ANNUAL REPORT 2021
LUNDBECK
ANNUAL REPORT 2021
= CONTENTS
9/111
LETTER TO
SHAREHOLDERS
Our Expand and Invest to Grow strategy
launched in 2019 is beginning to show
tangible results. We have made good
progress on expanding our early- and
mid-stage pipeline, based around our
expanded operating space. Our newest
strategic brand, Vyepti®, continues to
grow and gain momentum due to its
proven efficacy for patients.
We are well on our way with the strategic reorientation of our
business to discover and develop transformative medications for
indications in niche neurology and psychiatry treated by
specialists, and rare diseases in neurology, so we can best
deliver to patients and maintain a leadership position among
Europe based pharmaceutical companies of our size and scope.
As we continue to forge ahead with our Expand and Invest to
Grow strategy, we are pleased with our progress.
SHOWING GOOD GROWTH MOMENTUM
We are effectively maximizing our existing brands, showing
good growth momentum across all regions of the world. Our
newest launch, VyeptiⓇ is increasing pace in the U.S. and was
launched in the U.A.E. and Kuwait in 2021. It was also approved
in Canada, Australia, Singapore, Switzerland and is currently
under review in several countries around the world. We are
investing behind the global launch of VyeptiⓇ as our first
independent global launch.
We are expanding our brands through new indications
development for VyeptiⓇ in episodic cluster headache and
RexultiⓇ in agitation in Alzheimer's disease to further drive
growth. RexultiⓇ/RxultiⓇ was approved by the Food and Drug
Administration (FDA) in the U.S. after the submission of an
SNDA for the treatment of schizophrenia in pediatric patients 13
to 17 years of age.
Our largest brand, BrintellixⓇ/TrintellixⓇ, continues to grow, and
the most recent launch in Japan in 2019 has garnered 5.5%
market share in the anti-depressant market, just two years after
market entry.
ENSURING HIGHER PROBABILITIES OF SUCCESS
Three years ago, we set out to rebuild our pipeline and now we
have a more robust mid-stage pipeline, with several compounds
having moved into phase II in 2021. Multiple focused phase lb
studies are guiding the future development of other promising
compounds within an interesting phase I portfolio. Our journey
to transform research and development (R&D) has strong
momentum. Last year, we identified four biological clusters that
our therapies of the future would address. We have stringently
focused our R&D projects around these promising areas of
central nervous system (CNS) biology and have implemented
stronger derisking through experimental medicine and
biomarker approaches to ensure higher probabilities of success
as compounds eventually move towards the mid- and late-stage
pipeline.
To accelerate our advancements into neuroimmunology, we
acquired a promising CD40L inhibitor from AprilBio, with a
phase I study expected to start in 2022. Earlier in the year, we
entered a strategic partnership with Rgenta Therapeutics to
explore RNA-targeted therapies in our four biological clusters.
We are also continuing our joint phase III studies with Otsuka
Pharmaceutical Co., Ltd. (Otsuka) of brexpiprazole for agitation
in Alzheimer's disease and for the treatment of post-traumatic
stress disorder (PTSD).
PREPARING FOR THE FUTURE
As we execute our strategy, we will inevitably face challenges.
We are navigating a decline of revenue from NortheraⓇ post-
loss of exclusivity and VyeptiⓇ's pace of uptake has been
impacted by the pandemic. At the same time, we have ongoing
global industry changes that are putting increased pressure on
pricing.
We spent a good part of the year ensuring our business is best
prepared for the future to address these and other challenges
that may come our way. Although we have strong growth
prospects for the coming 5-7 years for the great portfolio of
existing brands we have today, we have taken steps to ensure
our business model and ways of working are most effective.
Using learnings from the pandemic and best practices in the
industry, we have taken action to reorient our business to
ensure it is better prepared to work using global technology
platforms and to develop globally available products. We have
also taken steps based on learnings from the pandemic to
ensure we are ready for a more digital future when it comes to
customer engagement.View entire presentation