Engineering the Medicines of Tomorrow

Transcription

1 January 7-11, 2018 Engineering the Medicines of Tomorrow Company Update

2 This presentation includes forward-looking statements. Actual results could differ materially from those included in the forwardlooking 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. The compounds discussed in this slide presentation are investigational products being developed by MorphoSys and its partners and are not currently approved by the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) or any other regulatory authority (except for guselkumab/tremfya ). MorphoSys AG, Company Update January

3 Investment Highlights Pipeline Leading antibody platform: over 100 active programs*, 28 in clinic Tremfya Potential blockbuster, offers lucrative royalty opportunity MOR208 Late-stage, proprietary candidate with promising data in DLBCL *Probability of success cannot be predicted MorphoSys AG, Company Update January

4 Business Model Building a Commercial, Product-Based Biopharmaceutical Company Partnered Discovery Maximizing utilization of technology Lucrative source of revenue from licence fees, milestones & royalties Proprietary Development Focus on oncology/inflammation Retained rights translate into greater revenue potential Value Partnered Discovery Proprietary Development Time MorphoSys AG, Company Update January

5 Our Clinical Pipeline 28 Product Candidates in Clinical Development, First Product Launched Program Partner Target Disease area Phase 1 Phase 2 Phase 3 Launched Tremfya (Guselkumab) Janssen IL-23p19 Psoriasis Gantenerumab Roche Amyloid-ß Alzheimer s disease MOR208 - CD19 DLBCL, CLL/SLL 2 Anetumab Ravtansine (BAY ) Bayer Mesothelin (ADC) Solid tumors BHQ880 Novartis DKK-1 Multiple myeloma Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome CNTO6785 Janssen - Inflammation Elgemtumab (LJM716) Novartis HER3 Cancer MOR103/GSK * GSK GM-CSF Inflammation 12 MOR202 I-Mab Biopharma** CD38 Multiple myeloma Tesidolumab (LFG316) Novartis C5 Eye diseases Utomilumab (PF ) Pfizer 4-1BB Cancer VAY736 Novartis BAFF-R Inflammation Xentuzumab (BI ) BI IGF-1 Solid tumors BAY Bayer TFPI Hemophilia MOR106 Galapagos IL-17C Inflammation MOR107 (LP2-3) Lanthio Pharma AT2-R Not disclosed NOV 7 Novartis - Eye diseases NOV 8 Novartis - Inflammation NOV-9 Novartis - Diabetic eye diseases NOV-10 Novartis - Cancer 13 NOV-11 Novartis - Blood disorders NOV-12 Novartis - Prevention of thrombosis NOV-13 Novartis - Cancer NOV-14 Novartis - Asthma PRV-300 (CNTO3157) ProventionBio TLR-3 Inflammation Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors Partnered Discovery Programs Proprietary Development Programs *MOR103/GSK is fully outlicensed to GSK. ** For development in Greater Chinese Market (China, Hong Kong, Taiwan, Macao) MorphoSys AG, Company Update January

6 MOR208: Proprietary Antibody in Hematological Cancers An Investigational Anti-CD19 Program for B Cell Malignancies The Drug Candidate IgG1 kappa antibody targeting CD19 In-licensed from Xencor Fc-engineered to enhance target cellkilling Mode of Action ADCC, phagocytosis, direct cytotoxicity Strong Preclinical Package MOR208 direct cytotoxicity ADCC Depletes B cells in in vitro and in vivo models Rationale for multiple combination therapies Fc-enhancement ADCP W Jurczak et al.; ASH 2016 ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity ADCP: Antibody-Dependent Cell-Mediated Phagocytosis MorphoSys AG, Company Update January

7 MOR208: Clinical Development Plan Opportunity Across Spectrum of B Cell Malignancies Indication DLBCL FDA Breakthrough Therapy Designation L-MIND TRIAL Lenalidomide + MOR208 in R/R DLBCL* B-MIND TRIAL Bendamustine + MOR208 vs. bendamustine + rituximab in R/R DLBCL* * Patients ineligible for high-dose chemotherapy and autologous stem-cell transplantation CLL COSMOS TRIAL MOR208 + idelalisib in R/R CLL BTKi-failures MOR208 + venetoclax in R/R CLL BTKi-failures Phase 2 Phase 3 MorphoSys AG, Company Update January

8 Best Overall Response (%)* MOR208: L-MIND Trial Response Rates MOR208 + Lenalidomide: ORR of 52% in a Phase 2 Study in R/R DLBCL Patients 100 n=44 NE: 14% (n=6) 80 PD: 21% (n=9) 60 SD: 14% (n=6) 40 PR: 20% (n=9) 20 CR: 32% (n=14) Objective response rate (ORR): 52% 0 *Differences due to rounding. R/R= relapsed/refractory; DLBCL = Diffuse Large B cell Lymphoma CR, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease Single-Arm phase 2 study of MOR208 combined with lenalidomide in patients with R/R DLBCL: L-MIND, ASH Abstract 2017 as of November 1, MorphoSys AG, Company Update January

9 MOR208: L-MIND Data in Perspective Duration of Response: Median Progression-Free Survival (PFS)* MOR208 + lenalidomide** L-MIND Salles et al Polatuzumab + RTX + BEN Sehn et al., 2017 Axi-CEL (CAR-T) ZUMA-1, Neelapu et al, RTX + BEN Dang et al., 2014 CTL019 (CAR-T) JULIET, Schuster et al., Median PFS (months) * Note limitations of cross-trial comparisons; ** Preliminary data; RTX, Rituximab; BEN, bendamustine MorphoSys AG, Company Update January

10 MOR202: Proprietary Anti-CD38 Antibody An Antibody for Multiple Myeloma & Potentially Other Cancers The Drug Candidate Developed to target a unique epitope on CD38 ADCC & ADCP cell-killing mechanisms Low NK cell depletion, which may translate into longer duration of response Clinical* Efficacy Responses ongoing in 65% of patients Patient with longest time on study with ongoing response: >22 months Infusion time of 2h, shorter time being explored Potentially opportunities in other oncology indications and auto-immune diseases ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity ADCP: Antibody-Dependent Cell-Mediated Phagocytosis ADCC ADCP *From ongoing phase 1/2a trial: Raab et al., Poster presentation at ASCO, June 5, 2017: Abstract #8024 MorphoSys AG, Company Update January

11 Best Overall Responses (%) MOR202: Efficacy Evaluation Comparison of Response Data Among Study Cohorts MOR202q1w + DEX cohorts MOR202q1w + LEN/DEX cohorts MOR202q1w + POM/DEX cohorts n=18 n=17 n= NE: 6% PD: 6% NE: 18% NE: 15% 80 PD: 6% SD: 6% PD: 8% SD: 8% 60 SD: 50% MR: 23% PR: 47% MR: 11% PR: 17% VGPR: 11% ORR: 28% VGPR: 18% CR: 6% ORR: 71% PR: 23% VGPR: 8% CR: 15% ORR: 46% CR, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease; VGPR, very good partial response; MR, marginal response; modified from Raab et al, ASCO 2017; ITT population shown MorphoSys AG, Company Update January

12 MOR202: First Partnering Deal Agreement with I-MAB Biopharma for Greater Chinese Market Agreement signed November 30, 2017 I-MAB receives exclusive development and commercialization rights in China, Taiwan, Hong Kong and Macao Payments to MorphoSys $20 million upfront Up to $100 million milestones Tiered, double digit royalties I-MAB s head of R&D was formerly responsible for the clinical development of Daratumumab in China as Janssen China s head of development MorphoSys AG, Company Update January

13 MOR106: Phase 1 Study in Atopic Dermatitis First Signs of Clinical Activity The Drug Candidate Ylanthia antibody against IL-17C, 50/50 co-development with Galapagos Clinical Top line results published end of September 2017: No clinically relevant safety signals At the highest dose level, 5 out of 6 patients (83%) reached an improvement of at least 50% in atopic dermatitis symptoms (EASI-50) by week 4 Results support progression to Phase 2 study Single ascending dose Healthy males, 7 cohorts, i.v. infusion (n=42) Placebo (n=14) 7-week follow up Multiple ascending dose Patients*, 3 cohorts, weekly i.v. infusion for 4 weeks (n=18) Placebo (n=6) 11-week follow up *Patients with moderate-to-severe atopic dermatitis MorphoSys AG, Company Update January

14 Partnered Discovery Program: Tremfya (Guselkumab) Developed by Janssen in Inflammatory Indications The Drug First-in-class IL-23-specific HuCAL antibody Status Approved in U.S., EU, Canada for moderate-to-severe psoriasis First royalties will be reflected in FY 2017 results Differentiation Compelling clinical efficacy Convenience: 8-weekly s.c. dosing Phase 3 Trials Ongoing Head-to-head vs. Cosentyx in psoriasis: ongoing Psoriatic arthritis: 2 trials ongoing Crohn s disease: planned MorphoSys AG, Company Update January

15 Financial Guidance 2017* Updated November 30, 2017 In million Q1-Q Guidance 2017 (Issued March 9, 2017) Guidance 2017 (Updated Nov. 30, 2017) Group Revenues to to 66 Proprietary R&D Expenses (incl. Technology Development) to to 100 EBIT Cash, cash equivalents & marketable securities as well as other short-term and long-term financial assets (end of reporting period) (53.8) (75) to (85) (66) to (71) Total shares issued (as of December 31, 2017): 29,420,785 MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR *Guidance for revenues and EBIT includes royalty income on Tremfya sales in Q Royalty income based on Tremfya sales in Q will be booked in Q MorphoSys AG, Company Update January

16 Proprietary Portfolio: Expected Newsflow 2018 Compound Indication Expected Newsflow MOR208 DLBCL L-MIND: Updated development plan following BTD interactions with FDA, Q CLL COSMOS: Phase 2 data mid 2019 MOR202 (I-MAB Biopharma*) Multiple myeloma Further partnering discussions ongoing Final data phase 1/2a study late 2018 MOR106 Atopic dermatitis Start of phase 2 trial Q MOR103/ GSK ** Rheumatoid arthritis Hand osteoarthritis Data from phase 2b trial Data from phase 2a trial * For development in Greater Chinese Market (China, Hong Kong, Taiwan, Macao) **MOR103/GSK is fully outlicensed to GSK. MorphoSys AG, Company Update January 2018

17 Partnered Pipeline: Expected Primary Completion Dates Up to 19 Clinical Phase 2 and 3 Read-outs Potentially Due in 2018* Phase 2 Phase 3 BSP804 Type I, III or IV Osteogenesis Imperfecta (ASTEROID) Bimagrumab (BYM338) Muscular atrophy after hip fracture surgery BSP804 Type I, III or IV Osteogenesis Imperfecta (METEOROID) Bimagrumab (BYM338) Sarcopenia Gantenerumab Mild Alzheimer's disease (open label extension) Guselkumab Pustular or Erythrodermic psoriasis Tesidolumab (LFG316) Geographic atrophy (+ CLG561) Tesidolumab (LFG316) Paroxysmal nocturnal hemoglobinuria VAY736 Primary Sjögren's syndrome Xentuzumab (BI ) Prostate cancer (+ enzalutamide) Tesidolumab (LFG316) Panuveitis VAY736 Rheumatoid arthritis VAY736 Pemphigus vulgaris Xentuzumab (BI ) Breast cancer Guselkumab Moderate to severe plaque psoriasis Guselkumab Moderate to severe plaque psoriasis (ECLIPSE; Head-to-head with Cosentyx ) Guselkumab Moderate to severe plaque psoriasis (POLARIS; Comparison to Fumaric Acid Esters) Guselkumab Palmoplantar pustulosis Guselkumab Severe plaque psoriasis *Anticipated primary completion dates, according to clinicaltrials.gov MorphoSys AG, Company Update January

18 Our Future Lucrative milestone & royalty streams from deep partnered pipeline Commercializing own products in selected geographies Innovative science and technology driving expansion of proprietary portfolio A fully-integrated biopharmaceutical company Attractive partner for big pharma and biotech MorphoSys AG, Company Update January

19 Thank You Anke Linnartz Head of Corporate Communications & IR Phone +49 (0)89 / Fax +49 (0)89 / investors@morphosys.com MOR208, MOR202, MOR106, MOR103, anetumab ravtansine, gantenerumab and all other product candidates mentioned here are investigational drugs and have not been approved by the FDA or other ex-us regulatory agencies. HuCAL, HuCAL GOLD, HuCAL PLATINUM, CysDisplay, RapMAT, aryla, Ylanthia, 100 billion high potentials, Slonomics, Lanthio Pharma and LanthioPep are registered trademarks of the MorphoSys Group. Tremfya is a trademark of Janssen Biotech, Inc.