Genmab A/s · OMXCOP:GMAB
Genmab A/s — Bank of America Merrill Lynch Global Healthcare Conference 2014
21 slides from Genmab A/s's conference presentation, Sep 19, 2014
Slide 1: Better Antibodies By Design
Better Antibodies By Design Bank of America Merrill Lynch Global Healthcare Conference 2014 September 19, 2014
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, inclu
Slide 3: Antibody Innovation Generating World Class Products
Antibody Innovation Generating World Class Products Focus on Cancer • Differentiated human antibodies • Track record breakthrough therapeutics Robust Product Pipeline • Ofatumumab – cancer & autoimmune potential (marketed as Arzerra® in various CLL indications) • Daratumumab blockbuster potential •
Slide 4: Innovative Pipeline
Innovative Pipeline Development Phase Product Disease Indications Pre- I I/II II III clinical Ofatumumab Chronic lymphocytic leukemia (CLL) 18 studies Target: CD20 Follicular lymphoma (FL) Partner: GSK Waldenström’s macroglobulinemia (WM) Pemphigus vulgaris (PV) Relapsing remitting multiple sclerosi
Slide 5: Daratumumab (HuMax-CD38)
Daratumumab (HuMax®-CD38) First-in-Class Antibody with Broad-Spectrum Killing Activity First-in-Class Fully Human Antibody • Targets CD38 - 5 different ways of attacking cancer cells • Multiple Myeloma & other blood cancers • Blockbuster potential • Promising early clinical MM data Additional Potent
Slide 6: Expansive Daratumumab Development
Expansive Daratumumab Development 9 Ongoing or Announced Studies in Multiple Myeloma Development Phase Indication Disease Stage Therapy Pre- I I/II II III IV clinical Dara + VMP* Front line Dara + Revlimid + (transplant & non- Dex* transplant) Multi combo 1 Study Dara + Revlimid + Dex 2 Studies Mult
Slide 7: Daratumumab: Early Signs of Clinical Activity
Daratumumab: Early Signs of Clinical Activity Phase I/II Monotherapy Study • Relapsed and refractory multiple myeloma, ASCO 2014 • Safety & efficacy in 49 patients • 35% response rate at 16 mg/kg • Treatment well tolerated Data presented at ASCO 2014 7
Slide 8: Daratumumab: Early Signs of Clinical Activity
Daratumumab: Early Signs of Clinical Activity Ph I/II Revlimid Combo Study in Multiple Myeloma 12/13 pts = 92% response Including all rate pts 15/20 = 75% response rate Limited treatment Data presented ASCO 2014 Ph I/II relapsed / refractory 8
Slide 9: Arzerra (ofatumumab)
Arzerra® (ofatumumab) Our First Marketed Product • Fully human antibody targeting CD20 on cancerous B-cells Sales Growth by GSK • Differentiated vs other CD20 mAb, targets slice of > $7B market Cancer • 2013 sales GBP • Approved* 74.9M (~$124M); • US 1st Line CLL in combo w/ chlorambucil royalty DKK
Slide 10: Arzerra Label Expansion: Phase III Data
Arzerra Label Expansion: Phase III Data Ofatumumab + Chlorambucil Extends Progression Free Survival • Ofa + chlorambucil vs. chlorambucil in front line CLL • 71% improvement in PFS • No unexpected safety findings - Most common SAEs: • Neutropenia (5%), anemia (4%), pneumonia (4%) and pyrexia (2%) 10
Slide 11: Ofatumumab: Planned & Ongoing Trials
Ofatumumab: Planned & Ongoing Trials Cancer (IV) Autoimmune (SC) Pivotal Study Readouts Ongoing & Planned Relapsed CLL* 2014 RRMS O maintenance vs Ph II monotherapy Ongoing observation 2015 Relapsed CLL PV OFC vs FC Ph III efficacy & safety 2016 Refractory FL O+B vs B RRMS Planned multiple Ph III’
Slide 12: Ofatumumab: Potential to Combine with Tyrosine Kinase Inhibitors
Ofatumumab: Potential to Combine with Tyrosine Kinase Inhibitors ADCC CDC TKIs knock out Ibrutinib - Ofatumumab most immune effector cells ofatumumab active CDC killing (NK cells, combination highly compared to other macrophages) so active in CLL, ISS CD20 mAb ADCC ineffective study at ASCO 2014 Sou
Slide 13: Ofatumumab - Future in Autoimmune
Ofatumumab - Future in Autoimmune Multiple Ph III Trials to Start in Autoimmune Indications Relapsing Remitting Multiple Sclerosis (RRMS) • Phase III’s in RRMS expected to begin in 2015 • Follow encouraging Phase II data • Sustained reduction cumulative number new brain lesions over 12 week period •
Slide 14: HuMax-TF-ADC: In the Clinic
HuMax®-TF-ADC: In the Clinic Next Generation Therapeutics Fully Human Antibody-drug Conjugate • Targets Tissue Factor (TF) 8 Tumors • Strong pre-clinical data in multiple solid cancers • Ongoing Phase I study • Ovary, cervix, • Collaboration: Seattle Genetics opt-in (after Ph I/II) endometrium, blad
Slide 15: DuoBody Technology
DuoBody® Technology Efficient & Versatile Platform for Bispecific Antibodies DuoBody • Dual-targeting, potential to improve specificity & efficacy • Large scale manufacturing • Minimal protein engineering • Excellent quality BsAb at very high yields • Differentiated from competitor platforms • Prope
Slide 16: HexaBody Technology
HexaBody™ Technology Robust Effector Function Enhanced Antibodies HexaBody • Enables antibodies to more readily form clusters of 6 (hexamers) • Induces & enhances target cell killing after binding via CDC • CDC capability to essentially any antibody • Builds on natural antibody biology - minimal eng
Slide 17: Partnerships: Creating Value With Our Technologies
Creating Value With Our Technologies HuMax-TF-ADC HuMax-AXL-ADC Ofatumumab Pipeline products Daratumumab HuMax-TAC-ADC DuoBody IL-8 + X Ownership Value Janssen DuoBody inflection Greater Partnerships Novartis DuoBody value after Greater Exchange Opt-ins PoC rewards for Licensing Products / technolog
Slide 18: Well-Capitalized Biotech – 2014 Guidance
Well-Capitalized Biotech – 2014 Guidance Income Statement DKKM USDM* Revenue 800 - 875 147 - 160 2014 Expense Base Operating expenses (600) – (650) (110) – (119) DKK 625M ($115M) Operating income 175 – 250 32 - 46 DKK 39M ($7M) DKK 80M Cash Position DKKM USDM* DKK 150M ($27M) 6% ($15M) Cash position
Slide 19: 2014 Goals: Fueling Growth Through Our Platforms & Products
2014 Goals: Fueling Growth Through Our Platforms & Products Priority Targeted Milestone Maximize value of 2015 » Ph III relapsed CLL ofa + FC data ofatumumab » Ph III maintenance CLL data X » Ph III bulky refractory CLL ofa vs physician’s choice data X » Ph III relapsed DLBCL; ofa + chemo vs RTX
Slide 20: On Track to a Sustainably Profitable Future
On Track to a Sustainably Profitable Future • Robust differentiated product pipeline • Daratumumab, ofatumumab, HuMax-TF-ADC • Innovative pre-clinical pipeline • Proprietary technologies -DuoBody & HexaBody • Partnerships → Product ownership • Well capitalized • Positioned for success • For patients
Slide 21: Better Antibodies By Design
Innovating, _ antibodies improving lives Better Antibodies By Design *Genmab
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