FY2005 First Quarter Financial Results Presentation · The Company’s corporate concept is to give...

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FY2005 First Quarter Financial Results Presentation Eisai Co., Ltd.

Transcript of FY2005 First Quarter Financial Results Presentation · The Company’s corporate concept is to give...

FY2005 First QuarterFinancial Results

Presentation

Eisai Co., Ltd.

1

Consolidated Performance

(0.0)

2.512011.014.910010.112.4Net Income

13.111382.3111.710580.398.6Gross Margin

102

99

98

107

107

105

105

YOY

FY2005 1Q

3.912017.223.415.919.5Ordinary Income

9.112152.243.1EPS (Yen)

3.812016.522.515.218.6Operating Income

7.611251.169.350.361.8SG&A Expenses

1.811014.719.914.818.2R&D Expenses

10017.724.119.724.1Cost of Sales

13.1111100.0135.8100.0122.7Net Sales

Increase(Decrease)

YOY%Results%Results

FY2004 1Q(billions of yen, %)

2Sales of Major Products

0.410225.324.8U.S.

Aciphex/ParietProton Pump Inhibitor

5.413023.518.1U.S.

AriceptAlzheimer’sTreatment

31630.70.5Asia

(0.0)991.81.8Europe

8104235226Millions of $

3.11956.33.2Japan

3.811334.130.3Total

0.21360.90.7Asia

0.61107.36.7Europe

54132219165Millions of $

1.01119.98.9Japan

7.312141.734.4Total

Increase(Decrease)

YOYFY2005

1QFY2004

1QAreaProduct Name

(billions of yen, %)

3Sales to Customers by Geographic Area

FY20051Q

13.1111100.0135.8100.0122.7Total9.011649.166.747.057.6Overseas Total1.01382.73.72.22.6Asia and Others

0.91097.710.47.89.5Europe

7.211638.752.637.145.5North America

4.110650.969.153.065.0Japan

IncreaseYOY%Results%Results

FY20041Q

(billions of yen, %)

4

FY20051Q

FY20041Q

IncreaseYOY%Results%Results

3.5116100.025.1100.021.6Sub-Total

120

134

119

139

134

101

52.6

3.2

7.2

42.2

47.4

0.3 (2.6)(2.9)Elimination/Corporation

3.8

3.3

0.1

0.5

2.7

0.2

22.5

13.2

0.8

1.8

10.6

11.9

18.6Total

Overseas Total

Asia and Others

Europe

North America

Japan

45.79.8

3.20.7

6.01.3

36.47.9

54.311.7

Operating Income by Geographic Area(Pre-royalty deduction)

(billions of yen, %)

5

810447.823511954.1226Aciphex

2613819.49513216.669Operating Income(Pre-royalty deduction)

92053.8181642.29Net Income

141965.7281723.414Operating Income

101456.733-5.423Zonegran

5413244.521910239.5165Aricept

73118100.0491117100.0418Total Revenue

IncreaseYOY%ResultsYOY%Results

FY20051Q

FY20041Q

Performance of Eisai Inc.(millions of dollars, %)

6

(21.0)(8.9)13.418.3(7.5)9.4FY20041Q

10.21.3(7.5) 10.82.712.1FY20051Q

6.912.1(2.1)4.94.816.9FY20031Q

-5.1-7.0-12.1FY20021Q

Increase(Decrease)Results

Increase(Decrease)Results

Increase(Decrease)Results

Free Cash FlowCapital

ExpenditureCash Flow from

Operating Activities

Consolidated Free Cash Flow

(billions of yen)

7

Provision of corporate concept added to articles of incorporation

1. The Company’s corporate concept is to give first thought to patients and their families, and to increase the benefits that health care provides. Under this concept, the Company endeavors to become a human health care (hhc) company.

2. The Company’s mission is the enhancement of patient satisfaction. The Company believes that revenues and earnings will be generated as a consequence of the fulfillment of the mission. The Company places importance on this positive sequence of the mission and the ensuing results.

3. Positioning compliance, the observance of legal and ethical standards, as a core in all business activities, the Company strives to fulfill corporate social responsibilities.

4. The Company’s principal stakeholders are patients, customers, shareholders and employees. The Company seeks to foster a good relationship with stakeholders and to enhance their value through making the following efforts:• Satisfying unmet medical needs, ensuring stable supply of high quality products, and

providing useful information of safety and efficacy.• Timely disclosure of corporate managerial information, enhancement of corporate value, and

proactive return to shareholders.• Ensuring stable employment, offering challenging and fulfilling duties, and providing full

opportunities for the development and enhancement of employees’ capabilities.

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Seven out of twelve members of the Board of Directors are outside directors. The Chair of the Board was appointed from outside directors.The Chairs of the Nominating Committee, Compensation Committee and Audit Committee were appointed from outside directors. All members of the Nominating Committee and Compensation Committee are outside directors.

The New Corporate Governance Structure

Tadashi Kurachi: Chair of the Board (Representative Director and Chairman, Kanematsu Corporation)Ikujiro Nonaka: Chair of the Nominating Committee (Professor, Hitotsubashi University Graduate School) Stuart Meiklejohn: Chair of the Compensation Committee (Partner, Sullivan & Cromwell)Mitsuo Minami: Chair of the Audit Committee (Professor, Bunkyo Gakuin University Graduate School)Naoto Nakamura (Founder and Partner, Law firm of Nakamura, Tsunoda, Matsumoto) Tadahiro Yoshida (Chairman and President, YKK Corporation)Yoshiyuki Kishimoto (Director of Strategy of Booz Allen and Hamilton Inc.) Yuji Naito: Honorary ChairmanHiromasa Nakai: Senior AdvisorTadashi TemmyoShintaro KataokaHaruo Naito: President and CEO (Representative Executive Officer)Notes: Blue letters shows the outside directors.

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Discovery Development ManufacturingSales

&Marketing

Pharmaco-vigilance

Fulfillment of

Unmet Medical

Needs

Safe UsageofDrugs

Stable Supplyof

Quality ProductsPatients

Seamless Value Chain

Logistics

10

Reinforcing Seamless Value Chain

Restructuring P-1 plant in Kashima for preparing drug substance of E7389.

Construction of the second production site in Suzhou Plant (China) corresponding to increasing sales in China.Expansion of Eisai Research Institute of Boston, Inc. (US)

Eisai Research Institute of Boston, Inc.

11Progress of Global BusinessEntering Switzerland (June) and four Nordic countries (July, Sweden)The launch of Zonegran (zonisamide: anti-epileptic agent) will expand the business in EU.• Launched in UK and Germany in June. Planning to

launch in other countries.• Expanding indications such as monotherapy for adult

partial seizures, migraine prophylaxis, and childhoodepilepsy, etc.

• Potential sales including additional indicationsis 200 M Euro.

Reinforcing our presence in Neurology by launching Inovelon (rufinamide: anti-epileptic agent)• Marketing Authorization Application to European

Medicines Agency as adjunctive therapy for Lennox-Gastaut Syndrome (LGS) was submitted in March.

In India, Aricept and Pariet will be launched. (September)

EU market coverage: 83% (Euro volume)• Ranging from UK to France, Germany, Spain, Italy, Ireland,

Austria, Switzerland, Sweden, Norway, Denmark and Finland.

12Opportunities in Key Areas/Countries

US Sales

EU market coverage 83% (Euro volume)

The first Japanese pharma company in

India

FY2000 FY2004

CAGR: 20.5%¥101.8 B

¥214.5 B

FY2000 FY2004

CAGR: 27.9%¥14.3 B

¥38.3 BEU Sales

Consecutive double-digit growth since

1996 in US

FY2000 FY2004

¥4.6 BCAGR: 26.8%

¥11.9 BAsia Sales

Japan Sales

Net Sales (Overseas) Operating Income BeforeRoyalty Deduction (Overseas)

FY2000 FY2004

¥120.7 B

¥264.7 B

CAGR: 21.7%FY2000 FY2004

¥14.2 BCAGR: 37.9%

¥51.3 B

FY2000 FY2004

¥241.0 B¥268.3 B

CAGR: 2.7%

The most successful Japanese pharma company in China,

rapid growth in Korea,outperforming the market growth

in Japan in recent years

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Progress in Q1 R&DApproval, Launch•Aricept (Alzheimer’s Disease)

-Approved as orodispersible tablet in UK (May)-Launched orally disintegrating tablet in US (June)

•Zonegran (Anti-epileptic agent):-Launched in June as adjunctive therapy for partial seizuresin adults (UK and Germany)

•D2E7: Psoriasis vulgaris (Japan)

•Cleactor (Anti-thrombolytic agent) -Additional indication for acute pulmonary embolismLaunched in July (Japan)

Phase II•E2007: Phase IIb indicated for migraine prophylaxis

Withdrawn•Cleactor: Cerebrovascular embolism (Phase II)

14Progress of Major Clinical TrialsE2007 AMPA-receptor antagonist

•Parkinson: Briefing Book for discussion about Phase III was submitted to EMEAEnd-of-Phase II meeting with FDA being scheduled

•Epilepsy: Phase IIb (POC)•Migraine: Phase IIb (POC)•Multiple Sclerosis: POC study plan is drafted

E7389 Microtubule growth suppressor•Breast cancer monotherapy (3rd line): Independent reviews are underway for 35 evaluable cases,

and 9 PRs were reported (4 confirmed, 5 unconfirmed)End-of-Phase II meeting with FDA scheduled in September

•Non Small Cell Lung Cancer monotherapy (2nd line): Independent reviews are underway for 52evaluable cases, and 5 PRs were reported (2 confirmed, 3 unconfirmed)

E5564 (eritoran) Endotoxin antagonist•Sepsis: Data analysis to be completed in early August

E7070 (indisulam) Cell-cycle G1 phase targeting agent•Breast cancer monotherapy: Discontinued•Colorectal & breast cancer combo therapy: Enrollment stopped.•Small cell lung cancer: Additional Phase I in preparation in combination with irinotecan•Stomach cancer (Japan): Phase I/II in progress

E5555 Thrombin receptor antagonist•Four Phase I studies were completed, and safety and platelet coagulation inhibition were confirmedBleeding time was not extended

•Five drug-drug interaction studies are ongoing•POC studies will start in 4Q FY2005

Subject: Stable angina patients, Acute myocardial patientsEndpoints: Vascular intima thickness observed with intravascular echogram

Inflammation marker (CRP:C-Reactive Protein etc.)Cardiac events

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Submissions for NDA/MAA in 2006E7389E2007Target

Microtubule Growth SuppressorAMPA Receptor AntagonistMode of Action

–Breast cancer: 3rd + 2nd + 1st line (2006)–NSCLC: 2nd/3rd + 1st line–Soft tissue sarcoma: 2nd + 1st line–Prostate cancer: 2nd line–Ovarian cancer: 2nd + 1st line

–Adjunctive therapy with levodopa for Parkinson’s disease (PD; 2006)–Epilepsy–Multiple Sclerosis (MS)–Migraine prophylaxis

Indication

Effective for taxane refractory tumorsSimilar to or better than MAO-B inhibitor and COMT inhibitor in shortening OFF time (PD)

Efficacy

–No severe peripheral neurotoxicity–Fewer hypersensitivity reactions (no need for premedication with steroid or anti-histamine)

–Excellent safety profile–No worsening of dyskinesia (PD)Safety

No major drug-drug interactionsNo major drug-drug interactionsDrug Interactions

Bolus (5-minute IV)Day 1, 8, 15, every 4 weeksOnce a day, oral administrationAdministration

Vials (solution)Small tabletsFormulation

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New Indications and Formulations in Development for Aricept and Aciphex/Pariet

Phase I (US)

Phase III (Japan)

Filed in March 2005 (Japan)

Phase I (US)

Phase III (US)

Plan to file in August 2005 (US)Plan to file in August 2005 (US)Plan to file in 3Q FY2005 (EU, JP)

Plan to submit additional data to FDA and resubmit in EU (FY2005)

Status

Sustained release formulation

Non-erosive GERD

Vascular dementia

AriceptAlzheimer’sTreatment

SevereAlzheimer’s disease

Mild cognitive impairment (MCI)

H. Pylori eradication

Indications FormulationsProducts

Extended release formulation

Aciphex/Pariet

Proton Pump Inhibitor

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Neurology Pipeline

E2007: Planning Phase IIbMultiple screlosisE2014 (Botulinus toxin): Phase II bridging study (Japan)

Aricept: Dementia with Parkinson’s disease, Planning to file in FY05 (EU)Agilect (rasagiline): Filed (US, Teva)E2007: Preparing for Phase III (US, EU), Phase I (Japan)

Zonegran: Preparation for clinical studies of monotherapy (EU)Inovelon (rufinamide): Filed Lennox-Gastaut Syndrome (EU)Preparation for filing Lennox-Gastaut syndrome and adult partial seizures (US)E2007: Phase II

Aricept: Completed Phase IIE2007: Phase IIZonegran: Preparation for Phase II

Aricept: Phase III (US)

Aricept: Planning to re-file (EU) and submit additional data in FY05 (US)

Aricept: Planning to file for severe Alzheimer’s disease in August 2005 (US) in 3Q of FY05 (EU and Japan)Aricept: Launched orally disintegrating tablet (US), approved (UK)Agilect (rasagiline): Phase II (US)Aβ modulator: Discovered candidate compound (E2012), planning IND in FY05

Pipeline

Vascular dementia

Migraine (Prophylaxis)

Cervical dystonia

Parkinson’s disease

Epilepsy

Mild cognitive impairment

Alzheimer’s Disease

Disease

Blue letters: Progression in 1Q of FY 05

18Cancer Agents in Clinical Development

Patient enrollment is almost complete (JP)Safety assessment in 1-year revealed no issues

P.O.Vitamin K2Hepato-

carcinomaPhase

II/IIIE0167

Solid tumor

Solid tumor

Solid tumor

ColorectalBreast

StomachSCLC

BreastNSCLC

Cancer Type

I.V.

P.O.

P.O.

I.V.

I.V.

Route

Patient enrollment for breast cancer monotherapy is nearly completed. Good response was confirmed. End-of-Phase II meeting with FDA scheduled in SeptemberPhase I in preparation (JP)

Microtubule growth suppressorPhase IIE7389

Patient enrollment was stopped in Phase II combination studies with irinotecan for colorectal cancer and with capecitabine for breast and colorectal cancer.Phase I/II monotherapy for stomach cancer in progress (JP)

Cell-cycle G1 phase targeting

agentPhase IIE7070

Phase I in progress (US)Alpha-2 integrin expression inhibitorPhase IE7820

Phase I in progress (US, EU)Phase I in preparation (JP)

VEGF receptor kinase inhibitorPhase IE7080

Phase I in progress (US)Hemiasterlin type

tubulin binding inhibitor

Phase IE7974

Phase Current StatusMode of ActionProject

Blue letters: Progress in 1Q FY2005

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Effective in patients resistant to existing Botulinus toxin Botulinus toxinE2014 (Cervical dystonia)

Phase I

Phase II

Preparing Phase III

Phase II/III

Phase III

Filed for approval

Stage

Reduction of off-time in PD as adjunct therapy with levodopaExcellent safety profile; no worsening of dyskinesiaAMPA receptor antagonistE2007

(Parkinson’s disease)

Less rebound than existing anti-viral agentHBV polymerase inhibitorClevudine(Hepatitis B)

Better anticancer efficacy than taxanesGood tolerability, less neurotoxicity

Microtubule growth suppressorE7389 (Cancer)

Different anticancer spectrum from existing cytotoxicsG1 Phase targetingE7070 (Cancer)

Reduce mortality and morbidity; good safety profileEndotoxin antagonistE5564 (Sepsis, CABG)

Dual action of anti-platelet and smooth muscle cell proliferation inhibition

Thrombin receptor antagonist

E5555 (Prevention of major cardiac events)

Survival benefit due to chronic tumor growth suppressionα2 integrin suppressorE7820 (Cancer)

Survival benefit due to chronic tumor growth suppressionVEGFR kinase inhibitorE7080 (Cancer)

Effective in multi-drug-resistant tumorsTubulin inhibitorE7974 (Cancer)

Reduce recurrence of hepatocellular carcinomaVitamin K2E0167 (Hepatocellular

carcinoma)

Strong and long-lasting efficacy for RA symptomsAnti-TNF antibodyAdalimumab(Rheumatoid arthritis)

Natural body weight loss based on dual actions of appetite suppression and energy consumption increase

Serotonin/Noradrenarin reuptake inhibitor

Sibutramine(Obesity Management)

Similar efficacy to salazosulfapyridine, a standard drug for RABetter safety profile with fewer severe adverse effects

Cytokine/Immunoglobulin suppressor

Careram® - igratimod(Rheumatoid arthritis)

Neuroprotective effect (Phase II for AD ongoing)Better safety profile than other MAO-B inhibitorsMAO-B inhibitorAgilect® - rasagiline

(Parkinson’s disease, Teva)

Adjunctive therapy for Lennox-Gastaut Syndrome, a severe disease with high unmet medical needs, and adult partial seizures

Na+ channel modulatorInovelon® - rufinamide(Epilepsy)

Target ProfileMode of ActionProject

Expanding Pipeline(New Molecular Entities)