P2 R and D Updated
P2 R and D Updated
P2 R and D Updated
Marcus Schindler
CSO and EVP of Research & Early development
7 MARCH
Forward-looking statements
Novo Nordisk’s reports filed with or furnished to the US Securities and Exchange Commission (SEC), including the statutory Annual Report 2023 and Form 20-F, which both were filed with the SEC in
January 2024 in continuation of the publication of the Annual Report 2023, this presentation, and written information released, or oral statements made, to the public in the future by or on behalf of Novo
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and terms of similar meaning in connection with any discussion of future operating or financial performance identify forward-looking statements. Examples of such forward-looking statements include,
but are not limited to:
• Statements of targets, plans, objectives or goals for future operations, including those related to Novo Nordisk’s products, product research, product development, product introductions and
product approvals as well as cooperation in relation thereto,
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measures,
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• Statements regarding the assumptions underlying or relating to such statements.
These statements are based on current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Novo
Nordisk cautions that a number of important factors, including those described in this presentation, could cause actual results to differ materially from those contemplated in any forward-looking
statements.
Factors that may affect future results include, but are not limited to, global as well as local political and economic conditions, such as interest rate and currency exchange rate fluctuations, delay or failure
of projects related to research and/or development, unplanned loss of patents, interruptions of supplies and production, including as a result of interruptions or delays affecting supply chains on which
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Nordisk’s products, introduction of competing products, reliance on information technology including the risk of cybersecurity breaches, Novo Nordisk’s ability to successfully market current and new
products, exposure to product liability and legal proceedings and investigations, changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property
protection and regulatory controls on testing, approval, manufacturing and marketing, perceived or actual failure to adhere to ethical marketing practices, investments in and divestitures of domestic
and foreign companies, unexpected growth in costs and expenses, strikes and other labour market disputes, failure to recruit and retain the right employees, failure to maintain a culture of compliance,
epidemics, pandemics or other public health crises, the effects of domestic or international crises, civil unrest, war or other conflict and factors related to the foregoing matters and other factors not
specifically identified herein.
For an overview of some, but not all, of the risks that could adversely affect Novo Nordisk’s results or the accuracy of forward-looking statements in the Annual Report 2023, reference is made to the
overview of risk factors in ‘Risk Management’ of the Annual Report 2023.
Unless required by law, Novo Nordisk has no duty and undertakes no obligation to update or revise any forward-looking statement after the distribution of the Annual Report 2023, whether as a result of
new information, future events, or otherwise.
therapeutic focus
• Progress towards zero environmental impact • Develop a leading portfolio of superior treatment
Innovation and
• Being respected for adding value to society solutions for obesity
sustainability
Purpose and
• Being recognised as a sustainable employer • Strengthen and progress the Rare disease pipeline
• Establish presence in Cardiovascular & emerging
(ESG)
therapy areas
Financials
• Secure a sustained growth outlook for Rare disease
allocation to shareholders
Note: The strategic aspirations are not a projection of Novo Nordisk's financial outlook or expected growth
4 Research & early development Innovation and therapeutic focus Novo Nordisk®
537
million people with
~15% 813
million people with
~2%
of people in of people medically
diabetes1 good control2 obesity3 treated
1International Diabetes Federation: Diabetes Atlas 10 th edition, 2021; 2Real-world studies indicate between 30-55% of patients reach HbA1c target <7% .e.g. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4388968/, taking 42.5% in good control of
treated people; 3World Obesity Atlas, 2023; 4WFH annual survey 2020 (120 of 147 countries responded): Prevalence by calculating expected number of patients using 20.9 per 100.000 in haemophilia - Identified patients as proxy for receiving some
sort of treatment; 5WHO. Cardiovascular Diseases 2023; 6Chris J Kapelios et al Cardiac Failure Review 2023;9:e14.; 7Younossi ZM et al. Hepatology. 2023;77:1335-1347; 8Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int
Suppl (2011). 2022 Apr;12(1):7-11
CKD: Chronic kidney disease; CVD: Cardiovascular disease; HFpEF: Heart failure with preserved ejection fraction; MASH: Metabolic dysfunction-associated steatohepatitis; WHO: World Health Organization
5 Research & early development Innovation and therapeutic focus Novo Nordisk®
AD: Alzheimer’s disease; CKD: Chronic kidney disease; CVD: Cardiovascular disease; MASH: Metabolic dysfunction-associated steatohepatitis; PD: Parkinson’s disease; RBD: Rare blood disorders; RED: Rare endocrine disorders;
siRNA: Small interfering ribonucleic acid
Note: Research and early development comprises activities from research until phase 2
6 Research & early development Innovation and therapeutic focus Novo Nordisk®
Diverse cohorts
80% more
African American cohort AI driven data mining and targets screened in 2023 compared to 2022.
Genes & Health Industry Consortium analyses linking disease to novel Capacity increasing in 2024
UK biobank targets
Disease cohorts
Alliance Genomic Discovery (Obesity)
ATTRACT (CVD) In silico analyses
Cellfi (Diabetes)
Significant number
of new targets expected to
Leverage real world evidence enter phase 1
Human centric in vitro assays
in early discovery
AI: Artificial intelligence; CKD: Chronic kidney disease; CVD: Cardiovascular disease
8 Research & early development Innovation and therapeutic focus Novo Nordisk®
37 Haemophilia A
partnerships focused on Proof of concept in non- Gene
cardiometabolic diseases and obesity human primates 2023
Therapy
21 Obesity
partnerships exploring new MoAs Phase 1 initiated in 20242 Small
Molecules
~50%
Atherosclerotic
of partnerships have resulted in projects
cardiovascular disease Small
entering the pipeline as of today
Phase 1 initiation expected Molecules
in 2024
1Partnerships
include drug-enabling technology and drug-based strategic partnerships and acquisitions; 2INV-347
MoA: Mode of action
9 Research & early development Innovation and therapeutic focus Novo Nordisk®
-15
-30
GalXCTM GalXC-PlusTM
Dicerna partnership since 2019, acquired in 2021 and
now Global Nucleic Acid Therapies
Enables RNA silencing in + Enables RNA silencing in
hepatic cells extra-hepatic cells
Allows Novo Nordisk to access patented siRNA research Disease targets Diabetes Obesity
(expressed genes)
technology platform
CVD
~5,000
extracellular
Investments made in CMC capabilities to deliver targets MASH CKD
Cell
industrial scale siRNA therapeutics across therapy areas
~21,000
Brain
intracellular disorders
targets
CKD: Chronic kidney disease; CMC; Chemistry manufacturing and controls; CVD: Cardiovascular disease; MASH: Metabolic dysfunction-associated steatohepatitis; RBD: Rare blood disorders; RED: Rare endocrine disorders; RNA: Ribonucleic acid;
siRNA: Small interfering ribonucleic acid
11 Research & early development Innovation and therapeutic focus Novo Nordisk®
3
11 phase 1 trial initiations with
GalXCTM since 2017
… phase 1 initiations on
First extra-hepatic phase 1 trial
average per year across
with GalXC-PlusTM in 2023
disease areas with the
siRNA platform is
on track
50% of upcoming phase 1 trials
expected to be with GalXC- Diabetes and Obesity RBD and RED
PlusTM
CVD and MASH Other projects
CVD: Cardiovascular disease; MASH: Metabolic dysfunction-associated steatohepatitis; RBD: Rare blood disorders; RED: Rare endocrine disorders; siRNA: Small interfering ribonucleic acid
Note: A project is defined when a target is identified and assigned team ask for resources to evaluate proof of concept
12 Research & early development Innovation and therapeutic focus Novo Nordisk®
Diabetes
Obesity
Therapy areas
CVD
RBD
MASH
RED
CKD
CKD: Chronic kidney disease; CVD: Cardiovascular disease; mAB: Monoclonal antibody; MASH: Metabolic dysfunction-associated steatohepatitis; RBD: Rare blood disorders; RED: Rare endocrine disorders; siRNA: Small interfering ribonucleic acid
Note: Currently active means Novo Nordisk is currently pursuing research projects, while exploratory indicates active early exploration activities and/or partnerships initiated
13 Research & early development Innovation and therapeutic focus Novo Nordisk®
Increased investments
2018 2024
Proteins & Peptides siRNA1 Small molecules Cell therapy Gene therapy
1primarily
siRNA projects
siRNA: Small interfering ribonucleic acid
14 Research & early development Innovation and therapeutic focus Novo Nordisk®
~80%
Increased investments
CKD: Chronic kidney disease; CVD: Cardiovascular disease; MASH: Metabolic dysfunction-associated steatohepatitis; RBD: Rare blood disorders; RED: Rare endocrine disorders
15 Research & early development Innovation and therapeutic focus Novo Nordisk®
NN1845 – GSI
Co-agonist to GIP
Mode of action
and GLP-1 receptors
NN1471 – Pumpsulin
Improved convenience
Differentiation
NN9041 – DNA Immunotherapy 12 injections yearly
Diabetes
Once monthly sc
NN9904 – OW oral semaglutide Dosing injection
NN9650
Phase 1 results
NN9650 – OM GIP/GLP-1 co-agonist (OM GLP-1/GIP) Next steps
expected in 2025
DNA: Deoxyribonucleic acid; GIP: Gastric inhibitory polypeptide; GSI: Glucose sensitive insulin; OM: Once-monthly; OW: Once-weekly; sc: Subcutaneous
16 Research & early development Innovation and therapeutic focus Novo Nordisk®
Complementary
NN9441 – INV-347 biologies for additive
Differentiation
effect
Obesity
1Campbell et.al. Cell Metabolism 2013 (17) 819-837; 2Hay et al. Pharmacological reviews 2015 (67) 564-600; 3Daquin et.al. 2004 164(4):509-14
Cagri: Cagrilintide; DIO: Diet induced obesity; g: gram; HFD: High-fat diet; LFD: Low-fat diet; nmol: nanomole; Sema: semaglutide
18 Research & early development Innovation and therapeutic focus Novo Nordisk®
0 -1.1
-6
Phase 1 key findings
Building a broad
Deep biology understanding pipeline
Maximise value in
>
incretin/amylin • GLP-1
biology
Maximise GLP-1 • Amylin
franchise
>
Protein/peptide development • GLP-1 • GIP
>
and engineering
• Amylin • Novel
• GLP-1
• GIP • Novel
• Novel
• Phase 1 initiation expected in 2024 • Phase 1 initiation expected within next Regulating appetite and
12 months energy expenditure
• New molecule for mono-therapy provides
opportunity for weight management • Potential for improved weight loss
efficacy
• Potential for combination therapy
• Potential for improved effect on Weight maintenance
obesity related comorbidities
+ + Sustained release
ILLUSTRATIVE
21 Research & early development Innovation and therapeutic focus Novo Nordisk®
5
Leverage AI/digital capabilities
throughout drug discovery process
Closing remarks
Continue to build on core capabilities and expand
beyond with new modalities