Shire plc: On Time Execution of Operating Plan Delivers Strong 2006 Performance
BASINGSTOKE, England, February 20, 2007 /PRNewswire-FirstCall/ -- Shire plc announces results for the twelve months to December 31, 2006 - a year in which significant milestones were met, providing long-term drivers for the future growth of the Company. In addition, Shire announces in a separate press release that it has agreed to acquire New River Pharmaceuticals Inc (New River) for US$2.6 billion in cash funded by US$2.3 new debt facilities and approximately US$800 million of equity financing, a move that will increase the value of its leadership in the US Attention Deficit and Hyperactivity Disorder (ADHD) market.
2006 Financial Highlights - Product sales up 16% to US$1,536 million; - Total revenues up 12% to US$1,797 million; - Cash and cash equivalents up US$470 million; - Dividends up 15%. Matthew Emmens, Chief Executive Officer, said:
"2006 was an exceptional year for Shire in which we increased our strong leadership position in the US ADHD market and successfully executed all our planned regulatory filings and new product launches. We delivered good financial results, including a 12% rise in revenues and strong cash generation.
"This is an important and complementary acquisition that gives us full control of VYVANSE, a novel drug. We are confident and expect that the final labeling will provide patients and physicians with real benefits that differentiate this compound from other ADHD products. It will enable us to drive the launch and future development of VYVANSE and gain the full economic benefits of the drug. Based on VYVANSE's expected profile, we believe it has the potential to be the next generation stimulant product to ADDERALL XR(R). This acquisition continues our leadership position in the growing US ADHD market, improves our operating margins, significantly enhances our earnings growth from late 2009 and delivers on our overall global growth strategy. The combined debt and equity financing announced today enables us to both acquire New River and retain the financial flexibility to make further acquisitions that will continue to drive Shire's growth."
Looking ahead, in 2007 we expect to see the positive impact of our strategic plan put in place three years ago. We will benefit from the recent launches of DAYTRANA(TM) and ELAPRASE(TM) and roll-out of FOSRENOL(R) in Europe and anticipate three additional product launches during the first half of the year namely LIALDA(TM) / MEZAVANT(TM), VYVANSE(TM) and DYNEPO(R). This year should also see the approval of SPD465 and SPD503 for ADHD. In addition, we have added nine new products into our development pipeline, including three new HGT (Human Genetic Therapies) products.
Shire continues to look at ways in which it can effectively apply its cash flow to generate long-term shareholder value through strengthening its pipeline of specialty products with long lifecycles and strong intellectual property."
2006 Product highlights
- ADDERALL XR - ADHD - Sales for 2006 up 18% to US$864 million.
- DAYTRANA - ADHD - Approved by the Food and Drug Administration (FDA) in April 2006 and launched in the US in June 2006. By December 31, 2006 DAYTRANA had a 2% share of the US ADHD market and had achieved sales of US$25 million.
- ELAPRASE - Hunter syndrome
- Launched in the US in August 2006 and by December 31, 2006 over 110 patients in the US had received treatment.
- EU pre-approval process commenced in July 2006. By December 31, 2006 over 100 patients were receiving treatment on a named-patient basis.
- Sales for 2006 of US$24 million.
- REPLAGAL(R) - Fabry disease - Sales for 2006 up 24% to US$118 million.
- FOSRENOL - Hyperphosphatemia
- Prescription growth of 34% in the US. While US net sales were down 16%, this was due to significant stocking of higher strength formulations at the end of 2005.
- Sales in Europe reached US$4.6 million.
- In October 2006, Health Canada granted a marketing license application for FOSRENOL. Launch in Canada is planned for Q2 2007.
2006 Pipeline highlights
- VYVANSE (NRP104) - ADHD - New River received a second approvable letter from the FDA on December 21, 2006. Shire expects New River to receive the FDA's final response by February 24, 2007 with launch for the pediatric indication still expected for Q2 2007, pending final scheduling discussions.
- SPD465 - ADHD - Filed with the FDA in July 2006. The Prescription Drug User Fee Act (PDUFA) date is May 21, 2007.
- SPD503 - ADHD - Filed with the FDA in August 2006. The PDUFA date is June 24, 2007.
- GA-GCB - Gaucher disease - Phase 3 clinical program initiated and enrolment began in January 2007.
- Shire Human Genetic Therapies (HGT) - Three projects advanced to pre-clinical development; namely enzyme replacement therapies for Sanfilippo syndrome (Mucopolysaccharidosis IIIA), Metachromatic Leukodystrophy and intrathecal delivery of ELAPRASE for Hunter syndrome patients with significant central nervous system symptoms.
- SPD491 - A once-a-day, non opiate, transdermal analgesic being developed with the goal of non-scheduled labeling to treat moderate to severe pain, will enter Phase 1 testing in Q1 2007.
- SPD535 - Pre-clinical evaluation for development of a novel platelet-lowering agent.
In addition we in-licensed:
- Rights to the transvaginal ring technology of Duramed Pharmaceuticals Inc. (Duramed) in the larger European markets in August 2006, together with a license in the same countries to Duramed's oral contraceptive, SEASONIQUE(R) (levonorgestrel/ethinyl estradiol).
- Global rights to SPD500 (Tissue Protective Cytokine Technology), from Warren Pharmaceuticals, Inc. (Warren) in September 2006. SPD500 is being developed pre-clinically in non-nervous system indications, including renal and genetic disease areas.
- Global rights to SPD493 (Valrocemide) and other related compounds, from Yissum Research and Development Company in July 2006. SPD493 is being developed at Phase 1 for the treatment of a number of central nervous system disorders.
2006 Business Highlights
- All pending patent infringement litigations with Impax Laboratories Inc. (Impax) and Barr Laboratories Inc. (Barr) in connection with ADDERALL XR were settled in January 2006 and August 2006, respectively.
- Repayment by IDB Biomedical Inc (IDB) of its loan for flu development (US$71 million plus interest of US$8 million) in February 2006.
- ADDERALL(R) (immediate-release mixed amphetamine salts) was sold to Duramed for US$63 million in August 2006.
- FOSRENOL - Hyperphosphatemia. Agreement with Abbott Laboratories (Abbott) signed in December 2006 for the co-promotion of FOSRENOL in the US. Abbott's US renal care sales team will co-promote FOSRENOL with Abbott's Vitamin D product ZEMPLAR(R). Shire's US renal sales force will also continue to promote FOSRENOL. Abbott's co-promotion activities began in Q1 2007 and will continue for a term of five years.
- Shire agrees to acquire New River for US$2.6 billion in an all cash tender offer and merger and raises approximately US$800 million in equity financing. For details see separate release.
- ELAPRASE - Marketing authorisation granted by the European Medicines Agency on January 8, 2007. Pricing and reimbursement procedures are underway in many EU countries and launch is expected across the majority of EU countries in 2007.
- LIALDA - Ulcerative Colitis. Approval received from the FDA on January 16, 2007. US launch is planned for Q1 2007.
- SPD754 - HIV. Shire licensed the US and Canadian rights for the investigational HIV compound, SPD754 (also known as apricitabine), to the Australian biotechnology company Avexa Limited (Avexa) on January 23, 2007. Shire received an up-front cash payment of USUS$10 million, 8 million additional Avexa shares (taking its shareholding in Avexa to just over 8%) and may receive further milestones and royalties.
- MEZAVANT XL - Ulcerative Colitis. UK national licence received from the Medicines and Healthcare Products Regulatory Agency on January 19, 2007.
- ADDERALL XR - Health Canada granted a marketing license application for the adult indication in February 2007.
- FOSRENOL - Launched in the UK on February 19, 2007.
- REPLAGAL - To launch in Japan with partner Dainippon Sumitomo Pharma Co., Ltd by the end of Q1 2007.
Non-Executive Director Changes
- July 2006 - Kate Nealon joined the Shire board as a Non-Executive Director and a member of the Remuneration Committee. Kate Nealon was Group Head of Legal & Compliance at Standard Chartered plc until 2004. She also holds Non-Executive Director positions with HBOS and Cable and Wireless plc.
- December 2006 - Mr Ronald Nordmann stepped down from Shire's Board after seven years of service following expiry of his term of office.
- January 2007 - Dr Jeffrey M. Leiden, MD, PhD joined Shire's board as a Non Executive Director. Dr Leiden served as President and Chief Operating Officer, Pharmaceutical Products Group and Chief Scientific Officer at Abbott Laboratories from 2001-2006.
Full Year 2006 Unaudited Results 2006 2005 US GAAP Adjustments Non Restated Restated Non GAAP(1) US GAAP Adjustments GAAP(1) US$M US$M US$M US$M US$M US$M _______ _____ __________ _______ _______ __________ Revenues 1,796.5 - 1,796.5 1,599.3 - 1,599.3 Income/(loss) from ongoing operations(2) 316.8 70.1 386.9 (491.7) 926.9 435.2 Net income/(loss) 278.2 10.7 288.9 (578.4) 892.4 314.0 Diluted earnings/(losses) per: Ordinary share 54.6c 2.1c 56.7c (115.6c) 178.2c 62.6c ADS 163.8c 6.3c 170.1c (346.8c) 534.6c 187.8c Q4 2006 Unaudited Results Q4 2006 Q4 2005 Non Non US GAAP Adjustments GAAP(1) US GAAP Adjustments GAAP(1) US$M US$M US$M US$M US$M US$M _______ _________ __________ _______ __________ __________ Revenues 497.0 - 497.0 464.9 - 464.9 Income from ongoing operations(2) 90.3 1.7 92.0 101.0 27.3 128.3 Net Income 68.6 1.2 69.8 69.0 20.6 89.6 Diluted earnings per: Ordinary 13.4c 0.2c 13.6c 13.7c 4.1c 17.8c share ADS 40.2c 0.6c 40.8c 41.1c 12.3c 53.4c Note: Average exchange rates for 2006 and 2005 were US$1.84: GBP1.00 and US$1.82: GBP1.00, respectively. Average exchange rates for Q4 2006 and Q4 2005 were US$1.92: GBP1.00 and US$1.75: GBP1.00, respectively.
(1)For an explanation of why Shire's management believes that these non-GAAP financial measures are useful to investors, see page 7. For a reconciliation of these non-GAAP financial measures to the most directly comparable financial measures prepared in accordance with US GAAP, see pages 26-27.
(2) Income/(loss) from continuing operations before income taxes and equity in earnings/(losses) of equity method investees.
Restatement of 2005 US GAAP Results
The Company today announces the restatement of its financial statements for the year to December 31, 2005, in respect of the value ascribed to in-process research and development (IPR&D), acquired as part of the Transkaryotic Therapies, Inc. (TKT) acquisition and subsequently written off as required under US GAAP in Q3, 2005. IPR&D represented those assets which, at the time of the acquisition, had not been approved by the FDA or other regulatory authorities, including I2S (now known as ELAPRASE) and GA-GCB.
The Company has determined that the value ascribed to IPR&D acquired as a result of the TKT acquisition did not include the benefit of tax amortization as required by the American Institute of Certified Public Accountants (AICPA) Practice Aid, Assets Acquired in a Business Combination to Be Used in Research and Development Activities: A Focus on Software, Electronic Devices, and Pharmaceutical Industries. The effect of this omission was to understate the value of IPR&D expensed in the year to December 31, 2005 by US$142 million, with a corresponding overstatement of goodwill as at December 31, 2005.
However, as the additional IPR&D write-off in the year ended December 31, 2005 is a non-cash accounting item, it has no impact on the cash flows of the Company for the year ended December 31, 2005. In addition, it has no impact on the cash flows or earnings of the Company for the year ended December 31, 2006 or beyond.
The results for the year to December 31, 2005 have been restated to record the value of IPR&D written off in Q3 2005 at US$815 million (previously US$673 million). As a result of this restatement the net loss as reported under US GAAP for the year to December 31, 2005 has increased from US$436.4 million to US$578.4 million, with the diluted loss per ordinary share as reported under US GAAP for the year to December 31, 2005 increasing from 87.2 cents to 115.6 cents per ordinary share.
Non-GAAP income from continuing operations of US$435.2 million, net income of US$314.0 million and diluted earnings per ordinary share of 62.6 cents (187.8 cents per ADS), for the year to December 31, 2005, are unaffected by this restatement.
R&D pipeline and new product launches
Shire has a strong product pipeline to support the future growth of the Company. In 2007 and H1 2008, the following launches are planned:
- VYVANSE in the US; - ELAPRASE in Europe; - LIALDA in the US and MEZAVANT in Europe; - FOSRENOL in the UK, Spain and Italy; - DYNEPO in Europe; and
- REPLAGAL in Japan by Shire's partner Dainippon Sumitomo Pharmaceuticals , Inc.
In addition, Shire is anticipating FDA decisions on:-
- SPD503 for ADHD in the US; and
- SPD465 for ADHD in the US.
Timings of approvals and launches are subject to the regulatory/governmental approvals process.
This outlook excludes the impact of the New River acquisition.
Shire's business continues to perform strongly. We expect 2007 revenue growth to be around 20% (assuming prescription growth in the ADHD market of 4-6%).
As in 2006, earnings for 2007 will continue to be impacted by the costs associated with the continued development and launch of new products. We anticipate that up to six new products will be launched during 2007 and H1 2008 in addition to the expected continued growth of DAYTRANA, ELAPRASE and FOSRENOL in the US and ELAPRASE and FOSRENOL in Europe.
- These launches will require additional advertising and promotional spend and in some cases additional sales representatives. Consequently, SG&A costs are expected to rise to between US$930 - 960 million for 2007;
- Phase 3(b) and Phase 4 studies to support new product launches and the continuation of Phase 3 trials on GA-GCB, the development of the Women's Health franchise, pre-clinical development of three HGT projects and two new Phase 1 projects and two further pre-clinical projects, are all expected to result in R&D spend in the range of US$360 - 380 million;
- The depreciation charge for the year is expected to increase by approximately 20% compared to 2006; and
- The effective tax rate for 2007 is expected to be approximately 26%.
In 2007 Shire intends to commence reporting its non-GAAP earnings based on adjusted EPS, which will exclude amortisation charges and the accounting impact of SFAS123R for share based compensation. Consequently the financial outlook for the full year stated above excludes amortisation charges, which are expected to rise by 20% over 2006 and the accounting impact of SFAS123R estimated at approximately US$45m, which will be split for GAAP purposes between cost of goods, R&D and SG&A in the approximate ratio of 10%, 20% and 70%, respectively.
In respect of the six months to December 31, 2006 the Board has resolved to pay a second interim dividend of 5.2455 US cents per ordinary share (2005: 4.419 US cents per share). Together with the first interim payment of 1.9346 US cents per ordinary share (2005: 1.8246 US cents per share), this represents total dividends for 2006 of 7.1801 US cents per share (2005: 6.2436 US cents per share), an increase of 15% in US Dollar terms over 2005.
Dividend payments will be made in Pounds Sterling to Ordinary Shareholders, US Dollars to ADS holders and Canadian Dollars to Exchangeable Shareholders. A dividend of 2.6933 pence per ordinary share, 15.7365 US cents per ADS and an amount in Canadian cents per Exchangeable Share, to be determined based on the February 20, 2007 noon rate of the Bank of Canada, respectively will be paid. The Board has resolved to pay the dividend on April, 5, 2007 to persons whose names appear on the register of members of the Company (or to persons registered as holders of Exchangeable Shares in Shire Acquisition Inc.) at the close of business on March 16, 2007.
Shire intends to pursue a progressive dividend policy.
New Accounting Standard - SFAS 123R
Shire's primary basis of financial reporting is US GAAP. From January 1, 2006 Shire has applied SFAS 123R in accounting for share-based compensation. This accounting standard applies a fair value methodology in quantifying the accounting charge associated with share-based compensation.
The Company has adopted SFAS 123R according to the modified retrospective method. As a result, comparatives, including accounting periods in 2005, have been retrospectively adjusted.
Notes to Editors
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on 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 believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. 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 Europe.
For further information on Shire, please visit the Company's website: 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, manufacturing and commercialisation; 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 dates of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release of mixed amphetamine salts) (ADHD), and VYVANSE (NRP104) (lisdexamfetamine dimesylate) (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to complete, and achieve anticipated benefits from the acquisition of New River; Shire's ability to secure new products for commercialisation and/or development; and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission.
This press release contains financial measures not prepared in accordance with US GAAP. These measures are referred to as "non GAAP" measures and include Non GAAP income from ongoing operations, Non GAAP net income, Non GAAP diluted earnings per ordinary share and Non GAAP diluted earnings per ADS. These non GAAP measures exclude the effect of certain cash and non-cash items, both recurring and non-recurring, that Shire's management believes are not related to the ongoing performance of Shire's business.
These non GAAP financial measures are used by Shire's management to make operating decisions because they facilitate internal comparisons of the Company's performance to historical results and to competitors' results. These measures are also considered by the Remuneration Committee of Shire's Board of Directors in assessing the performance and compensation of employees, including its executive officers.
The non GAAP measures are presented in this press release as the Company's management believe that they will provide investors with a means of evaluating, and an understanding of how Shire's management evaluates, the Company's performance and results on a comparable basis that is not otherwise apparent on a GAAP basis, since many one-time or infrequent items that the Company's management believe are not indicative of the ongoing performance of the business may not be excluded when preparing financial measures under US GAAP.
However, these non GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with US GAAP.
The tender offer described in this press release has not yet commenced, and this press release is neither an offer to purchase nor a solicitation of an offer to sell New River common stock. Investors and security holders are urged to read both the tender offer statement and the solicitation/recommendation statement regarding the tender offer described in this report when they become available because they will contain important information. The tender offer statement will be filed by a subsidiary of Shire with the Securities and Exchange Commission (SEC), and the solicitation/recommendation statement will be filed by New River with the SEC. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed by Shire or New River with the SEC at the website maintained by the SEC at www.sec.gov. The tender offer statement and related materials may be obtained for free by directing such requests to Shire at Hampshire International Business Park, Chineham, Basingstoke, Hampshire, England, RG24 8EP, attention: Investor Relations. The solicitation/recommendation statement and such other documents may be obtained by directing such requests to New River at 1881 Grove Avenue, Radford, Virginia 24141, attention: Director of Corporate Communications.
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) AGRYLIN(R) (anagrelide hydrochloride) CALCICHEW(R) range (calcium carbonate with or without vitamin D3) CARBATROL(R) (carbamazepine extended-release capsules) COLAZIDE(R) (balsalazide) DAYTRANA(TM) (methylphenidate transdermal system) ELAPRASE(TM) (idursulfase) FOSRENOL(R) (lanthanum carbonate) GENE-ACTIVATED(R) LIALDA(TM) (mesalamine) LODINE (R) (etodolac) MEZAVANT (TM) (mesalamine) REMINYL(R) (galantamine hydrobromide) (UK and Republic of Ireland) REMINYL XL(TM) (galantamine hydrobromide) (UK and Republic of Ireland) REPLAGAL(R) (agalsidase alfa) SOLARAZE(R) (3%, gel diclofenac sodium (3%w/w)) VANIQA(R) (eflornithine hydrochloride) VYVANSE(TM) (lisdexamfetamine dimesylate) XAGRID(R) (anagrelide hydrochloride)
The following are trademarks of third parties referred to in this press release:
3TC (trademark of GlaxoSmithKline (GSK)) DYNEPO (trademark of Sanofi Aventis) MMX Multi Matrix Systems (trademark of Cosmo Technologies Limited) PENTASA (trademark of Ferring) RAZADYNE (trademark of Johnson & Johnson) RAZADYNE ER (trademark of Johnson & Johnson) REMINYL (trademark of Johnson & Johnson, excluding UK and Republic of Ireland) REMINYL XL (trademark of Johnson & Johnson, excluding UK and Republic of Ireland) SEASONIQUE (trademark of Barr Laboratories, Inc.) ZEFFIX (trademark of GSK) ZEMPLAR (trademark of Abbott Laboratories) OVERVIEW OF US GAAP FINANCIAL RESULTS 1. Introduction Summary of 2006
Revenues from continuing operations for the year to December 31, 2006 increased by 12% to US$1,796.5 million (2005: US$1,599.3 million).
Income from continuing operations (before income taxes and equity in earnings/(losses) of equity method investees) for the year to December 31, 2006 was US$316.8 million (2005: loss of US$491.7 million, as restated (see page 4)). The difference is primarily due to the write-off in 2005 of in-process R&D of US$815.0 million following the TKT acquisition.
Cash inflow from operating activities for the year to December 31, 2006 increased by 38% to US$531.9 million (2005: US$384.3 million). The net increase resulted mainly from favourable movements in working capital, in particular the timing of sales within the final quarter of 2006 coupled with a reduction in the net tax paid of US$48.5 million.
Cash and cash equivalents, restricted cash and short-term investments at December 31, 2006 totaled US$1,156.7 million (December 31, 2005: US$694.0 million). The increase in cash and cash equivalents during the year of US$470.4 million was primarily due to positive cash flows from Shire's operations, the sale of product rights to Duramed for US$63.0 million and proceeds from loans repaid by IDB of US$70.6 million, offset by purchases of property, plant and equipment (US$100.3 million) and a milestone payment to Noven Pharmaceuticals Inc. (Noven) on DAYTRANA's approval (US$50.0 million).
Summary of Q4 2006
Revenues from continuing operations for the three months to December 31, 2006 increased by 7% to US$497.0 million (2005: US$464.9 million) with ELAPRASE and DAYTRANA contributing US$34.5 million to Q4 2006 sales.
Income from continuing operations (before income taxes and equity in earnings/(losses) of equity method investees) for the three months to December 31, 2006 was US$90.3 million (2005: US$101.0 million).
Cash inflow from operating activities for the three months to December 31, 2006 was US$188.8 million (2005: US$155.0 million). This increase primarily resulted from favourable movements in working capital.
2. Product sales
For the year to December 31, 2006 product sales increased by 16% to US$1,535.8 million (2005: US$1,327.7 million) and represented 86% of total revenues (2005: 83%). Product Highlights Sales Sales US Rx US Market Product US$M Growth (2) Growth (1) Share (1) (2) ADDERALL XR 863.6 +18% +8% 26% DAYTRANA 25.1 n/a n/a 2% CARBATROL 68.3 -5% -9% 42% PENTASA 137.8 +1% +2% 18% REPLAGAL(3) 117.7 n/a n/a n/a ELAPRASE 23.6 n/a n/a n/a XAGRID(4) 53.3 +14% n/a n/a FOSRENOL 44.8 -16% +34% 9% (1) IMS Prescription Data - Product specific (December 2006). (2) Compared to 2005.
(3) REPLAGAL was acquired as part of the TKT acquisition, which completed in July 2005. Total sales for REPLAGAL, including pre-acquisition sales, for the year ended 2005 were US$94.6 million with total growth for the year ended 2006, including pre-acquisition sales, of 24%. In 2005 total post-acquisition sales were US$41.3 million.
(4) Worldwide sales excluding US and Canada.
ADDERALL XR for the treatment of ADHD
ADDERALL XR is the leading brand in the US ADHD market with an average market share of 26% in 2006 (2005: 25%). US ADHD market growth of 4% and the 1% increase in average market share contributed to an 8% increase in US prescriptions for ADDERALL XR for year to December 31, 2006 compared to the same period in 2005.
Sales of ADDERALL XR for the year to December 31, 2006 were US$863.6 million, an increase of 18% compared to the same period in 2005 (2005: US$730.8 million). Product sales growth was significantly higher than prescription growth due primarily to price increases in August 2005 and April 2006.
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 received correspondence from the FDA in April 2006 stating that, due to the complex issues raised requiring extensive review and analysis by the FDA's officials, a decision cannot yet be reached by the FDA. The FDA did not provide any guidance as to when that decision may be reached.
On August 14, 2006 Shire and Barr announced that all pending litigation in connection with Barr's Abbreviated New Drug Application (ANDA) and its attempt to market generic versions of Shire's ADDERALL XR had been settled. As part of the settlement, Barr entered into consent judgments and agreed to permanent injunctions confirming the validity and enforceability of Shire's US Patents Nos. 6,322,819 (the "'819 Patent"), 6,601,300 (the "'300 Patent") and 6,913,768 (the "'768 Patent"). Barr has also admitted that any generic product made under its ANDA would infringe the '768 patent. Under the terms of the settlement, Barr will not be permitted to market a generic version of ADDERALL XR in the US until April 1, 2009, except in certain limited circumstances, such as the launch of another party's generic version of ADDERALL XR. No payments to Barr are involved in the settlement agreement.
In January 2006, Shire settled its ADDERALL XR patent infringement lawsuits with Impax. 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 the Company 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 the Company's authorized generic. No payments to Impax are involved in the settlement agreement.
Litigation proceedings concerning Shire's ADDERALL XR patents are ongoing. 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, 2005 and our most recent Quarterly Report on Form 10-Q for the period ended September 30, 2006.
DAYTRANA for the treatment of ADHD
Following its launch in June 2006, DAYTRANA achieved a 2% share of the US ADHD market by December 31, 2006. Sales for the year to December 31, 2006 were US$25.1 million, a level of sales which triggered the first of three potential US$25.0 million sales milestone payments to Noven. This milestone, which was paid on February 14, 2007, has been capitalized as at December 31, 2006 and will be amortized over 10 years. Net sales for 2006 were impacted by the redemption of US$14 million of coupons issued to support the product launch.
The addition of DAYTRANA, combined with growth in ADDERALL XR market share has helped Shire grow its total share of the US ADHD market to 28% at December 31, 2006 compared to 26% (which included a 1% share relating to ADDERALL) at December 31, 2005.
CARBATROL for the treatment of Epilepsy
US prescriptions for the year ending December 31, 2006 were down 9% compared to the same period in 2005. This was primarily due to a 6% decline in the US extended release carbamazepine prescription market. CARBATROL's US market share remained at 42%.
Sales of CARBATROL for the year ending December 31, 2006 were US$68.3 million, a decrease of 5% compared to the same period in 2005 (2005: US$72.1 million). The fall in sales is due to the decrease in the extended release carbamezapine market and a reduction of pipeline inventory in 2006 compared to stocking in 2005, offset by price increases in October 2005 and July 2006.
In July 2006 Impax deployed a sales force to begin promotion of CARBATROL under a promotional services agreement for the US market signed in January 2006.
Patent litigation proceedings with Nostrum Pharmaceuticals, Inc. and Corepharma LLC relating to CARBATROL are ongoing. Further information about the ongoing proceedings relating to the Company's CARBATROL patents can be found in our filings with the US Securities and Exchange Commission, including our Annual Report on Form 10-K for the period ended December 31, 2005 and our most recent Quarterly Report on Form 10-Q for the period ended September 30, 2006.
PENTASA for the treatment of Ulcerative Colitis
US prescriptions for the year ending December 31, 2006 were up 2% compared to the same period in 2005 primarily due to a 4% increase in the US oral mesalamine prescription market. PENTASA's US market share remained at 18%.
Sales of PENTASA for the year ending December 31, 2006 were US$137.8 million, an increase of 1% compared to the same period in 2005 (2005: US$136.1 million). Sales growth is marginally lower than prescription growth due to the lower levels of pipeline stocking in 2006, partly offset by the impact of price increases in January 2006 and November 2006.
REPLAGAL for the treatment of Fabry Disease
Sales for the year ending December 31, 2006 were US$117.7 million, of which 88% were in Europe and 12% in the rest of the world. Sales for REPLAGAL for the year ending December 31, 2005 were US$94.6 million, including pre-acquisition sales of US$53.3 million. This represents a like-for-like increase in sales of 24% which was due to greater European coverage by an increased number of sales representatives and strong growth in the rest of the world market (excluding the US).
ELAPRASE for the treatment of Hunter Syndrome
ELAPRASE was launched in the US in August 2006 and has had a strong start with over 110 patients receiving treatment by the end of December 2006. In addition, through the pre-approval process, over 100 patients were receiving treatment in Europe by the end of the year. Sales reached US$23.6 million by December 31, 2006.
XAGRID for the treatment of Thrombocythemia
Sales for the year ended December 31, 2006 were US$53.3 million, an increase of 14% compared to the same period in 2005 (2005: US$46.8 million). Expressed in transaction currencies (XAGRID is primarily sold in Euros), sales increased by 13% due mainly to strong growth in France and Spain. In addition there was a benefit of 1% from favorable exchange rate movements against the US dollar.
AGRYLIN sales in North America (US and Canada) were US$7.5 million for the year ended December 31, 2006 (2005: US$46.0 million). This reduction was expected following the approval of generic versions of AGRYLIN in the US market in April 2005.
FOSRENOL for the treatment of Hyperphosphatemia
US prescriptions for the year ending December 31, 2006 were up 34% compared to 2005 due to FOSRENOL increasing its average share of the total US phosphate binding market to 9% (2005: 7%) and market growth of 9% over the same period. FOSRENOL was launched in the US in January 2005.
US sales of FOSRENOL for the year ending December 31, 2006 were US$40.2 million (2005: US$53.0 million). The decrease in net sales of 16% compared to prescription growth of 34% is primarily due to destocking in 2006 compared to significant stocking of higher strength formulations at the end of 2005.
An agreement with Abbott was signed in December 2006 for the co-promotion of FOSRENOL in the US. Abbott's US renal care sales team will co-promote FOSRENOL with its own renal product ZEMPLAR. Shire's US sales force will also continue to promote FOSRENOL. This agreement began in Q1 2007, and will continue for a term of five years.
European sales of FOSRENOL for the year ending December 31, 2006 were US$4.6 million (2005: US$0.5 million), giving total FOSRENOL sales worldwide of US$44.8 million (2005: US$53.5 million).
FOSRENOL has now been launched in Germany, France and a number of other European countries. Launches will continue throughout 2007 in the EU including the UK, Italy and Spain, subject to finalization of national licensing and conclusion of pricing and reimbursement negotiations.
On October 18, 2006 Health Canada granted a marketing license application for FOSRENOL. The Canadian launch is planned for Q2 2007.
Royalty revenue remained constant at US$242.9 million for the year to December 31, 2006 (2005: US$242.9 million).
Royalty Highlights Worldwide sales by Royalties to Royalty (1) licensee (2) in 2006 Shire Growth Product US$M % US$M 3TC 150.9 -6% 1,138 ZEFFIX 34.8 14%(3) 301 Other 57.2 9% n/a Total 242.9 0% (1) Compared with 2005. (2) GSK
(3) The impact of foreign exchange movements has contributed +1% to the reported growth.
Royalties from sales of 3TC for the year to December 31, 2006 were US$150.9 million, a decrease of 6% compared to the prior year (2005: US$159.8 million).
Shire receives royalties from GSK on worldwide 3TC sales. GSK's worldwide sales of 3TC for the year to December 31, 2006 were US$1,138 million, a decrease of 6% compared to prior year (2005: US$1,211 million). The nucleoside analogue market for HIV has continued to grow, however competitive pressures within the market have increased, leading to a decline in 3TC sales.
Royalties from sales of ZEFFIX for the year to December 31, 2006 were US$34.8 million, an increase of 14% compared to the prior year (2005: US$30.5 million).
Shire receives royalties from GSK on worldwide ZEFFIX sales. GSK's worldwide sales of ZEFFIX for the year to December 31, 2006 were US$301 million, an increase of 13% compared to prior year (2005: US$266 million). This increase was mainly due to strong growth in the Korean, Japanese and Chinese markets.
Other royalties are primarily in respect of REMINYL and REMINYL ER (known as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide (excluding the UK and the Republic of Ireland) by Janssen Pharmaceutical N.V. (Janssen), an affiliate of Johnson & Johnson. Shire has the exclusive marketing rights in the UK and the Republic of Ireland.
Sales of the REMINYL/ RAZADYNE range, for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer's type, continue to grow.
In June 2006 Janssen and Synaptech, Inc. filed a law suit against Barr for infringement of their patent rights relating to RAZADYNE ER as a result of Barr filing an ANDA with the FDA for a generic version of RAZADYNE ER. No court date has been set.
Barr and other companies have filed ANDAs with the FDA for generic versions of RAZADYNE and Janssen and Synaptech Inc. have filed law suits against some of those ANDA filers. The court date for the first of these proceedings is May 2007.
4. Financial details
Cost of product sales
For the year to December 31, 2006 the cost of product sales was 16% of product sales (2005: 16%). The cost of product sales for REPLAGAL in 2006 included a US$47.0 million adjustment in respect of acquired inventories (2005: US$41.9 million). This fair value adjustment increased Shire's cost of product sales as a percentage of sales for the year ended December 31, 2006 by 3% (2005: 3%).
For the year to December 31, 2006 cost of product sales included a charge of US$3.2 million for share based compensation under SFAS 123R (2005: US$1.5 million).
Research and development (R&D)
R&D expenditure increased from US$339.1 million in the year to December 31, 2005 to US$386.9 million in the year to December 31, 2006, an increase of 14%. The increase was primarily due to:
- The addition of two significant R&D projects following the acquisition of TKT (ELAPRASE and GA-GCB); and
- Upfront payments made to Duramed and Warren of US$25.0 million and US$5.5 million, respectively.
Expressed as a percentage of total revenues, R&D expenditure was 22% for the year to December 31, 2006 (2005: 21%). In both periods payments were made to New River of US$50 million for in-licensing VYVANSE. These payments have both been expensed in accordance with Shire's accounting policy. The payments to New River, Duramed and Warren in the year to December 31, 2006 totalled US$80.5 million, equivalent to 5% of total revenues. In the year to December 31, 2005 the US$50.0 million payment to New River was equivalent to 3% of total revenues.
For the year to December 31, 2006 R&D included a charge of US$5.4 million for share based compensation under SFAS 123R (2005: US$2.9 million). Selling, general and administrative (SG&A)
SG&A expenses increased from US$655.5 million in the year to December 31, 2005 to US$835.4 million in the year to December 31, 2006, an increase of 27%. As a percentage of product sales, SG&A expenses were 54% (2005: 49%).
The increase in SG&A expenses was expected, with additional expenditure required for:
- The promotion and launch of DAYTRANA (including an increase in the ADHD sales force);
- The recruitment of a new GI sales force in the US;
- The recruitment of new US and European sales forces to launch Elaprase; and
- Pre-launch activities relating to the 2007 launches of DYNEPO, LIALDA and VYVANSE.
For the year to December 31, 2006 SG&A included a charge of US$34.4 million for share based compensation under SFAS 123R (2005: US$24.8 million), representing 2% of total revenue (2005: 1%).
Depreciation and amortization
The depreciation charge for the year to December 31, 2006 was US$43.3 million (2005: US$29.2 million, including US$6.5 million for impairments of property, plant and equipment). The amortization charge for the year to December 31, 2006 was US$56.3 million (2005: US$45.2 million). The increase in both depreciation and amortization is primarily due to the inclusion of a full year's amortization and depreciation charge in respect of assets acquired through the TKT acquisition, together with the amortization of capitalized milestone payments for DAYTRANA following its launch in June 2006.
Intangible asset impairment
The charge for intangible asset impairments for the year to December 31, 2006 was US$1.1 million (2005: US$5.6 million). The impairment charge for the year to December 31, 2006 resulted from the decision to stop selling a non-core product.
The impairment charge for the year to December 31, 2005 resulted from the approval of generic versions of AGRYLIN and the decision not to support and promote certain non-core products.
For the year to December 31, 2006 the Company incurred US$5.6 million of costs associated with the integration of the TKT business into the Shire group (2005: US$9.7 million). This included retention payments for key staff of US$3.0 million, IT costs of US$1.2 million and other costs of US$1.4 million.
Gain on sale of product rights
For the year to December 31, 2006 the Company recognized a pre-tax gain of US$63.0 million (2005: US$nil) on the disposal of ADDERALL to Duramed for US$63.0 million in cash.
For the year to December 31, 2006 the Company received interest income of US$50.5 million (2005: US$35.3 million). This income primarily related to interest received on Shire's cash balances. Interest income for the year ending December 31, 2006 is higher than for the year ending December 31, 2005 primarily as a result of increases in US dollar interest rates.
For the year to December 31, 2006 the Company incurred interest expense of US$26.4 million (2005: US$12.0 million).
In both years this expense primarily relates to a 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. The trial date for the appraisal rights litigation has been set for April 23, 2007. 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, 2005 and our most recent Quarterly Report on Form 10-Q for the period ended September 30, 2006.
Other income, net
For the year to December 31, 2006 other income totaled US$9.5 million. This included US$4.6 million of investment income, foreign exchange gains of US$3.2 million and US$3.8 million of other income, offset by impairments of long-term investments of US$2.1 million.
For the year to December 31, 2005 other income totaled US$9.9 million. This included US$4.3 million of investment income, a gain on sale of available-for-sale securities of US$3.9 million, a gain on sale of the drug formulation business of US$3.6 million and US$1.5 million of other income, offset by impairments of long-term investments of US$2.0 million and foreign exchange losses of US$1.4 million.
The effective rate of tax for the year to December 31, 2006 was 26.8% (2005: 27.5%, after excluding the impact of the US$815.0 million write-off of in-process R&D in respect of the TKT acquisition). The effective rate has fallen by 0.7% as a result of a reduction in deferred taxes offset by an increase in current taxes as a result of additional tax contingencies of US$187 million recognised in relation to ongoing tax audits. The reduction in deferred taxes was primarily due to the reversal of valuation allowances following changes in estimates as to the realisation of certain deferred tax assets. Following this reversal of valuation allowances the net deferred tax asset has increased to US$261.0 million at December 31, 2006 (December 31, 2005: US$116.2 million). Realization of deferred tax assets is dependent upon generating sufficient taxable income to utilize such assets. Although realization of these assets is not assured, it is more likely than not that the amount recognized will be realized.
Equity in earnings/(losses) of equity method investees
Net earnings of equity method investees of US$5.7 million were recorded for the year to December 31, 2006 (2005: net losses of US$1.0 million). This comprised earnings of US$6.2 million from the 50% share of the antiviral commercialization partnership with GSK in Canada (2005: US$5.3 million), offset by losses of US$0.5 million being the Company's share of losses in the GeneChem and EGS Healthcare Funds (2005: losses of US$6.3 million). Unaudited US GAAP results for the years to December 31, 2006 and 2005 Consolidated Balance Sheets 1 Adjusted and restated December 31, December 31, 2005 2006 US$M US$M ___________ ___________ ASSETS Current assets: Cash and cash equivalents 1,126.9 656.5 Restricted cash 29.8 30.6 Short-term investments - 6.9 Accounts receivable, net 310.8 329.9 Inventories 131.1 136.0 Deferred tax asset 105.7 54.2 Prepaid expenses and other current assets 106.0 98.1 ___________ ___________ Total current assets 1,810.3 1,312.2 Non current assets: Investments 55.8 50.2 Property, plant and equipment, net 292.8 234.0 Goodwill 237.4 225.6 Other intangible assets, net 762.4 729.3 Deferred tax asset 155.3 62.0 Other non-current assets 12.4 42.9 ___________ ___________ Total assets 3,326.4 2,656.2 ___________ ___________ LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable and accrued expenses 566.1 431.8 Liability to dissenting shareholders 452.3 427.6 Other current liabilities 313.6 106.0 ___________ ___________ Total current liabilities 1,332.0 965.4 Non-current liabilities 52.1 43.5 ___________ ___________ Total liabilities 1,384.1 1,008.9 ___________ ___________
1 Retrospectively adjusted following the adoption of SFAS 123R, and restated for the correction to the value ascribed to IPR&D acquired with the acquisition of TKT, as explained on page 4.
Unaudited US GAAP results for the years to December 31, 2006 and 2005 Consolidated Balance Sheets (continued) 1 Adjusted and restated December 31, December 31, 2006 2005 US$M US$M ___________ ___________ Shareholders' equity: Common stock of 5p par value: 750 million shares authorized; and 506.7 million shares issued and outstanding (2005: 750 million shares authorized; and 495.7 million shares issued and outstanding) 43.7 42.7 Exchangeable shares: 1.3 million shares issued and outstanding (2005: 2.2 million) 59.4 101.2 Treasury stock (94.8) (2.8) Additional paid-in capital 1,493.2 1,327.5 Accumulated other comprehensive income 87.8 71.5 Retained earnings 353.0 107.2 ___________ ___________ Total shareholders' equity 1,942.3 1,647.3 ___________ ___________ Total liabilities and shareholders' equity 3,326.4 2,656.2 ___________ ___________
1 Retrospectively adjusted following the adoption of SFAS 123R, and restated for the correction to the value ascribed to IPR&D acquired with the acquisition of TKT, as explained on page 4.
Unaudited US GAAP results for the 3 months and years to December 31, 2006 and 2005 Consolidated Statements of Operations
1 Adjusted and 1 Adjusted restated 3 months to 3 months to 12 months 12 months December December to December to December 31, 2006 31, 2005 31, 2006 31, US$M US$M US$M 2005 US$M ___________ ___________ ___________ ___________ Revenues: Product sales 427.6 397.5 1,535.8 1,327.7 Royalties 61.1 61.8 242.9 242.9 Other revenues 8.3 5.6 17.8 28.7 ___________ ___________ ___________ ___________ Total revenues 497.0 464.9 1,796.5 1,599.3 ___________ ___________ ___________ ___________ Costs and expenses: Cost of product sales 62.4 79.1 247.7 215.5 Research and development 82.9 85.9 386.9 339.1 Selling, general and administrative 241.3 171.9 835.4 655.5 Depreciation and amortization 27.3 24.3 99.6 74.4 Intangible asset impairment 1.1 2.6 1.1 5.6 Reorganization costs - - - 9.4 Integration costs 1.7 6.2 5.6 9.7 In-process R&D write-off - - - 815.0 Gain on sale of product rights - - (63.0) - ___________ ___________ ___________ ___________ Total operating expenses 416.7 370.0 1,513.3 2,124.2 ___________ ___________ ___________ ___________ Operating income/(loss) 80.3 94.9 283.2 (524.9) Interest income 13.7 7.4 50.5 35.3 Interest expense (7.3) (7.3) (26.4) (12.0) Other income, net 3.6 6.0 9.5 9.9 ___________ ___________ ___________ ___________ Total other income, net 10.0 6.1 33.6 33.2 ___________ ___________ ___________ ___________ Income/(loss) from continuing operations before income taxes and equity in earnings /(losses) of equity method investees 90.3 101.0 316.8 (491.7) Income taxes (21.9) (29.9) (84.9) (88.8) Equity in earnings/(losses) of equity method investees 0.2 (1.1) 5.7 (1.0) ___________ ___________ ___________ ___________ Income/(loss) from continuing operations 68.6 70.0 237.6 (581.5) Gain/(loss) from discontinued operations (net of income tax expense of US$nil and US$nil) - (1.0) 40.6 3.1 __________ ___________ ___________ ___________ Net income/(loss) 68.6 69.0 278.2 (578.4) ___________ ___________ ___________ ___________
1 Retrospectively adjusted following the adoption of SFAS 123R, and restated for the correction to the value ascribed to IPR&D acquired with the acquisition of TKT, as explained on page 4.
Unaudited US GAAP results for the 3 months and years to December 31, 2006 and 2005 Consolidated Statements of Operations (continued)
1 Adjusted and 1 Adjusted restated 3 months to 3 months to 12 months 12 months December December to December to December 31, 2006 31, 2005 31, 2006 31, 2005 ___________ ___________ ___________ ___________ Earnings per share - basic Income/(loss) from continuing operations 13.6c 14.0c 47.2c (116.2c) Gain/(loss) on disposition of discontinued operations - (0.2c) 8.1c 0.6c ___________ ___________ ___________ ___________ Earning/(loss) per ordinary share - basic 13.6c 13.8c 55.3c (115.6c) ___________ ___________ ___________ ___________ Earnings per share - diluted Income/(loss) from continuing operations 13.4c 13.9c 46.6c (116.2c) Gain/(loss) on disposition of discontinued operations - (0.2c) 8.0c 0.6c ___________ ___________ ___________ ___________ Earnings/(loss) per ordinary share - diluted 13.4c 13.7c 54.6c (115.6c) ___________ ___________ ___________ ___________ Earnings/(loss) per ADS - diluted 40.2c 41.1c 163.8c (346.8c) ___________ ___________ ___________ ___________ No. of No. of No. of No. of shares shares shares shares Weighted average number of shares: Millions Millions Millions Millions Basic 502.5 501.7 503.4 500.2 Diluted 510.3 504.1 509.3 500.2 ___________ ___________ ___________ ___________
Unaudited US GAAP results for the 3 months and years to December 31, 2006 and 2005 Consolidated Statements of Cash Flows
1 Adjusted and 1 Adjusted restated 3 months to 3 months to 12 months 12 months December December to December to December 31, 2006 31, 2005 31, 2006 31, 2005 US$M US$M US$M US$M ___________ ___________ ___________ ___________ CASH FLOWS FROM OPERATING ACTIVITIES: Net income/(loss) 68.6 69.0 278.2 (578.4) Adjustments to reconcile net income/(loss) to net cash provided by operating activities: Depreciation and amortization: - in cost of product sales 1.3 0.8 4.8 3.5 - in other costs and expenses 26.8 23.9 99.1 68.0 Share based compensation 17.2 8.4 43.0 29.2 In-process R&D write-off - - - 815.0 Write-down of long-term assets 2.0 3.1 3.8 14.1 Gain on sale of long-term assets (0.5) - (0.3) (3.9) Gain on sale of drug formulation business - (3.6) - (3.6) Equity in (earnings)/losses of equity method investees (0.2) 1.1 (5.7) 1.0 Gain on sale of product rights - - (63.0) - Loss/(gain) on disposition of discontinued operations - 1.1 (40.6) (3.1)
Posted: February 2007