Better Antibodies By Design. Investor Presentation November 2015

Similar documents
Better Antibodies By Design. Investor Presentation September 2015

Antibody therapeutic approaches for cancer

Genmab an antibody innovation powerhouse. Jan van de Winkel

Innovating Antibodies, Improving Lives. 37 th Annual J.P. Morgan Healthcare Conference January 9, 2019

Better Antibodies By Design. 36 th Annual J.P. Morgan Healthcare Conference January 10, 2018

Quarter End Results. Period Ended September 30, 2018

Quarter End Results. Period Ended March 31, 2018

Quarter End Results. Period Ended June 30, 2018

Genmab Announces Financial Results for the First Half of 2016 and Improves 2016 Financial Guidance

Genmab Announces Financial Results for the First Quarter of 2016

Genmab Announces Financial Results for the First Nine Months of 2016 and Improves 2016 Financial Guidance

Q&A GENMAB 4TH OF MARCH 2015 WITH JAN VAN DE WINKEL

Q&A GENMAB 11TH OF MAY 2017 WITH JAN VAN DE WINKEL

Genmab Announces U.S. FDA Approval of DARZALEX (daratumumab) for Relapsed Multiple Myeloma and Updates Financial Guidance

Q&A GENMAB 21ST OF NOVEMBER 2018 WITH JAN VAN DE WINKEL

Antibody therapeutic approaches for cancer building a career at the interface of science & business

Changing Lives. Daniel Junius, President and CEO June 3, Nasdaq: IMGN

ImmunoGen, Inc. Reports Fourth Quarter and Fiscal Year 2013 Financial Results and Provides Fiscal Year 2014 Financial Guidance and Corporate Update

Post ASH Seminar. Antibody Innovation Generating World Class Products. December 17, 2012

INVESTOR PRESENTATION FULL YEAR 2007 RESULTS. February 2008

GSK 916: anti-bcma ADC An exciting potential advance in the treatment of Multiple Myeloma

Deborah Dunsire, M.D. President and CEO. Annual Meeting of Shareholders Cambridge, MA May 4, 2006

Safety and Efficacy of Daratumumab with Lenalidomide and Dexamethasone in Relapsed, or Relapsed and Refractory Multiple Myeloma

J.P. Morgan Healthcare Conference. January 15, 2009

Trubion Investor Presentation BioCentury NewsMakers in the Biotech Industry Conference September 6, 2007

DEVELOPING FIRST-IN-CLASS TREATMENTS IN HAEMATOLOGIC CANCERS

Strategic Collaboration with Amgen to develop MP0310

Daratumumab for multiple myeloma: A journey from phase 1 towards approval for marketing

The science behind Betalutin : why is it unique? Roy H. Larsen PhD Sciencons AS, Oslo, Norway

Immune Design Reports Third Quarter 2017 Financial Results and Provides Corporate Update

SAMPLE. Millennium Pharmaceuticals, Inc. Product Pipeline Review 2013

INVESTOR PRESENTATION

Multiple Myeloma Update PMMNG 13 Feb Outline. Alfred Garfall MD Edward Stadtmauer MD

Jefferies 2017 Healthcare Conference

Daratumumab (Darzalex )

Investor Presentation: Phase II Data for LCP Tacro. March 3, 2008

Karyopharm Reports Second Quarter 2016 Financial Results and Highlights Recent Progress

Developing First-in-Class Treatments in Haematologic Cancers DNB Healthcare Conference, Thursday December 15 th, 2016

Jefferies Healthcare Conference. June 2016

Management of Multiple Myeloma: The Changing Paradigm

Corporate Presentation. April 2016

Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot program

Patient Case and Question

Abridged version of ASCO presentation June 4, 2012, for Genmab.com/investors

CORPORATE OVERVIEW: REINVENTING THERAPEUTIC ANTIBODIES FOR THE TREATMENT OF CANCER

Corporate Overview. June 2017

Agios Pharmaceuticals, Inc.

Good morning and thank you for joining us for our quarterly update.

Investor Update. Roche to present new data from its industry-leading haematology portfolio at the American Society of Hematology 2018 Annual Meeting

Affimed Presents Data from Phase 1b Combination Study of AFM13 with Pembrolizumab at ASH

DEVELOPING FIRST-IN-CLASS TREATMENTS IN HAEMATOLOGIC CANCERS

Treatment strategies for relapsing and refractory myeloma

Media Release. Roche to present new data across a range of blood diseases at the American Society of Hematology (ASH) 2017 Annual Meeting

Advancing the Frontiers of mab mixtures

IMMUNOTERAPIA NEL MIELOMA MULTIPLO E NEL LINFOMA DI HODGKIN: Ruolo nel paziente con MM ricaduto

Introducing a First-in-Class treatment for Non-Hodgkin Lymphoma Carnegie Healthcare Conference, March 17, 2016 Marco Renoldi, Chief Business Officer

Q Results Conference Call

Nasdaq: MBRX. Moleculin Biotech, Inc. Reports Financial Results for the Third Quarter Ended September 30, 2017

Multiple Myeloma Highlights From the 2015 ASCO Annual Meeting and the 20 th Congress of EHA

Cortendo and Antisense Therapeutics Announce Licensing Agreement for ATL1103 for Acromegaly

Immuno-Oncology Opportunities and Challenges In Moving Toward a Cure for Multiple Myeloma

Jefferies 2018 Healthcare Conference June 7, 2018

Eli Lilly and Company

ABOUT GLYCOSTEM. Company Overview

Introducing a First-in-Class treatment for Non-Hodgkin Lymphoma BioEquity Europe 2016, Copenhagen May 11, 2016 Luigi Costa, Chief Executive Officer

Focused on the Cure. Corporate Presentation June 2017

Focused on the Cure. Corporate Presentation June 2017

More Effective Treatments for Multiple Myeloma Convention Connection: American Society of Hematology Meeting December 2010 Dan Vogl, M.D.

DARATUMUMAB, A CD38 MONOCLONAL ANTIBODY IN PATIENTS WITH MULTIPLE MYELOMA Data from the dose-escalation part of the FIH study Abstract #8512

Clinical-Stage Pipeline Today

DEVELOPING PRECISION THERAPIES IN HAEMATOLOGIC CANCERS

35 th Annual J.P. Morgan Healthcare Conference. Gwan Sun Lee. President & CEO

Marina Biotech Monetizes UNA Intellectual Property Estate through Agreement with Arcturus Therapeutics

This talk will cover. Treatment for relapsed and/or refractory myeloma. What is relapsed myeloma and refractory myeloma. Treatment options for relapse

FORWARD-LOOKING STATEMENTS

AVEO Oncology Reports Third Quarter 2016 Financial Results and Provides Business Update

Treatment strategies for relapsing and refractory myeloma

Myeloma treatment algorithm 1999

Multiple Myeloma Research Consortium Clinical Trial Pipeline

Spectrum Pharmaceuticals Jefferies 2015 Global Healthcare Conference

Second Quarter 2016 Financial Results. August 4, 2016

Engineering the Medicines of Tomorrow

JP Morgan Healthcare Conference January 9, 2012

Deutsche Bank 40th Annual Health Care Conference

MorphoSys. Company Update. Jefferies 2016 Healthcare Conference June 7 10, 2016

Results FY2017 & Outlook 2018

The Spanish biotech sector Case: ADVANCELL

PARADIGME UPDATE APRIL Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway IR contact:

Ygalo - Targeted Alkylator for the Treatment of Myeloma. Pareto Healthcare Conference: September 7 th, 2017

The Early Chimeric Antigen Receptor (CAR) T-cell Experience From An Academic Perspective. CARs: LEARNING TO DRIVE

Clinical Policy: Lenalidomide (Revlimid) Reference Number: CP.CPA.275 Effective Date: Last Review Date: Line of Business: Commercial

Precigen Company Update

MMRF and MMRC. Collaborative Research Model for a Rare Disease. Susan L. Kelley, M.D. MMRF and MMRC 11/23/2009. Collaborative Model

CD19 ADCs Effectively Targeting B Cell Malignancies a clinical perspective.

Dr Guy Pratt Consultant Haematologist, Heart of England NHS Foundation Trust. Natural course of myeloma. Some definitions. First relapse.

ENGINEERED CAR-T THERAPIES

First Quarter 2018 Financial Results. May 8, 2018

September 2017 CORPORATE OVERVIEW NASDAQ: GLYC. Innovation Today, Healing Tomorrow.

JP Morgan Healthcare Conference January 2019

Vertex and Moderna Establish Exclusive Collaboration to Discover and Develop mrna Therapeutics for Cystic Fibrosis

Transcription:

Better Antibodies By Design Investor Presentation November 2015

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, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding our present and future business strategies and the environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Further, certain forward looking statements are based upon assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak only as at the date of this presentation. 2

Antibody Innovation Generating World Class Products Focus on Cancer Differentiated human antibodies Track record breakthrough therapeutics Robust Product Pipeline Daratumumab blockbuster potential (marketed as Darzalex in MM) Ofatumumab cancer & autoimmune potential (marketed as Arzerra in various CLL indications) HuMax -TF-ADC in Phase I solid cancers Passion for Innovation World class antibody know-how Proprietary technologies DuoBody & HexaBody Innovative pre-clinical pipeline Partnerships Product Ownership Key collaborations drive current pipeline Product opt-ins + retain products for future value Well capitalized 3

Innovative Pipeline Product Ofatumumab Target: CD20 Indication: Cancer Partner: Novartis Ofatumumab Target: CD20 Indication: AI Partner: GSK (transfer to Novartis) Daratumumab Target: CD38 Partner: Janssen HuMax-TF-ADC Target: TF Partner: Seattle Genetics Teprotumumab Target: IGF-1R Partner: River Vision HuMax-TAC-ADC Target: CD25 Partner: ADCT HuMax-IL8 Target: IL-8 Partner: Cormorant 30 Active Pre-clinical programs incl. HuMax-AXL-ADC Disease Indications Chronic lymphocytic leukemia (CLL) Follicular lymphoma (FL) Pemphigus vulgaris (PV) (SubQ) Relapsing remitting multiple sclerosis (RRMS) (SubQ) Neuromyelitis optica (NMO) (SubQ) Multiple myeloma (MM) Non-Hodgkin s Lymphoma (NHL) Solid Cancers Graves Orbitopathy Diabetic macular edema Lymphoma Acute myeloid leukemia (AML) Metastatic solid tumors Partnered programs: HuMab, DuoBody & HexaBody Proprietary programs: HuMab, HuMab-ADC, DuoBody, DuoBody-ADC & HexaBody Preclinical Announced Development Phase I II III Announced Announced 4

Darzalex (daratumumab) First-in-Class Antibody with Broad-Spectrum Killing Activity First-in-Class Fully Human Antibody Additional Potential Blood Cancer Indications DLBCL, FL, Plasma Cell Leukemia, Mantle Cell Lymphoma, CLL, ALL, AML Targets CD38 - five ways of attacking cancer cells Multiple Myeloma & other blood cancers Blockbuster potential Promising MM clinical data Broad & expansive development in MM Breakthrough Therapy Designation Partner: Janssen Biotech Janssen funds development & commercialization > $1.1B potential deal value, + double-digit royalties Zero cost / limited financial risk for Genmab Approved by the FDA, November 2015 MAA filed with EMA, September 2015, accelerated assessment granted 5

Multiple Myeloma** Expansive Daratumumab Clinical Development Indication Disease Stage Therapy No. Pts* Development Phase I I/II II III Front line (transplant & non-transplant) Dara + VMP 700 Dara + Revlimid + Dex 730 Dara + VTD 1,080 MMY3007 (Alcyone) MMY3008 (Maia) MMY3006 (Cassiopeia) Multi combo: 1 Study 190 MMY1001 (Equuleus) Dara + Revlimid + Dex 45 GEN503 Dara + Revlimid + Dex 570 MMY3003 (Pollux) Relapsed or Refractory Dara + Velcade + Dex Dara +Vel+Dex, Japan 480 6 MMY3004 (Castor) MMY1005 Mono, Japan 9 Mono, safety 104 Subcutaneous 128 MMY1002 GEN501 MMY1004 *Approx. no. based on clinicaltrials.gov **Maintenance integrated into some study protocols VMP = bortezomib & melphalan-prednisone VTD = bortezomib, thalidomide & dexamethasone BTD = Breakthrough Therapy Designation 6

NHL (DLBCL / MCL / FL) Multiple Myeloma** Expansive Daratumumab Clinical Development Additional Indications Indication Disease Stage Therapy No. Pts* Development Phase I I/II II III High Risk Smoldering Mono 120 SMM2001 (Centaurus) Double Refractory Mono, BTD population (BLA PDUFA March 9, 2016) 124 MMY2002 (Sirius) Relapsed or Refractory Mono 210 LYM2001 (Carina) *Approx. no. based on clinicaltrials.gov. **Maintenance integrated into some study protocols BTD = Breakthrough Therapy Designation 7

Positive Results: Daratumumab Ph II Study Double Refractory MM (filed FDA) Study Design 2 part study, enrolled 124 pts Part 1: defined optimal daratumumab regimen Part 2: expansion based on Part 1 Pts received at least 3 prior lines of therapy incl. a PI & an IMiD, or double refractory to PI & IMiD Primary Objective: define optimal dose, determine efficacy of 2 daratumumab treatment regimens as measured by ORR Results Median prior lines of therapy: 5 29.2% ORR (31/106) in 16 mg/kg dose group. 13 pts VGPR or better Robust, durable single agent activity 7.4 month median duration of response 95% refractory to last PI & IMiD 63% refractory to pomalidomide Manageable safety profile 48% refractory to carfilzomib 8

Daratumumab: Early Signs of Clinical Activity Ph I/II Revlimid Combo Study in Multiple Myeloma CR 31% CR 6.7% CR 6.7% CR 8.0% CR 11.8% VGPR 46% PR 23% VGPR 43% PR 37% VGPR 43.3% VGPR 52% VGPR 52.9% Part 1; ORR 100% (31% CR, 46% VGPR) Part 2; ORR 87% (7% CR, 43% VGPR) 75% VGPR or better in patients treated for at least 6 months Data presented at ASH 2014 9

Number of patients Daratumumab: Early Signs of Clinical Activity Ph Ib MM Combo Study with Velcade / Pomalidomide Regimens 12 ORR 100% ORR 54.5% 10 8 6 4 PR PR PR PR PD SD MR PR PD SD MR PR VGPR 2 0 VGPR VD + DARA (n=6) VGPR VMP + DARA (n=8) VGPR CR VTD + DARA (n=10) VGPR scr POM-D + DARA (n=11) CR scr ORR: 100% in newly diagnosed group (Velcade combinations) 54.5% in relapsed group 2 scr (POM-D combination) V, bortezomib; D, dexamethasone; DARA, daratumumab; M, melphalan; P, prednisone; T, thalidomide; POM, pomalidomide. scr, stringent complete response; VGPR, very good partial response; PR, partial response; MR, minimal response; PD, progressive disease. Data presented at EHA 2015 10

Arzerra (ofatumumab) Our First Marketed Product Sales by GSK 2014 sales GBP 54.5M (~$82.2M); royalty DKK 101M Genmab Cancer Royalty = 20% Human antibody targeting CD20 on cancerous B-cells Differentiated vs other CD20 mab, targets slice of > $8B market Cancer Approved* US 1 st Line CLL in combo w/ chlorambucil EU 1 st Line CLL in combo w/ chlorambucil or bendamustine Fludarabine and alemtuzumab refractory CLL Phase III trials in CLL & FL Partnered with Novartis US & EU reg. subm. for maintenance therapy relapsed CLL PDUFA date: Jan. 21, 2016 Autoimmune diseases (unapproved) Phase III trial ongoing in PV Relapsing remitting MS Ph III s & pivotal NMO trials announced Current partner GSK; Aug. 2015 Novartis announced acquisition of AI rights from GSK *In US approved in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate as well as for the treatment of patients with CLL refractory to fludarabine and alemtuzumab. In EU approved in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabinebased therapy, as well as for the treatment of patients with CLL refractory to fludarabine and alemtuzumab. 11

2017 2016 2015 Planned Ongoing Ofatumumab: Planned & Ongoing Trials Cancer (IV) Pivotal Study Readouts (Novartis) Autoimmune (SC) Ongoing & Planned (GSK*) Relapsed CLL OFC vs FC d PV Ph III efficacy & safety Refractory FL O+B vs B RRMS multiple Ph III s Relapsed FL O mono vs R mono NMO pivotal study Note: The indications above are unapproved *AI rights to be acquired by Novartis 12

HuMax -TF-ADC: In the Clinic Next Generation Therapeutics Fully Human Antibody-drug Conjugate 8 Tumors Ovary, cervix, endometrium, bladder, prostate, head & neck, esophagus, lung Potential in pancreatic cancer Targets Tissue Factor (TF) Strong pre-clinical data in multiple solid cancers Ongoing Phase I study Data presented at ASCO 2015 Safely dosed up to 1.8mg/kg Preliminary evidence of efficacy encouraging Collaboration: Seattle Genetics opt-in (after Ph I/II) Pre-clinical Cervical Cancer Model 13

HuMax-TF-ADC in Patients with Solid Tumors Best Response and Duration of Follow-up Footnote: X denotes time of disease progression. Patients still in the trial have an O following the end of their bar. Dashed vertical line at 6 weeks denotes the SD-threshold, Not evaluable (because of insufficient follow-up) patients are denoted with an NE. SD: stable disease, PR: partial response. 14

HuMax-AXL-ADC Efficacy in in vivo Tumor Model Fully Human Antibody-Drug Conjugate Targets AXL signaling molecule expressed on many solid cancers HuMax-AXL-ADC shows anti-tumor activity in patient-derived xenograft model with heterogeneous target expression Collaboration: Seattle Genetics AXL expression in xenograft model AXL antibody 15

DuoBody Technology Efficient & Versatile Platform for Bispecific Antibodies DuoBody Ongoing Collaborations Dual-targeting, potential to improve specificity & efficacy Large scale manufacturing Minimal protein engineering Excellent quality BsAb at very high yields Differentiated from competitor platforms Proper in vivo half-life Fc-effector functions Good manufacturability 5 Commercial deals Novartis (2 progr., $175M potential deal value + royalties) Janssen Biotech (20 progr., $3.6B potential deal value + royalties) Novo Nordisk (2 progr. $250M each exclusive license / $200M each non-exclusive license + royalties) BioNovion* (expansion research deal, joint development / ownership) BioNTech (joint development / ownership) 4 Research deals Undisclosed major Biotech, Agenus, Humabs BioMed, Pierre Fabre *Sept 2015 Aduro BioTech, Inc. announced definitive agreement to acquire BioNovion 16

HexaBody Technology Robust Effector Function Enhanced Antibodies HexaBody Enables antibodies to 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 engineering Create novel, differentiated products in cancer & infect. dis. Repurpose / rescue drug candidates that failed in Phase II/III Life cycle management Collab. w. undiscl. major Biotech, Humabs BioMed & Agenus 17

% ly s is % v ia b le c e lls % ly s is Genmab s Robust Innovative Pre-Clinical Pipeline formats format 8 0 8 0 1 0 0 6 0 6 0 8 0 6 0 4 0 4 0 4 0 2 0 2 0 2 0 0 0.0 0 0 1 0.0 1 1 1 0 0 1 0 0 0 0 C o n c e n tra tio n A b (n g /m L ) D u o B o d y -C D 3 x A 0 0.0 0 1 0.0 1 0.1 1 1 0 C o n c e n tr a tio n A b ( g /m L ) D u o B o d y -A x B -A D C m o n o v a le n t-a -A D C + B -A D C 0 0.0 0 1 0.0 1 0.1 1 1 0 C o n c e n tr a tio n A b ( g /m L ) H e x a B o d y -X r e fe r e n c e a n tib o d y (Ig G 1 ) 18

Licensing Opt-ins Partnerships Ownership Creating Value With Our Technologies HuMax-TF-ADC HuMax-AXL-ADC Pipeline products Ofatumumab Daratumumab Joint Dev /Ownership (BioNovion* / BioNTech) Janssen DuoBody Novartis DuoBody Products / Technology Validation HuMax-TAC-ADC Exchange for technology Many shots on goal Greater value after PoC Creates sustainable company Value inflection Greater rewards *Sept 2015 Aduro BioTech, Inc. announced definitive agreement to acquire BioNovion 19

Well-Capitalized Biotech 2015 Guidance Income Statement DKKM USDM* 2015 Expense Base DKK 575M ($86M) Revenue 1,025 1,100 154-165 Operating expenses (550) (600) (83) (90) Reversal of GSK Liability 175 26 Operating income 625-700 94-105 DKK 160M ($24M) 28% DKK 47M ($7M) 8% 14% DKK 97M ($14M) Cash position at end of year** 3,000 3,100 451-466 34% *USD 1.00 = DKK 6.6588 (September 30, 2015) **Cash, cash equivalents and marketable securities 2015 Guidance November 3, 2015. Revised on November 16, 2015 following the approval of Darzalex Development Research Salary Depreciation & Warrants Other 18% DKK 112M ($17M) DKK 159M ($24M) 20

2015 Goals: Maximizing Pipeline Value Priority Maximize daratumumab clinical progress Optimize ofatumumab value Strengthen differentiated product pipeline Broaden partnership portfolio with next generation technologies Disciplined financial management Targeted Milestone X» Phase II MM monotherapy data and if favorable, discuss regulatory next steps with health authorities» Start multiple new MM trials» Start non-mm clinical trial» File for an additional indication» Phase III relapsed CLL data» Start Phase III sc autoimmune trials*» Phase I HuMax-TF-ADC data» Progress HuMax-AXL-ADC» Progress pre-clinical DuoBody & HexaBody projects» Expand DuoBody & HexaBody collaborations» Progress partnered programs» New IND filings» Maintain cost base while selectively investing to advance pipeline *This milestone is not expected to be completed in 2015 due to the expected transfer of the rights for ofatumumab in autoimmune indications from GSK to Novartis. 21

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 & shareholders 22

Better Antibodies By Design