Investor Presentaiton
Novo Nordisk Annual Report 2023
Introducing Novo Nordisk Strategic Aspirations Risks
Management
Consolidated statements
Additional information
Research and development progress
DIABETES
Regulatory events
⚫ Rybelsus® (oral semaglutide) was approved as first-line
treatment option by the FDA.
⚫ Results from Rybelsus® (oral semaglutide) formulation
change and PIONEER PLUS were submitted to the EMA.
• Marketing authorisation application was submitted to the EMA,
FDA, CDE and PMDA for approval of insulin icodec for treatment
of both type 1 diabetes (T1D) and type 2 diabetes (T2D).
• Marketing authorisation application was submitted to the
EMA for the approval of dasiglucagon for treatment of
severe hypoglycaemia.
Clinical progress
• Phase 3b trial, PIONEER PLUS, investigating 25.0 and 50.0 mg
oral semaglutide in patients with T2D was completed.
Phase 3b trial, ASCEND PLUS, investigating oral semaglutide
in patients with T2D and no history of prior myocardial
infarction (MI) or stroke was initiated.
⚫Phase 3b kidney outcomes trial, FLOW, investigating
subcutaneous once-weekly semaglutide 2.4 mg in people
with T2D and chronic kidney disease (CKD) was stopped early
based on interim analysis due to efficacy.
⚫ Phase 3a programme, REIMAGINE, investigating once-weekly
combination of semaglutide and cagrilintide in people with
T2D was initiated.
⚫ Phase 2 trial investigating the combination of semaglutide
and GIP in people with diabetes was completed. The project
was terminated.
⚫ Phase 1 trial investigating the effects of the combination of
semaglutide and SGLT2i inhibitor dapagliflozin in people with
T2D was completed. The project was terminated.
⚫ Phase 1 trial investigating the SOMA device for oral treatment
was completed.
⚫ Phase 1 trial investigating oral GLP-1/GIP co-agonist for
treatment of T2D was completed. Novo Nordisk is planning to
initiate a phase 2 trial with a subcutaneous formulation of the
GLP-1/GIP co-agonist.
•
OBESITY
Regulatory events
WegovyⓇ (semaglutide 2.4 mg) was approved for treatment
of obesity in adolescents by the EMA.
WegovyⓇ (semaglutide 2.4 mg) was approved as an adjunct
to diet and exercise for the use of weight management in
adults with obesity by the PMDA.
⚫ Results from the phase 3b cardiovascular outcomes trial
(CVOT) SELECT were submitted to the FDA and the EMA.
Clinical
progress
•⚫ Phase 3b CVOT trial, SELECT, investigating subcutaneous
once-weekly semaglutide 2.4 mg was completed.
⚫ Phase 3a trial, STEP HFPEF, investigating subcutaneous
once-weekly semaglutide 2.4 mg in people with HFPEF
was completed.
⚫ Phase 3a trial, OASIS 1, investigating oral semaglutide in
people with obesity was completed.
Phase 1/2 investigating NNC0165-1875 in combination
with semaglutide in people with obesity was completed.
The project was terminated.
• Novo Nordisk acquired Inversago Pharma, with lead assets
INV-202 (a phase 2 ready asset for treatment of obesity) and
INV-347 (a phase 1 ready asset for treatment of obesity).
RARE DISEASE
Regulatory events
• Marketing authorisation application was submitted to the
EMA for the approval of concizumab for treatment of
haemophilia A or B with inhibitors.
⚫ A Complete Response Letter requesting further information
was received from the FDA as a response to the concizumab
marketing authorisation application.
• Alhemo® (concizumab) was approved for the treatment of
haemophilia A or B with inhibitors by the PMDA.
Sogroya® (somapacitan) was approved for treatment of
growth hormone deficiency in children by the FDA, EMA
and PMDA.
⚫ Rivfloza™ (nedosiran) was approved for the treatment of
primary hyperoxaluria type 1 by the FDA.
Clinical progress
•
Etavopivat transitioned from phase 2 to phase 3 trial in the
ongoing seamless phase 2/3 HIBISCUS trial, investigating the
safety and efficacy of etavopivat in adults and adolescents
with sickle cell disease.
CARDIOVASCULAR & EMERGING THERAPY AREAS
Clinical progress
• Phase 3a trial, HERMES, investigating ziltivekimab in
people with HfpEF was initiated.
• Novo Nordisk acquired ocedurenone, a phase 3 oral
administrated small molecule, non-steroidal
mineralocorticoid receptor antagonist for treatment of
patients with uncontrolled hypertension and advanced CKD.
• Phase 1/2 trial investigating the ability of cell therapy HS-001
to restore heart function in people with advanced heart
failure was initiated in collaboration with Heartseed.
⚫ Phase 1 trial investigating ANGPTL3 mAb in people with
cardiovascular disease was initiated.
⚫ Phase 1 trial investigating the ability of cell therapy
STEM-PD to restore dopamine nerve cells lost in the brain
of people with Parkinson's was initiated in collaboration
with Lund University.
⚫ Phase 1 trial investigating STAT3 in people with tumour-
associated immune cells was initiated.
⚫ Phase 1 trial investigating VAPi-1 in people with MASH
was initiated.
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