BASINGSTOKE, England and PHILADELPHIA, February 21 /PRNewswire-FirstCall/ -- Shire plc the global specialty biopharmaceutical company announces results for the twelve months to December 31, 2007 - a year which has seen significant growth in launched products.
(1) New product sales include VYVANSE, LIALDA/MEZAVANT, DYNEPO, ELAPRASE, FOSRENOL and DAYTRANA
Matthew Emmens, Chief Executive Officer, commented:
“Shire had an excellent 2007, growing sales from our portfolio of both new and established products by a total of 41% and raising revenue guidance throughout the course of the year. We generated substantial cash inflows from operations of $475 million, after expending $156 million on the acquisition of new product candidates in both our Human Genetic Therapies and Specialty Pharmaceutical businesses. Based on these strong results we were able to bring forward several new R&D programs.
During the year, we undertook three major new product launches - VYVANSE, LIALDA / MEZAVANT and DYNEPO - which have gone well and also continued the roll-out of ELAPRASE and FOSRENOL into new geographies. These products, together with DAYTRANA that was launched last year, represented 32% of our fourth quarter product sales.
The acquisition of New River Pharmaceuticals gave us full ownership and control of VYVANSE, and this new generation ADHD treatment is establishing itself in the US, where it has already gained a market share of 6%(i). The launch of VYVANSE continues to progress well and we are confident about the medication’s future growth supported by new clinical studies and expected additional indications. Our total ADHD franchise has now grown to 32% of the total US ADHD market, compared to 28% at the end of 2006, extending our leadership position in this specialist area.
We’ve also acquired five pipeline compounds in new technologies and new markets, by licensing the marketing and co-development rights to a range of both biological and small molecule products from Renovo, Amicus Therapeutics and Alba Therapeutics.
Looking forward, we will continue to execute our strategy, which has provided good returns for shareholders, by building on the success of our growing specialist drugs portfolio focused on the treatment of symptomatic diseases. We currently expect 2008 revenue growth to be in the mid to high teens range and positive revenue growth through 2010.”
(i) per IMS weekly prescription data at February 8, 2008
Product Highlights
- VYVANSE(TM) - Attention Deficit and Hyperactivity Disorder (“ADHD”).
- Approved by the US Food and Drug Administration (“FDA”) for use in the pediatric population in February 2007 and launched in the US in July 2007 (dosage strengths 30mg, 50mg and 70mg).
- On December 10, 2007 the FDA approved three additional dosage strengths (20mg, 40mg and 60mg) which will be available in retail pharmacies in the US in the second quarter of 2008. These additional strengths are designed to increase dosing flexibility.
- By February 15, 2008 VYVANSE had achieved a US ADHD market share of 6.3% based on daily prescription volume.
- Launch has been tracking in line with other blockbuster Central Nervous System drug launches.
- Over 900,000 prescriptions since launch.
- Over 50% (23,000) of high volume physicians prescribing.
- Coupons are now less than 15% of total prescriptions.
- ADDERALL XR(R) - ADHD - Sales for 2007 were up 19% to $1,030.9 million (2006: $863.6 million).
- DAYTRANA(TM) - ADHD.
- Sales for 2007 were up 156% to $64.2 million (2006: $25.1 million).
- On January 9, 2008 the FDA issued a Warning Letter to Noven Pharmaceuticals Inc. (“Noven”) which related to Noven’s manufacture of DAYTRANA. Further regulatory action could result if the FDA’s concerns are not satisfied fully. Noven submitted a response to the FDA on January 30, 2008.
- LIALDA(TM)/MEZAVANT(R) - Ulcerative Colitis.
- LIALDA, the only once-daily oral formulation of mesalamine was approved by the FDA in January 2007 and launched in the US in March 2007, acquiring 8.0% share of the US oral mesalamine market at December 31, 2007. Sales for 2007 were $50.5 million.
- Shire’s share of the US oral mesalamine market from LIALDA and PENTASA(R) combined was 26.0% at February 8, 2008.
- The product was launched in the UK in November 2007 as MEZAVANT XL, with further launches planned in the EU in 2008. It was launched in Canada on January 28, 2008 as MEZAVANT.
- FOSRENOL(R) - Hyperphosphatemia - International launches continued and FOSRENOL is now available in 24 countries with worldwide sales in 2007 of $102.2 million (2006: $44.8 million).
- DYNEPO(R) - Anemia associated with chronic kidney disease (“CKD”) - DYNEPO is the first and only erythropoiesis-stimulating agent produced in a human cell line. The product has been launched in several EU countries and sales for 2007 were $14.2 million.
- ELAPRASE(R) - Hunter syndrome.
- On February 11, 2008 ELAPRASE was approved for commercial sale by the Mexican Federal Commission for the Protection against Sanitary Risk. ELAPRASE is now approved in 37 countries worldwide and sales for the year to December 31, 2007 were $181.8 million (2006: $23.6 million).
- In October 2007 ELAPRASE was launched in Japan, with sales and distribution managed by Genzyme Corporation. Shire’s gross profit on the arrangement equates to an effective royalty of approximately 25% to 30%, but revenues will be recorded within product sales.
- REPLAGAL(R) - Fabry disease.
- REPLAGAL is now approved in 41 countries and sales for 2007 were up 22% to $143.9 million (2006: $117.7 million).
- In February 2007 REPLAGAL was launched in Japan through Shire’s partner Dainippon Sumitomo Pharma Co., Ltd. Similar to ELAPRASE, Shire will record revenues within product sales.
Pipeline Highlights
Shire has expanded its product pipeline by in-licensing the following drug compounds and technologies in 2007:
- JUVISTA(R)
- In August 2007 Shire acquired exclusive rights to develop and commercialize JUVISTA worldwide (with the exception of EU member states) from Renovo Limited (“Renovo”). JUVISTA, which is being investigated for the prevention and reduction of scarring in connection with surgery, is in late Phase 2 development.
- Seven Phase 2 efficacy trials for JUVISTA have now been reported of which six demonstrated statistically significant efficacy. Phase 2 clinical trials in multiple other surgery types are ongoing and are expected to report during 2008 and 2009.
- Pharmacological chaperone compounds for Lysosomal Storage Disorders (“LSDs”) - In November 2007 Shire in-licensed from Amicus Therapeutics, Inc. (“Amicus”) the rights to three compounds in markets outside the US:
- AMIGAL(TM) for Fabry disease (Phase 2) received orphan drug designation by the EMEA, which may provide it with up to ten years market exclusivity in the EU;
- PLICERA(TM) for Gaucher disease (Phase 2) received orphan drug designation by the EMEA, which may provide it with up to ten years market exclusivity in the EU; and
- AT2220 for Pompe disease is currently in Phase 1 clinical trials.
- SPD550 (Larazotide Aceotate) for Gastro Intestinal (“GI”) disorders - In December 2007 Shire licensed rights to SPD550 (also known as AT-1001), in markets outside of the US and Japan, from Alba Therapeutics Corporation (“Alba”). SPD550 is Alba’s lead inhibitor of barrier dysfunction in various GI disorders and is currently in Phase 2 development for the treatment of Celiac disease.
- SPD487 (Amphetamine transdermal system (“ATS”)) - ADHD - In June 2007 Shire acquired exclusive development rights to ATS following completion of early development work by Noven.
During 2007 Shire has made $155.9 million of up-front payments for the in-licensing of the above products comprising $75.0 million to Renovo, $50.0 million to Amicus, $25.0 million to Alba and $5.9 million to Noven. Shire also made a $50 million equity investment in Renovo Group plc.
Existing pipeline developments:
- VYVANSE for ADHD in adult patients
- In September 2007, the FDA accepted the filing of a supplemental New Drug Application for VYVANSE for the treatment of ADHD in adult patients. The Prescriptions Drug User Fee Act (“PDUFA”) action date is April 28, 2008.
- On October 25, 2007 Shire released results from the Phase 3 clinical trials in adults. In this double-blind, placebo-controlled, four-week study with dose escalation in 414 adults aged 18 to 55 years, treatment with VYVANSE at all doses studied (30mg, 50mg, 70mg) was significantly more effective than placebo.
- Adults represent the largest and fastest growing segment of the ADHD market with a total of 9.9 million patients, of which 7.5 million are untreated.
- DAYTRANA - ADHD - Regulatory submissions were filed for approval of the product with Health Canada on November 29, 2007 and with the Netherlands, as the reference member state for approval in the EU via the decentralized procedure, on December 12, 2007.
- INTUNIV(TM) (previously known as SPD503) - ADHD - A non-stimulant “non-scheduled” medication for the treatment of ADHD. In June 2007 Shire received an approvable letter from the FDA for INTUNIV. Shire is in discussions with the FDA regarding additional clinical work which is designed to enhance the label. While the precise timing of the approval of INTUNIV is unknown, Shire now anticipates that launch will occur in H2 2009.
- SPD465 - ADHD - In May 2007 Shire received an approvable letter from the FDA. Shire is not currently taking any steps to move this product towards approval.
- FOSRENOL - Hyperphosphatemia - On October 16, 2007 the FDA Cardiovascular and Renal Drugs Advisory Committee recommended by a majority vote the use of phosphate binders, including FOSRENOL, to treat hyperphosphatemia in CKD stage 4 patients. Shire is working with the FDA to explore the regulatory pathway to approval for use in pre-dialysis patients.
- LIALDA/MEZAVANT - Phase 3 worldwide clinical trials investigating the use of the product for the treatment of diverticulitis, a colonic disease, were initiated in 2007.
- ELAPRASE - for Hunter syndrome patients with significant central nervous system symptoms - In December 2007 Shire completed all pre-clinical work and filed an Investigational New Drug (“IND”) application. The IND was accepted by the FDA on January 23, 2008.
- Velaglucerase alfa (GA-GCB) - Gaucher disease - A worldwide Phase 3 clinical program was initiated in 2007 and is ongoing. It is anticipated that this development program will support filing of velaglucerase alfa from H2 2009.
- Whilst a number of preclinical products are underway in early stage development, Shire has discontinued the following projects: SPD491 (a pain product), SPD493 (formerly known as Valrocemide), SPD500 (Tissue protective cytokine technology) and NRP290 (a pain product acquired with the New River Pharmaceuticals Inc. (“New river”) acquisition).
Business Highlights
- SPD754 (Apricitabine) - HIV - Shire licensed its residual rights (for the US and Canada) for the investigational HIV compound to Avexa Limited (“Avexa”) on January 23, 2007. In return Shire received an upfront cash payment of $10 million and Avexa shares valued at approximately $3 million.
- In April 2007 Shire completed the acquisition of New River by way of a short-form merger for $64 per share, or approximately $2.6 billion, partly funded by a private equity placing of $0.9 billion in February 2007.
- In May 2007 Shire issued $1.1 billion principal amount of convertible bonds due 2014. The proceeds of the bonds were used by Shire to repay borrowings under its bank facilities previously drawn to partially fund the acquisition of New River.
- Product divestments - In December 2007 Shire completed the sale of a portfolio of non-core products, including SOLARAZE(R) and VANIQA(R) to Laboratorios Almirall S.A. (“Almirall”) for a cash consideration of $209.6 million, net of costs of $2.2 million. During the year Shire also received cash consideration of $24.8 million from the sale of other non-core products.
- Legal settlements
- In October 2007, all parties to the 2003 Transkaryotic Therapies, Inc. class action securities lawsuit relating to REPLAGAL reached an agreement in principle to resolve the matter, subject to court approval, for $50 million. Shire will contribute $27 million toward the settlement (recognized in Q3 2007 within Selling, General and Administration (“SG&A”) costs) and its insurance companies will contribute the remaining $23 million.
- In November 2007 Shire agreed to pay Applied Research Systems Holding N.V and Serono S.A. (“Serono”) $12 million for a fully-paid, worldwide, non-exclusive license to Serono’s patents related to gene-activation, including the US Patent No. 5,272,071. Serono’s infringement suit against the Company in the Massachusetts’s District Court was subsequently dismissed.
Note: Average exchange rates for 2007 and 2006 were $2.00:GBP1.00 and $1.84:GBP1.00 respectively. Average exchange rates for Q4
2007 and Q4 2006 were $2.04:GBP1.00 and $1.92:GBP1.00 respectively.
(1) Non GAAP operating income, Non GAAP net income, Non GAAP diluted earnings per ordinary share and Non GAAP diluted earnings per ADS exclude intangible asset amortization charges, the accounting impact of share-based compensation and other items as described on page 8. For an explanation of why Shire’s management believes that these non GAAP financial measures are useful to investors, see page 8. For a reconciliation of these non GAAP financial measures to the most directly comparable financial measures prepared in accordance with US GAAP, see pages 29-32.
2008 Outlook
R&D pipeline and new product launches in the next two years
Subject to obtaining relevant regulatory/governmental approvals, the following product launches are planned over the next two years:
- MEZAVANT in the EU and Canada during 2008;
- VYVANSE for use in adult patients in the US in Q2 2008 (PDUFA date April 28, 2008);
Shire’s business continues to perform strongly. We expect 2008 total revenue growth to be in the mid to high teens range with VYVANSE sales between $350 to $400 million, assuming that the adult indication is launched by mid year 2008.
Costs are estimated as follows:
- Phase 3(b) and Phase 4 studies to support existing launches in the Specialty Pharmaceuticals (“Specialty”) business and new product development in both the Specialty and Human Genetic Therapies (“HGT”) businesses will result in Research and Development (“R&D”) spend for 2008 in the range of $450 to $475 million (or $465 to $490 million including FAS123R charge);
- Existing and planned launches will require additional advertising and promotional spend resulting in SG&A costs for 2008 in the range of $1,080 to $1,120 million (or $1,125 to $1,165 million including FAS123R charge);
- Business expansion including new and enlarged manufacturing and research facilities for HGT, the enlargement of other facilities and the global roll out of new and upgraded IT infrastructures, will see a significant cash investment in capital projects in 2008 in the range of $320 to $350million (2007: $110 million);
- Due to the higher capital expenditure, the depreciation charge for 2008 is expected to increase by approximately 50% compared to 2007 (2007: $59 million);
- The effective tax rate on non GAAP income from ongoing operations for 2008 is expected to be approximately 23%; and
- Fully diluted share capital (inclusive of options and convertible bonds) will be approximately 590 million shares, with $13 million of convertible bond interest (after tax) added back to net income for the purpose of calculating fully diluted EPS.
From 2008, Shire will report its non GAAP earnings based on net income/(loss) adjusted for the following items, all of which are excluded from the financial outlook for the full year as stated above:
- Intangible asset amortization charges, which are expected to rise approximately 25% over the 2007 charge of $95 million primarily due to a full year’s amortization of the VYVANSE pediatric intangible asset;
- Release of deferred gains on the sale of non-core products, (including Almirall and other non-core product right gains), of $29 million; and
- Upfront payments and milestones in respect of in-licensed products.
In contrast to 2007, no adjustment will be made to exclude FAS123R charge from non GAAP earnings in 2008.
Dividend
In respect of the six months to December 31, 2007 the Board has resolved to pay a second interim dividend of 6.4690 US cents per ordinary share (2006: 5.2455 US cents per share). Together with the first interim payment of 2.147 US cents per ordinary share (2006: 1.935 US cents per share), this represents total dividends for 2007 of 8.616 US cents per share (2006: 7.180 US cents per share), an increase of 20% in US Dollar terms over 2006.
Dividend payments will be made in Pounds Sterling to Ordinary Shareholders and US Dollars to American Depositary Share (“ADS”) holders. A dividend of 3.3151 pence per ordinary share and 19.407 US cents per ADS, respectively, will be paid. The Board has resolved to pay the dividend on April 3, 2008 to persons whose names appear on the register of members of the Company at the close of business on March 14, 2008.
Shire intends to pursue a progressive dividend policy.
Redemption of Exchangeable Shares
On February 12, 2008, a subsidiary of Shire exercised a redemption call right and purchased each exchangeable share of Shire Acquisition Inc. remaining in public ownership. Exchangeable shareholders received either three ordinary shares of Shire plc or one ADS (representing three ordinary shares of Shire plc) for each Exchangeable Share held. Exchangeable Shares were issued to Canadian resident shareholders of Biochem Pharma Inc. in 2001 as consideration for the acquisition by the Shire group of Biochem Pharma Inc. The Exchangeable Shares, which were listed on the Toronto Stock Exchange, have now been de-listed from the Toronto Stock Exchange.
Changes in Executive and Non-Executive Directors
In January 2007 Dr Jeffrey Leiden, MD, PhD joined Shire’s Board of Directors as a Non-Executive Director and has been a member of the Remuneration and Nominations Committee since July 2007.
In May 2007 the Hon. James Grant, Q.C. retired from the Board following completion of his term of office.
In October 2007 David Mott joined Shire’s Board of Directors as a Non-Executive Director and was appointed to Shire’s Audit, Compliance and Risk Committee on December 12, 2007. Mr Mott is Chief Executive Officer and President of MedImmune, Inc, a role he was appointed to in 2000.
In December 2007 Shire announced its Board succession plans. Dr James H Cavanaugh will retire as Non-Executive Chairman; Matthew Emmens will succeed him as Non-Executive Chairman; and Angus Russell will be appointed as Chief Executive Officer. Shire is now working to identify a replacement Chief Financial Officer to ensure an orderly succession. These Board changes will become effective at Shire’s AGM in June 2008, at which time David Kappler will be appointed as Deputy Chairman in addition to his existing role as Senior Independent Director.
Shire would like to thank the Hon. James Grant Q.C. for his contributions during six years of service.
Changes in Senior Management
In September 2007 Shire appointed Sylvie Gregoire as President of its HGT business.
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 Europe. Shire believes that a carefully selected portfolio of products with relatively small-scale sales forces will deliver strong results.
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 materialize, 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 TGF beta 3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization 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 commercialization 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 December 31, 2006.
Non GAAP Measures
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 operating income, Non GAAP net income, Non GAAP diluted earnings per ordinary share, Non GAAP diluted earnings per ADS, Non GAAP R&D, Non GAAP SG&A and effective tax rate on Non GAAP income. 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 core 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 Shire’s Remuneration Committee in assessing the performance and compensation of employees, including its executive directors.
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 US GAAP basis, since many one-time, infrequent or non-cash items that the Company’s management believe are not indicative of the core performance of the business may not be excluded when preparing financial measures under US GAAP.
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.
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Revenues from continuing operations for the year to December 31, 2007 increased by 36% to $2,436.3 million (2006: $1,796.5 million).
Operating loss for the year to December 31, 2007 was $1,379.1 million (2006: income of $283.2 million). The loss in 2007 primarily arose from the $1,866.4 million write-off of in-process research and development (“IPR&D”) acquired as part of the $2.6 billion acquisition of New River; this amount represents the value of the acquired development projects, including VYVANSE for use in adult patients. Excluding IPR&D, operating income rose by $204.1 million compared to 2006, primarily due to revenue growth.
Cash inflow from operating activities for the year to December 31, 2007 decreased by 11% to $474.7 million (2006: $531.9 million). Excluding upfront payments and milestones in respect of in-licensed technology of $155.9 million in 2007 and $80.5 million in 2006 (see section 4 - R&D below for details), cash inflow from operating activities for the year to December 31, 2007 increased by 3% to $630.6 million (2006: $612.4 million). This increase is lower than the increase in operating income (excluding IPR&D) of $204.1 million primarily as a result of increased receivables generated by higher sales in December 2007 over December 2006 and increases in inventory to support new products.
Cash, cash equivalents and restricted cash at December 31, 2007 totaled $802.0 million (December 31, 2006: $1,156.7 million). The decrease of $354.7 million was primarily due to the acquisition of New River in April 2007 being partly funded from Shire’s pre-acquisition cash resources.
Summary of Q4 2007
Revenues from continuing operations for the three months to December 31, 2007 increased by 46% to $724.5 million (2006: $497.0 million).
Operating income for the three months to December 31, 2007 was $232.2 million (2006: $80.4 million). The increase primarily resulted from higher revenues and related earnings in Q4 2007 (compared to Q4 2006) and gains on disposal of non-core products of $115.7 million (2006: $nil), which were partially offset by upfront payments for in-licensed technology totaling $75.0 million (2006: $nil).
Cash inflow from operating activities for the three months to December 31, 2007 decreased by 65% to $66.6 million (2006: $188.8 million). Excluding upfront payments and milestones in respect of in-licensed technology of $75.0 million in 2007 (2006: $nil) (see section 4 - R&D below for details), cash inflow from operating activities for the year to December 31, 2007 decreased by 25% to $141.6 million (2006: $188.8 million). This decrease was primarily as a result of increased receivables generated by higher sales in December 2007 over December 2006.
2. Product sales
(1) Product specific prescription data is provided by IMS Health (“IMS”), a leading global provider of business intelligence for the pharmaceutical and healthcare industries. All other US market share data stated in the text below is also provided by IMS.
(2) Compared to 2006.
Specialty Pharmaceuticals
ADDERALL XR - ADHD
As a result of the launch of VYVANSE in July 2007 ADDERALL XR’s average share of the US ADHD market for 2007 fell to 25.5% (2006: 26.1%). US prescriptions for ADDERALL XR for the year to December 31, 2007 increased by 3% compared to the same period in 2006 due to a 6% growth in the US ADHD market offset by the 0.6% fall in average market share.
Sales of ADDERALL XR for the year to December 31, 2007 were $1,030.9 million, an increase of 19% compared to the same period in 2006 (2006: $863.6 million). Product sales growth was higher than prescription growth due primarily to price increases in January and October 2007.
As previously disclosed, the United States Federal Trade Commission (“FTC”) informed Shire on October 3, 2006 that it was reviewing the ADDERALL XR patent litigation settlement agreement between Shire and Barr Laboratories, Inc (“Barr”). On June 22, 2007, the Company received a civil investigative demand requesting that it provides information to the FTC relating to its settlement with Barr and its earlier settlement with Impax Laboratories, Inc. The Company is cooperating fully with this investigation and believes that the settlements are in compliance with all applicable laws.
Litigation proceedings concerning Shire’s ADDERALL XR patents are ongoing. Further information on this litigation can be found in our filings with the SEC, including our Annual Report on Form 10-K for the year to December 31, 2006 and our most recent Quarterly Report on Form 10-Q for the period to September 30, 2007.
VYVANSE - ADHD
VYVANSE was launched in the US market in July 2007 and at December 31, 2007 its market share had reached 5.2% (average annual market share 1.8%). Product sales of $76.5 million for the year to December 31, 2007 were net of $42 million sales deductions, primarily coupons, wholesaler discounts and rebates, which are expected over time to trend to approximately 28% of product sales before sales deductions.
All initial launch stocks of VYVANSE totaling $57.8 million were recognised into revenue during the year to December 31, 2007.
DAYTRANA - ADHD
Product sales for the year to December 31, 2007 were $64.2 million (2006: $25.1 million). DAYTRANA’s average share of the US ADHD market increased to 2.1% in 2007 compared to 0.8% in 2006 (DAYTRANA was launched in June 2006). US prescriptions of DAYTRANA for the year to December 31, 2007 over 2006 benefited from a full year of demand, 6% growth in the US ADHD market and higher market share. For the six month period to December 31, 2007 prescriptions of DAYTRANA were up 31% compared to the same period in 2006. During September 2007 Shire announced a voluntary market withdrawal of a limited quantity of DAYTRANA patches following feedback from patients and caregivers who had experienced difficulty in removing the release liner. Patches are now being manufactured using an enhanced process, which Shire believes offers improved ease of use when peeling off the release liner.
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 December 31, 2007 compared to 28.0% at December 31, 2006. Shire has the leading portfolio of products in the US ADHD market.
PENTASA - Ulcerative colitis
US prescriptions of PENTASA for the year to December 31, 2007 were up 3% compared to the same period in 2006 primarily due to a 4% increase in the US oral mesalamine prescription market, offset by a 0.1% decrease in PENTASA’s average market share from 17.3% in 2006 to 17.2% in 2007.
Sales of PENTASA for the year to December 31, 2007 were $176.4 million, an increase of 28% compared to the same period in 2006 (2006: $137.8 million). Sales growth is higher than prescription growth primarily due to restocking to normal levels in 2007 and the impact of price increases in November 2006 and August 2007.
LIALDA/MEZAVANT - Ulcerative colitis
Shire launched LIALDA in the US oral mesalamine market in March 2007, and by December 31, 2007 LIALDA had reached a market share of 8.0% (average annual market share 3.9%). LIALDA’s product sales for the year to December 31, 2007 were $50.5 million. All initial launch stocks of
