J.P. Morgan Healthcare Conference. Company Update January 14, 2016

Transcription

1 J.P. Morgan Healthcare Conference Company Update January 14, 2016

2 Safe Harbor This presentation includes forward-looking statements. Actual results could differ materially from those included in the forward-looking statements due to various risk factors and uncertainties including changes in business, economic competitive conditions, regulatory reforms, foreign exchange rate fluctuations and the availability of financing. These and other risks and uncertainties are detailed in the Company s Annual Report. MorphoSys AG, Company Update - January

3 Broad Therapeutic Pipeline with Multiple Near-Term Catalysts Proprietary Clinical Programs MOR208 shows strong single-agent efficacy Being positioned in R/R DLBCL and ibrutinib-refractory CLL Pivotal trial in DLBCL expected to start in 2017 MOR202 differentiated from other CD38 antibodies Clear safety and administration advantages Pipeline Provides Strong Foundation for Growth Over 100 compounds in development Phase 3 data for bimagrumab (Novartis) and guselkumab (J&J) expected in 2016 More than 20 clinical studies to be completed in 2016 Proven Technology Leadership HuCAL platform most productive antibody library in industry New developments in antibodies & lantipeptides MorphoSys AG, Company Update - January

4 The MorphoSys Pipeline 25 Clinical Product Candidates, 104 Total Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3 Bimagrumab (BYM338) Novartis ActRIIB sibm (musculoskeletal) Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis Gantenerumab Roche Amyloid-ß Alzheimer s disease MOR208 - CD19 ALL, CLL, NHL MOR202 - CD38 Multiple myeloma MOR103/GSK GSK GM-CSF Inflammation BHQ880 Novartis DKK-1 Multiple myeloma BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome CNTO3157 Janssen - Inflammation CNTO6785 Janssen - Inflammation LFG316 Novartis C5 Eye diseases LJM716 Novartis HER3 Cancer Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors VAY736 Novartis BAFF-R Inflammation MOR209/ES414 Emergent PSMA/CD3 Prostate cancer Anetumab Ravtansine (BAY ) Bayer Mesothelin (ADC) Solid tumors BAY Bayer TFPI Hemophilia BI BI IGF-1 Solid tumors NOV 7 Novartis - Eye diseases NOV 8 Novartis - Inflammation NOV-9 Novartis - Diabetic eye diseases NOV-10 Novartis - Cancer NOV-11 Novartis - Blood disorders PF Pfizer 4-1BB Solid tumors Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors MOR106 Galapagos - Inflammation MOR107 (LP2) - AT2-R Fibrosis Immuno-oncology program Merck Serono - Cancer Immuno-oncology program Immatics - Cancer 6 MOR programs - - Various In addition, 26 partnered programs in pre-clinic, and 43 partnered programs in discovery Most advanced development stage 90 Partnered Discovery Programs 13 MOR Programs 1 Outlicensed Program MorphoSys AG, Company Update - January

5 The MOR Portfolio Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3 Unpartnered MOR208 NHL FTD, orphan status US & EU CLL ALL CD19 Orphan status US & EU MOR202 Multiple myeloma CD38 MOR107 Fibrosis AT2-R Immuno-oncology program Cancer 6 Programs Various Various Co-development & co-promotion MHC-associated peptides MOR209/ES414 (Emergent) MOR106 (Galapagos) Immuno-oncology program (Merck Serono) Outlicensed to GSK MOR103/ GSK Prostate cancer Inflammation Cancer RA/hand osteoarthritis PSMA / CD3 Undisclosed Undisclosed GM-CSF MorphoSys AG, Company Update - January

6 MOR208 Superior to Other CD19 & CD20 MAbs in R/R CLL Response Rates Based on IWCLL2008 Criteria anti-cd19 MAbs anti-cd20 MAbs SD, PD & non-evaluable ORR mpfs (months) 38% MOR208 12mg/kg (n=16) 24% MEDI-551 phase 1/2 12mg/kg (n=26) 30% Obinutuzumab phase 2 (n=20) 23% Ofatumumab phase 3 (n=196) 13% Rituximab (n=110) 14 NR MEDI-551 data source: Poster ASCO 2013, 12mg/kg dosing group Obinutuzumab data source: GAUGUIN study, Cartron et al, Blood 2014 Ofatumumab data source: control arm in ibrutinib vs. O phase 3 trial (RESONATE, ASCO 2014) Rituximab data source: Late breaking abstract #6, ASH 2013 Criteria: Hallek et al 2008 (including CT) [NR not reported] MorphoSys AG, Company Update - January

7 MOR208 Strong Single Agent Efficacy in R/R NHL Best overall response* n (%) DLBCL n=35 inhl incl. FL n=45 MCL n=12 Total n=92 Complete response 2 (6%) 5 (11%) 0 7 (8%) Partial response 7 (20%) 7 (16%) 0 14 (15%) Stable disease 5 (14%) 21 (47%) 6 (50%) 32 (35%) Progressive disease 11 (31%) 7 (16%) 5 (42%) 23 (25%) Not evaluable 10 (29%) 5 (11%) 1 (8%) 16 (17%) ORR (CR + PR) 9 (26%) 12 (27%) 0 21 (23%) ORR (Evaluable pts) 9 (36%) 12 (30%) 0 21 (28%) *Investigator assessed inhl cohort not expanded due to heterogeneity Post-baseline response assessment not performed/data unavailable CR, complete response; PR, partial response; ORR, objective response rate Jurczak et al, #1528, ASH 2015 MorphoSys AG, Company Update - January

8 Patients with CR or PR MOR208 Very Encouraging Duration of Response Duration of response DLBCL, n=9 Indolent NHL,* n=12 Ongoing response, n=9 Time to response, n= Months * Includes follicular lymphoma and other indolent NHLs DLBCL, diffuse large B-cell lymphoma; NHL, non-hodgkin s lymphoma. Jurczak et al, #1528, ASH 2015 MorphoSys AG, Company Update - January

9 MOR208 Comprehensive Clinical Development Plan Indication NHL MOR208 (12 mg/kg); N=92 DLBCL MOR208 (12mg/kg) + lenalidomide; 2 nd line R/R; N=80 Safety evaluation leading into anticipated pivotal study MOR208 (12 mg/kg) + bendamustine; 2 nd line R/R; N~320 CLL MOR208 (12mg/kg) + idelalisib; BTKi-failures; N=120 MOR208 (9mg/kg) + lenalidomide; R/R, naive & Richter s Transformation; MOR208 + ibrutinib in ibrutinib failures; N=80 (Ohio State Univ. IIT) ALL MOR208 (12mg/kg) + NK cells; pediatric ALL; N=13 (St Jude s IIT) Phase 2 Phase 2/3 IIT: Investigator-initiated trial MorphoSys AG, Company Update - January

10 MOR202 First Phase 1/2a Efficacy Data Preliminary Results of Single Agent MOR202 (weekly + Dex) VGPR and PR: 3/9 evaluable patients SD: 6/9 evaluable patients ORR of 33% Preliminary Results of combo of MOR202 with ImiDs VGPR and PR: 3/6 evaluable patients MR: 1/6 evaluable patients Clinical benefit rate of 67% Responder Analysis (all patients) Immediate decrease in M-Protein Improvement in remission quality with longer treatment duration Ongoing responses: 5/6 patients Best stabilization: 52+ weeks * Data from patients treated with the clinically relevant dose regimens who received > 1 treatment cycle. Raab et al, #3035, ASH 2015 MorphoSys AG, Company Update - January

11 Patients Treated MOR202 Phase 1/2a Time on Study and Best Response SD SD PR PR MR PR SD SD SD VGPR VGPR PR MOR202 q1w + Dex cohorts 4 mg/kg + Dex 8 mg/kg + Dex 16 mg/kg + Dex 8 mg/kg + POM/Dex PD 8 mg/kg + LEN/Dex PD SD Response recorded Ongoing patients Weeks Data from patients treated with the clinically relevant dose regimens who received > 1 treatment cycle. Dex, dexamethasone; LEN, Lenalidomide; MR, minor response; POM, Pomalidomide; PD, progressive disease; PR, partial response; q1w, weekly; SD, stable disease; VGPR, very good partial response. Raab et al, #3035, ASH 2015 MorphoSys AG, Company Update - January

12 % specific killing % specific NK cell killing MOR202: Differentiated by Clinical Safety & Potentially by Durability of Response MOR202 shows best-in-class infusion tolerability & convenience Infusion time MOR202 Daratumumab Isatuximab 2h 6.5 h (1st infusion) 3.5 h (3rd infusion) IRRs (with Steroids) 6% (grade 1 only) 70 / 77% 52% 4-6 h * Janssen Symposium IMW 2015 MOR202 shows best-in-class difference between MM and NK-cell killing CD38-expressing MM cell line CD38-expressing NK cells MOR202 Daratumumab Isatuximab MOR202 Daratumumab Isatuximab adapted from Boxhammer et al, #3015 ASH 2015 MorphoSys AG, Company Update - January

13 MOR202 Clinical Development Plan Indication MOR202 monotherapy, dose escalation & confirmation cohorts; N~62* Multiple myeloma MOR202 (8 & 16mg/kg) + lenalidomide & confirmation cohorts; N~24** MOR202 (8 & 16mg/kg) + pomalidomide & confirmation cohorts; N~24* MOR202 combo study to be based on Phase 2 Phase 2 (recruitment phase) Phase 2/3 * Patients who have failed at least 2 prior therapies ** Patients who have failed at least 1 prior therapy MorphoSys AG, Company Update - January

14 Clinical Programs from Partnered Discovery Alliances (I) Program Partner Target Indication Phase 1 Phase 2 Phase 3 Bimagrumab Novartis ActRIIB sibm (RESILIENT) (BYM338) sibm (extension) sibm (long-term study) Hip fracture surgery Cachexia (COPD) Sarcopenia (dose-ranging) Sarcopenia (withdrawal extension study) Guselkumab Janssen/J&J IL23p19 Psoriasis (VOYAGE 1) (CNTO1959) Psoriasis (VOYAGE 2) Psoriasis (NAVIGATE) Pustular/Erythrodermic psoriasis Moderate to severe plaque-type psoriasis Palmoplantar pustulosis Active psoriatic arthritis Gantenerumab Roche Amyloid-ß Mild Alzheimer s disease Prodromal Alzheimer s disease Genetically predisposed BHQ880 Novartis DKK-1 MM (renal insufficiency) Smoldering MM BPS804 Mereo/Novartis Sclerostin Osteoporosis Hypophosphatasia (HPP) Osteogenesis Imperfecta CNTO3157 Janssen/J&J n.d. Asthma Safety/Pharmacokinetic CNTO6785 Janssen/J&J n.d. COPD Rheumatoid arthritis LFG316 Novartis C5 Age-related geographic atrophy Geographic atrophy (combo with CLG561) Panuveitis Paroxysmal nocturnal hemoglobinuria MorphoSys AG, Company Update - January

15 Clinical Programs from Partnered Discovery Alliances (II) Program Partner Target Indication Phase 1 Phase 2 Phase 3 LJM716 Novartis HER3 ESCC (combo with BYL719) HER2 + cancer (combo BYL719 & trastuzumab) HER2+ cancer, combo with trastuzumab PF Pfizer 4-1BB Advanced malignancies, with avelumab Solid tumors, NHL (+rituximab) Solid tumors, combo with PD-1i MK-3475 Advanced solid tumors, with mogamulizumab Tarextumab Oncomed/GSK Notch 2 Pancreatic cancer (ALPINE) (OMP-59R5) Small cell lung cancer (Pinnacle) Solid tumors VAY736 Novartis BAFF-R Pemphigus vulgaris Primary Sjögren s syndrome Primary Sjögren s syndrome BAY Bayer TFPI Bleeding disorders BAY Bayer Mesothelin Solid tumors Anetumab Ravtansine Advanced malignancies (Japan) BI BI IGF-1 Solid tumors, Japanese patients EGFR mutant NSCLC Metastatic breast cancer CRPC + enzalutamide Various solid cancer Advanced solid tumors NOV-7 Novartis n.d. Eye disease NOV-8 Novartis n.d. Inflammation NOV-9 Novartis n.d. Diabetic eye disease NOV-10 Novartis n.d. Cancer NOV-11 Novartis n.d. Blood disorders Vantictumab Oncomed/Bayer Fzd 7 Solid tumors (OMP-18R5) Metastatc breast cancer Pancreatic cancer (combo) NSCL MorphoSys AG, Company Update - January

16 Bimagrumab (BYM338) A Novartis Musculoskeletal Program Bimagrumab HuCAL antibody specific for ActRIIB, antagonizes myostatin binding to muscle cells Lead indication: sporadic inclusion body myositis (sibm) FDA breakthrough therapy designation Orphan drug designation Current Status Pivotal study in sibm with 240 patients ongoing, phase 3 data expected in H Listed by Novartis as planned filing 2016 Phase 2 studies in sarcopenia, cachexia and hip fracture surgery WK Engel and V Askanas; Neurology 2006; MorphoSys AG, Company Update - January

17 Bimagrumab (BYM338) Promising Phase 2 Data in sibm* Bimagrumab, single dose, 30 mg/kg Muscle mass increased approx. 5% more than placebo Muscle gain was functional Increases in strength parallel to physical performance and in 6-minute walking distance Data courtesy of Novartis [*] A Amato et al; Neurology; Nov 7, 2014, online [1] Statistically significant difference MorphoSys AG, Company Update - January

18 Guselkumab (CNTO1959) A Janssen Anti-Inflammatory Program Guselkumab A HuCAL antibody specific for IL-23, does not bind IL-12 IL-23 blockade inhibits production of multiple cytokines beyond IL-17A and preserves Th1 & Treg regulatory pathways Being developed in psoriasis and psoriatic arthritis Current Status Six Phase 3 clinical trials ongoing First Phase 3 data expected in 2016 Anticipated filing in 2016 Source: Jetten AM, Nucl Recept Signal, 2009 MorphoSys AG, Company Update - January

19 Guselkumab (CNTO1959) Clinical Data Highest levels of durable skin clearance with less intensive dosing regimens vs. anti-il-17 class Potential for similar safety profile vs. long-term blockade of IL with STELARA Potential for long-term, drug-free efficacy Data courtesy of Janssen MorphoSys AG, Company Update - January

20 Highlighted Programs All Have Blockbuster Potential Program Indication Forecast Peak Sales* MOR208 NHL CLL ALL $790m $350m $250m MOR202 Multiple myeloma $2.1bn $1.4bn Bimagrumab sibm Cachexia Sarcopenia Atrophy after hip fracture surgery $400m-$890m $1.0bn-$2.0bn $1.6bn $872m-$1.3bn $3.9bn-$5.8bn Guselkumab Psoriasis Pustular psoriasis Psoriatic arthritis $1.6bn $871m $299m $2.8bn * Based on an external study by Defined Health using publicly available information; the forecasted peak sales do not represent company guidance. MorphoSys - January

21 PHASE 1 PHASE 2 PHASE 3 Pipeline Set to Deliver a Lot of Clinical Data Bimagrumab sibm Guselkumab Psoriasis (VOYAGE 2) Bimagrumab sibm (extension) Guselkumab Psoriasis (VOYAGE 1) Guselkumab Psoriasis (NAVIGATE) Guselkumab Pustular/Erythrodermic Psoriasis Bimagrumab Sarcopenia (Withdrawal Extension) Bimagrumab Sarcopenia (dose ranging) MOR208 CLL + idelalisib Bimagrumab Hip fracture surgery MOR208 DLBCL + lenalidomide Guselkumab Psoriatic Arthritis PF Solid tumors + avelumab LFG316 Panuveitis MOR202 Multiple Myeloma MOR103/GSK RA Tarextumab Small cell lung cancer LFG316 PNH MOR208 NHL MOR202 Multiple Myeloma VAY736 Pemphigus Vulgaris LJM716 ESCC + BYL716 Tarextumab Pancreatic cancer MOR208 CLL (IIT) VAY736 Primary Sjögren s Syndrome (PD) Anetumab Ravtansine Advanced malignancies BI Advanced solid tumors BI EGFR mutant NSCLC LJM716 + BYL716 & trastuzumab MOR209 Prostate cancer Based on published information and MorphoSys estimates BAY Bleeding disorders BI Metastatic breast cancer BI CRPC + enzalutamide PF NHL + rituximab PF Solid tumors + MK-3475 VAY736 Primary Sjögren s Syndrome Partnered Discovery Programs MOR Programs/Outlicensed programs MorphoSys AG, Company Update - January

22 Financial Guidance 2015 in million 2014A 9M 2015 Guidance 2015 Group Revenues to 106 Proprietary R&D Expenses (incl. Technology Development) to 63 EBIT to 16 Cash, cash equivalents & marketable securities as well as other short-term and long-term financial assets MorphoSys AG, Company Update - January

23 What to Expect? MOR208 DLBCL Phase 2 lenalidomide combo trial to start in Q Phase 2 bendamustine combo safety evaluation to start mid 2016 Phase 3 bendamustine combo pivotal study planned for 2017 CLL Phase 2 idelalisib combo trial to start in Q ALL Phase 2 pediatric IIT with NK cell transfusion to start in H MOR202 MM Updated data from phase 1/2a trial at ASCO 2016 MOR209 Prostate cancer First phase 1 data expected in 2016 Bimagrumab sibm Data from pivotal trial and regulatory filing expected in 2016 Guselkumab Psoriasis Data from 3 pivotal trials and regulatory filing expected in 2016 Pipeline MOR106 & MOR107 to start clinical development in 2016 Potential in-licensing of additional compounds MorphoSys AG, Company Update - January

24 Thank You Dr. Claudia Gutjahr-Löser Head of Corporate Communications & IR Phone +49 (0)89 / Fax +49 (0)89 / investors@morphosys.com HuCAL, HuCAL GOLD, HuCAL PLATINUM, CysDisplay, RapMAT, aryla, Ylanthia and 100 billion high potentials are registered trademarks of MorphoSys AG. Slonomics is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.