Shire plc. Matthew Emmens, CEO

Transcription

1 Shire plc Matthew Emmens, CEO

2 THE SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein that are not historical facts are forwarding-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 plc'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 commercialization; the impact of competitive products, including, but not limited to, the impact of those on Shire plc's Attention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents, including but not limited to, legal challenges relating to Shire plc's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of CONNEXYN TM (SPD503) (ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476) (ulcerative colitis), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire plc'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 and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the US Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, The following are trademarks of Shire plc or its subsidiaries, which are the subject of trademark registrations in certain countries. ADDERALL XR (mixed salts of a single-entity amphetamine product), AGRYLIN (anagrelide hydrochloride), CALCICHEW (range (calcium carbonate with or without vitamin D 3 )), CARBATROL (carbamazepine), EQUETRO TM (carbamazepine), FOSRENOL (lanthanum carbonate), XAGRID (anagrelide hydrochloride), REPLAGAL TM (agalsidase alfa), MESAVANCE (mesalamine), CONNEXYN TM (guanfacine extended release) The following are trademarks of third parties. 3TC (trademark of GlaxoSmithKline (GSK)), PENTASA (trademark of Ferring AS) ), DYNEPO (trademark of Aventis Pharma Holdings GmbH), ZEFFIX (GSK), REMINYL/RAZADYNE (trademark of Johnson & Johnson, excluding UK and Republic of Ireland), DAYTRANA (methylphenidate transdermal) (trademark of Noven Pharmaceuticals Inc. (Noven)) 2

3 Opening comments Shire continues to demonstrate ability to execute and deliver on stated goals. Over the last 4 months: DAYTRANA launched in US ELAPRASE launched in US FOSRENOL launch commenced in Europe SPD465 filed with FDA CONNEXYN (SPD503) filed with FDA 3 additional product launches expected through Q1 07: NRP104 US launch MESAVANCE US launch DYNEPO European launch 3

4 ADHD Progress ADDERALL XR US market share leader: 26%* All pending litigation settled with Barr Laboratories, Inc. Citizen Petition still under review by the FDA DAYTRANA Strong launch in the US market: 1.5% share* Very positive response from patients and physicians NRP104 - US PDUFA October 6, 2006 SPD465 filed with the FDA on July 21 PDUFA May 21, 2007 SPD503 filed with the FDA on Aug 24 PDUFA June 24, 2007 *source IMS 4

5 Barr settlement All pending litigation with regard to Barr s attempt to market generic ADDERALL XR is settled. No payments to Barr are involved in the settlement agreement. Barr will be permitted to market generic versions of Shire s Adderall XR products from April 1, A separate agreement has been entered into for Barr s women health products, including its transvaginal ring technology, as well as a license to Barr s currently marketed oral contraceptive, SEASONIQUE. Product development expenses will be reimbursed up to $140M over eight years, capped at $30M per annum. The agreement also provides for the sale of ADDERALL (immediaterelease mixed amphetamine salts) for $63M. 5

6 ADHD Portfolio Positioning Products Differentiating Pediatric Adult US Europe features ADDERALL XR Stimulant / amphetamine First in Class / 8-10 hours DAYTRANA Stimulant / methylphenidate First transdermal patch NRP104 Pro drug / *amphetamine Low abuse potential SPD465 Stimulant / amphetamine Long acting 16 hours CONNEXYN Non-stimulant / guanfacine (SPD503) = approved = = in development - not yet filed = filed not yet approved = future development planned *with potential to treat within the non-stimulant market 6

7 HGT ELAPRASE (Hunter Syndrome) US approval received, launch commenced First patient infused August 21 4 weeks following approval Potential for up to 500 patients in the US European response expected before year-end Pre-approval access received for France, Italy, Spain and Sweden GA-GCB (Gaucher Disease) Phase 3 enrollment to start before year end 7

8 Renal and GI FOSRENOL (Hyperphosphatemia) Product performing well in launched markets Major European countries to launch in Q DYNEPO European launch set to commence in Q1 07 MESAVANCE (Ulcerative Colitis) US PDUFA October European and Canadian responses expected Q

9 R&D Pipeline and new product launches H1 06 H2 06 H1 07 MESAVANCE Filed in Canada and EU SPD465 FDA filed CONNEXYN FDA filed NRP104 US Launch DYNEPO EU Launch MESAVANCE EU / Canada Launch DAYTRANA Launched in US ELAPRASE Launched in US ELAPRASE EU Launch MESAVANCE US Launch GA-GCB Phase III enrollment FOSRENOL Continue the roll-out in Europe The above launch and filing dates are indicative and subject to the regulatory/government approvals process. 9

10 Concluding Remarks Good results - in line with expectations Guidance re-affirmed 2006 revenue growth expected to be in the low double digit range Demonstrating our ability to execute ADDERALL XR settlement reached with Barr Laboratories, Inc. DAYTRANA strong US launch, 1.5% share ELAPRASE approved and launched in US in just 4 weeks SPD465 filed with FDA CONNEXYN (SPD503) filed with FDA FOSRENOL international roll-out building momentum Planned launches before mid on track NRP104 MESAVANCE DYNEPO 10

11 Questions and answers All