karolinska development q3 2012 interim report presentation

18
Karolinska Development 3Q 2012 Conference Call – November 22, 2012 Torbjörn Bjerke, CEO

Upload: karolinskadevelopmentab

Post on 21-May-2015

827 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Karolinska Development Q3 2012 Interim Report Presentation

Karolinska Development 3Q 2012 Conference Call – November 22, 2012Torbjörn Bjerke, CEO

Page 2: Karolinska Development Q3 2012 Interim Report Presentation

Today’s Presentation

Third Quarter Highlights

Selected Portfolio Companies

Financial Information

Summary

2

Page 3: Karolinska Development Q3 2012 Interim Report Presentation

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

3

Page 4: Karolinska Development Q3 2012 Interim Report Presentation

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

Page 5: Karolinska Development Q3 2012 Interim Report Presentation

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%

5

*Including indirect ownership. Ownership in Axelar and GliGene shown after all tranches in recent investment round. Ownership in Aprea after share

swap transaction.

Page 6: Karolinska Development Q3 2012 Interim Report Presentation

TECHNOLOGY Ownership* Concept development Prototype Development Product Sales

IMPLANTSPromimic AB 28%Oss-Q AB 16%

The Portfolio has a Significant Market Potential

6

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%

6

Page 7: Karolinska Development Q3 2012 Interim Report Presentation

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

7

Page 8: Karolinska Development Q3 2012 Interim Report Presentation

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

8

Phase II data

Page 9: Karolinska Development Q3 2012 Interim Report Presentation

Selected Portfolio Companies

9

Page 10: Karolinska Development Q3 2012 Interim Report Presentation

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

10

Page 11: Karolinska Development Q3 2012 Interim Report Presentation

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

Page 12: Karolinska Development Q3 2012 Interim Report Presentation

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

12

Source: van Balen et al, BMJ 2003

Page 13: Karolinska Development Q3 2012 Interim Report Presentation

Financial Information

13

Page 14: Karolinska Development Q3 2012 Interim Report Presentation

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

14

Page 15: Karolinska Development Q3 2012 Interim Report Presentation

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

15

Page 16: Karolinska Development Q3 2012 Interim Report Presentation

Strong Shareholder Base

As per September 30, 2012

16

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%

Page 17: Karolinska Development Q3 2012 Interim Report Presentation

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

17

Page 18: Karolinska Development Q3 2012 Interim Report Presentation

Questions

18