Innovating
Antibodies,
Improving Lives
39th Annual J.P. Morgan Healthcare
Conference
13 January 2021
© Genmab For Investor audience only. Not for public information or use. Not for promotional use.
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.
© Genmab | 2 |
For Investor audience only. Not for public information or use. Not for promotional use.
On the Road to 2025: Evolving Into a Fully Integrated Biotech
Core Purpose
To improve the lives of patients
by creating & developing innovative antibody products
Our Strategy
- Focus on core competence
- Turn science into medicine
- Build a profitable & successful biotech
Vision
By 2025, our own product has transformed cancer treatment and we have a pipeline of knock-your-socks off antibodies
Our Core Purpose, Strategy & Vision
Guide Our Work
© Genmab | 3 |
For Investor audience only. Not for public information or use. Not for promotional use. |
Well Positioned for Future Growth
Consistent and solid track record
World-class pipeline & innovation with two potential near-term launches
Partnerships | Strong Financials |
with innovators and | to invest in growth |
industry leaders | opportunities |
© Genmab | 4 |
For Investor audience only. Not for public information or use. Not for promotional use.
Consistent, Solid Track Record Fuels Our Growth:
Over 20 Years of Achievements
- 38 Cumulative INDs since 1999
- 22 Genmab-created product candidates in ongoing clinical trials
- Multiple Genmab-created products approved
- 8 Years of profitability & expanding top line
- Investing in our capabilities
- Experienced, international management team
- Dual-listedin US & DK with 2019 US IPO
© Genmab | 5 |
For Investor audience only. Not for public information or use. Not for promotional use. |
The Genmab Difference
Strong pipeline | |
of 1st-in-class / | |
best-in-class | |
products | |
Deep insight into | Proprietary technologies |
antibody biology | allow us to build a |
& disease targets | world-class pipeline |
Match in-house expertise with
strategic partnerships
© Genmab | 6 |
For Investor audience only. Not for public information or use. Not for promotional use. |
Innovative Clinical Pipeline: Genmab Proprietary* and Partnered Products - Most Advanced Development Phase
Phase 1 | Phase 1/2 | Phase 2 | Phase 3† | Approved‡ | ||||
Genmab | 1 | DuoBody-PD-L1x4-1BB1 |
DuoBody-CD40x4-1BB | Epcoritamab2 | |
owned | DuoHexaBody-CD372 | 9 |
products | DuoBody-CD3x5T42 | Tisotumab vedotin |
≥50% |
HexaBody-DR5/DR5
Products owned by 3rd party
Talquetamab3 | Teclistamab3 | Amivantamab3 | Daratumumab3 |
JNJ-637091783 | Mim86 | Ofatumumab10 | |
JNJ-638980813 | Camidanlumab tesirine7 | Teprotumumab11 | |
JNJ-675712443 | PRV-0158 | ||
JNJ-702189023 | |||
HuMax-IL84 | |||
Lu AF824225 | |||
*Products where Genmab has ownership of at least 50%
-
For epcoritamab and tisotumab vedotin, Phase 3 FPD anticipated 2021
‡See local prescribing information for full indications / safety information
150/50 co-development with BioNTech 250/50 co-development with AbbVie; 3Development by Janssen Biotech, Inc; 4Development by BMS; 5Development by Lundbeck; 6Development by Novo Nordisk, approved in the US; 7Development by ADC Therapeutics; 8Development by Provention Bio; 950/50 co-development with Seagen; 10Development by Novartis; 11Development by Horizon Therapeutics, approved in the US
© Genmab | 7 |
For Investor audience only. Not for public information or use. |
Not for promotional use.
Investing in the Breadth & Depth of our Pipeline
R&D Engine
- DuoBody® technology
- HexaBody® technology
- DuoHexaBody® technology
- HexElect® technology
Expanding & maturing trials for our
proprietary* assets
8 assets
8 assets
6 assets
5 assets
2 assets | 4 assets |
2016 | 2017 | 2018 | 2019 | 2020 | 2021e |
© Genmab
For Investor audience only. Not for public information or use. Not for promotional use.
Phase 1 Phase1/2 Phase 2 Phase 3
*Genmab owned ≥50%; number of active clinical trials in 2021 is estimated 8
Tisotumab Vedotin
in Collaboration with Seagen
First-in-class
- Antibody-drugconjugate (ADC) directed against Tissue Factor (TF)
Very favorable efficacy with manageable safety profile
- Very favorable overall response in Phase 2 innovaTV 204 study vs. prior reported SoC, with manageable safety profile
Broad population in innovaTV 204 study
- Not restricted to biomarker selection
- Pre-treatedas per current SoC
- Regardless of histology
In Phase 2 innovaTV 204 study: Tisotumab vedotin demonstrated very favorable, durable responses and a manageable safety profile in 2L+ r/m cervical cancer patients
© Genmab | 9 |
For Investor audience only. Not for public information or use. Not for promotional use. |
Epcoritamab
in Collaboration with AbbVie
Novel MoA
- Next-generation,bispecific antibody
Potential best-in-class
- Potential for Improved efficacy & safety
Subcutaneous administration
-
Enhanced convenience & ease of
administration for HCPs & patients compared to IV infusion
Comprehensive development plan
- Trials in several B-cell malignancies
- Trials across multiple lines of therapy
- Exploration as both monotherapy and in combination
Currently investigated in several clinical trials across B- cell NHL histologies / in various combinations: Phase 2 expansion part is ongoing, as is Phase 1b exploring combinations with multiple SoC treatments. Phase 3 initiated in DLBCL, FPD anticipated 2021
© Genmab 10
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Epcoritamab: Potential Best-in-Class
Updated Dose-escalation Data Presented at ASH 2020*
Novel, off-the-shelf therapy with convenient SubQ administration
- Phase 1/2 study (NCT03625037) in patients with relapsed, progressive or refractory B-cell lymphoma
- RP2D: 48 mg reached with no DLTs; MTD not reached
Demonstrated substantial single-agent activity in heavily pre-treated patients with B-NHL
- Patients with DLBCL receiving ≥48 mg:
- Responses achieved in 10 of 11 evaluable patients, including CR in 6 patients
-
All patients receiving ≥12 mg who achieved
CR remain in remission - Patients with FL receiving ≥12 mg: ORR was
80%, with 60% CR - Encouraging responses, including CR, observed in 2 of 4 evaluable patients with
MCL
Favorable safety profile
- Supports potential for combination therapies / future outpatient administration
- CRS events were Grade 1 and 2
Binds to distinct epitope
- Different from that of rituximab and obinutuzumab:
- Has potential to be partner of choice in combinations with SoC therapies containing rituximab
© Genmab
For Investor audience only. Not for public information or use. Not for promotional use.
*"Subcutaneous Epcoritamab Induces Complete Responses with an Encouraging Safety Profile Across Relapsed/Refractory B-cell11 Non-Hodgkin Lymphoma Subtypes, Including Patients with Prior CAR-T Therapy: Updated Dose-escalation Data" Hutchings, et al.
DuoBody-PD-L1x4-1BB(GEN1046) & DuoBody-CD40x4-1BB(GEN1042) in Collaboration with BioNTech
GEN1046
- First-in-classbispecific next generation checkpoint immunotherapy
- Designed to enhance T-cell and NK cell function through conditional 4-1BBco-stimulation
- Simultaneously blocking the PD-L1 axis
- Enhances proliferation and cytokine production of activated T-cells
- Activates immune cells in the tumor-draining lymph nodes
- Induces tumor regression in vivo.
GEN1042
- First-in-classbispecific antibody
- Designed to conditionally activate both CD40- expressing antigen- presenting cells (APC) and 4-1BB-expressing T cells
- Conditionally activates T cells and APC in the presence of CD40-expressing cells
© Genmab 12
For Investor audience only. Not for public information or use. Not for promotional use.
Earlier Stage Clinical Development
DuoHexaBody-CD37
- Combination of DuoBody & HexaBody platforms
- Novel target for hematological malignancies
- Unique MoA
- Dose escalation ongoing
- 50:50 co-development with AbbVie
DuoBody-CD3x5T4 | HexaBody-DR5/DR5 | ||||
▪ | Based on proprietary | ▪ | First HexaBody in the clinic | ||
▪ | DuoBody Technology | ▪ | Targets 2 distinct DR5 | ||
CD3 bispecific, T cell | ▪ | epitopes | |||
mediated cytotoxicity of | DR5 clustering & DR5 | ||||
▪ | 5T4+ tumor cells | ▪ | agonist activity | ||
5T4 expressed on | Dose escalation ongoing in | ||||
multiple solid tumors, | multiple solid tumors | ||||
limited expression in | |||||
▪ | healthy tissue | ||||
Dose escalation ongoing | |||||
▪ | 50:50 co-development | © Genmab | 13 | ||
with AbbVie | For Investor audience only. Not for public information or use. Not for promotional use. | ||||
Approved Antibody Therapeutics Created by Genmab
DARZALEX® (daratumumab) &
DARZALEX FASPRO® Redefining
Treatment of Multiple Myeloma*
Collaboration with Janssen Biotech, Inc.: Genmab entitled to tiered royalty of 12-20% of net sales
DARZALEX FASPRO first and only SubQ CD38 mAb approved in U.S. for treatment of MM
Kesimpta® (ofatumumab)
Approved in U.S. in Relapsing
Multiple Sclerosis*
Collaboration with Novartis: Genmab entitled to royalty of 10% of net sales
First B-cell therapy that can be self- administered by patients at home using Sensoready® autoinjector pen
TEPEZZA® (teprotumumab)
Approved in U.S. in Thyroid Eye disease (TED)*
Developed and commercialized by Horizon Therapeutics: Genmab entitled to mid single digit royalty of net sales
First and only U.S. FDA-approved medicine for treatment of TED
*See local prescribing information for full indication and safety information. | © Genmab | 14 |
For Investor audience only. Not for public information or use. Not for promotional use. |
Building Our Capabilities
Research
Track record of success and investing for tomorrow
- State-of-the-artfacilities
- Novel technologies and formats
- External innovation
Development
Scaling up to expand from early to late stage
- Clinical development & operations
- Disease area expertise
- Medical Affairs, Safety and Regulatory
Commercialization
Step change in our business
- Leadership team in place
- Focused on U.S. and Japan
- Building expanded team
Enabling functions to support growth & manage risk
Data Sciences to drive insights
© Genmab 15
For Investor audience only. Not for public information or use. Not for promotional use.
2020 Guidance: Recurring Revenue Growth and Focused Investments
Income | DKKM | ~USDM* | Key Observations | ||
Statement | Summary P&L | ||||
• DARZALEX royalties of ~DKK 4.1bn to ~DKK 4.5bn to | |||||
Revenue | 9,250 - 9,850 | 1,423 - 1,515 | |||
drive recurring revenue growth | |||||
• | Nearly 90% of USD 750M upfront from AbbVie collab. | ||||
Operating | (3,850) - (3,950) | (592) - (608) | |||
recognized immediately | |||||
Expenses | |||||
• Growth in operating expenses driven by expanding and | |||||
Operating | |||||
5,350 - 5,950 | 823 - 915 | accelerating our clinical pipeline | |||
Income | |||||
DARZALEX Sales of USD 3.9bn - USD 4.2bn | |||||
• Significant opportunity for growth in 1L MM market | |||||
• SubQ DARZALEX approvals in H1 in U.S. & EU | |||||
• Market share gain in the U.S. and RoW driven by uptake | |||||
in all lines of treatment | |||||
• | 8 approved indications in U.S., late stage to 1L MM | ||||
*2020 Guidance - November 4, 2020 / USD 1.00 = DKK 6.50. | © Genmab | 16 |
For Investor audience only. Not for public information or use. Not for promotional use. |
Key 2021 Priorities: Build a Strong Differentiated Product Pipeline & Bring Own Medicines to Market
Priority | Targeted Milestones |
» Tisotumab vedotin1 - U.S. FDA decision on BLA and progress to market | |
Bring our own medicines to | » Tisotumab vedotin - JNDA submission in cervical cancer |
patients | » Epcoritamab2 - acceleration & maximization of development program by advancing |
expansion cohorts and initiating additional Phase 3 trials | |
» DuoBody-PD-L1x4-1BB3 - expansion cohort data | |
Build world-class differentiated | » DuoBody-CD40x4-1BB3 - dose escalation data |
product pipeline | » Tisotumab vedotin - data in other tumor indication |
» Earlier stage products - progress & expand innovative product pipeline | |
Become leading | » Operational commercialization model in US & Japan |
integrated innovation | |
» Further strengthen solid financial foundation | |
powerhouse | |
1. 50:50 dev. w/ Seagen; 2. 50:50 dev w/ AbbVie; 3. 50:50 dev. w/ BioNTech | © Genmab | 17 |
For Investor audience only. Not for public information or use. Not for promotional use. |
Well On Track to Reaching Our 2025 Vision
Successful track record
Genmab profile today
Strategy | |||
Focus Areas | ▪ Focus on core competence | ||
▪ Turn science into medicine | |||
▪ Build a profitable and successful | |||
biotech | |||
Progress | Sustained Execution | ||
2025 Vision
By 2025, our own product has transformed cancer treatment and we have a pipeline of knock-your-socks-off antibodies
Building fully integrated biotech innovation powerhouse
2 potential near-term Genmab owned product launches
Imperative to invest
Remain focused and disciplined
© Genmab 18
For Investor audience only. Not for public information or use. Not for promotional use.
© Genmab 19
For Investor audience only. Not for public information or use. Not for promotional use.
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Genmab A/S published this content on 13 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 January 2021 19:13:06 UTC