0808 algeta 2q08 presentation v8 tom slide...

Algeta ASA

Second quarter results 2008

13 August 2008

Thomas Ramdahl, President & CEO

Øystein Soug, CFO

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Disclaimer

THIS PRESENTATION HAS BEEN PREPARED BY ALGETA ASA (THE ”COMPANY”) EXCLUSIVELY FOR INFORMATION PURPOSES. THIS PRESENTATION HAS NOT BEEN REVIEWED OR REGISTERED WITH ANY PUBLIC AUTHORITY OR STOCK EXCHANGE. THE DISTRIBUTION OF THIS PRESENTATION AND ANY OFFERING, SUBSCRIPTION, PURCHASE OR SALE OF SECURITIES ISSUED BY THE COMPANY IN CERTAIN JURISDICTIONS IS RESTRICTED BY LAW. POTENTIAL INVESTORS ARE REQUIRED BY THE COMPANY TO INFORM THEMSELVES ABOUT AND TO COMPLY WITH ALL APPLICABLE LAWS AND REGULATIONS IN FORCE IN ANY JURISDICTION IN WHICH IT INVESTS AND MUST OBTAIN ANY CONSENT, APPROVAL OR PERMISSION REQUIRED UNDER THE LAWS AND REGULATIONS IN FORCE IN SUCH JURISDICTION. THE COMPANY SHALL NOT HAVE ANY RESPONSIBILITY OR LIABILITY FOR THESE OBLIGATIONS. THIS PRESENTATION DOES NOT CONSTITUTE AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY ANY SECURITIES IN ANY JURISDICTION TO ANY PERSON TO WHOM IT IS UNLAWFUL TO MAKE SUCH AN OFFER OR SOLICITATION IN SUCH JURISDICTION.

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Agenda

• Background and Highlights of Q2 2008

• Alpharadin clinical program– ALSYMPCA phase III study

– New supporting studies

– US clinical development

• Financial results

• Outlook

4

Agenda






• Outlook

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Background

• Academic spin-out in 1997

• Exclusive focus on cancer therapeutics

• Listed at Oslo Stock Exchange Q1 2007

• IPO raised $41 million

• Leading international life science investors

• Experienced management and Board

• Proprietary technology

– unique tumor-targeted alpha-emitters

• Lead product, Alpharadin, in phase III development

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2Q 2008 Highlights

• Start of ALSYMPCA trial in HRPC– ALpharadin in SYMptomatic Prostate CAncer

– Phase III – potential registration trial

– International - Europe, Asia and the Americas

– Primary endpoint - overall survival (OS)

– First patient enrolled in June

• Strongly positive data from new studies – BC1-05 trial shows uniquely advantageous clearance route

– Preclinical data show efficacy against difficult-to-treat cancer cells

• BC1-03 dose-response palliation trial completed in June– Currently conducting final analysis of the data

• Preparation for important US trial complete– Phase I pharmacokinetic, dosimetry and biodistribution study to begin at leading US cancer hospital

– First patient enrollment in August

– Provides platform for US development and regulatory program

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Agenda






• Outlook

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Alpharadin – key features

• Targeted cancer therapeutic based on radium-223– Convenient – supplied as ready-to-use solution

– Easy to use – monthly injection in out-patient setting

– Naturally targets bone metastases

• First indication in HRPC with bone metastases– Prostate cancer is most common cancer in US men

– ~ 85% of late-stage (HRPC) patients have bone metastases

– Current treatments are poor – unmet need high

– Superior efficacy / safety profile shown in Phase I and II trial

• Increased overall survival (lifespan)

• Safe and well tolerated

– Extensive interest from key opinion leaders worldwide

• Potential to target other cancers that metastasize to bone– Approx. 1.5 million cancer patients suffer from bone metastases worldwide

– Breast cancer

– Early prostate cancer

• Global patents with extensive term

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Alpharadin increased lifespan

Maxim

um

treatm

ent

duration

• 41% increase in life span when given Alpharadin

• 30% (10/33) patients treated with Alpharadin were alive at two years, compared with (4/31) in placebo arm

• Treatment was limited to 4 doses only

Pro

ba

bilit

y o

f s

urv

iva

l

HR 2.103, p= 0.017

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Alpharadin: comprehensive clinical development program

Phase I Phase II Phase III

ATI-BC-1 (n=31)Safety and tolerability, preliminary efficacy and PK

Single and multiple doses:46 – 250 kBq/kg

Prostate and breast cancer

Complete

BC1-05 (n=6)Biodistribution, PK, dosimetry.

Asymptomatic or symptomatic HRPC

Recruitment complete. Report in preparation.

BC1-02 (n=64)Efficacy and safety

HRPC patients with painful skeletal metastasis referred for palliative EBR

Multiple doses:4 x 50 kBq/kg or placebo at 4 weeks interval

Recruitment completeTwo year data published

BC1-04 (n=117)Efficacy and safety

Asymptomatic or symptomatic HRPC

Multiple doses:3 x 25, 50, or 80 kBq/kg at 6 weeks interval

Recruitment completePreliminary results expected 2H 2008

BC1-03 (n=100)Efficacy (dose-response) and safety, palliation

HRPC with painful skeletal metastasis

Single doses: 5, 25, 50 or 100 kBq/kg

Recruitment completeResults expected 2H 2008

ALSYMPCA (n=750)Confirmatory efficacy and safety.

HRPC with symptomatic skeletal metastaties, no planned use of cytotoxics within 6 months.

Multiple doses:6 x 50 kBq/kg or placebo at 4 weeks interval.

Recruitment ongoing

All patients with skeletal metastases

BC1-08 (n=9-18)Biodistribution, PK, dosimetry. (US trial)

HPRC with skelatalmetastases.

Single doses:50, 100, 200 kBq/kg

Recruitment ongoing

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ALYMPCA objectives

• Setting:

– Patients with symptomatic HRPC and skeletal metastases for whom no cytotoxic drug treatment is planned

• Study arms:

– Alpharadin plus best standard of care

– Placebo plus best standard of care

– Alpharadin arm stratified between pre-and post-docetaxel patients

• Primary endpoint:

– Overall survival (OS)

• Secondary endpoints:

– Time to occurrence of specified disease events

– Changes and time to progression in serum PSA and total ALP concentrations

– Acute and long term safety profile

– Quality of life

– Health economics

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ALSYMPCA study design

RANDOMIZE

Patient population:• progressive symptomatic HRPC• ≥ 2 bone metastases by bone scan• no known visceral metastases

Alpharadin 50 kBq/kg b.w. q4 wks

Saline placebo q4 wksn = 750

> 125 centres

M0 M30 M36

Treatment

6 injectionsq 4 weeks

M18 M 24

2

1

M6 M12

Follow-up

Every 2 months for first yearEvery 4 months thereafter

Allocation ratio

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Metastatic HRPC

Refuse DocetaxelDocetaxel Ineligible Rx Docetaxel

2nd-Line TherapyAll Other

� Other outcomes include:

– Continued docetaxel

– Ineligible for additional

treatment

– Refuses additional

treatment

– Death

Alpharadin Eligible

Populations

� Patients are docetaxel

ineligible due to :

– Performance status

– Age

– Other co-morbidities

� Patients often opt out of

therapy with docetaxel for

personal cost-benefit

reasons

� Many patients never

respond to docetaxel

ALSYMPCA positions Alpharadin in areas of unmet need

Source: Algeta-commissioned market research

• US Physicians estimate that up to 75% of HRPC patients could be eligiblefor treatment with Alpharadin

• Trial design distinguishes between pre- and post-docetaxel groups

• Trial avoids positioning Alpharadin against docetaxel

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Agenda






• Outlook

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BC1-05: confirms specific targeting to bone

BC1-05 confirms that Alpharadin delivers alpha particles quickly to bone tumors. Other parts of the body are left largely unaffected

• Fast elimination of the activity from blood

• Repeat injections have similar biodistribution and kinetics

• Main route of excretion is fecal

• Low absorbed dose to normal organs

• Kidney toxicity unlikely

Data were presented at the 55th Annual Meeting of Society for NuclearMedicine, New Orleans, June 2008

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Baseline Day 2 Day 6

BC1-05: typical scan – patient 104 (front)

99mTc-MDP 223RaImagingbased on

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Dose to medium (Gy)0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8

Su

rviv

al

(% o

f c

on

tro

l)

1

10

100

NHIK 3025

NHIK 3025 DOX (MDR+)

NHIK 3025 Plateau

NHIK 3025 cells are cervix carcinoma cancer cells.

DOX = doxorubicin resistant, multidrug resistant.

Plateau = resting, quiescent cells not in active cell cycle

Nonclinical studies of Alpharadin in resistant cancer

• Inherent or acquired resistance is a major problem in cancer treatment

• We examined the effectiveness of Alpharadin against cells that were:

• resistant to a common cancer drug

• quiescent (not in cell cycle)

• hypoxic

• Alpharadin maintained effectiveness in conditions that may adversely effect other anticancer drugs or radiation therapy

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Agenda


• Alpharadin clincial program– ALSYMPCA phase III study


– US clinical program


• Outlook

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Alpharadin in the US

• IND opened February 2008

• First US clinical study (BC1-08) study has started– Phase I pharmacokinetic, biodistribution and dosimetry in HRPC patients

– Memorial Sloan-Kettering Cancer Center– Complements BC1-05 (phase I)– Requested by FDA during discussions in 2007– Important step for eventual FDA approval of Alpharadin

– First patient included in August

• End-of-phase II meeting with FDA 2H 2008– Present dosimetry data (BC1-05) – Phase II safety & efficacy data (BC1-02, BC1-03)– BC1-06 Phase III RoW protocol update– Discuss US clinical program

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Agenda





• Financial Results

• Outlook

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Profit & loss(TNOK)

2Q07 1Q08 2Q08 2Q07 1Q08

Net income 0 0 0

Payroll 5 503 9 140 7 131 1 628 -2 009

Other costs 13 393 28 266 48 355 34 962 20 089

Depreciation 281 427 492 211 65

EBIT -19 176 -37 833 -55 978 -36 802 -18 145

Net financial 3 408 3 074 3 394 -14 320

EBT -15 768 -34 759 -52 584 -36 816 -17 825

Growth vs

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Cash flow(TNOK)

2Q07 1Q08 2Q08

Net cash from

Operating activities -26 512 -24 063 -45 127

Investments -667 -873 -965

Financing activities 2 017 0 88

Net Change -25 162 -24 936 -46 004

Cash at beginning of period 341 164 281 254 256 318

Cash at end of period 316 003 256 318 210 314

in USD 53 469 50 160 41 482

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Balance sheet(TNOK)

2Q07 1Q08 2Q08

Non-current assets 3 733 6 549 7 077

Current assets 319 853 268 087 223 570

Total assets 323 585 274 636 230 647

Shareholders' equity 308 844 232 228 180 788

Current liabilities 14 741 42 408 49 859

Total equity & liability 323 585 274 636 230 647

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Financial highlights

• Higher operating costs due to ALSYMPCA trial

– NOK 89 million in 2007

– NOK 38 million in 1Q08

– NOK 56 million in 2Q08

– Costs expected to remain high in 3Q08 and slightly lower thereafter

• Total liquid funds of NOK 210 million at end 2Q08

– Compared to NOK 256 million end of 1Q08

– Liquid funds invested in money market funds and held on bank accounts

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Algeta ASA has a total of 825.667 share options outstanding (vested and unvested)

International shareholder base

Shareholders as of 14 May 2008:

Shares Of total Country

HealthCap 2 743 300 16,6 % SWE

Advent Private Equity Fund IV 1 861 380 11,3 % GBR

Selvaag Venture Capital AS 1 366 140 8,3 % NOR

S.R. One Ltd 1 158 200 7,0 % USA

NorgesInvestor III AS 986 280 6,0 % NOR

Tredje AP-Fonden 756 800 4,6 % SWE

Morgan Stanley & Co. Inc. (nominee) 484 929 2,9 % GBR

Bank Of New York, Brussels Branch (nominee) 455 080 2,8 % GBR

Roy Larsen 394 840 2,4 % NOR

Deutsche Bank AG London (nominee) 391 449 2,4 % GBR

Abingworth Bioequities Master Fund 357 720 2,2 % USA

SEB (nominee) 345 300 2,1 % SWE

Nordea Bank Sweden AB (nominee) 306 478 1,9 % SWE

JPMBLSA (nominee) 297 770 1,8 % LUX

JPMorgan Securities Ltd. 227 800 1,4 % GBR

Zetta Invest 176 000 1,1 % NOR

Spar Investor Norge 175 000 1,1 % NOR

Outvest ANS 170 000 1,0 % NOR

Trinity Capital AS 160 000 1,0 % NOR

Erik Martin Vik 153 200 0,9 % NOR

Total owned by top 20 12 967 666 78,5 %

Other 3 543 942 21,5 %

Grand Total 16 511 608 100,0 %

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Agenda






• Outlook

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Outlook second half 2008

• Continue commercial preparations

– Evaluate licenising options

– Retain sales and marketing rights in selected territories

– Finalise US and EU market research for Alpharadin

• Advance Alpharadin clinical program

– Continue patient enrolment for ALSYMPCA

– Initiate BC1-08 dosimetry study at MSKCC

� First patient included in August

– Discuss clinical development program with FDA by year-end

• Report and present additional Alpharadin clinical data

– Report supplemental phase I and II trials

• Pre-clinical pipeline

– Progress pipeline towards clinical trials

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Alpharadin future clinical development

• Near term

– BC1-08: HRPC phase I PK/biodistribution/dosimetry (MSKCC)

– BC1-09: breast cancer phase II

– BC1-10: HRPC phase I/II combination with docetaxel

• Mid term

– HRPC phase II/III (possible three arm design: Alpharadin, Alpharadin plus docetaxel, docetaxel)

• Long term

– Breast cancer phase III

– Early prostate cancer phase III

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3Q report will be released on

12 November 2008

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www.algeta.com

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