Karolinska Development Interim Report January - June 2012

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Karolinska Development Interim Report January - June 2012

  1. 1. Karolinska Development2Q 2012 Conference Call – August 23, 2012Torbjörn Bjerke, CEO
  2. 2. Today’s Presentation Second Quarter Highlights Selected Portfolio Companies Financial Information Summary2
  3. 3. 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 – 14 projects in clinical phase  Large portfolio of companies removes binary risk – 26 companies, 35 projects  Cash position provides funding through major clinical data  Strong focus on business development activities across the portfolio3
  4. 4. Highlights During and Since the Second Quarter 2012  Pharmanest initiated Phase I and Phase II trials with SHACT, a product developed for pain relief in connection with IUD insertion  Karolinska Development AB and Industrifonden signed a share swap agreement whereby Industrifonden will exchange Karolinska Development AB’s shares in Oncopeptides AB for its shares in Aprea AB  Pergamum reported top-line Phase II-data from the clinical trial with PXL-01 for prevention of post-surgical adhesions  Strengthened Management team in Karolinska Development: – Dr Gunilla Ekström recruited as VP Operations – Ann-Sofie Sternås recruited as VP IPR  Akinion Pharmaceuticals announced the publication of preclinical results for AKN-028 in highly cited scientific journal4
  5. 5. The Portfolio has a Significant Market Potential Concept Lead Lead Preclinical Ownership* Phase I Phase II Phase III Launch PHARMACEUTICALS development discovery optimization development ONCOLOGY Axelar AB 50% Aprea AB 41% Oncopeptides AB 43 % KDev Oncology AB (AKN-028) 90% KDev Oncology AB (GliGene) 44% DERMATOLOGY Pergamum AB (DPK-060, atopic dermatitis) 62% Pergamum AB (DPK-060, external otitis) 62% Pergamum AB (PXL01) 62% Pergamum AB (LL-37) 62% WOMEN’S HEALTH Dilafor AB 55% Pharmanest AB 59% Umecrine Mood AB 43% INFECTIOUS DISEASE Dilaforette AB 62% Biosergen AS 60% CARDIOVASCULAR Athera Biotechnologies AB (Annexin A5) 65% Athera Biotechnologies AB (PC-mAb) 65% CNS BioChromix Pharma AB 70% Umecrine Cognition AB 54% INFLAMMATION NovaSAID AB 89% ProNoxis AB 22% OPHTHALMOLOGY Clanotech AB 88% Solid colored area = completed phase Shaded colored area = ongoing phase *Including indirect ownership. Ownership in Axelar and GliGene shown after all tranches in recent investment round. All shares in Oncopeptides will be exchanged for Industrifondens shares in Aprea. Ownership in Aprea after share swap transactiona will be 69%.5
  6. 6. The Portfolio has a Significant Market Potential TECHNOLOGY Ownership* Concept development Prototype Development Product Sales IMPLANTS Promimic AB 28% Oss-Q AB 16% DIAGNOSTICS Athera Biotechnologies AB (CVDefine®) 65% BioChromix AB 14% PHARMACEUTICAL FORMULATION Inhalation Sciences Sweden AB 72% XSpray Microparticles AB 62% Lipidor AB 46% MEDICAL EQUIPMENT NeoDynamics AB (Fourier/AS) 21% NeoDynamics AB (Therapy/PRFA) 21% Solid colored area = completed phase Shaded colored area = ongoing phase *Including indirect ownership6
  7. 7. Portfolio Focus in 2012 and 2013 Axelar – AXL1717 Phase I/II data  Axelar – AXL1717 for NSCLC Initiate Phase II  Akinion – AKN-028 for AML Initiate clinical studies  ONCOLOGY Aprea – APR-246 Complete Phase I/II Akinion – AKN 028 Complete Phase I/II Axelar – AXL1717 for NSCLC Complete Phase II Pergamum – PXL01 for surgical adhesion Complete enrolment of Phase II  Pergamum – DPK-060 for external otitis Initiate Phase II  DERMATOLOGY Pergamum – DPK-060 for skin infection Preparation for Phase IIb Pergamum – LL-37 for chronic wounds Initiate clinical studies 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  WOMEN’S HEALTH Dilafor – Tafoxiparin for protracted labor Initiate Phase IIb with partner Pharmanest – SHACT for pain relief at IUD insertion Complete Phase I and II Umecrine Mood – Severe PMS and PMDD Initiate Phase I/II Dilaforette – Sevuparin for malaria Initiate Phase I/II  OTHER Dilaforette – Sevuparin for malaria Complete Phase I/II7
  8. 8. Anticipated Major Clinical Data Phase I data LL-37 Phase I data PXL01 Phase II data  DPK-060 Phase II data Phase II data Phase II data in NSCLC 2012 2013 2014 Phase I data Phase I/II data Phase I/II data Tafoxiparin Phase IIb data8
  9. 9. Significant Deal Values in Our Focus Areas Therapeutic Total Deal Date Licensor Licensee Product Phase at Deal Area Value (USDm) February 16, 2011 AVEO Pharmaceuticals, Inc. Astellas Pharma, Inc. Oncology AV951 Phase II 1480 February 29, 2012 Galapagos NV Abbott Laboratories Inflammatory GLPG0634 Phase II 1350 November 10, 2009 Alder Biopharmaceuticals Inc. Bristol-Myers Squibb Company Inflammatory ALD518 Phase II 1049 December 8, 2011 Pharmacyclics, Inc. Janssen Biotech, Inc. Oncology PCI32765 Phase II 975 September 3, 2009 Algeta ASA Bayer Healthcare Pharmaceuticals, Inc. Oncology Alpharadin Phase II 800 December 21, 2009 Incyte Corporation Eli Lilly & Co Inflammatory INCB28050 Phase II 755 February 12, 2009 Portola Pharmaceuticals Inc. Novartis AG CVD PRT128 Phase II 575 May 4, 2011 Molecular Partners AG Allergan Inc. Ophthalmology MP0112 Phase II 420 September 5, 2011 Evotec AG Roche Holding, Ltd. CNS EVT302, RG1577 Preclinical 830 Janssen Pharmaceuticals Inc./ June 1, 2010 Orexo AB Respiratory OX-CLI, OX-ESI Preclinical 586 Johnson & Johnson June 8, 2011 Affectis Pharmaceuticals AG Merck Serono S.A. CNS P2X7 Antagonist Preclinical 409 January 1, 2012 Virobay, Inc. LEO Pharma A/S Dermatology Preclinical 307 MP0260, August 21, 2012 Molecular Partners AG Allergan Inc. Ophthalmology Discovery 1400 eye disease DARPins December 20, 2010 Avila Therapeutics, Inc. Sanofi Oncology Discovery 964 January 5, 2012 Forma Therapeutics, Inc. Boehringer Ingelheim Corporation Oncology Discovery 8159
  10. 10. Selected Portfolio Companies10
  11. 11. AXL1717 - Block Buster Potential in Lung Cancer Ownership: 50% 12 Avastin, Tarceva and Iressa Sales (USDbn) Company: Axelar AB 10 Active ingredient: Small molecule 8 6 Primary indication: Non Small Cell Lung Cancer 4 Current Phase: Phase II 2 0 Status Market Overview  The only small-molecule IGF-1R inhibitor in man  Around 420 000 new cases of NSCLC in the without insulin receptor inhibition industrialized countries each year  Unique preclinical efficacy  UBS estimated total US lung cancer sales in 2010 for  Promising Phase I/II data Avastin at USD 1150m, Tarceva at USD 400m, and  Phase II ongoing – Top-line data expected in the Iressa at USD 310m beginning of 2013  Next indication Glioblastoma Source: Datamonitor AXL1717 - Potential in Multiple Cancers11
  12. 12. AXL1717 – Promising Phase I/II-data (March 30 Update) Ownership: 50% SAFETY Progression-free survival and overall survival of 15 patients with progressive and refractory NSCLC treated with single AXL1717 was well-tolerated with reversible neutropenia agent AXL1717 in 3rd or 4th line. Patients with a treatment duration longer than 14 days. Status per March 30, 2012 as dose limiting toxicity - Even at exposures 5-10 fold higher than those needed for anti-tumor activity in animals. - No changes in blood levels of glucose, insulin or C-peptide were reported. CLINICAL BENEFIT For the NSCLC patients treated for 14 days or longer (Mar 30, 2012): Median survival 60 weeks Median time to progression 31 weeks One Partial Response according to RECIST12
  13. 13. Normalizing p53 to Overcome Drug Resistance Ownership: 41%* Platinum refractory patients in ovarian cancer (US) Company: Aprea AB First Line Treatment (60500 patients) 86% 14% Active ingredient: Small molecule Second Line Treatment (30500 patients) 58% 42% Primary indication: Ovarian cancer Current Phase: Phase I/II Third Line Treatment (18000 patients) 25% 75% Patients given platinum-based therapy Patients ineligible for platinum-based therapy Status Market Overview  Aprea has identified small molecules that reactivate  63 500 patients are diagnosed with ovarian cancer p53, considered a prime target for new first-line cancer each year in 7MM, 25 % with an advanced disease at therapies diagnosis  Gained orphan drug status for indication AML in the  Close to half of the patients in second line treatment EU develop resistance to platinum-based treatment  Planning in progress of a Phase I/II study in  Apreas drug candidate aims to target this problem chemotherapy-resistant patients *Ownership in Aprea will be 69% after share swap13 transaction with Industrifonden.
  14. 14. AKN-028 - Targeting all AML Tumor Types Ownership: 90% AML Treatment Outcomes 70% Company: Akinion 60% 30 day Treatment Pharmaceuticals AB 50% Mortality Active ingredient: Small molecule 40% 30% Resistance Primary indication: Acute Myeloid 20% Leukemia (AML) 10% Complete Remission after Current Phase: Phase I/II 0% cytarabine + daunorubicin <56 56-65 66-75 >75 treatment Age Group Status Market Overview  Targets FLT3 and c-Kit – important factors in leukemia  Chemotherapy is the only viable pharmaceutical development treatment for AML today  Unique preclinical efficacy in chemotherapy resistant  About 42 000 patients are affected by AML each year cells in the US, EU and Japan  Phase I/II ongoing in AML  5-year survival: 33% in patients under 65, 4% in patients over 65 years Sources: Datamonitor, NCCN, SEER, Appeldaum et al 200614
  15. 15. Ex vivo Efficacy of AKN-028 vs. Quizartinib Ownership: 90% Cytotoxic response to AKN-028 and Quizartinib (AC220) in 11 primary AML samples outlined as individual dose–response curves from the FMCA (a–f ). Samples are grouped according to in vitro response to Quizartinib. Because of the configuration of data for Quizartinib, a sigmoid curve fitting was not possible. SI, survival index. (Eriksson et al 2012)15
  16. 16. Synergistic Response of AKN-028 with Chemotherapy Ownership: 90% Cytotoxic response to AKN-028 in combination with standard cytotoxic agents cytarabine (a) and daunorubicin (b) in MV4-11 cell line in three different sequences; (I): pretreatment with chemotherapy (24 h), followed by AKN-028; (II): simultaneous treatment with both agents; (III): pretreatment with AKN-028 (24 h). Results are presented as mean CI, (n¼11–16) of all experimental combination data points with effect levels between 10–90%, error bars representing s.e.m. CI o0.7 indicate synergy and CI of 1 additive interactions. (Eriksson et al 2012)16
  17. 17. SHACT - Pain Management in Gynecology Ownership: 59% Company: Pharmanest AB Active ingredient: Small molecule Primary indication: Pain in connection with IUD-insertion Current Phase: Phase II Status Market Overview  Unique formulation and applicator developed for  UN estimates the prevalence of IUD at 15 million local pain relief during gynecological procedures women in the developed world  Last patient dosed in Phase I safety and  Assuming an IUD insertion every 5 year, the annual pharmacokinetics study number of IUD insertions is 3 million in developed countries  A randomized, double blind Phase II-study with  China represents a large market potential - Over about 200 patients initiated in 2Q 2012 100 million women with IUD  Phase II-data is expected in 2H 2013  Potential to expand to other indications such as hysteroscopy, abortions and obstetric pain Sources: United Nations, World Contraceptive Use (2011)17
  18. 18. Financial Information18
  19. 19. Key Financial Information for the Group 2012 2011 2011 Amounts in SEKm Jan-June Jan-June Full year Income statement Revenue 5.5 5.2 10.5 Profit/loss after tax -189.2 -130.8 -385.7 Earnings per share before and after dilution (SEK) -3.52 -3.09 -8.07 Balance sheet Cash and cash equivalents 170.3 162.1 163.3 Short-term investments 291.1 577.5 457.2 Share information Net asset value per share (SEK) 42.5 49.6 44.7 Share price, last trading day in the reporting period (SEK) 19.5 29.4 24.0 Portfolio information Investments in portfolio companies* 115.7 226.2 297.6 Of which investments not affecting cash flow - 84.1 94.9 Valuation of total portfolio holdings 1,564.4 1,652.1 1,546.9 * Portfolio companies comprise subsidiaries, joint ventures, associated companies and other long-term securities holdings19
  20. 20. Strong Shareholder Base 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% Swedbank Robur Funds 1 920 074 4.0% 3.1% Jarla Investeringar AB 1 629 354 3.4% 2.6% Foundation Asset Management AB 1 392 035 2.9% 2.2% Länsförsäkringar Group 1 364 415 2.8% 2.2% Skagen Funds 1 297 700 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% Government of Norway 781 951 1.6% 1.3% Holberg Funds 754 653 1.6% 1.2% SBSB Innovation AB 692 000 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% KL Ventures AB 300 000 0.6% 0.5% Lingfield AB 281 989 0.6% 0.5% Sum listed shareholders 1 503 098 28 329 673 61.5% 69.9% Sum other shareholders 0 18 698 646 38.5% 30.1% Sum all shareholders 1 503 098 47 028 319 100.0% 100.0% As at June 30, 201220
  21. 21. 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 – 14 projects in clinical phase  Large portfolio of companies removes binary risk – 26 companies, 35 projects  Cash position provides funding through major clinical data  Strong focus on business development activities across the portfolio21
  22. 22. Questions22

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