karolinska development q3 2012 interim report presentation
TRANSCRIPT
Karolinska Development 3Q 2012 Conference Call – November 22, 2012Torbjörn Bjerke, CEO
Today’s Presentation
Third Quarter Highlights
Selected Portfolio Companies
Financial Information
Summary
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Karolinska Development in Summary
Exclusive access to top class medical innovations
First-in-class drug candidates with multi billion dollar sales potential
Significant clinical progress – 15 projects in clinical phase, 11 in the active portfolio
Large portfolio of companies removes binary risk – 25 companies, 34 projects
Cash position provides funding through major clinical data
Strong focus on business development activities across the portfolio
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Highlights During and After the Third Quarter 2012
Pergamum reported top-line Phase II data from the clinical trial on the prevention of post-surgical adhesions
The first patient was dosed with Pergamum’s drug candidate LL-37 for treatment of hard-to-heal wounds
Aprea announced positive data from a Phase I/II clinical study with APR-246 in patients with advanced cancers
CARDIOVASCULARAthera Biotechnologies AB (Annexin A5) 65%Athera Biotechnologies AB (PC-mAb) 65%
The Portfolio has a Significant Market Potential
DERMATOLOGYPergamum AB (DPK-060, infected eczema) 62%Pergamum AB (DPK-060, external otitis) 62%Pergamum AB (PXL01) 62%Pergamum AB (LL-37) 62%
WOMEN’S HEALTHDilafor AB 55%Pharmanest AB 60%Umecrine Mood AB 43%
INFECTIOUS DISEASEDilaforette AB 66%Biosergen AS 60%
CNSBioChromix Pharma AB 76%Umecrine Cognition AB 54%
INFLAMMATIONNovaSAID AB 89%
Solid colored area = completed phase Shaded colored area = ongoing phase
PHARMACEUTICALS Ownership* Concept development
Lead discovery
Lead optimization
Preclinical development Phase I Phase II Phase III Launch
ONCOLOGYAxelar AB 50%Aprea AB 69%KDev Oncology AB (AKN-028) 90%KDev Oncology AB (GliGene) 44%
OPHTHALMOLOGYClanotech AB 88%
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*Including indirect ownership. Ownership in Axelar and GliGene shown after all tranches in recent investment round. Ownership in Aprea after share
swap transaction.
TECHNOLOGY Ownership* Concept development Prototype Development Product Sales
IMPLANTSPromimic AB 28%Oss-Q AB 16%
The Portfolio has a Significant Market Potential
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Solid colored area = completed phase Shaded colored area = ongoing phase
*Including indirect ownership
DIAGNOSTICS
Athera Biotechnologies AB (CVDefine®) 65%BioChromix AB 14%
MEDICAL EQUIPMENTNeoDynamics AB (Fourier/AS) 21%NeoDynamics AB (Therapy/PRFA) 21%
PHARMACEUTICAL FORMULATIONInhalation Sciences Sweden AB 75%XSpray Microparticles AB 62%Lipidor AB 46%
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Portfolio Focus in 2012 and 2013Axelar – AXL1717 for NSCLC Initiate Phase II Akinion – AKN-028 for AML Initiate clinical studies Aprea – APR-246 Complete Phase I/II
Akinion – AKN 028 Complete Phase I/II
Axelar – AXL1717 for NSCLC Complete Phase II
Pergamum – DPK-060 for external otitis Initiate Phase II Pergamum – LL-37 for chronic wounds Initiate Phase I/II Pergamum – DPK-060 for skin infection Preparation for Phase IIb
Pergamum – LL-37 for chronic wounds Complete Phase I/II
Pergamum - DPK-060 for external otitis Complete Phase II
Pharmanest – SHACT for pain relief at IUD insertion Initiate Phase I
Pharmanest – SHACT for pain relief at IUD insertion Initiate Phase II
Dilafor – Tafoxiparin for protracted labor Initiate Phase IIb with partner
Pharmanest – SHACT for pain relief at IUD insertion Complete Phase II
Umecrine Mood – Severe PMS and PMDD Initiate new Phase I/II
Dilaforette – Sevuparin for malaria Initiate Phase I/II Dilaforette – Sevuparin for malaria Complete Phase I/II
ONCOLOGY
DERMATOLOGY
WOMEN’S HEALTH
OTHER
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Anticipated Major Clinical Data
2012 2013 2014
PXL01 Phase II data Phase II data in NSCLC
DPK-060 Phase II data
Phase I data
Tafoxiparin Phase IIb data
LL-37 Phase I/II data
Phase I/II dataPhase I/II data
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Phase II data
Selected Portfolio Companies
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Normalizing p53 to Overcome Drug Resistance Ownership: 69%
Company: Aprea AB
Active ingredient: Small molecule
Primary indication: Ovarian cancer
Current Phase: Phase I/II
Status
Aprea has identified small molecules that reactivate p53, a key protein involved in tumor growth and chemotherapy resistance
Positive Phase I/II data - recently published in Journal of Clinical Oncology
Planning in progress of a Phase II proof of concept study in ovarian cancer relapsing after platinum treatment
Market Overview
63 500 patients are diagnosed with ovarian cancer each year in 7MM, 25 % with an advanced disease at diagnosis
Close to half of the patients in second line treatment develop resistance to platinum-based treatment
Aprea's drug candidate aims to target this problem
Third Line Treatment (18000 patients)
Second Line Treatment (30500 patients)
First Line Treatment (60500 patients)
25%
58%
86%
75%
42%
14%
Platinum refractory patients in ovarian cancer (US)
Patients given platinum-based therapyPatients ineligible for platinum-based therapy
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APR-246 – Positive Phase I/II
Good safety and pharmacokinetic profile Predicted therapeutic levels reached,
well below dose limiting toxicity No overlap in toxicity with cytotoxic
therapies – combination treatment feasible
Ownership: 69%
Source: Lehmann et al., 2012, J Clin Oncol 30:3633-3639
Signs of clinical effect APR-246 activates the p53 response genes in cancer patients –
mechanism supported Two patients experienced anti-tumor effects
DPK-060 – A Novel Anti-infective Peptide
Status Patient recruitment of the Phase II trial has been
finalized Proof-of-concept in external otitis opens for use of
DPK-060 in further indications of skin and soft tissue infections
Market Overview External otitis is a painful infection of the outer ear
and ear canal The disease is caused by a wide range of gram-
positive and gram-negative bacteria as well as fungal infections, which are all targets of DPK-060 treatment
8 million people are estimated to suffer from external otitis each year in the US and EU alone
Ownership: 62%
Company: Pergamum AB
Active ingredient: Therapeutic Peptide
Primary indication: External Otitis
Current Phase: Phase II
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Source: van Balen et al, BMJ 2003
Financial Information
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Key Financial Information for the Group (SEK)
Amounts in SEKm 2012 2011 2011
Jan-Sep Jan-Sep Full yearIncome statement
Revenue 7.4 7.1 10.5Profit/loss after tax -315.9 -271.3 -385.7
Earnings per share before and after dilution (SEK) -5.99 -5.88 -8.07Balance sheet Cash and cash equivalents 202.7 165.4 163.3
Short-term investments 213.2 526.5 457.2Share information
Net asset value per share (SEK) 40.4 46.7 44.7Share price, last trading day in the reporting period (SEK) 16.3 25.8 24.0
Portfolio information Investments in portfolio companies* 207.0 237.9 297.6Of which investments not affecting cash flow 72.8 86.5 94.9
Valuation of total portfolio holdings 1,535.6 1,563.9 1,546.9
* Portfolio companies comprise subsidiaries, joint ventures, associated companies and other long-term securities holdings
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Key Financial Information for the Group (USD)
Amounts in USDm 2012 2011 2011
Jan-Sep Jan-Sep Full yearIncome statement Revenue 1.1 1.1 1.52Profit/loss after tax -48.4 -41.6 -55.9
Earnings per share before and after dilution (USD) -0.92 -0.90 -1.17Balance sheetCash and cash equivalents 31.1 25.3 23.7
Short-term investments 32.7 80.7 66.3Share information
Net asset value per share (USD) 6.2 7.1 6.48Share price, last trading day in the reporting period (USD) 2.5 4.0 3.48
Portfolio information
Investments in portfolio companies* 31.7 36.4 43.1Of which investments not affecting cash flow 11.1 13.2 13.8
Valuation of total portfolio holdings 235.2 239.5 224.2
* Portfolio companies comprise subsidiaries, joint ventures, associated companies and other long-term securities holdings
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Strong Shareholder Base
As per September 30, 2012
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Shareholder A Shares B Shares Cap % Votes %
Third Swedish National Pension Fund 4 678 500 9.6% 7.5%Karolinska Institutet Holding AB 1 503 098 2 453 933 8.2% 28.2%Coastal Investment Management LLC 3 470 541 7.2% 5.6%The Foundation of Baltic and East European Studies 3 345 537 6.9% 5.4%Jarla Investeringar AB 1 629 354 3.4% 2.6%Länsförsäkringar Group 1 514 620 3.1% 2.4%Swedbank Robur Funds 1 454 167 3.0% 2.3%Foundation Asset Management AB 1 392 035 2.9% 2.2%Skagen Funds 1 301 200 2.7% 2.1%Stefan Persson 1 261 278 2.6% 2.0%Insamlingsstiftelsen för främjande och utveckling av medicinsk forskning vid Karolinska Institutet 1 150 323 2.4% 1.9%Holberg Funds 800 330 1.6% 1.3%Norges Bank Investment Management 750 000 1.5% 1.2%SBSB Innovation AB 700 000 1.4% 1.1%Ruffer Funds 450 000 0.9% 0.7%Fourth Swedish National Pension Fund 383 959 0.8% 0.6%Gålö Foundation 375 535 0.8% 0.6%Nordea Funds 366 600 0.8% 0.6%OTK Holding A/S 325 000 0.7% 0.5%KL Ventures AB 300 000 0.6% 0.5%Sum listed shareholders 1 503 098 28 102 912 61.0% 69.5%Sum other shareholders 0 18 925 407 39.0% 30.5%Sum all shareholders 1 503 098 47 028 319 100.0% 100.0%
Karolinska Development in Summary
Exclusive access to top class medical innovations
First-in-class drug candidates with multi billion dollar sales potential
Significant clinical progress – 15 projects in clinical phase, 11 in the active portfolio
Large portfolio of companies removes binary risk – 25 companies, 34 projects
Cash position provides funding through major clinical data
Strong focus on business development activities across the portfolio
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Questions
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