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MarketScreener Homepage  >  Equities  >  NASDAQ OMX COPENHAGEN  >  Genmab A/S    GMAB   DK0010272202

GENMAB A/S

(GMAB)
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Genmab A/S : 2020 Virtual Capital Markets Day – November 13, 2020

11/13/2020 | 08:41am EST

WELCOME

Genmab's

2020 Capital

Markets Day

November 13, 2020

Webcast Live from Utrecht and Princeton

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. Genmab does not undertake any obligation to update or revise forward looking statements in this presentation nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Confidential. © Genmab 2020

Today's Speakers

Jan van de Winkel

Judith Klimovsky

Anthony Pagano

Anthony Mancini

President & CEO

EVP & CDO

EVP & CFO

EVP & COO

Tahi Ahmadi

Kate Sasser

David Satijn

Rob de Jong

SVP, Head of Oncology

CVP, Translational Research

VP, New Antibody Products

Dir. Antibody Research & Tech.

Confidential. © Genmab 2020

Delivering on Our Promise: Today's Agenda

On the Road to 2025: Evolving into a Fully Integrated Biotech

Jan van de Winkel

Our Strong Financial Foundation

Anthony Pagano

Innovation Powerhouse: Building on Our World-Class R&D Capabilities

Judith Klimovsky

Innovation in Action: Next-Generation Proprietary Technologies

Rob de Jong, David Satijn

Delivering on our Promise - Potential First-in-ClassDuoBody-PD-L1x4-1BB (GEN1046)

Tahi Ahmadi, Kate Sasser

Evolving into a Fully Integrated Biotech

Anthony Mancini, Tahi Ahmadi, Judith Klimovsky

Beyond 2020: Genmab's Journey is Just Beginning

Jan van de Winkel

LIVE Q&A

Confidential. © Genmab 2020

On the Road to 2025: Evolving Into a Fully Integrated Biotech

Our Core Purpose, Strategy & Vision Guide Our Work

Core Purpose

Our Strategy

Vision

To improve the lives of patients

Focus on Core Competence

By 2025, our own product has

by creating & developing innovative

transformed cancer treatment and

antibody products

Turn science into medicine

we have a pipeline of knock-your-

Build a profitable & successful biotech

socks off antibodies

Confidential. © Genmab 2020

The Genmab Difference

Integrated Innovation Powerhouse Transforming Cancer Treatment

Strong pipeline of 1st-in-class /best-in-class potential therapies

Match in-house expertise with strategic partnerships

Proprietary technologies allow us to build a world-class pipeline

Deep insight into antibody biology & disease targets

Growing capabilities in four international locations

Confidential. © Genmab 2020

Innovation Powerhouse: Pipeline

Four Transformative Waves have Shaped Development of Biopharmaceutical industry

R.J. Deshales, Nature 2020; 580: 329-338

Confidential. © Genmab 2020

Innovation Powerhouse: Successful Network of Collaborations

Supporting Our Vision & Broadening Differentiated Antibody Pipeline

Partner of

Approved

Medicines

Choice

Created by

Genmab

1

2

1

3

H. Lundbeck A/S

1

2

1Janssen Biotech, Inc.; 2Novartis; 3Horizon Therapeutics

Confidential. © Genmab 2020

Our Strong

Financial

Foundation

Anthony Pagano, Executive Vice President & Chief Financial Officer

Strong Foundation

Robust pipeline built on Genmab tech

Partnerships with innovators and industry leaders across the value chain

Focused and disciplined approach to capital allocation

Strong financials to invest in growth opportunities

Confidential. © Genmab 2020

Growing Recurring Revenues

$1.5B

$0.8B

$0.5B

$0.3B

$0.2B

$0.7B

$220M

$0.3B

$80M

2016

2018

2020e

Recurring

Non-Recurring

Recurring revenues up ~9x over last five years

3 Products driving near term Revenue Growth

  • DARZALEX® is transforming MM Treatment
  • 2 Potential Blockbuster Products Launched in 2020 - Kesimpta® and TEPEZZA®

Significant cash flows to invest in building our business

*2020e based on Genmab collected consensus, ** Recurring revenue defined as royalties and sales of own products, USD 1 = DKK 6.5

Confidential. © Genmab 2020

On the Path to Reaching Our 2025 Vision

Successful track record

Genmab profile today

Strategy

2025 Vision

Focus Areas

Progress

  • Focus on core competence
  • Turn science into medicine
  • Build a profitable and successful biotech

SUSTAINED

EXECUTION

By 2025, our own product has transformed cancer treatment and we have a pipeline of knock-your-socks-off antibodies

BUILDING FULLY

INTERGRATED BIOTECH

INNOVATION

POWERHOUSE

Confidential. © Genmab 2020

2 potential near-term Genmab owned product launches

Imperative to invest

Remain focused and disciplined

Strong Rationale to Invest

Retain 50%+ ownership of products

Own Development and

Commercialization

Driving

Build Team and

better

Capabilities to

outcomes

Succeed

for

Patients

Capture Greater

Value

Confidential. © Genmab 2020

Focused on Execution

Investing for today and tomorrow

Building Our Capabilities

Research

Development

Commercialization

Track record of success and

Scaling up to expand from

Step change in our business

investing for tomorrow

early

to late stage

State of the art facilities

Clinical development & operations

Leadership team in place

Novel technologies and formats

Disease area expertise

Focused on U.S. and Japan

External innovation

Medical affairs and Regulatory

Building expanded team

Enabling functions to support growth

Data Sciences to drive insights across

& manage risk

the value chain

Confidential. © Genmab 2020

Investing for Today and Tomorrow

Top Priorities for Today

  • Filing and launch of tisotumab vedotin
  • Rapid acceleration and maximization of epcoritamab
  • Expansion of DuoBody-PD-L1x4-1BB
  • Standing up U.S. and Japan commercialization organizations

Investing for Tomorrow

  • Progress earlier stage pipeline
  • Generate next wave of innovative IND candidates
  • Maximize current technologies & stay at cutting edge of antibody science
  • Focused investment in adjacent technologies & external innovation

Confidential. © Genmab 2020

Partnerships with Industry Leaders and Innovators

Strong Foundation

Generating significant cash flows today and more shots on goal moving forward.

Near-term pipeline

Maximizing our ability to get our pipeline products to more patients and faster.

Future Growth

Being a networked company is part of our DNA. Will continue to seek partnerships that bolster our internal strengths.

Confidential. © Genmab 2020

Strong Revenue Growth Anticipated the Next 5 Years

Recurring Revenue spilt and growth*

***

$1.9B

$0.7B

2020e

2025e

2025e

DARZALEX®

Kesimpta®

TEPEZZA®

Amivantamab Genmab Near-term Launches

Recurring revenues from existing products anticipated to grow ~2.5x

Amivantamab filing expected in Q4

Potential for 2 near-term launches from our pipeline

  • Tisotumab vedotin in cervical cancer
  • Epcoritamab in B-cell malignancies

*2020e -2025e based on Genmab collected consensus, ** Recurring revenue defined as

***Potential additions to Recurring Revenues

royalties and sales of own products, USD 1 = DKK 6.5

Confidential. © Genmab 2020

Summary

  • Strong foundation with significant growth opportunities
  • Clear path to reach our 2025 Vision
  • Two potential near-term product launches
  • Focused and disciplined investment approach

Confidential. © Genmab 2020

Innovation Powerhouse:

Building on Our World-Class R&D Capabilities

Judith Klimovsky, Executive Vice President & Chief Development Officer

Delivering On Our Promise Throughout Our Journey 2025 Vision

Products on the market

Strategic

Partnerships

Develop proprietary tech

First programs in the clinic

Confidential. © Genmab 2020

Delivering On Our Promise

Investing in the Breadth & Depth of our Pipeline

25

20

15

10

5

0

Total Products in Clinical Development: 23

Proprietary* Products - Latest Dev. Stage: 8

9

8

7

6

5

4

3

2

1

0

Total Indiv. Prod.

2016

2017

2018

2019

2020

2016

2017

2018

2019

2020

Phase 1

Phase 1/2

Phase 2

*Genmab owned ≥50%

Confidential. © Genmab 2020

Innovative Clinical Pipeline

Genmab Proprietary* and Partnered Products: Most Advanced Development Phase

Phase 1

Phase 1/2

Phase 2

Phase 3

Approved

DuoBody-CD40x4-1BB1

Epcoritamab2

Tisotumab vedotin7

DuoHexaBody-CD372

DuoBody-PD-L1x4-1BB1

DuoBody-CD3x5T42

Enapotamab vedotin

HexaBody-DR5/DR5

Talquetamab3

Mim86

Teclistamab3

Amivantamab3

Daratumumab3

JNJ-637091783

Camidanlumab tesirine8

Ofatumumab10

JNJ-638980813

PRV-0159

Teprotumumab11

JNJ-675712443

JNJ-702189023

HuMax-IL84

Lu AF824225

*Products where Genmab has ownership of at least 50%

1 50/50 co-development with BioNTech; 2 50/50 co-development with AbbVie; 3 Development by Janssen; 4 Development by BMS; 5 Development by Lundbeck; 6 Development by Novo Nordisk; 7 50/50 co-development with

Seagen; 8Development by ADC Therapeutics; 9 Development by Provention Bio; 10 Development by Novartis; 11

Development by Horizon Therapeutics

Confidential. © Genmab 2020

Delivering On Our Promise

Solid Science - Data Driven & Integrated

Confidential. © Genmab 2020

Growing in an Integrated Fashion

Partnerships & Collaborations

Discovery /

Technology

Product

Partnerships &

Academic

Collaborations

Collaborations

Collaborations

H. Lundbeck A/S

H. Lundbeck A/S

Confidential. © Genmab 2020

Continue to Build in an Integrated Fashion

Clinical

Pharmacology

Operations

Medical

Affairs

Confidential. © Genmab 2020

Innovation

in Action:

Next Generation Proprietary Technologies

Rob de Jong, Director Antibody Research & Technology

Natural Immunity Inspires Innovative Technologies and Products

The power of our immune system inspires us

We are curious to understand basic immunological principles

We translate this to innovative technologies

We create differentiated antibody products

Confidential. © Genmab 2020

DuoBody® Technology: Bispecific Antibodies

Inspired by Nature - Designed for Success

DuoBody® Discovery

  • Bispecific IgG antibodies compatible with any IgG antibody sequence and subclass
  • DuoBody® molecules retain prized IgG1-like stability
  • CD3 arm and inert backbone available
  • Enables creation of huge combinatorial DuoBody® lead panels in the therapeutically applied format

DuoBody® Development

  • >10 clinical programs active
  • Ample large scale manufacturing experience
  • Technology transferred to multiple CMO's
  • Adopted by multiple collaboration partners

Confidential. © Genmab 2020

HexaBody® Technology: Potentiated Antibodies

Antibodies designed to work as a team

HexaBody® Product Design

  • IgG1 antibodies that self-organize at the cell surface only after target binding
  • IgG hexamerization can elicit agonistic target signaling or potentiate immune effector functions
  • Target signaling does not depend on crosslinking by the recruitment of immune cells

HexaBody® Development

  • Clinical experience available
  • Large scale manufacturing experience was gathered at multiple CMO's
  • Compatible with standard IgG manufacturing processes

Confidential. © Genmab 2020

DuoHexaBody® Technology: Potentiated Bispecific Antibodies

Bispecific antibodies designed to work as a team

DuoHexaBody® Product Design

  • DuoHexaBody® technology combines the dual targeting of bispecific antibodies with the potentiation of IgG hexamerization
  • DuoHexaBody® enables multiple mechanisms of action to contribute to maximize the potency of therapeutic compounds
  • Clinical and manufacturing experience is gathered within the DuoHexaBody-CD37 development program

Confidential. © Genmab 2020

Antibody Platforms Provide a Portal to Target Space

Different target combinations impose specific molecular requirements

Individual Targets

Target Combinations

DuoBody®

DuoHexaBody®

ClassicalHexaBody®

Antibodies

AntibodyHexElect®

Combinations

Confidential. © Genmab 2020

Innovation in Action:

Next Generation Product Candidates

David Satijn, Vice President, New Antibody Products

Cell-Cell Trans Communication Can Be Mimicked By Bispecific Antibodies

Protein-protein interactions on the surface of different cells can induce and transmit a communication signal

Confidential. © Genmab 2020

Cell-Cell Trans Communication Can Be Mimicked By Bispecific Antibodies

  • Cell-celltrans communication can be mimicked by bispecific antibodies
  • Applied for different product applications

Confidential. © Genmab 2020

The DuoBody® Technology is a Proven Platform for High- Throughput Bispecific Antibody Library Generation and Screening

Standard BsAb discovery process

DuoBody® discovery process

  • Hundreds, thousands of DuoBody® variants can be screened and tested
  • Enables the generation of large libraries and the selection of the best candidate

Confidential. © Genmab 2020

Agonistic Activation of T-Cells by HT Functional and Unbiased DuoBody® Library Screening of Multiple IO Targets

  • Multiple different IO targets and antibody panels belonging to the B7/CD28 and TNF/TNFR families have been tested functionally and unbiased in DuoBody® transactivation screen
  • DuoBody-CD40x4-1BBwas one of the hits identified from thousands of DuoBody® variants

Confidential. © Genmab 2020

Functional Screening of Different CD3 DuoBody® Affinity Variants for T-Cell Mediated Kill of Malignant B-Cells

CD19

CD20

CD22

CD25

CD37

CD40

CD74

CD72

CD79b

CD122

CD138

  • B-celltargets and high and low affinity CD3 antibodies generated a library of several hundred of DuoBody® molecules
  • Epcoritamab, containing high affinity CD3 and CD20 arms, was selected from functional screening

Confidential. © Genmab 2020

Identification of Novel Products for the Tumor Specific Activation of Innate Immune Cells Benefit From DuoBody® Library Screening

Cells of the innate immune system such as macrophages and natural killer cells can also be targeted in a tumor specific way using the DuoBody®.

Confidential. © Genmab 2020

Delivering on

Our Promise:

Potential First-in-ClassDuoBody-PD-L1x4-1BB (GEN1046)*

Tahi Ahmadi, Senior Vice President, Head of Oncology

Kate Sasser, Corporate Vice President, Translational Research

*50/50 Development with BioNTech

Mechanism of Action of GEN1046

GEN1046 is a first-in-class, next generation, checkpoint immunotherapy designed to enhance T-cell and NK cell function through conditional 4-1BBco-stimulation, while simultaneously blocking the PD-L1 axis.

GEN1046 enhances proliferation and cytokine production of activated T-cells, activates immune cells in the tumor-draining lymph nodes, and induces tumor regression in vivo.

Confidential. © Genmab 2020

GEN1046 Safety Trial in Patients with Malignant Solid Tumors (NCT03917381)

Phase 1

Dose Escalation

N = 61

All STs

Cycle

Q3W

1200 mg

800 mg

400 mg

200 mg

140 mg

RP2D

100 mg

Phase 2a

Dose Expansion

N = Up to 40 per cohort

EC1: NSCLC <2-4L p. ICI

EC2: NSCLC <2-4L ICI n.

EC3: Urothelial Ca <2-4L p. ICI

EC4: Endometrial Ca <2-4L ICI n.

EC5: TNBC <2-4L CPI n./p. ICI

EC6: SCCHN <CPI n./p. ICI

EC7: Cervical Ca <2-4L ICI n.

80 mg

Study Endpoints

Safety and Tolerability

50 mg

PK/PD

25 mg

Anti-Tumor Activity

Biomarkers

https://clinicaltrials.gov/ct2/show/NCT03917381

Confidential. © Genmab 2020

Dose Escalation Patient Demographics

Dose Escalation Cohort

All patients

N=61

Median age, years (range)

59 (23, 79)

Age group, n (%)

<65 years

44

(72.1)

≥65 years

17

(27.9)

Female, n (%)

28

(45.9)

Cancer type, a n (%)

Colorectal cancer

12

(19.7)

Ovarian cancer

9 (14.8)

Pancreatic cancer

6

(9.8)

NSCLC

6

(9.8)

Other

28

(45.9)

Median number of prior regimens, (range)

3 (1-11)

Prior treatment with PD-(L)1 inhibitor, n (%)

23

(37.7)

  • A total of 61 patients were enrolled in the dose escalation part of the trial
  • Patients were heavily pretreated, receiving a median (range) of 3 (1-11) treatments; nearly 40% had received prior
    PD-(L)1 treatment

Confidential. © Genmab 2020

Safety Profile

TEAEs occurring in ≥10% of patients

TRAEs occurring in ≥10% of patients

All patients

Dose Escalation Cohort

N=61

All grades, n (%)

Grade 3, n (%)

Grade 4, n (%)

Any TRAE

43 (70.5)

15

(24.6)

3 (4.9)

TRAEs in > 10% of patients, by preferred term

16 (26. 2)

6

(9.8)

0

Transaminase elevation

Hypothyroidism

11 (18.0)

0

1 (1.6)

Fatigue

8 (13.1)

1

(1.6)

0

  • The most common treatment- related adverse events were transaminase elevations, hypothyroidism and fatigue.
  • Treatment-relatedtransaminase elevations occurred in 26.2% of patients. 9.8% of patients had grade 3 transaminase elevations
  • There were no patients with Grade 4 transaminase, or treatment-related bilirubin increases
  • MTD has not been reached

Confidential. © Genmab 2020

Anti-Tumor Activity - Dose Escalation

Data cut-off: September 29, 2020. Post-baseline scans were not conducted for five patients. aMinimum duration of response (5 weeks) per RECIST v1.1 not reached.

bPR was not confirmed on a subsequent scan.

NE, non-evaluable; NSCLC, non-small cell lung cancer; PD, progressive disease; PD-(L)1, programmed death (ligand) 1; PR, partial response; SD, stable disease; SoD, sum of diameters; uPR, unconfirmed partial response.

Disease control was achieved in 65.6% patients, including 4 partial responses in TNBC (1), ovarian cancer (1), and ICI-pretreated NSCLC (2) patients

Click toadd text

Dose levellevels

Dose level

Confidential. © Genmab 2020

Anti-Tumor Activity - ICI-R/R NSCLC Expansion

As of October 12, 2020, 24 patients were enrolled in expansion cohort 1, which includes patients with NSCLC with progression on or after ICI therapy

  • 12 patients had post-baseline scans; six patients were still on treatment with GEN1046, six patients discontinued
  • Preliminary efficacy in 12 patients who could be objectively assessed showed two patients who achieved confirmed PR, one with unconfirmed PR, and four patients with SD.

Data cut-off: October 12, 2020.

*Denotes patients with ongoing treatment. aPR was not confirmed by a subsequent scan.

Includes all patients who had at least one post-baseline tumor assessment (schedule is every 6 weeks), and thus could be assessed for clinical benefit; 6 of 12 patients are still on treatment.

BOR, best overall response; ICI, immune checkpoint inhibitor; NA, not available, NE, non-evaluable; NSCLC, non- small cell lung cancer; PD, progressive disease; PD-(L)1, programmed death (ligand) 1; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; SoD, sum of diameters; TPS, tumor proportion score; uPR, unconfirmed partial response.

Confidential. © Genmab 2020

PK/PD Profile

GEN1046 PK for the first two dosing cycles given every 3 weeks

Modulation of peripheral pharmacodynamic markers

• Pharmacological activity was observed across a

broad range of dose levels.

• Increased levels of peripheral IFN-g and IP-10,

increased frequency of proliferating (Ki67+) total

• Peak concentrations shortly after end of infusion

CD8 and effector memory CD8+ T cells were

observed.

• Mean half-life of 2.3-10.3 days after first dose

Data extraction: June 26, 2020.

Maximal fold-change from baseline measured during cycle 1. Lower doses correspond to dose levels ≤ 200 mg

and higher doses correspond to dose levels ≥ 400 mg.

Wilcoxon-Mann-Whitney test. IFN, interferon; IP-10,interferon-gamma-inducible protein 10.

Confidential. © Genmab 2020

PDL1 Status is Being Assessed in Current FIH Trial

  • PD-L1expression was assessed in tumor biopsies obtained prior to PDL1X4-BB therapy (22C3 assay)
  • Current expansion cohort includes robust biomarker profiling to discern appropriate patient population for future development

Confidential. © Genmab 2020

Evolving

Into a Fully

Integrated

Biotech

Anthony Mancini, Executive Vice President & Chief Operating Officer

Building Capabilities to Achieve our 2025 Vision

A Knock-Your-Socks-Off Pipeline & Products That Transform Cancer Treatment

Strengthening

Development

Creating

Innovative Antibody

Therapeutics

Building

Commercialization

Excellence

Confidential. © Genmab 2020

Focused Genmab Go-To-Market Model

Positions Prioritized Assets for Success in the US & Japan

Tisotumab vedotin: ADC Targeting TF

Priority

Late-Stage Epcoritamab: CD3 x CD20

Products

Priority Markets

Confidential. © Genmab 2020

Epcoritamab

(DuoBody® Technology)

Diffuse Large B-Cell Lymphoma

(DLBCL) & Other B-Cell Malignancies

Confidential. © Genmab 2020

DLBCL is the Most Common Type of B-CellNon-Hodgkin Lymphoma (NHL)

36% of DLBCL patients in the US die from their disease within 5 years of diagnosis

Older Population

Population Aging

QoL Impact

Average age at initial diagnosis is between 60-65

Prevalence is expected to continue increasing

Symptoms typically appear at advanced stages of disease, but their impact is often swift and severe

Sources: SEER https://seer.cancer.gov/statfacts/html/dlbcl.html; Ries, L. A. G. et al. (2007) SEER Survival Monograph: Cancer Survival among

Adults: U.S. SEER Program, 1988-2001, Patient and Tumor Characteristics; American Cancer Society. "Types of B-cell Lymphoma." Available at

https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html; Lymphoma Research Foundation, "Diffuse Large B-Cell

Lymphoma." Available at https://lymphoma.org/aboutlymphoma/nhl/dlbcl/; Crump, Michael, et al. "Outcomes in Refractory Diffuse Large B-Cell

Lymphoma: Results from the International SCHOLAR-1 Study." Blood, American Society of Hematology, 19 Oct. 2017,

Confidential. © Genmab 2020

www.ncbi.nlm.nih.gov/pmc/articles/PMC5649550/.

Over 100k Patients in US, EU5 and Japan Are Treated for DLBCL

Addressable DLBCL Active Patients: >100k

US: 27,685

EU5: 23,396

Japan: 17,723

US: 8,296

EU5: 6,186

Japan: 6,986

US: 2,857

EU5: 2,168

Japan: 4,411

1L DLBCL patients:

68,804

2L DLBCL patients:

21,468

3L+ Patients:

9,436

1L

2L

3L+ Initialcommercial opportunity

Source: Kantar Health Drug Treated Patients (2020 Report); GlobalData (2020)

Confidential. © Genmab 2020

Phase 1/2 Trial of Epcoritamab in R/R B-cell NHL

  • At time of ASH Abstract cut off, 67 subjects were enrolled in Phase 1/2 first-in-humandose-finding study in R/R B-cell NHL; epcoritamab demonstrated antitumor efficacy as a single agent, with no DLTs
  • No discontinuation due to AEs unrelated to PD
  • In DLBCL: ORR were 66.7% (34% CR) with ≥12 mg (n=18) and 100% (29% CR) with ≥48 mg**

TEAEs occurring in ≥20% of patients

DLBCL

FL

≥12 mg

≥48 mg

≥0.76 mg

≥12 mg

Evaluable patients

18a

7

8

3

Overall response rate, %

66.7

100

100

100

Complete response, n (%)

6 (33.3)

2 (28.6)

2 (25.0)

2 (66.7)

Partial response, n (%)

6 (33.3)

5 (71.4)

6 (75.0)b

1 (33.3)

Stable disease, n (%)

1 (5.6)

0

0

0

Progressive disease, n (%)

5 (27.8)

0

0

0

Hutchings M, et al. ASH 2020. Abstract 402.

**48 mg, n=4; 60 mg, n=3

Confidential. © Genmab 2020

Hutchings M, et al. EHA 2020. Abstract 1218.

Case

Diffuse Large B-cell Lymphoma (DLBCL)

CT

PET

Merged (PET-CT)

  • 82 yr female
  • DLBCL (de novo) diagnosis in 2017

• 3 prior treatment lines; refractory to

Baseline

last line

  • 4 nodal lesions(SPD = 27 cm2) plus involvement of spleen and left pleura (lung membrane)
  • Epcoritamab 12 mg

• Started epcoritamab on 14 Oct

Week 06

2019

  • PR at Week 6 & CR at Weeks 12, 18, 24 & 48
  • Ongoing at cycle 15 with most recent response assessment at

Week 48: SPD = 0 cm2 (DS = 1)

Week 24

Courtesy of Dr. Martin Hutchings, site DK01, Copenhagen

Confidential. © Genmab 2020

GCT3013-01 Study Design

Single-arm,Open-label,Multi-CenterFirst-in-human Phase 1/2 Study Ongoing

Key Inclusion Criteria

  • R/R CD20+ B-NHL
  • Prior treatment with anti- CD20 mAbs
  • ECOG PS 0-2
  • Measurable disease by CT, MRI, or PET/CT scan

Objectives:

Primary •MTD •RP2D

Secondary •Safety/Tolerability •Anti-tumoractivity

Dose Escalation: Standard Titration:

Dose Expansion

0.0128-3 mga

6 mg

12 mg

24 mg

48 mg

RP2D

DLBCL

Dose schedule

CT or MRI scans were

n=128-158

• Cycle 1-2: Q1W

conducted:

Weeks 6, 12, 18, 24 and every

• Cycle 3-6: Q2W

FL

• Cycle ≥7: Q4W

12 weeks thereafter.

n=128-158

Single SC 1-mL injection of flat-dose epcoritamab

MCL

administered in 28-day cycles until disease

progression or unacceptable toxicity

n=100

Confidential. © Genmab 2020

GCT3013-02 Study Design

Open-Label Trial to Assess the Safety and Preliminary Efficacy of SubQ Epcoritamab in Combination with Other Agents in Patients with B-cellNon-Hodgkin Lymphoma

Dose Escalation

RP2D

Dose Expansion

Objectives

Dose escalation:

  • Safety and tolerability

Dose Expansion:

  • Anti-Tumoractivity

Arm 1:

Arm 3:

Arm 4:

Arm 5:

1L DLBCL

Arm 2:

R/R DLBCL

R/R DLBCL

IPI ≥3

R/R FL

1L FL

Pre-ASCT

SCT ineligible

R-CHOP + EPCO

R2 + EPCO

BR + EPCO

R-DHAX/C + EPCO

GemOx + EPCO

Confidential. © Genmab 2020

GCT3013-03 Study Design

Phase 1b/2, Open-Label, Safety & Efficacy Study of Epcoritamab in Relapsed/Refractory Chronic Lymphocytic Leukemia

Patient population:

  • R/R CLL after receiving at least 2 prior lines of systemic antineoplastic therapy, including treatment with (or intolerance of) a BTK inhibitor

Endpoints:

  • Phase 1b: Safety, PK, PD, immunogenicity
  • Phase 2: ORR, undetectable MRD

Site Selection:

• US, HOVON, NORDIC CLL, GCLLSG

Phase 1b

Phase 2

Dose Escalation

Dose Expansion

MTD/

Expansion

Dose Level 2.

48 mg

RP2D

RP2D

Dose Level 1

Confidential. © Genmab 2020

GCT3013-05 Study Design

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs. Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Patient population (n=480)

Relapsed/Refractory DLBCL with at

Epcoritamab

least 1 prior line of therapy that

included an anti-CD20 Ab.

Refractory to or ineligible for ASCT.

Prior CAR-T allowed.

Comparator Investigator's Choice: (R-

R 1:1

GemOx or BR)

Endpoints:

Investigator

Choice

Primary endpoint: OS

(R-GemOx,

• Secondary: PFS, ORR, CR, DOR,

BR)

MRD, Safety

Confidential. © Genmab 2020

Positive Perception of Next-Gen CD3xCD20 Bispecifics & Potential to Transform B-cell Malignancy Treatment

B-NHL Type

Intervention

Study Phase

Preclinical

I

I/II

II

III

DLBCL, FL, MCL and other histologies

Front-line

DLBCL

FL

Relapsed or refractory

B-NHL (DLBCL, FL, MCL) ASCT eligible DLBCL DLBCL

FL

B-NHL (Japanese patients)

DLBCL

CLL

Relapsed or refractory

Epcoritamab + R-CHOP

Epcoritamab + BR

Epcoritamab monotherapy

Epcoritamab + R-DHAX/C Epcoritamab + GemOx Epcoritamab + R2 Epcoritamab monotherapy

Epcoritamab vs SOC

Epcoritamab monotherapy

GCT3013-02 (Ph Ib)

GCT3013-02 (Ph Ib)

GCT3013-01 (Ph I/II)

GCT3013-02 (Ph Ib)

GCT3013-02 (Ph Ib)

GCT3013-02 (Ph Ib)

GCT3013-04 (Ph I/II)

GCT3013-05 (Ph III)

GCT3013-03 (Ph Ib)

B-NHL:B-cellNon-Hodgkin Lymphoma; BR: bendamustine + rituximab; DLBCL: diffuse large B-cell lymphoma; Confidential. © Genmab 2020

FL: follicular lymphoma; MCL: mantle cell lymphoma; SOC: standard of care; R2 = Revlimid + rituximab

Customer Perception of Next Generation CD3xCD20 is Very Positive

CD3xCD20

Agents

Awareness

Efficacy & Safety

Route of Administration

Indication

Growing awareness & enthusiasm

High ORR & lack of high- grade CRS events

Preference for SubQ administration

Initial use in 3L+ with potential to apply to all CD20+ cancers

Confidential. © Genmab 2020

Epcoritamab: Potentially Superior Treatment in a Transformative Class of Therapies in B-cell Lymphomas

New MOA,

Potential

Subcutaneous

Easy to Use/Combine

Best-in-Class

Administration

Next-Generation

Improved efficacy

Enhanced convenience &

& safety

ease of administration for

Bispecific Antibody

HCPs & patients

Confidential. © Genmab 2020

An Ambitious Development Program Enables Potential Expansion Across Multiple Lines of Therapy

Expansion Opportunities: Estimated Drug Treated Patients (2027)*

~111.1k

DLBCL

(Diffuse Large B-Cell Lymphoma)

~51.4k

FL

(Follicular Lymphoma)

~44.6k

CLL

(Chronic Lymphocytic Leukemia)

~13.7k

MCL

(Mantle Cell Lymphoma)

* Epcoritamab has the potential to show clinical efficacy signals across all listed potential indications

Source: Kantar Estimated Drug Treated Patients (2020 Report)

Confidential. © Genmab 2020

Tisotumab vedotin (HuMax® Technology)

Cervical Cancer

Confidential. © Genmab 2020

Advanced Cervical Cancer Patients Have a

Poor Prognosis

83% of patients with metastatic Cervical Cancer (mCC) die within 5 years

Younger

Most frequently diagnosed between 35-44 years old

Women

Socioeconomic

Disproportionately impacts women of lower SES

Status

Stigmatized

Due to association with HPV and availability of the vaccine

Disease

Source: Kantar Health (2019); Cervivor.org (accessed June 2020);

Confidential. © Genmab 2020

WHO; Cancer.org (accessed September 2020)

Over 17k Patients Treated for Metastatic Cervical Cancer (mCC) in US, EU5 and Japan

Addressable mCC active patients: >17.5k

US: 4,495

EU5: 4,467

Japan: 2,569

US: 1,825

EU5: 1,652

Japan: 1,036

US: 600

EU5: 521

Japan: 298

1L patients:

11,531

2L patients:

4,513

3L+ Patients:

1,419

1L

2L

Initial

commercial opportunity

3L+

Source: Kantar Health Drug Treated Patients (2020 Report);

Confidential. © Genmab 2020

Tisotumab Vedotin in Previously Treated Recurrent or Metastatic Cervical Cancer: Results From the Phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 Study

Robert L. Coleman,1 Domenica Lorusso,2 Christine Gennigens,3 Antonio González- Martín,4 Leslie Randall,5 David Cibula,6 Bente Lund,7 Linn Woelber,8 Sandro Pignata,9 Frederic Forget,10 Andrés Redondo,11 Reshma Rangwala,12 Signe Diness Vindeløv,13 Menghui Chen,12 Jeffrey R. Harris,12 Leonardo Viana Nicacio,14 Melinda S. L. Teng,14 Margaret Smith,12 Bradley J. Monk,15 Ignace Vergote16

1US Oncology, The Woodlands Houston, TX, USA; 2Multicentre Italian Trials in Ovarian Cancer and Gynaecological Malignancies Group (MITO) and Scientific Directorate and Department of Women and Child Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; 3Department of Medical Oncology, Centre Hospitalier Universitaire de Liège, Liège, Belgium; 4Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Department of Medical Oncology, Clínica Universidad de Navarra, Madrid, Spain; 5Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA; 6Central and Eastern European Gynecologic Oncology Group (CEEGOG) and Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic; 7Aalborg University Hospital, Aalborg, Denmark; 8Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) study group and University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 9MITO and Istituto Nazionale per lo Studio e la Cura dei Tumori, "Fondazione G. Pascale" IRCCS, Naples, Italy; 10Centre Hospitalier de l'Ardenne, Libramont, Belgium; 11Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Hospital Universitario La Paz-IdiPAZ, Madrid, Spain;

12Genmab US, Inc., Princeton, NJ, USA; 13Genmab, Copenhagen, Denmark; 14Seattle Genetics, Inc., Bothell, WA, USA; 15Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ, USA; 16Belgium and Luxembourg Gynaecological Oncology Group, University of Leuven, Leuven Cancer Institute, Leuven, Belgium.

Confidential. © Genmab 2020

innovaTV 204 Study Design

innovaTV 204 (NCT03438396) is a pivotal phase 2 single-arm, multicenter (United States and Europe) study evaluating tisotumab vedotin in patients with previously treated recurrent and/or metastatic cervical cancer

Key Eligibility Criteria

  • Recurrent or extrapelvic metastatic cervical cancer
  • Progressed during or after doublet chemotherapya with bevacizumab (if eligible)
  • Received ≤2 prior systemic regimensb
  • ECOG PS 0-1

Enrolled: 102c

Treated: 101*

Tisotumab

Until PD or

vedotin

unacceptable

2.0 mg/kg IV

toxicity

Q3W

Tumor responses assessed using CT or MRI at baseline, every 6 weeks for the first 30 weeks, and every 12 weeks thereafter

Primary Endpoint

  • ORRd per RECIST v1.1, by independent imaging review committee (IRC)

Secondary Endpoints

  • ORRd per RECIST v1.1, by investigator
  • DOR, TTR, and PFS by IRC and investigator
  • OS
  • Safety

Exploratory Endpoints

  • Biomarkers
  • HRQoL

*Study sample size calculated assuming a confirmed ORR of 21% to 25% with tisotumab vedotin and to provide ≥80% power to exclude an ORR of ≤11%e

aPaclitaxel plus platinum (cisplatin or carboplatin) or paclitaxel plus topotecan. bAdjuvant or neoadjuvant chemotherapy or if administered with radiation therapy, was not counted as a prior systemic regimen. cJune 2018 to April 2019. dResponses were confirmed by subsequent repeat imaging performed ≥4 weeks after initial response assessment. eUsing one-sided exact binomial test at 0.025 significance level.

CT, computed tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; HRQoL, health-related quality of life; IRC, independent review committee; IV, intravenous; MRI, magnetic resonance imaging; OS, overall survival; PD, progressive disease; Q3W, every 3 weeks; RECIST v1.1, Response Evaluation Criteria In Solid Tumors version 1.1; TTR, time to response.

Antitumor Activity by IRC Assessment

Clinically meaningful and durable responses were observed

Response

1.00

N=101

0.80

0.60

Confirmed ORR (95% CI),a %

24 (15.9−33.3)

in

CR, n (%)

7

(7)

Remaining

0.40

PR, n (%)

17

(17)

0.20

SD, n (%)

49

(49)

0

PD, n (%)

24

(24)

0

Not evaluable, n (%)

4

(4)

No. at risk

24

DOR

Median DOR

(95% CI)

8.3 months (4.2−NR)

2

4

6

8

10

12

Time (months)

22

16

11

8

3

0

Data cutoff: February 06, 2020. Median duration of follow-up: 10.0 months. aBased on the Clopper-Pearson method.

CI, confidence interval; CR, complete response; DOR, duration of response; IRC, independent review committee; NR, not reached; ORR, objective response rate; PD, disease progression; PR, partial response; SD, stable disease.

Confidential. © Genmab 2020

Baseline Scans

42-year-old

Sep 2017 Received concurrent chemoradiation

Jan 2018 - Biopsy confirmed recurrence in extra-pelvic lymph nodes. Received carboplatin + paclitaxel

Nov 2018 - Started on innovaTV 204

• Confirmed Complete Response(IRC-assessed)

• DOR: 8.5 mos

Scans Confirming Response (Cycle 5)

Confidential. © Genmab 2020

PFS by IRC Assessment and OS

PFS

1.00

Median PFS

6-month PFS Rate

0.80

(95% CI)

(95% CI)

PFS

0.60

4.2 months

30%

0.40

(3.0−4.4)

(20.8−40.1)

0.20

0

0

3

6

9

12

15

18

Time (months)

No. at risk 101

53

23

14

4

1

0

1.00

0.80

OS

0.60

0.40

Median OS

(95% CI)

0.20

12.1 months

0

(9.6−13.9)

0

3

No. at risk 101

90

OS

6-month OS Rate

(95% CI)

79%

(69.3−85.6)

6

9

12

15

18

Time (months)

77

61

35

8

0

Data cutoff: February 06, 2020. Median duration of follow-up: 10.0 months. CI, confidence interval; OS, overall survival; PFS, progression-free survival.

Confidential. © Genmab 2020

Most Common TRAEs with Tisotumab Vedotin

Patients (%)

  • Most TRAEs were grade 1 or 2 and no new safety signals were reported
  • One death due to septic shock was considered by the investigator to be related to therapyb

TRAEs with ≥10% incidencea

100

90

N=101

80

28%

Series1

Series2

70

60

50

40

2%

30 64%

1%

1%

1%

20

38%

30%

10

27%

26%

24%

23%

15%

12%

12%

12%

11%

11%

10%

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Data cutoff: February 06, 2020. Median duration of follow-up: 10.0 months.

Median duration of treatment: 4.2 months (range, 1-16).

aAny-grade AEs included if ≥10%. bThree treatment-emergent deaths unrelated to therapy included one case of ileus and two with unknown causes.

TRAE, treatment-related adverse event.

Confidential. © Genmab 2020

Conclusions

Clinically meaningful and durable responses were observed consistent across subgroups

Tisotumab vedotin had a manageable and tolerable safety profile

The most common treatment-related adverse events included alopecia, epistaxis, nausea, conjunctivitis, fatigue and dry eye

BLA submission planned under FDA's accelerated approval pathway

Confidential. © Genmab 2020

Evaluation is ongoing in 37 (37%) patients. AE, adverse event; CR, complete response, DOR, duration of response; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TF, tissue factor; TTR, time to response.

Our Goal in Cervical Cancer: Establish Tisotumab Vedotin as the Clear Choice in 2L+ Settings

mCC Treatment Landscape

1L

Chemotherapy +/- Bevacizumab*

2L

3L+

~50% PD-L1+

~50% PD-L1-

Pembro**, Other

IO, or Chemo

All Patient Types

Pembrolizumab or

Chemotherapy

Source: Kantar Treatment Architecture: Cervical Cancer; NCCN Treatment Guidelines; 2020 TV ATU (Strategic Research Insights)

Confidential. © Genmab 2020

*Pembrolizumab & other IOs are being evaluated in 1L treatment **Pembrolizumab is approved for 2L r/mCC in the US; not approved in JPN or EU

Tisotumab Vedotin Demonstrates Clinically Meaningful, Durable Responses and a Manageable Safety Profile in 2L+ r/mCC Patients

First-in-Class

Superior

Broad Applicability

Therapeutic Profile

Antibody-drug conjugate (ADC) directed against Tissue Factor (TF)

Superior efficacy, durable responses and reduced toxicity compared to SoC

Efficacy in a broad patient

population without

biomarker requirement

Source: 2020 TV ATU (Strategic Research Insights)

Confidential. © Genmab 2020

Building Capabilities to Achieve our 2025 Vision: Knock-Your-Socks-Off Pipeline and Products That Transform Cancer Treatment

Strengthening

Development

Creating

Innovative Antibody

Therapeutics

Building

Commercialization

Excellence

Confidential. © Genmab 2020

Beyond 2020:

Genmab's Journey is Just Beginning

Jan van de Winkel, President & Chief Executive Officer

Key Events in Genmab's 21-Year Journey

2012 - 2015

2019

2003 - 2007

Janssen agreement

U.S. IPO

daratumumab

Ofatumumab RMS

CD38 mAbs generated

HexaBody® platform

sBLA

Daratumumab selected

DARZALEX® 1st

CureVac AG agreement

GSK agreement

U.S approval

HexaBody-CD38

ofatumumab

BioNTech agreement

agreement (Janssen)

1999 - 2002

  • Genmab Founded
  • Copenhagen IPO
  • 1st partnership (Roche)
  • Ofatumumab program announced

2008 - 2011

  • Arzerra® 1st U.S. & EU approvals
  • DuoBody® platform
  • Strategy update
  • 1st collab. w/ Seattle Genetics

2016 - 2018

2020

DARZALEX®

AbbVie partnership

1st EU & Japan approvals

U.S. Approvals for:

HexElect® platform

®

Immatics agreement

Kesimpta

DARZALEX

FASPRO

TEPEZZA®

1st DuoBody* awarded

Kesimpta (ofatumumab) developed by Novartis; DARZALEX (daratumumab) and DARZALEX FASPRO ( daratumumab and hyaluronidase-fihj) developed by Janssen; TEPEZZA (teprotumumab) developed by Horizon Therapeutics; *amivantamab developed by Janssen

BTD

Confidential. © Genmab 2020

Beyond 2020

Genmab's Journey is Just Beginning

Expanded use of our

Our own

Strong financial

next-generation

proprietary

products on the

foundation

technologies

market

Building and

Additional

Fully integrated

expanding

strategic

biotech

capabilities

partnerships

transforming the

worldwide

lives of cancer

patients

Confidential. © Genmab 2020

Q&A

Disclaimer

Genmab A/S published this content on 13 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 November 2020 13:40:04 UTC


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Jan G. J. van de Winkel President & Chief Executive Officer
Deirdre P. Connelly Chairman
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