-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Otitdmy2eaouNXlI2+kKSpaUX6QSzLlmuAoj/FR88VnCKVL9NBn0k6Qdbs9+0HTl yOA4T3ncr/7Of+MWfWwPKw== 0000950162-01-500509.txt : 20010726 0000950162-01-500509.hdr.sgml : 20010726 ACCESSION NUMBER: 0000950162-01-500509 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20010723 ITEM INFORMATION: FILED AS OF DATE: 20010725 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP PLC CENTRAL INDEX KEY: 0000936402 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-29630 FILM NUMBER: 1688980 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 BUSINESS PHONE: 1264333455 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 8-K 1 shire8kpre.txt FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported): July 23, 2001 Shire Pharmaceuticals Group plc - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) England and Wales - -------------------------------------------------------------------------------- (State or other jurisdiction of incorporation) 0-29630 N/A - --------------------------------- ------------------------------------------- (Commission File Number) (IRS Employer Identification No.) Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP England - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip code) Registrant's telephone number, including area code 44 1256 894 000 ------------------------------ - -------------------------------------------------------------------------------- (Former name or former address, if changed since last report) Item 7. Financial Statements and Exhibits (c) Exhibits. The following exhibit is filed herewith: 99.1 Presentation relating to first quarter results. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: July 25, 2001 SHIRE PHARMACEUTICALS GROUP PLC By: /s/ Angus C. Russell ---------------------------------------- Name: Angus C. Russell Title: Group Finance Director EXHIBIT INDEX Number Description 99.1 Presentation relating to first quarter results. EX-99.1 2 shireex1.txt PRESENTATION Second Quarter and Interim results ended 30 June 2001 - -------------------------------------------------------------------------------- Shire Pharmaceuticals Group plc - -------------------------------------------------------------------------------- 1 Rolf Stahel - -------------------------------------------------------------------------------- Chief Executive Shire Pharmaceuticals Group plc - -------------------------------------------------------------------------------- 2 Comment on the "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995 The statements made during today's presentation, or in response to questions during the Question & Answer period, that are not historical facts, are forward-looking statements that involve risks and uncertainties, including but not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialisation, the impact of competitive products, patents, and other risks and uncertainties, including those detailed from time to time in periodic reports, including the Annual Report filed on Form 10K by Shire with the Securities and Exchange Commission. 3 Q2 Financial Highlights (before APB 25 and exceptional merger charges) |X| Revenues $ 211m +32% |X| Operating income $ 65m +56% |X| Income before tax $ 71m +72% |X| EPS (diluted) o Ordinary shares 10.6 cents) ) +66% o ADS 31.7 cents) 4 Key Royalty Income Q2 01 Q2 00 Royalty $m $m Growth % - -------------------------------------------------------------------------------- 3TC*(1) 31.1 29.4 +6 - -------------------------------------------------------------------------------- Zeffix* 4.4 2.9 +49 - -------------------------------------------------------------------------------- Other 3.0 1.3 +128 - -------------------------------------------------------------------------------- * Trade Mark (1) 3TC Franchise: Epivir/Combivir/Trizivir trademarks of GlaxoSmithKline 5 Adderall** |X| Revenues: Q2 01 up 56% at US$69m |X| Market Share: 32.7% Rx US ADHD* market(1) |X| Adderall XR(2) o Novel, once a day formulation of Adderall** o Phase III data presented at the APA(3) on 9 May 2001 o NDA submitted early - 3 October 2000 o Anticipated launch in Q4 2001(4) (1) IMS data - June 2001 (2) Trade mark under registraton (3) American Psychiatry Association (4) Subject to regulatory approval * ADHD: Attention Deficit Hyperactivity Disorder ** Trademark 6 Agrylin* |X| Revenues: Q2 01 up 39% at US$26m |X| Market Share: 21.3% Rx US market(1) |X| Unique Selling Points: o Only US approved treatment for Essential Thrombocythaemia o Orphan drug status granted in US, EU, and Japan o Selectively reduces platelets o Offers a new therapy for avoiding potential risks of "pan-marrow" treatments o Extensive safety database >4000 patients with myeloproliferative disorders (MPD's) (1) IMS data - June 2001 * Trade Mark 7 3TC** Franchise Epivir/Combivir/Trizivir(1) |X| Royalties: Q2 01 up 6% at US$31m |X| Unique Selling Points: o Minimal side effects o Ease of compliance (simple dosing, no food/water restrictions) o Benefits of the M184V mutation (1) 3TC, Epivir, Combivir and Trizivir are trademarks fo GlaxoSmithKline (2) IMS data - June 2001 ** Trade Mark 8 Reminyl** |X| Market Share: 7.1% NRx US AD* market(1) at week nine. |X| Unique Selling Points: o Dual mode of action widely acknowledged(2,3) o First AD* treatment to demonstrate effectiveness in treating patients with vascular dementia and mixed dementia(4,5) o Studies planned in Lewy body dementia and mild cognitive impairment(6) (1) IMS data - to June 2001 (2) Europe - included in labelling (3) US - included on promotional materials approved by DDMAC (FDA) (4) XVII World Congress of Neurology, June 2001 (5) Reminyl is not yet approved for these indications (6) Conducted by Janssen Research Foundation * AD: Alzheimer's ** Trade Mark 9 Reminyl UK IMS data Line graph depicting the following data:
First Year of Launch Market share of new prescriptions No. of Prescriptions (projected) Month 1 2 3 4 5 6 7 8 9 10 11 12 - ---------------------------------------------------------------------------------------- Reminyl 104 0 238 490 671 561 1305 Aricept 314 693 1149 1777 1810 2431 2530 2694 2929 3173 2204 3428 Exelon 33 162 105 160 233 244 229 214 483 541 496 350 * IMS Data
10 Zeffix(1) |X| Royalties: Q2 01 up 49% at US$4.4m |X| Unique Selling Points: o Only approved oral treatment for hepatitis B o Efficacy and durability of response o Endorsement by key opinion leaders in Asia Pacific(2) (1) Zeffix is a trademark of GlaxoSmithKline (2) Asia Pacific Consensus Group on the Prevention and Management of Chronic Hepatitis B and C 11 Post merger structure Diagram representing Biologics (US/Canada), Search (US/Canada/UK), Shire Labs Drug Delivery (US), and Lead Optimisation (Canada) allowing Shire Development (UK/US/Canada) to bring products to market to be sold by all sales and marketing forces in UK/Eire, Canada, US, Spain, Germany, Italy, and France. 12 Merger Integration New Appointments Previous Employer - -------------------------------------------------------------------------------- President, Shire Biologics Randall Chase BioChem Pharma* Senior VP Shire Pharmaceutical Development Gervais Dionne BioChem Pharma* Global Head of Legal Affairs Tatjana May AstraZeneca Global Head of Human Resources Chrisian Proulx BioChem Pharma* Commercial Director (Strategic Marketing) Mark Webster Abbott Laboratories Vice President - Global IP Shona McDiarmid BioChem Pharma* *Canada 13 Angus Russell - -------------------------------------------------------------------------------- Group Finance Director Shire Pharmaceuticals Group plc - -------------------------------------------------------------------------------- 14 1H 01 Financial Highlights (before APB 25 and exceptional merger charges) |X| Revenues $401m +29% |X| Operating income $121m +46% |X| Income before tax $128m +50% |X| EPS (diluted) o Ordinary shares 19.2 cents ) ) +45% o ADS 57.7 cents ) 15 Key Product Sales Q2 01 vs. Q2 00 Q2 01 Q2 00 Sales Scrip** $m $m Growth % Growth % Adderall* 69.4 44.4 +56 +14 Agrylin* 25.8 18.5 +39 +26 Pentasa* 19.1 13.2 +45 +5 ProAmatine* 10.5 5.9 +79 +28 Carbatrol* 9.9 5.3 +87 +28 * Trade Mark ** IMS Data 16 Key Product Sales 1H 01 vs. 1H 00 1H 01 1H 00 Sales Scrip $m $m Growth % Growth % Adderall* 139.6 98.9 +41 +17 Agrylin* 42.9 29.5 +45 +33 Pentasa* 33.5 23.5 +42 +8 Carbatrol* 19.5 10.9 +79 +35 ProAmatine* 18.1 9.4 +92 +30 * Trade Mark 17 Key Product Royalties 1H 01 vs. 1H 00 1H 01 1H00 Royalty $m $m Growth % 3TC* 58.6 56.4 +4 Zeffix* 8.1 5.3 +54 Other 3.9 1.9 +104 * Trade Mark 18 Financial Ratios (before APB 25 and exceptional merger charges) 1H 01 Q2 01 Q2 00 FY 00 % % % % COGS: Product sales 17 16 19 19 Gross margin 83 84 81 81 R&D: Revenues 20 20 25 23 S,G&A (excl D&A): 30 31 29 26 Revenues Operating margin 30 31 26 30 19 Exceptional merger charges |X| Asset impairments $ 85.4m |X| Merger transaction costs $ 83.5m |X| Disposal of assets $ 8.1m |X| Total $ 177.0m 20 Cash Flow Q2 2001 Cash generation _______________________________ +$24m - -$12m______________________ Tax/interest - -$9m ____________________ Product acquisitions -$2m ____ Fixed assets Financing _____________________________ +$18m Net cash surplus $19m 21 Balance Sheet 30.06.01 30.06.00 31.12.00 $m $m $m Net Assets 1,091 1,076 1,175 Net Cash 295 200 250 Gearing nil nil nil 22 Wilson Totten - -------------------------------------------------------------------------------- Group R&D Director Shire Pharmaceuticals Group plc - -------------------------------------------------------------------------------- 23 Development pipeline Therapeutic PC/Phase 1 Phase II and beyond Total Area - ---------------- ------------ -------------------- --------- CNS 6 4 10 Antivirals 2 0 2 Oncology 1 3 4 Biologics 4 0 4 Metabolic/GI 0 4 4 -------------------------------------------------- Total 13 11 24 -------------------------------------------------- 13 early stage projects, 11 late stage 24 Reminyl* |X| UK NICE recommends Alzheimer's disease treatments to be made available for UK patients |X| Reminyl* first to show efficacy in dementia with vascular components(1) o 6 month data presented at AAN(2) May 2001 o 12 month data presented at WCN(3) in June 2001 |X| Study ongoing in patients with vascular dementia(4) |X| Studies planned in Lewy body dementia and mild cognitive impairment (1) Not yet approved by regulatory agencies (2) American Association of Neurology (3) World Congress of Neurology (4) Trials ongoing by J&J *Trademark 25 Adderall XR(1) (SLI 381) |X| |X| Positive Phase III data presented at APA(2) May 2001 o All doses of Adderall XR showed significant improvement in CGIS-T(3) and CGIS-P(4) assessments in all treatment weeks compared to placebo o The extended release nature of the Adderall XR(1) formulation was shown by continued, significant improvement in afternoon assessments by teachers and early afternoon and late afternoon assessments by parents o o Trade Mark under registration (2) American Psychiatric Association (3) Conners Global index Scale-Teacher (CGIS-T) (4) Conners Global index Scale-Parent (CGIS-P) 26 Frakefamide |X| AstraZeneca offer to return rights to Shire |X| Results from Phase II study contradict previous positive results |X| If development continues o Likely to be slower and... o Risk of failure higher than previously anticipated 27 Epilepsy |X| SPD 418, extended release formulation of established anti-epileptic drug, discontinued o Unsatisfactory Phase I results |X| Shire remains committed to epilepsy o Two follow on projects initiated |X| Potentially powerful global epilepsy strategy 28 Agrylin* |X| Orphan drug designation granted for EU o Already granted for US and Japan o |X| EU filing planned early 2002 o Following discussions with regulatory authorities * Trademark 29 Foznol |X| |X| |X| First EU filing 13 March 2001 |X| |X| US filing to FDA planned for end 2001 30 Rolf Stahel - -------------------------------------------------------------------------------- Chief Executive Shire Pharmaceuticals Group plc - -------------------------------------------------------------------------------- 31 Q2 01 Summary |X| Revenue growth 32% |X| EPS growth 66% |X| Reminyl* launched in the US by Janssen Pharmaceutica and Ortho McNeil; 7.1% market share at week nine |X| Rapid integration of BioChem Pharma Inc. merger *Trademark 32 Forthcoming news flow and events |X| FDA approval and launch of Adderall XR(R) (expected Q4 01) |X| Foznol US filing (expected Q4 01) |X| Foznol first European approval (expected Q2 02) |X| Agrylin* European filing (expected Q1 02) |X| Second Look US approval (expected Q4 01) *Trademark 33 - -------------------------------------------------------------------------------- Shire Pharmaceuticals Group plc - -------------------------------------------------------------------------------- 34 Reminyl US IMS data Line graph depicting the following data:
First Year of Launch Market share of new prescriptions No. of Prescriptions (projected) Week of launch 1 2 3 5 6 7 8 9 - ---------------------------------------------------------------------------------------------------- Reminyl 488 777 954 1527 1808 2005 2194 1940 Aricept 1002 2592 3382 4857 5306 7144 8198 8713 Exelon 323 693 1328 2448 3043 2865 3679 4194
* IMS Data 35 US Alzheimer's Market Share Line graph depicting the following data:
% of Prescriptions (projected) 06/04/01 13/04/01 20/04/01 27/04/01 04/05/01 11/05/01 18/05/01 25/05/01 01/06/01 08/06/01 15/06/01 22/06/01 - ------------------------------------------------------------------------------------------------------------------------------ Reminyl 0.0 0.0 0.0 0.1 0.2 0.6 1.1 1.3 1.5 2.1 2.7 3.0 Aricept 78.7 78.8 78.8 77.9 78.3 77.7 77.0 76.8 77.0 76.5 76.0 76.0 Exelon 21.0 20.9 20.8 21.7 21.2 21.3 21.6 21.6 21.2 21.1 21.0 20.7
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