash consideration for 37.1 million outstanding shares of New River common stock at US$64 per share (net of 1.5 million of common stock repurchased through a prepaid forward purchase 2,276.0 contract(1)) Cash cost of settling New River's stock options and SARs 124.5 Cash cost for settling sold warrants over 4.0 million shares 133.0 of New River's common stock Direct acquisition costs 61.0 __________ 2,594.5 __________ (1) New River entered into this prepaid forward purchase contract with
Merrill Lynch in
Accounting for the Effective Settlement of the New River Collaboration Agreement
Prior to the acquisition of New River, on
Under the terms of the New River Collaboration Agreements, the parties were required to collaborate on the development, manufacturing, marketing and sales of VYVANSE in the US. Profits from the collaboration arising in the US were to be divided according to a predetermined formula, based on the scheduling of VYVANSE by the DEA. Post-approval milestones were due under the New River Collaboration Agreements if the product received favourable scheduling (schedule III, IV or V or unscheduled) and on the achievement of certain sales milestones.
Through the New River Collaboration Agreements Shire also acquired the license in the RoW territory to develop and commercialise VYVANSE, in consideration of a low double-digit royalty.
Shire paid an initial sum of US$50 million to New River in
As Shire has a pre-existing relationship with New River, Shire has accounted for the acquisition of New River as a multiple element transaction, with one element being the business combination and one element being the effective settlement of Shire's pre-existing relationship with New River. As no specific guidance exists under IFRS 3 'Business Combinations' governing the accounting for business combinations when a pre-existing relationship is present, Shire has analogised the multiple element approach as outlined in IAS 18, 'Revenue', together with specific guidance in US GAAP in respect of accounting for business combinations when pre-existing relationships exist as outlined in Emerging Issues Task Force 04-1, 'Accounting for Pre-existing Relationships between the Parties to a Business Combination' ("EITF 04-1"). In accounting for the New River acquisition under IFRS, Shire has therefore applied the principles outlined in EITF 04-1 in accounting for the effective settlement of the New River Collaboration Agreements.
In accordance with the principles of EITF 04-1, Shire has measured the
effective settlement of the New River Collaboration Agreements resulting from
its pre-existing relationship with New River and has determined that, in
respect of the US Collaboration Agreement, it was less favourable to Shire
when compared with pricing for current market transactions for similar items.
The RoW Territory License Agreement was determined to be at current market
rates. The valuation of the New River Collaboration Agreements and their
current market comparators has been based upon information available at the
time of the acquisition and using the expectations and assumptions that have
been deemed reasonable by Shire's mana
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