Bavarian Nordic A/S
CSE:BAVA
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Good
day,
and
thank
you
for
standing
by.
Welcome
to
the
Bavarian
Nordic
Annual
Report
2021
Conference
Call.
At
this
time,
all
participants
are
in
a
listen-only
mode. After
the
speakers'
presentation,
there'll
be
a
question-and-answer
session.
[Operator Instructions]
Please
be
advised
that
today's
conference
is
being
recorded.
[Operator Instructions]
I
would
now
like
to
hand
the
conference over
to
your
speaker
today,
Rolf
Sørensen.
Please
go
ahead,
sir.
Yeah.
Thank
you,
operator.
And
good
morning
to
some
of
you
and
good
afternoon
to
the
rest
of
you,
and
welcome
to
this
full
year
presentation
2021
of
Bavarian
Nordic.
And
as
usual,
I
have
with
me
here
the
A-team,
President
and
CEO,
Paul
Chaplin; and Executive
Vice
President
and
CFO,
Henrik
Juuel.
And
before
we
start
our
presentation,
I
just
want
to
quickly
go
through
the
forward-looking
statements.
This
presentation
includes
forward-looking
statements
that
involve
risks,
uncertainties
and
other
factors,
many
of
which
are
outside
of our
control
that
could
cause
actual
results
to
differ
materially
from
the
results
discussed.
Forward-looking
statements
include
statements
regarding
our
short-term
objectives,
opportunities,
financial
expectations
for
the
full
year
and
financial
preparedness
as
of
year-end,
as
well
as
statements
concerning
our
plans,
objectives,
goals,
future
events,
performance
and
other
information
that
is
not
historical
information.
All
such
forward-looking
statements
are
expressly
qualified
by
these
cautionary
statements.
We
undertake
no
obligation
to
publicly
update
or
revise
forward-looking
statements
to
reflect
subsequent
events
or
circumstances
after
the
date
made,
except
as
required
by
law.
So,
with
this,
I
will
hand
the
presentation
over
to
Paul
Chaplin.
Thanks,
Rolf.
And
welcome,
everyone,
to
our
investor
call. If
you
turn
to
slide
3,
I'd
like
to
start
with
just
a
few
high
level
observations
before
I
move
on
and
talk
about
the
great
progress
we
made
in
2021
and
the
exciting
steps
we
have
ahead
of
us
during
this
year.
So,
back
in
2020,
when
we
expanded
our
commercial
portfolio
with
the
acquisition
of
our
two
new
products;
one
against
rabies
and
one
against
TBE,
we
said
at
the
time
that
we
wanted
to
build
up
our
commercial
infrastructure
to
drive
profitable
growth,
but
at
the
same
time,
we
came
out
with
a
vision
that
by
2025
we
want
to
be
one
of
the
largest
pure-play
vaccine
companies.
And
to
do
that,
we
had
to
broaden
our
commercial
portfolio
and
bring
more
products,
either
through
our
R&D
innovation
or
through
additional
M&A.
Last
year,
we
were
lucky
to
be
able
to,
through
capital
raises,
raise
money
from
our
investors
who
wanted
to
support
us
in
this
endeavor
to
become
one
of
the
largest
pure-play
vaccine
companies
and
through
funding
through
the
Danish
Government.
We're
now
in
a
rather
privileged
position
that
through
these
huge
advances
that
we've
made
in
our
pipeline
during
last
year
we're
in
a
position
that
we
can
make
strategic
investments
in
two
blockbuster
indications
that
will
springboard
us
to
achieving
our
vision
of
becoming
this
pure-play
vaccine
company
by
2025.
The two
programs
that
we'll
be
investing
heavily
in
in
2022,
I'll
come
back
to
in
more
details,
but
that's our
innovative
RSV
program
that
would
be
entering
Phase
3
and
our
COVID-19
program,
ABNCoV2,
which
is
funded
through
the
Danish
Government.
Both
these
programs
have
generated
really
exciting
data
during
2021
that
I'll
remind
you
of
in
the
coming
slides
and
have
really
met
the
threshold
to
invest
and
move
forward
to
launch
in
the
coming
years.
In
addition
to
these
R&D
investments,
we
will
continue
to
invest
in
our
manufacturing
infrastructure
that
will
allow
us
to
bring
our
commercial
assets,
the
manufacturing
of
our
commercial
assets
in-house
and
will
set
the
ground
stone
for
us
to
be
able
to
manufacture
life-saving
vaccines
in
the
future.
So,
we
are
transitioning
to
a
really
exciting
stage
in
Bavarian
Nordic
where
we're
investing
in
our
strategic
assets
to
secure
future
growth.
And
when
we
came
out
with
the
desire
to
move
to
a
commercial
entity
with
profitable
growth,
we
did
indicate
that
there
would
be
temporary
periods
where
we
may
be
loss-making
as
we
would
have
to
make
significant
investments
to
be
able
to
achieve
the
vision
of
becoming
one
of
the
largest
pure-play
vaccine
companies.
So,
if
we
go
to the
next
slide,
slide
4,
2021
was
a
remarkable
year
in
many
respects
and
will
probably
remembered
most
for
the
two significant
advances
we
made
in
our
pipeline.
We
reported
fantastic
data
for
ABNCoV2,
our
COVID-19
vaccine,
which
also
coincided
with
funding
from
the
Danish
Government,
which
has
now
secured
our
ability
to
move
this
program
to
launch,
which
hopefully
will
happen
next
year.
On
RSV,
we
also
reported
efficacy
data,
which
is
highly
competitive.
The
US
authorities
have
recognized
our
excellent
data
with
a
breakthrough
designation,
and
we're
now
gearing
up
to
move
into
Phase
3
following
the
generous
support
of
our
existing
shareholders.
On
the
commercial
side,
yes,
we
still
hit
headwinds
due
to
COVID-19
on
some
of
our
sales
activities
for
different
reasons.
Our
rabies
is
a
travel
vaccine
here
in
Europe,
which
has
been
heavily
impacted
due
to
the
travel
restrictions.
And
on
TBE,
there
was
a
restriction
or
availability
to
physicians
in
Germany,
one
of
our
key
markets.
However
fortunately,
last
year
we
were
able
to
secure
revenues
from
our
smallpox
and
Ebola
business
that
really
allowed
us
to
fulfill
and
achieve
our
guidance
for
2021.
So,
if
we
go to
the
next
slide,
slide
5,
I
want
to
talk a
little
bit
about
the
investments
that
we
have
made
and
will
continue
to
make
in
our
manufacturing
site
here
in
Denmark.
It
really
has
expanded
over
the
last
few
years.
We've
completed
the investment
in
a
state-of-the-art
fill-finish
facility.
The
first
commercial
product
was
transferred
and
we
manufactured
our
first
doses
of
our
smallpox
vaccine,
which
we
invoiced
last
year
to
the
US
Government.
We
continue
to
do
tech
transfers
into
that
facility,
both
for
our
rabies
products,
our
Rabipur/RabAvert
and
also
our
freeze-dried
smallpox
version.
We
are
currently
expanding
the
bulk
facility
to
allow
us
to
take
in
Encepur
and
Rabipur
in
the
coming
years.
And
due
to
that
expansion,
we've
had
to
actually
close
the
facility
for
approximately
a
year,
started
last
year
and
it
will
be
opened
again
later
this
year
in
the
autumn.
And
that
actually
has
an
impact
on
our
ability
to
continue
to,
obviously,
manufacture.
So,
we
will
not be
able
to
manufacture
bulk
for
the
US
Government
during
2022 or
Ebola
orders
for
our
partner
Janssen,
which obviously –
and
Henrik
will
get
to
that
in
the
coming
slides –
has
impacted
guided
revenue
for
2022. However,
all
these
investments
are
going to
allow
us
to
manufacture
our
commercial
portfolio
in-house
and
is
the
cornerstone
and,
I
would
say,
the
foundation
to
allow
us
to
become
one
of
the
pure-play
vaccine
companies
in
the
coming
years.
If
we
go
to
the
next
slide,
as
I
said,
we're
in
a
rather
privileged
position
in
that
we've
got
two
extremely
exciting
assets,
both
in
blockbuster
indications,
which
are
ready
for
Phase
3.
As
I
said,
through
the
support
of
our
investors,
but
also
through
funding
from
the
Danish
Government,
we
have
the
funds
to
execute
on
these
Phase
3
programs
and
bring
these
products
to
market.
Both
these
products
are
in
blockbuster
indications.
They
will
through
these
investments
secure
future
growth
and
allow
us
to
bring
true
life-saving
vaccines
to
the
market.
This,
however,
does
mean
that
we
have
to
make
significant
investments.
And
we'll
be
investing
close
to
DKK
2
billion
in
R&D
in
the
coming
year,
and
that,
of
course,
has
a
massive
impact
on
our
guidance
for
this
year.
The
revenue,
as
I
said,
is
slightly
lower
than
it
was
last
year
due
to
the
facility
closure,
and
obviously,
our
R&D
investments
are
increasing
by
four-fold,
which
means
we
are
in
a
temporary
loss-making
period.
But
as
I
said,
these
investments
were
planned
and
will
allow
us
to
secure
the
future
growth
in
the
years
ahead.
So,
if
we
skip
a
couple
of
slides
and
move
to
ABNCoV2.
I
often
get
the
question,
what
is
the
future
market
for
COVID
now
that
society
is
opening
up
again,
the
sun
is
shining
and
we're
all
feeling
much
better
about
our
life
moving
forward.
And
I
would
remind
all
of
you
that
asked
me
that
question,
I
was
asked
the
same
question
this
time
last
year,
that we
were
too
late,
there
was
no
real
need
for
a
new
vaccine
and
then,
unfortunately,
as
the
year
progressed,
we
all
realized
with
the
emergence
of
Omicron
that
we
were
going
back
into
lockdown
and
we
all
needed
a
new
booster.
The
data
that
is
being
generated
through
the
booster
programs
around
the
world
is
already
beginning
to
indicate
that
the
neutralizing
titers
or
the
efficacy
is
waning
six
months
later
and
most
people
are
predicting
that
we
will
need
another
booster
later
this
year
and
most
people
believe
that
with
current
batch
of
vaccines
that
we
will
probably
be
moving
to
annual
boosters
particularly
for
risk
groups
and
elderly
subjects.
And
that's
one
speculation that
that's
how
the
market
will
develop
into
a
flu-like
market
where
elderly –
unfortunately,
that
probably
includes
myself –
and
risk
groups
will
be
vaccinated.
However,
there
could
be
other
vaccines
to ABNCoV2
that
give
you
longer-lasting
protection,
and
that
market
will
then
develop
into
more
of
a
shingles
[indiscernible]
(00:12:21) market
where
elderly
and
risk
populations
need
regular
boosters,
but
more
likely
every
three
to
five
years.
And
how
that
market
develops
we'll
only
be
able
to
tell
you
as
the
data
is
generated.
But
it's
certainly
a
huge
unmet
medical
need
for
improved
vaccines
and
there's a
huge
commercial
opportunity
that
lies
ahead
of
us.
If
we
go
to
the
next
slide,
we
have
already
reported
some
of
the
Phase
2
data
last
year.
And
if
I
just
remind
you
of
the
trial
design
at
the
bottom
left,
there
were
three
groups; two
groups
that
were
seropositive,
meaning
they've been
previously
vaccinated
that
received
a
single
booster
of
either
100 micrograms
or
50
micrograms –
and
we've
already
reported the 100
microgram
data
and
shown
that
data –
and
there
was
a
seronegative
group
that
received
two
vaccinations
of
100 microgram
four
weeks
apart.
We
have
now
completed
this
study
and
reported
the
data
a
few
weeks
ago.
And
essentially,
we
see
in
the
booster
indication
very,
very
strong
booster
responses
against
all
the
tested
variants
of
concern,
and
I'll
show
that
data
in
coming
slides.
No
real
difference
between
50
micrograms
and
100
micrograms;
both
showing
very
strong
booster
responses.
For
various
reasons
that
I'll
get
to
in
the
coming
slides,
we
have
selected
the
100 microgram
dose
to
move
forward
into
Phase
3.
And
we
believe
we've
met
the
threshold
now
to move
into
Phase
3,
as
we
have
secured
the
Phase
3
trial
design
with
the
authorities,
and
we
believe
we've
met
the
data
threshold
to
move
forward.
So,
if
we
go
to
the
next
slide,
slide
10,
this
is
a
reminder
of
the
data
that
we've
already
shared
with
all
of
you
with
the
100 micrograms.
This
is
a
booster
indication,
given
a
single
vaccination.
It's
a
bit
busy.
But
if
you
look
at
the
far
left
graph,
the
overall
response,
here
you
can
see
that we
see
a
strong
booster
response
to
titers
that
are
typically
indicative
of
protective
titers
greater than
90%.
And
the
fold
increase
and
the
titer
increases
vary
depending
on
the
starting
titers,
which
are
the
next
three
graphs,
but
the
overall
picture
doesn't
really
change.
We
can
boost
the
memory
response
induced
by
either
previous
RNA
vaccine
or
adenovirus
vaccine
to
extremely
high
protected
levels
with
a
single
vaccination
of
ABNCoV2.
If we
go
to
slide
11,
again,
this
is
a
reminder,
we
see
very
strong
booster
responses
to
all
the
variants
that
we
evaluated,
including
Delta,
which
isn't
included
on
this
slide,
which
again
is
a
differentiating
factor
to
the
existing
batch
of
vaccines.
They
vary
greatly
in
their
ability
to
generate
strong
neutralizing
titers
to
all
variants.
ABNCoV2
appears
to
be
able
to
do
that.
We
are
still
moving
ahead.
We're
generating
data
against
Omicron.
The
reason
why
we
believe
we
can
move
forward
with
the
decision
for
Phase 3
is
simply
that
Phase
3
is
design is
a
non-inferiority to
an
RNA-based
vaccine,
based
on
the
original
Wuhan's
isolate.
If we
go
to
slide
12,
this
is
the
data
between
the
two
different
doses; the 100
micrograms,
which
I've
already
shown
you;
and
the
new
data,
the 50
micrograms.
You'll
see
that
the
responses
look
incredibly
similar
in
terms
of
the
titers
that
are
generated;
again,
titers
associated
with
very
high
levels
of
efficacy,
greater
than
90%.
There
was
no
difference
in
the
safety
profile
between
the
two
doses.
So,
no
advantage
to
go
to
a
lower
dose
regarding
safety.
There
were
no
differences
in
the
responses
against
the
variants
of
concern
we've
evaluated.
So,
again,
the
same
results that
I've just shown you.
However,
a
sub-analysis
looking
at
the
time
since
the
booster
vaccination –
since
the
last
vaccination
with
RNA,
or
the
initial
starting
titer,
really
imply
that
the
higher
dose
trended
towards
higher
neutralizing
titers.
And
it's
for
that
reason
we've
decided
to
move
ahead
into
Phase
3
later
this
year
with
100
micrograms
dose.
Slide
13.
This
is
the
third
group,
which
is
people
that
are
seronegative,
has
not
been
previously
vaccinated,
and
they
received
two
vaccinations
at
week
0
and at
week
4.
And
just
as
in
the
Phase
1,
we
saw
extremely
high
titers
after the
second
vaccination,
again,
to
titers
greater
than
90%
efficacy.
So,
again,
confirming
the
data we
reported
last
year
in
Phase
1 for people
that
are
seronegative.
So,
ABNCoV2
is
really
performing
at
all
levels;
strong
booster
responses,
very
high
titers,
similar
titers
to
all
variants
of
concern
and
in
the
seronegative,
really a
strong
vaccine
with
two
shots.
If
we
go
to
slide
14, if
we
talk a
little
bit
about
the
Phase
3,
as
I
said,
we've
been
in
discussions
with
most
of
the
regulators,
particularly
in
Europe.
And
we
have
a
Phase
3
design
that
we've
agreed,
which
will
be
a
non-inferiority
study
comparing
the
neutralizing
titers
stimulated
by
ABNCoV2
to
an
mRNA-based
vaccine. The
Phase
3
manufacturing
is
advancing
as
planned.
The
bulk
or
drug
substance
is
already
manufactured.
And
in
fact,
the
first
doses
were
also
filled
and
finished
this
week
at
our
facility
in
Denmark.
So,
we
are
completely
on
track
and
online
to
initiate
the
Phase
3
study
in
the
first
half
of
this
year,
with
data
being
reported
later
this
year
and
beginning
to
file
for
approval
by
year-end.
So,
we
should
be
seeing
pivotal
results
later
this
year
with a
view
that
launch
will
occur
in
2023.
Again,
if
we
just skip
a couple
of
slides
and
move
to
slide
16,
change
now
and talk
about
our other
blockbuster
indication,
which
is
RSV.
As
you
know,
we've
been
developing
this
vaccine
for
a
number
of
years
now.
We've
completed
a
number
of
different
clinical
studies
that
we've
published
and
reported.
We've
shown
excellent
efficacy
in
the
human
challenge,
and
that's
on
the
back
of
showing
very
strong
immune
responses,
broad
immune
responses,
both
antibodies
and
T
cells.
And
this
data
is
so
impressive
that
the
FDA
have
granted
Breakthrough
Designation,
which
means
we
can
get
fast
track
and
priority
review.
And
as
I
said,
we're
now
moving
forward
with
a
Phase
3
design
that
we've
also
had
discussions
and
approval of
with
the
regulators.
One
other
thing
I
would
like
to
say
on
the
summary
slide
is
that,
of
course,
while
we
have
the
financial
freedom
right
now
to
advance
this
Phase
3
program,
we
are
looking
for
commercial
partners
and
we
will
continue
to
do
so.
However,
having
the
cash in
hand
means
that
we
can
take
our
time
and
find
the
right
partner.
There
are
some
territories
in
the
world
where
we
may
need
to
get
moving
sooner
rather
than later,
where
additional
clinical
studies
might
be
required
to
work
together
with
a
partner
in
certain
territories
like
Japan
for
example.
So,
there,
you
may
see
that
we
do
partnering
deals
in
certain
territories.
We
may
also
be
looking
for
a
global
partner.
But
as
I
said,
it
is
also
open
that
there
may
be
different
partners
in
different territories
of
the world.
Going to
the
next
slide,
slide
17,
this
is
just
a
reminder
of
the
efficacy
data
we
reported
last
year.
This
is
from
a
human
challenge
study.
We
showed
a
significant
reduction
in
the
viral
load, which
was the
primary
endpoint,
and
we
showed
an
ability
to
prevent
RSV
symptoms
to
almost
an 80%
efficacy
in
these
subjects.
So,
really
impressive
efficacy
data
for
a
vaccine
that
already
has
a
very
impressive
dataset
in
terms
of the
immune
responses
and
certainly
fulfills
the
criteria
for
moving
to
Phase
3.
So,
if
you
go
to
the
my last
slide,
slide 18,
the
Phase
3
design
that
we've
agreed
with
the
authorities
will
be
in 20,000
subjects, 10,000
receiving
our RSV
vaccine
and 10,000
receiving
placebo.
Right
now,
it
looks
as
if
we
will
be
enrolling
both
in
the
US
and
Germany,
and
we
plan
to
initiate
this
study
in
the
first
half
of
this
year.
As
I
said,
this
is
a
significant
investment,
but
it's
one
that
has
met
the
criteria
based
on
the
dataset
that
I've
walked
you through
and
it
really
is in
a
blockbuster
indication.
And
although
competition
is
hot,
the
market
is
significant
and
multiple
RSV
vaccines
are
most
likely
needed.
And
we
truly
believe
with
the
data
that
we've
generated,
we
may
have
an
advantage
as
our
vaccine
is
a
very
strong
inducer of
T
cells
and
T
cells
is
widely
reported
as
being
the
component
of
immune
response
that
prevents
severe
disease.
So,
a
really
exciting
year
ahead
where
we're
investing
in
two
pivotal
studies
that
will
springboard
us
to
our
vision
to become
one
of
the
largest
pure
play
vaccine
companies.
And
with that, I'll hand over to Henrik Juuel.
Thank
you,
Paul.
And
I
think,
as
usual,
we
will
start
with
taking
you
through
the
commercial
performance
for
2021.
So,
on
slide
20,
you
will
see
a
breakdown
of
our
total
revenue
for
2021.
We
achieved
consolidated
total
sales
of
close
to
DKK
1.9
billion,
exactly
in
line
with
our
guidance
for
2021.
As
Paul
alluded
to
previously,
we
did
face
continued
headwinds
against
Encepur,
Rabipur
and
RabAvert
markets
due
to
COVID.
I
will
come
back
to
that
in
more
detail.
But
as
you
will
see
on
the
table
to
the
right
here, we
benefited
from
our
diversified
portfolio
with
JYNNEOS/IMVANEX,
our
smallpox
business
and
our
Ebola
business
in
particular
being
much
more
resilient
to
sort of the
COVID
situation.
So,
if
you
see
our
smallpox
business
that's
JYNNEOS/IMVANEX,
we
had
a
total
revenue
level
of DKK
734
million
for
2021.
So,
it was
a
good
year.
Behind
those
numbers,
we
have
approximately
DKK 90
million
of
revenue
to
a
handful
of
European
markets
and
the
rest
really
comes
from
both
manufacturing
of
bulk
to
the US
government,
but
also
the
first
liquid-frozen
finished
product
filled
at our
own
site
in
Kvistgaard.
So, DKK
1.9
billion
approximately
in
line
with the
guidance
and
slightly
ahead
of
the
level
we
saw
in
2020.
On
the
next
slide,
let's
dig
into
some
of
the
details
on
the –
first
of
all
the
rabies
vaccine.
So,
if
we
start
with
the
upper
left
part,
we
look
at
the
US
rabies
market,
this
is
a
market
that
has
during
COVID
been
impacted
both
on
the
post-exposure
and
the
pre-exposure
part,
but
we
have
actually
seen
some
signs,
good
signs
of
recovery.
And
if
we
look
at
the
full year of
2021,
we're
actually
looking
at
a
growth
rate
of
13%
compared
to
2020.
So,
good
growth
and
some
good
signs
in
the
last
quarters
here
promising
well
for
the
future
to
come.
But
of
course,
if
you
look
at
the
fourth
quarter of 2021
in
isolation,
we
see
we
are
still
behind
the
pre-COVID
market
levels.
So,
there
is
some
catching
up
to
do,
but
good
signs
of
recovery.
Then,
next
is
Germany,
which
we
use
as
a
good
proxy
for
the
market
performance
in
Europe.
In
Europe,
I
think
the
rabies
vaccine
is
a
pure
travelers'
vaccine,
and
therefore,
have
been
extremely
hard
hit
by
COVID-19.
And
we
have
actually
seen,
if
you
just
do
the
year-over-year
comparison
again,
a
decline
of
55%.
But
if
you
look
at
the
details,
you
will
also
see
that
the
second
half
of
2021,
we
are
starting
to
see
signs
of
recovery
also
in
Germany,
however,
from
a
very
low
level
of
course.
And
when
we
look
at
the
minus
55%
compared
to
2020,
a
lot
of
that
is
of
course
explained
by
the
first
quarter
of
2020, which
was
before
COVID
really
had
an
impact
on
the
rabies
business.
So,
also
signs
of
recovery
in
the
German
markets,
but
coming
from
a
very
low
base
obviously.
So,
to
the
right
on
this
graph,
we
just
look
at
our
performance
of
DKK 506
million
for
the
full-year,
19%
down
compared
to
last
year,
and
that
is
of
course
explained
by
the
continued
impact
from
COVID,
US
market
being
the
exception
to
the
decline
we
have
seen.
And
then,
it
is
also
explained
by
the
expected
market
share
drop
in
the
US
where, over
the year
2021,
our
market
share
changed
from
75%
to
70%,
which
was
in
line
with our
own
expectations,
as
this
is
caused
by
a
competitor
being
back
after
stock-out
situation.
We
still
hold
a
higher
market
share
than
prior
to
the
stock-out
situation.
On
slide
22,
if we
look
at
the
TBE
vaccine
market,
the
TBE
business
is
entirely
a
European
business.
It's
an
endemic
vaccine.
So,
it's
not
as
such
impacted
by
traveling.
But
unfortunately,
what
we
have
seen
is
that
the
market
has
still
been
impacted
by
COVID,
as
in
particularly
in
Germany
but
also
some
of
the
other
key
markets
the
physicians
have
been
occupied
with
COVID
vaccinations
and
there
hasn't
been
the
same
kind
of
access
to
vaccinations
as
we
saw
pre-COVID.
So,
therefore,
in
Germany,
we
have
seen
a
drop
in
the
market
compared
to
2020
of
13%.
And
if
you
look
at
just
quarter-by-quarter
back
to
2020,
we
are
still
5%
behind
last
year
and
12%
behind
the
pre-COVID
level.
So,
there is
definitely
some
catching
up
to
be
done
here.
We
delivered
DKK
363
million
in
total
revenue
for
the
year,
which
is
20%
below
the
prior
year,
explained
by
the
market
declines
and
some
wholesaler
and
partner
inventory
movements.
I
think
on
the
positive
side,
I
think
during
this
turbulent
time,
we
have
managed
to
remain
pretty
stable
market
share
around
31%
in
Germany.
On
slide
23,
an
overview
of
our
full
P&L. As
said,
total
revenue
close
to
DKK
1.9
billion
and
in
line
with
our
guidance.
Production
cost
of
approximately
DKK
1.3
billion,
and
here,
I
need
to
mention
that
this
includes
inventory –
or
provisions
for
inventory
write-downs
caused
by
COVID-19.
Some –
or
most
of
that
provision
really
covers
expected inventory
write-offs
in
the
future,
given
what
we
have
on
stock
and
the
orders
that
we
have
placed
with
GSK.
R&D,
DKK
399
million,
so
up
from
last
year
and
really
explained
– up
from
2020,
I
should
say,
sorry,
and
the
increase
explained
by
the
investments
in
RSV already
last
year,
where
we
manufactured
the
clinical
trial
material,
and
we
also
started
pre-spending
on
the
Phase
3,
so
we
could
be
ready
this
year.
SG&A
costs,
DKK
485 million,
below
the
2020
level and
mainly
explained
by
lower
distribution
costs.
That's
a
consequence
of
us
taking
over all
the
markets
from
GSK.
Adding
all
of
this
up
gives
an
EBITDA
of DKK
75
million
against
our
guidance
of
DKK
70
million
for
2021,
so
slightly
better
than
what
we
had
guided.
Slide
24,
cash
flow
and
balance
sheet.
On
the
cash
flow
side,
net
cash
flow
for
the
period
ended
positive
at
DKK
300
million
approximately,
which
was
composed
of
negative
cash
flow
from
operating
activities
primarily
explained
by
a
negative
net
profit,
but
also
some
increases
in
working
capital
following
a substantial
revenue
that
we
recognized
in
December
and
where
we
will
receive
the
money
here
during
the first
quarter.
Cash
flow
from
investment
activities
includes
many
items.
For
instance,
payments
– continued
payments
to
GlaxoSmithKline
that
follows
along
with
reaching
certain
milestones;
continued
investments
in
our
manufacturing
and
also,
let's
say,
transfer
of
Rabipur/RabAvert
and
Encepur;
and
then
also
capitalized
costs
related
to
our
COVID-19
vaccine.
In
this
amount
for
the
investment
activities,
approximately
DKK 1.7
billion
of
net
investment
in
securities
is
also
included.
That
is
us
placing
our
cash
in
safe
securities.
Cash
flow
from
financing
activities
is
of
course
heavily
impacted
by
the
capital
raise
we
did
in
2021.
It's
also
impacted
by
the
funding
agreement
we
did
with
the
Danish
Ministry
of
Health.
We
did
receive
DKK
160
million last
year
out
of
the
total
agreement
of
DKK 800
million.
So,
again,
ending
up
with
net
positive
cash
flow of
DKK
300
million,
but
really
I
think
you
should – to
understand
what
capacity
we
have
and how
liquid
we
are,
you
should
really
add
back
the
investments
we've
done
in
securities,
approximately
DKK 1.7
billion.
To
the
right
is
our
selected
balance
sheet
figures.
In
respect
of
time
here,
I
will
focus
on
our
cash
situation
at
the
end.
So,
if
you
look
at
the
line
securities,
cash
and
cash
equivalents, DKK
3.7
billion.
That
includes DKK
500
million
from
a
repo
transaction
with
the
bank,
which
should
really
be
excluded
when
trying
to
understand
the
cash
position
against
the
guidance.
So,
that
takes
us
to
DKK
3.2
billion
against
a
guidance
of
DKK
3.1
billion.
So,
slightly
ahead
of
what
we
guided
for
2021.
Our
outlook
for
2022,
as
Paul
alluded
to,
I
think
these
are
numbers
that
are
heavily
impacted
by
the investments
that
we
are
making
in
the
future
and
in
our
pursuit
of
our
vision
to
become
one
of
the
largest
pure
play
vaccine
companies.
We
are,
for
2022,
guiding
revenue
in
the
range
between
DKK
1.1
billion
and
DKK
1.4
billion.
The
midpoint
of
this
interval here
really
assumes
a
partial
return
to
normality
for
the
TBE
market
and
the
rabies
market,
and
a
somewhat
slower
return
to
the
normality
for
the
European
rabies
market
where
this
is
a
pure
travelers'
vaccine.
We
have –
in
this
revenue
guidance,
we
have
not
included
any
orders
that
have
not
been
confirmed
with
the
US
government,
which
means
that
what
is
included
is
an
order
we
already
received
of
DKK
100
million
approximately,
and
then
also,
as
previously
announced,
our
order
with
the
Public
Health
Agency
of
Canada
amounting
to
DKK
203
million.
So,
no
additional
orders
to
BARDA
is
included
in
our
revenue
guidance.
And
as
Paul
also
said,
quite
in
line
with
our
plans,
we
had
to
shut
down
the
bulk
facility
in
Kvistgaard
starting
the
autumn
last
year,
and
that
will
end
in
the
autumn
of
2022,
which
means
that
our
ability
to
manufacture
bulk
both
for
our
smallpox
business
but
also
for
our
Ebola
businesses
is
quite
limited
for
2022.
I
think
even
if
we
manufacture
bulk
for
any
of
these
two
business
areas,
it
will
happen
so
late
that
we
would
not
be
able
to
revenue
recognize
it
in
2022.
So,
that
explains
part
of
our
revenue
guidance
for
2022.
Also,
I
have
to
say
that
we
have
included
also
in
the
revenue
guidance
limited
revenue
from
our
partner
agreements
with
Valneva
and
Dynavax.
As
we
have
announced
previously,
we
have
– earlier
this
year,
we
have
launched
two
traveler
vaccines
from
Valneva,
Ixiaro
and
Dukoral,
and
we
are,
later
during
this
first
half year,
going
to
launch
Heplisav-B
from
Dynavax.
[ph]
That
work
(00:35:19) is
going
to
be
a
real
launch
of
a new
product
in
Europe.
We
have
not
included
any
potential
income
from
RSV
partnering
in
our
financial
numbers
as
well,
and
as
Paul
alluded
to,
we
are
still
pursuing
a
strategy
of
finding
commercial
partners
to
our
RSV
assets.
Our
heavy
investments
in
R&D,
which
is
approaching
DKK
2
billion
or
more
than
4
times
a
normal
year
for
Bavarian
Nordic,
of
course
impacts
our
EBITDA
significantly.
We
are
capitalizing
the
investments
in
R&D
for
ABNCoV2.
So,
that
will
not
appear
on
the
R&D
line
once
we
have
a
full
P&L
for
2022. But
still,
it
is
more
than
DKK
1.2
billion
that
will
be
visible
on
the
R&D
line
for
the
full
year
of
2022.
So,
quite
heavily
impacted
by
the
investments
in
R&D
when
we
look
at
the
EBITDA
guidance
of
where
we
are
guiding
a
loss
between
DKK
1
billion
and
DKK 1.3
billion.
We
do
hold
a
very
strong
cash
position,
thanks
to
the
capital
raises
we
did
last
year
and
the
support
from
the
Danish
government
really
enabling
us
to
pursue
our
strategy
and
invest
in
the
future
and
still
leave
a
good
cash
position
by
the
end
of
2022
of
DKK
1
billion
to
DKK
1.2
billion.
Next
slide,
slide
26,
is
the
final
slide
just
to
give
you
a
quick
update
on
some
of
the
key
strategic
objectives
for
2022.
And
Paul
actually
already
talked
to
most
of
these.
And
of
course,
some
of
the
very
important
ones
will
be
both
RSV
and
COVID-19.
We
are
soon
going
to
start
Phase
3
on
these
two
very
important
assets
targeting
potential
blockbuster
markets.
So,
on
RSV,
we
will
initiate
the
Phase
3
during
first
half
this
year
and
complete
enrollment
by
the
end
of
the
year.
And
in
parallel,
we
will
continue
to
prepare
for
commercial
launch,
which
both
involves
being
prepared
from
a
manufacturing
site
regulatory-wise,
but
also
from
a
commercial
perspective.
On
COVID-19,
same
thing,
we
are
soon
going
to
initiate
the
enrollment
into
a
Phase
3
study
and
we
will
be
able
to
report
the
data
in
the
second
half
of
2022,
same
time
prepare
for
the
regulatory
submission
and
start
preparing
for
commercial
launch.
Again,
this
involves
scaling
up
manufacturing,
be
prepared
to
supply
commercial
goods
and
also
be
prepared
from
a
commercial
perspective.
And
again,
we
continue
our
work
on
the
freeze-dried version
of
our
smallpox
vaccine,
JYNNEOS,
which
eventually
will
unlock
the
option
we
have
with
the
US
government
of
$299
million
that
we
will
be
able
to
revenue
recognize
over
the
next
years.
Within
the
manufacturing
side,
I
think
this
is
all
about
continuing
the
transfer
of
our rabies
and
TBE
vaccines
into
our
plant
in Kvistgaard.
And
specifically,
for
2022, I
think
one
of
the
key
targets
would
be
to
complete
the
qualification
of
the
packaging
of
these
products.
We
will
also
complete
the
investments
in
the
expansion
of
the
bulk
facility,
so
that
that
is
ready
for
transferring
the
manufacturing
of
the
bulk
of
these
products
for
the
future.
Within the
commercial
area,
it's
all
about
defending,
gaining
market
shares
for
our
commercial
products
and
continue
improving
the
awareness
of
Bavarian
Nordic
among
the
key
stakeholders
in
the
market.
And
then,
as
I
already
mentioned,
we
have
already
assumed
marketing
and
distribution
responsibility for
Ixiaro
and
Dukoral
from
Valneva
and
we
are
going
to
launch
Heplisav-B
in
Germany
in-licensed
from
Dynavax.
So,
with
that,
I
will
just
end
up
by
saying
that
this
is
really
going
to
be
a
pivotal
year
for
Bavarian
Nordic.
First
time
ever
are
we
going
to
run
two
significant
Phase
3
trials
in
parallel
targeting
potential
blockbuster
markets.
And
by
this,
I
think
we
are
really
fueling
our
vision
to
become
one
of
the
largest
pure
play
vaccine
companies.
I
think
with
that,
I
will
give
the
word
back
to
the
operator
and
ask
you
to
open
up
for
Q&As,
please.
Thank
you.
[Operator Instructions]
Your
first
question
today
comes
from
the
line
of
Thomas
Bowers
from
Danske
Bank.
Please
go
ahead.
Your
line
is
open.
Yes.
Great.
Thank you
very
much.
I
think
I'd
kick
off
with
a
couple
of
JYNNEOS
questions
here.
So,
first
of
all,
I
understand
that,
you
can
say,
the
freeze-dried
BLA
has
been
postponed
until
2023.
So, I'm
just
wondering
if
you
can
add
a
bit
of
color
on
the
reason
behind
this.
I
understand
it's
related
to
FDA
inspection.
So,
the
reason
behind
the
change,
and
maybe
even
more
importantly,
does
it
sort
of
change
how
we
should
think
of
BARDA
revenue
under
this
$299
million
US
contract?
So,
of
course,
primarily
timelines
and
potential
revenue
recognition
impact
for
2023,
now
I
guess
we
should
expect
FDA
approval
to
happen
not
before
2024.
And
then,
just
in
addition
to
this,
you
already
have
produced
a
lot
of
bulk
material
ahead
of
the
freeze-dried
approval.
So,
this
revenue
that
you
do
not
recognize
in
your
2022
guidance
yet,
so
is
this
potentially
additional
bulk
contracts
or
is
it
something
related
to
the
freeze-dried
instead,
so more
related to maybe
some
milestones?
So,
just
wondering
if
there's
any
potential
for
revenue
recognition
on
top
of
this
DKK
100
million
you
have
included
in
your
guidance
from
BARDA?
And
then
lastly,
just
maybe
as
a
reminder –
maybe
I
just
forgot.
But
just
on
the
potential
DOD
contracts,
is
there
any
immediate
hurdle
steps
that
still
needs
to
overcome for
this
actually
to
materialize
at
some
point?
Thank
you.
Yeah.
Thanks,
Thomas.
Let
me
start
with
the BLA.
So,
yes,
I
think
we
provided
a
little
bit
more
of
an
update
in
the
material
that
the
freeze-dried
JYNNEOS
probably
now
looks
like
the
approval,
as
you
just
highlighted,
will
be
pushed
out
to
2024.
The
change
is
driven
basically
by
the
fact
that
the
FDA
wants
to
do
one
inspection
both
for
the
liquid,
which
we
already tech
transferred
but
also
the
freeze-dried.
So,
we've
had
to
adjust
some
of
the
freeze-dried
activities
to
fit
in with
when
the
FDA
anticipates
to
be
here, because
they
want
to
see
some
actual
activities
while
they're
here.
So, that's
the
main
reason
for
the
change.
Will
that
have
an
impact
on
our
ability
to
revenue
recognize?
Well,
it's
a
little
bit
like
all the
bulk
and
the
previous
liquid-frozen
doses
that
we
received
and
revenue
recognized
last
year, it
has
no
impact.
So,
we
will
be –
if
the
option –
that's
the
other
slight
caveat.
If
the
option
is
exercised,
we
will
be able
to
revenue
recognize
as
we
manufacture.
So, it's
going
to
have
no
impact
if
the
option
is
exercised,
the
fact
that
the
FDA
approval
will
be
pushed
out
to
2024.
Let
me
take
the
DOD contracts.
Last
year,
we
included
revenue
for
manufacturing
approximately
1
million
doses
of
liquid-frozen,
which
was
on
a
new
line
in
Denmark,
and
that
is
destined
for
the
SNS
we're
storing
ourselves
right
now.
But
that's
where
DOD
will
take
the
doses
for
any
military
that
are
being vaccinated.
That
doesn't
mean
that
we
don't
anticipate
new
orders
to
come
through.
But
with DOD,
they have
been,
like
everywhere
else
in
the
world, a little
paralyzed
by
COVID
and
there
has
been
delays
in
their
transition
to
JYNNEOS for
the
military.
Okay.
I think your
third –
yeah.
Your
third
component
was –
I
think
it
was
related
to
could
we see
any
additional
revenues
beyond
what's
already
included
in
the
guidance?
I
think
that's
what
you
were
asking.
Yeah.
And
I
think
basically
due
to
the
shutdown
of
the
facility
and
the
very
limited
period
of
manufacturing,
that
is
very,
very
unlikely
simply because
even
if
we
received
an
order,
the
revenues
would
be
pushed
out
into
the
following
year.
Yeah. So, that
means orders
would
likely
be
for
bulk
material
rather
than
potential
front-end
loaded
milestones
or
anything
like
that,
that
you
have
maybe
previously
received
from
BARDA?
Yeah,
all
liquid.
Yeah.
Yeah,
yeah. Yeah,
sorry.
And
then,
maybe
just
lastly
if
I
can
squeeze
in
one
last
here,
so
just
on
the
encephalitis
vaccine
candidates
that
you
were
quite upbeat
on
a
few
years
ago
and
that
of
course
also
have
been
impacted
by
COVID,
I
assume.
But
is
there
anything
that
sort
of
points
to
any
new
information
that
we
could
anticipate
here
in
the
next,
let's say,
12
months'
time,
any
potential
advantages
to
advance
this
into
a
late-stage
project
also,
of
course,
looking
at
potential
contracts
for
this?
Yeah.
I
think
that
whole
funding
from
the
US
government
has
been
impacted
and
delayed
completely by
COVID.
We
actually
have
no
indication
even
from
BARDA
or
NIH
if
and
when
they're
going
to
pick
that
up
again
because,
as
I said,
still
their
primary
focus
right
now
is
still
on
COVID.
Yeah,
sure.
Okay,
great.
Thank
you very
much.
Thanks.
Thank
you.
Your
next
question
comes
from the
line
of
Gil
Blum
from
Needham.
Please
go
ahead.
Your
line
is
open.
Good
morning
and
good
afternoon,
and
thanks
for
taking
our
questions.
So,
maybe
a
couple
on
COVID
first.
In
your
pivotal
non-inferiority
study,
will
there
be
longer
term
follow-up,
maybe
to
help
us
understand
how
immunity
wanes
when
you
compare
the
Bavarian
Nordic
vaccine
to an
mRNA
one?
Yeah.
Sorry.
I
thought
you're
going
to ask
another
question,
but
that's
fine.
Long-term
follow-up,
yes,
there
will
be
a
long-term
follow-up
included
in
the
protocol.
There
actually
is
six
months
follow-up
in
the
Phase
2.
If
I
just
take
the
Phase
2,
there
are
some
complications,
in
that
if
you
remember
in
the
Phase
2,
we
ran
the
study
in
Germany
and
we
were
enrolling
subjects
late
last
year.
And
in
Germany,
there
was
a
requirement
that
you
needed
a
booster
shot
to
have
a
vaccine
pass,
which
you
needed
to
go
to
restaurants
and
all
the
rest
of
it.
And
so,
some
of
the
subjects
we've
lost
that
even
though
they
were
enrolled
in
our
study,
they
subsequently
went
and
got
a
booster
shot
of
whatever.
So,
obviously,
the
long-term
follow-up
is
negated.
The
good
thing
is,
is
that
the
German
authorities
now
recognize
ABNCoV2
from
the
experimental
vaccine
is
sufficient
for
a
vaccine
pass for
individuals
in
Germany.
So,
we've
addressed
that
issue.
However,
how
that
will
impact
the
long-term
data
from
Phase 2
we'll have
to
wait
and
see
when
we
get
the
data.
In
terms
of
the
Phase
3,
there
will
be
a
follow-up
and
there
will
be
a
comparison.
But
whether
that
is
really
part
of
the
filing,
because
obviously
we'll
be
filing
by
the
end
of
the
year, is
another
thing.
But
it
will
be
subsequently
filed
as
a
follow-up
during
the
review.
All
right,
that
makes
a
lot
of
sense.
Maybe
also
a
financial
question
on
that
end.
So,
we're
going to
have
pivotal
data
second
half
of
2022
and
potential
ramp-up
in
production
for
COVID
vaccine.
Is
this
taken
into
account
in
your
financial
guidance?
Yes.
I
think
our
whole
– this
is
Henrik. Hi,
Gil.
I
think
the
whole
COVID-19
project
is
assumed
in
our
guidance.
So,
in
parallel
to
all
the
clinical
activities,
we
are
working
with
a
contract
manufacturer
to
scale
up
the
manufacturing
of
the
product
which
eventually is
filled
at
our
own
site
in
Kvistgaard,
Denmark.
As
Paul
said,
we
already
filled
the
first
batch
for
the
clinical
trial.
So,
everything
needed
to
basically
take
the
product
to
hopefully
an
approval
next
year
is
included
in
our
guidance.
Okay,
excellent.
And
maybe
a
last
one
on
the
RSV
competitive
environment.
Considering
the
pivotal
study
is
going
to
start
this
year,
what
would
you
consider
a
potential
key
differentiator?
There's
quite
a
few
vaccines
being
developed
right
now
in
RSV.
Yeah.
There's
a
few.
So,
I
think
the
biggest
differentiator
for
our
approach,
which
differs
from
everyone
else,
is
that
we
have
a
[indiscernible]
(00:50:07)
T
cell
component
to
the
vaccine,
and
we've
shown
in
Phase
2
and
in
the
efficacy
trial
very
strong
T
cell
responses
to
all
five
proteins
we've
included.
The
reason
I
flag
that
as
a
differentiator
is
that
the
literature
is
pretty
clear
that
antibodies,
which
is
primarily
the
approach
of
all
our
competitors,
are
important
in
the
upper
respiratory
tract
infections,
the
milder
infections.
But
in
the
lower
respiratory
tract
infections,
which
are
all
the results
– which
are
all
the
endpoints
for
Phase
3,
it's
believed
T
cells
play
a
much
more
important
role.
In
actual
fact,
some
of
the
data
that
was
just
recently
reported
on
a
therapeutic
antibody
from
Sanofi
and
AstraZeneca
is
quite
telling,
in
that
children
treated
with
the
antibody,
there
was
a
reduction
in
mild
symptoms,
significant,
a
70%-something
efficacy
against
mild
symptoms.
But
again, in
hospitalization, there
was
absolutely
no
difference
between
the
vaccinated
group
and
the
placebo
group,
which
again argues
are
antibodies
really
the
sole
answer
to
severe
disease?
We
don't
think
so.
And
we
think
that would
maybe
give
us
a
differentiating
factor.
Okay.
So,
just
to
make
sure
I
understand
and
clarify
this
for
myself
as
well,
a
part
of
the
data
that
will
be
given
at
the
end
of
the
study
will
include
the
rate
of
hospitalizations
and
that
could
potentially
be
a
differentiator of
itself?
So,
the
primary
endpoint
of
our
Phase
3
and
everyone
else's
Phase
3
for
RSV
is
a
reduction
in
hospitalizations
caused
by
lower
respiratory
tract
infections,
which
is
basically
the
most
severe
infections
of
the
lung
that
cause
a
hospitalization
that
would be
confirmed
to
be
RSV.
That's
the
endpoint.
It's
not
mild
symptomatic
disease.
It's
severe
disease
leading
to
hospitalization
that
we
need
to
see
a
reduction
in
in
the
vaccine
group.
Right.
Thank
you
for
the
clarification
and
thanks
for
taking
our
questions.
Thank
you.
Thank
you.
Your
next
question
comes
from
the
line
of
Michael
Novod
from
Nordea.
Please
go
ahead.
Your
line
is
open.
Yeah.
Thanks
a
lot.
It's
Michael
from
Nordea.
A
couple
of
questions.
Maybe
one
for
Henrik
first
on
the
sort
of
trajectory
for
both
Rabipur/RabAvert
and
Encepur
going
into
next
year.
I'm
fully
aware
that
it is
going to
be
the
majority
of
your
revenues,
but
maybe
just
a bit
more
clarity
on
the
exact
split
on
those
two
products.
And
then,
on
ABNCoV2,
so
how
do
you
think
about
the
potential
advance
procurement
orders? Do
you
still see
the same
possibilities for
this or
has
the
market
changed
given
we
are
sort
of
circling
more
through
the
pandemic?
And
how
do
you
see
potential
orders
from
sort
of
the
more
exotic
regions
of
the
world?
We
have
seen
that
COVID-19
remains
a
significant
issue
in
many
of
those
parts
of
the
world.
And
then
lastly
on
RSV,
what
is
the
reason –
maybe
it's
just
me that
has
misunderstood
the
previous
comments.
But
what
is
the
reason
that
Australia
or
the
Southern
Hemisphere
is
not
included
in
the
trial
anymore?
It
seems
to
be
only
US
and
Germany
you're
going to
enroll.
Thanks.
Okay.
Thanks,
Michael.
Let
me
take
maybe
the
first
two
questions
and
we
can
start
with
ABNCoV2
and
potential
advance
purchase
agreements.
First,
I
can
say
that
we
have
not
assumed
any
advance
purchase
orders
in
our
guidance
at
all.
But
it
is
of
course
something
that
we
are
going
to
pursue.
It's
a
good
question
you're
raising,
is
the
market
prepared
to
do
these
advance
purchase
agreements
or
not.
We
will
see,
but
we
will
definitely
pursue
this
when
we
feel
that
we
have
progressed
the
development
of
the
vaccine far
enough
to
have
those
discussions.
Then,
on
[ph]
the
EnRa
(00:54:24)
name
for
our
Encepur
and
then
rabies
business,
we
have
not
-obviously, we have
not
guided
for
any
specific
split
between
these
products.
But
let
me
elaborate
a
little
on
what
our
thinking
is
in
terms
of
the
markets
that
these
vaccines
are
operating
in.
I
think
if
you
take
first
the
TBE
market,
which
is
probably
the
most
difficult
market
to
predict
where
it's
going,
because
in
principle,
I
think
the
TBE
market
should
not
be
impacted
by
COVID-19,
but
it
did
anyway
last
year –
in
the
second
half
of
last
year
due
to
the –
as
you
know,
the
physicians
being
occupied
with
COVID
vaccinations.
So,
in
principle,
the
TBE
market
could
come
back
full-scale
this
year,
that
would need
to
happen
very
soon
if
that
is
the
case,
or
you
could
have
the
same
situation
as
last
year
really
depending
on,
for
instance,
in
a
market
like
Germany,
what
their
booster
vaccination
plans
are
when
they
are
done
with
their
current
booster
vaccination
campaigns.
So,
what
we
are
assuming
there
is –
in
our
guidance
is
that
we
see
some
progress
towards
normality,
but
definitely
not
back
to
normal
yet
in
2023
on the
TBE business.
And
on
rabies,
again,
two
very
different
markets,
where
the
US,
we
have
already
seen
good
signs
the
last
couple
of
quarters
and
we
are
approaching
the
pre-COVID
level,
and
we
do
believe
that
that
trend
is
going
to
continue
for
2022.
And
I
think
our
job
there
of
course
is
to
hang
on
to
our
market
share
of
approximately
70%
in
that
market.
When
it comes
to
the
European
rabies
market,
we
have
seen
nice
growth
the
last
couple
of
quarters.
But
as
you
know,
it
comes
from
a
very
low
level
[ph]
as the
(00:56:26)
current
market
in
Europe
is
approximately
one-fourth
of
what
it
was
pre-COVID.
So,
depending
on
really
the
degree
and
the
speed
of
normalization
in
Europe
and
maybe
also
[indiscernible]
(00:56:41)
uncertainty
with
the
war
between
Ukraine
and
Russia
[indiscernible]
(00:56:46) probably
a
little
uncertain
when
people
are
going
to
travel
in
larger
scale
to
the
exotic
destinations.
But
our
assumption
has
been
that
we
also
see
stepwise
movements
toward
normalization
on
the
European
rabies
market.
So,
I
think without
giving
you
an
exact
split,
I
hope
it
made
you
a
little
more
insightful
in
terms
of
our
thinking
about
how
the
markets
will
develop.
Sure.
Yeah.
Let
me
take
the
RSV
question.
You're
right.
You're
very
good.
You
spot
these
little
things.
We
dropped
the
little
flag
from
Australia
from
the slide.
The
main
reason
for
that
is
the
incident
rate
in
Australia
right
now
is
quite
low.
Now,
whether
that
is
because
it's
a
seasonal
effect
or
whether
it's
because,
as
you
know,
within
Australia,
they're
still
very
much
or
have
been
in
quite
strict
lockdown,
we
don't
know.
But
when
we
did
the
evaluation
with
the
CRO,
we
were going
to
need
an
awful
lot
more
sites
in
Australia
to
really
allow
us
to
see
the
sort
of
events
that
we
wanted
to
see
in
terms
of
the
hospitalization.
And
again,
when
we've
now
looked
at
the
more
thorough
analysis
of
Germany
and
the
US,
we
believe
we
have
a
much
better
chance
of
seeing
the
number
of
events
that
we
need
in
the
timeframe
that
we
need
this
year.
So,
yeah,
it's
nothing
more
dramatic
than
the
assessment
of
the
country,
the
[indiscernible]
(00:58:25) we
were
looking at,
and
we've
decided
to
focus
on
Germany
and
the
US.
Okay.
Thanks
a
lot.
Thank
you.
Thank
you.
Your
next
question
comes
from
the
line
of
Boris
Peaker
from
Cowen.
Please
go
ahead.
Your
line
is
open.
Good
morning
or
good
afternoon,
I
guess, for
you
guys.
I've
just got
a
follow-up
on
COVID
vaccine.
I'm
just
curious
if
COVID
becomes
endemic,
and
every
year
– let's
say
every
six
months,
we
get
a
new
strain,
do
you
think
you'd
have to
run
a
clinical
trial
in
each
case
to
show
that
your
vaccine
works
against
the
specific
strain
or
is
there
regulatory
way
to
get
an
approval
broadly
and
not have
to
redo
it
every
six
months
to
a
year?
Yeah.
Thanks,
Boris.
It's
a
good
question.
Obviously,
right
now,
I'm
sure
you're
aware
that
[ph]
this
batch
(00:59:26)
vaccines
have
not
really
– the
only
approval
that
they've received
is
based
from
the
efficacy
against
Wuhan
when
they
did
the
field
trials.
And
yet,
those
are
the
vaccines
that
are
being
used
as
boosters
against
currently
Omicron.
And
to
be
honest,
the
real
world evidence
shows that they're pretty
effective at
preventing
severe
disease
and
hospitalization
even
against
Omicron.
What
is
also
clear
from
the
current
[indiscernible]
(00:59:56) vaccines
is
the
level
of
neutralizing
antibody
definitely
differs
between
the
different
variants.
I mean,
on
the
latest study
that
I
saw
only
a
few
days
ago
that
after
the
booster
shots,
the
decline
against
Omicron
is
[indiscernible]
(01:00:13) decline
against
Wuhan.
So,
there
are
variances
against
the different
variants.
And so,
the
answer
is
I
don't
know. However,
what
we're
going
toward
is
an
approval
based
on non-inferiority
to
Wuhan,
which
is
the
only
efficacy
marker
for
any
COVID
vaccine,
and
to
show
that
we
get
broad
neutralizing
titers
against
all
the
current
variants
of
concern.
But
you're
right,
how
the
regulatory
world
is
going
to
adapt to
the
current
situation
of
moving
out
of
pandemic
as
we
are
into
an
endemic,
we'll
have
to
wait
and
see
how they
[indiscernible]
(01:01:01).
Got
it.
And
my
second
question
is
I'm
just
curious
also
on
the
COVID
vaccines.
So,
your
design
is
to
show
non-inferiority.
And
I
understand
it's
sufficient
from
the
regulatory
perspective,
but
I'm
just
curious
with
mRNA
vaccines
being
the
dominant
variant
of
vaccines
used
out
there,
if
all
you
show
is
non-inferiority, do
you
think
that's
commercially
sufficient
to
gain
traction
or
do
you
think
new
modalities
of
vaccine
– and
I'm
talking
more
broadly
about
anybody
else
developing
new
modalities
outside
of
mRNA –
will
ultimately
have
to
show
superiority
to
mRNA
to
really
gain
significant
traction?
So,
we're
talking
about
non-inferiority
[ph]
of the peak responses (01:01:50)
I
think
where
we
could
have
a
differentiating
factor,
which
isn't
part
of
the
primary
end
point
of
the
Phase
3,
one
could
be
on
durability.
And
we
all
know
based
on
the
data
that's been
published of
the
mRNA
vaccines,
whether
that's
a
platform
thing
or
whether
that's
COVID
thing,
really
struggling
to
generate
a
robust
[indiscernible]
(01:02:13)
short-lived
protection.
So, we
could
have
a
longer,
more durable
response, which
could
be
a
differentiating
factor.
And
the
other,
as
I
said,
is
a
greater
response
against
the
emerging
variants
[indiscernible]
(01:02:30) more
durable
responses.
And,
thirdly,
anyone
who's had
several
RNA
vaccines
know
they're
quite
[ph]
iatrogenic.
So,
they (01:02:42)
could be
differentiators
on the
safety
profile
compared
to
RNA
vaccines.
And,
lastly,
you've
got
the
storage
[indiscernible]
(01:02:53)
be
still
a
major
issue
of RNA
vaccines,
or
at
least
[indiscernible]
(01:02:59).
Great.
Thank
you very
much
for
taking my
questions.
Thank
you.
Your
next
question
comes
from
the
line
of
Peter
Verdult
from
Citi.
Please
go
ahead.
Your
line
is
open.
Thank
you.
I'm
Pete
Verdult,
Citi.
I've
got
a
few,
but
some
are
very
quick,
so
forgive
me.
Just maybe
a
follow-on,
Paul,
from
the
previous
question
just
in
terms
of
how
problematic
or
not
executing
the
ABNCoV2
trial
in
this
current
environment
is
or
will
not
be?
I
realize
that you're
just
looking
for
non-inferiority
and
neutralizing
antibodies,
but
given
the
hospitalization
rate
is
so
low,
is
that
problematic
or
timelines
could
maybe
problematic
in
the
current
environment?
Second
question,
I
realize
you're
being
conservative
when
you're
saying
that
you're
only booking
confirmed
orders
in
your
initial
guidance.
I
believe
there's
a potential
$100 million
smallpox
US
Government
contract
out
there.
Should
we
assume
that that
is
an
abundance
of
caution
on
your
part
or
is
that
more
sort
of
up
in
the
air
as
to
whether
you
will
or
not secure
that
contract?
Last two
for
me,
quick
one,
just whether
you'd
be
willing
to
quantify
the
inventory
write-offs
that
you
took
in
2021?
And
then,
last
one,
there's a little bit of a
debate
in
the
market
today,
the
revenue
pressures
you
cite
are
clearly
temporary,
but
is
there
an
implication
in
terms
of
potentially
having to
tap
the
equity
markets
once
more
to
achieve
your
vision
given
the
investments you're
making?
Thank
you.
Yeah.
Thanks.
Let's
try
and
walk
through
those
questions.
So,
I
think
the
first
question
related
to
the
access
to
the
comparative
vaccine
to
do
the
Phase
3
for
ABNCoV2.
And
no, I
think
we've
been
flagging
for
some
time
that
that
could
be
an
issue
given
that
those
vaccines
currently
not
commercialized
from
a
true
traditional
sense,
but
are
sold
directly
to
governments
and
direct
access
is
problematic.
That's
one
of
the
reasons
that
in
parallel
to
a more
standard,
randomized
clinical
study,
we've
also
been
in
dialogue
with
the
regulators
that
what
if
we
can't
get
access
to
a
comparator,
how
we'd
be
able
to
do
a
comparative
study.
And
there
we
have
had a
positive
feedback
and
we
are
able
to
conduct
the
study
in
a
slightly
different
way
where
we
can
tap
into
national
vaccination
booster
programs.
And
of
course,
now
the
onus
is
on
us,
together
with
the
CRO,
to
find
countries
or
regions
of
countries
that
are
lagging
in
their
vaccination
boosters,
where
we
can
tap
into
the
booster
program
and
do
the
comparator
study.
And
that's
exactly
what
we've
been
working
on.
We've
been
working
on
both
paths
in
parallel,
but
we
are
confident
that
we
should
be
able
to
do
that.
I
think
there
was
a
question
related
to
JYNNEOS
and...
Yeah,
perhaps
I
can
take
that
one.
Just
on
JYNNEOS,
Peter,
I think
I
heard
you
talk
about
a
potential $100
million
order.
I
think
as
we
said,
we
have
only
included
confirmed
orders
in
our
guidelines
for
2022.
And
the
only,
I can
say,
additional
order
that
is
out
there,
which
is
still
at
an
option
level,
that's
the $299 million
on
freeze-dried.
I'm
not
sure
where
that $100
million
comes
from,
but
I
think
what
we
are
expecting
once
the authorities
start
exercising
that
option
is
probably
that
it
comes
in
tranches.
It
could
be
of
like
$100
million,
but
I think
even
if
they
exercise
that
option
this
year,
it
should
be
executed
next
year.
So,
I
think
it's
the only
thing
I
can
think
of in
relation
to
that
$100
million.
And
in
terms
of
the
other
markets,
what
if
there's
a
higher
demand
in
the
market,
I
think
[indiscernible]
(01:07:13)
the
upsides
that
we
might
have,
of
course,
is
related
to
our
commercial
business
that
is
on
the
rabies
and
the
TBE
business.
I
think
if
the
market
grows
faster than
what
we
are
expecting
in
our
guidance
here,
I
think
we
have
the
products
to
follow
the
market
basically.
As
I
said
earlier
in
our
presentation,
we
have
made
the provisions
for
potential
inventory
write-offs.
That
is
not
because
these
are
out of sales
side
right
now,
but
they
might
become
in
2022 or
2023
and
these
products
can
still
be
sold.
So,
we
have
a
buffer
to
follow
the
demand
should
it
surge
faster
than
what
we
had
expected.
And then,
I think
there's
a
question
asked,
do
we
have
plans
to
go
back
to
the
capital
markets?
And
I
think
the
answer
to that
is
definitely
not.
And
then
thank
you
for
the
clarification.
Just
on
the
inventory
write-offs,
can
you
give a
ballpark
quantification,
please?
So,
yes,
I
think
it's –
the
number
is
DKK
172
million
included
for
2021.
So,
quite
a
substantial
amount.
Some
of
it
was
included
already
in
the
first
nine
months,
the
rest
in
the
fourth
quarter.
So,
DKK
172
million
was
a
provision
we
made
for
potential
write-offs
of
the
rabies
and
TBE
products.
A
lot
of
it,
of
course,
driven
by
the
significant
market
decline
in
Europe
on
the
rabies
business.
Thank
you.
Thank
you.
Your
next
question
comes
from
the
line
of
Peter
Welford
from
Jefferies.
Please
go
ahead.
Your
line
is
open.
Hi.
Thanks.
Two
quick
questions
left.
Just
firstly
on
our RSV.
If
we
look
at
the
data
that nirsevimab published,
and
also
I
take
your
point
on
the
lower
respiratory versus
upper
respiratory,
but
I
guess,
if
we
look
at
the
size
of
the
Phase
3
studies
that
these
vaccines
are
conducting,
it
still
seems
possible
that
with
antibodies
you
could
end
up
with
a
statistically
significant
difference
in
hospitalizations
driven
by
an
antibody
response.
And
so,
I
guess
curious
if
you
could
give
us
your
take,
statistics
aside,
what
is
a,
I
guess,
firstly,
regulatory
approvable;
and
secondly,
clinically
meaningful
reduction
in
hospitalizations
that you
would
be
required
for
an
RSV
vaccine.
And
then,
secondly,
just
on
the
outlook.
If
I
take
your
TBE
sales
–
sorry,
together with
the
rabies sales
for
this
year
and
then
add
on
the
Canada
order
of
DKK 200
million
and
the
US DKK
100
million, you're
already
getting
just
above
the
bottom
end
of
the
guidance
for
revenues.
So,
it
seems
as
though
the
revenue
outlook
is
assuming
pretty
modest
increases
in
TBE
and rabies
and
also
no
contract
revenue
from BARDA
or
anything
booked
this
year.
And so,
I
guess,
two
questions.
Firstly,
is
that
right?
And
secondly,
is
it
fair
to
assume
that
contract
revenue
will
be
[indiscernible]
(01:10:23)
minimal
this
year
compared
to
prior
years?
Thank
you.
Yeah.
Maybe
I
can
start
with
that.
The
contract
revenue,
yes,
will
be
relatively
low.
You
will
see
since
2020
to
2021,
it
has
declined.
And
that
has
very
much
in
the
past
been
driven
by
the
agreement
we
have
with
BARDA
on
supporting
us
on
our
CMC
and
qualification
activities
on
the
fill
and
finish
facility,
but
also
the
Phase
3
on
the
freeze-dried.
So,
that
is
sort
of
waning
off
and
that
will
continue
that
way.
So,
we
are
not
anticipating
much
in
terms of
contract
work.
And
I
think
as
I've
said,
I
think
if
you
add
up
our
numbers,
I
think
you
can
say,
we
are
– probably
with
the
market
sort
of
starting
to
move
towards
normality,
I
think
that
that
reflects
sort
of
the
midpoint
in
our
guidance.
And
those
are
the
assumptions
I
alluded
to
earlier
when
I
described
sort
of
how
we
see
the
individual
segments
of
the
markets
develop.
So,
Paul,
then
there
was
one
on
RSV.
Yeah.
It was
a
good
question,
actually.
What
level
of
efficacy
probably
could
lead
to
approval?
Again,
without
going
into
any
stats
or
what
our
assumptions
are,
I
think for
RSV,
of
course,
there's
currently
no
vaccine.
So,
I
would
say
it's
probably
in
the
region
of
the
65%,
70%
level.
That's
great.
Thank
you very
much.
Thank
you.
Your
next
question
comes
from
the
line
of
Suzanne
van
Voorthuizen
from
Kempen.
Please
go
ahead.
Your
line
is
open.
Hi,
guys.
Thanks
for
taking
my
question.
I
have
two.
The
first
one
is,
how
confident
are
you
in
the
timelines
for
the
Phase
3
with
ABNCoV2,
with
the
start
in
H1
and
the
data
in
H2?
Is
the
start
of
the
study
really
imminent
or
is
this
more
towards
summer?
And
is
the
data
more
like
a
fall event
or
more
towards
year-end?
Any
color
will
be
appreciated.
And
my
second
question
is
a
follow-up
on
the
differentiation
point.
And,
yeah,
how
to
facilitate the
commercial
proposition?
The
durability
factor
will
take
more
time
before
that
becomes
clear
from
the
long-term
follow-up,
I
guess,
but
regarding
the
feature
of
ABNCoV2
being
more
variant-proof,
how
do
you
plan
to
build
that
case
further
from
the
Phase
3?
Are
you,
for
example,
planning
to
include
some
secondary
endpoints,
analyzing
the
responses
against
a
range
of
variants
and,
yeah,
really
in
a
head-to-head
comparison
to
the
mRNAs,
or
how
are
you
thinking
about
that?
Yeah.
Thanks.
Thanks
for
questions.
So,
let's
take
the trial
design.
So,
the
primary
endpoint is
non-inferiority
of
the
peak
neutralizing
titers
to
a
comparator,
which
will
be
an
mRNA-based
vaccine.
However,
there
are,
of
course,
secondary
endpoints;
of
course,
safety
being
one,
but
we'll
also, yes, we'll
look
at
variants
of
concern,
currently
we all
know
what
those
are,
and
any
new
variants
that
come
through
during
the
trial,
and
they
will
also
be
compared
to
the
comparator.
You
mentioned
also
durability, that
will
be
done
as
a
secondary
endpoint.
But
again,
as
I
said
already
to
one
of the
previous
questions,
that's
not
likely
to
be
part
of
the
main
file
because,
again,
getting
to
your
timing,
we
are
confident
as
we
sit
here
now
that
we
will
be
starting
the
study
in
the
first
half
of
this
year.
We
will
report
data
in
the
second
half
in
time
to
allow
us
to
start
regulatory
submissions
by
year-end.
I
think
that's...
[indiscernible]
(01:14:27)
Got it. All right. No. Thanks a lot.
All
right.
Thanks.
Thank
you.
Your
next
question
comes
from
the
line
of
[ph]
Stuart
Berry
(01:14:40)
from
[indiscernible]
(01:14:41).
Please
go
ahead.
Your
line
is
open.
Yes.
Good
afternoon.
[indiscernible]
(01:14:48).
A
few
questions.
Firstly,
in
your
annual
report,
you're
mentioning
that
you
hope
to
be
able
to
come
up
with
a
better
value
proposition
compared
to
currently
marketed
COVID
vaccines.
Could
you
spend
some
more
– or
shed
some
more
light
on
what
kind
of
proposals
these
are?
That
would be
my
first
question.
Yeah.
So,
getting
back
to
the
differentiating
factors,
so
can
a booster
with
ABNCoV2
be
more
durable
or
can
we
move
away
from
boosters,
which
looks
like
every
six
months
or
from
a
year
to
something
a
bit
longer,
maybe
three,
five
years?
That
data
obviously
takes
time
to
generate
and
won't
be
available
at
the
time
of
the
launch.
But
certainly,
one
of
the
differentiating
factors
that we're
after, based
on
the
science
of
the
VLP
versus
what
we're
beginning
to
understand
with
RNA.
And
so,
that's
one.
The
other
one
is
the
breadth
of
response.
I
think
from
the
Phase
1,
which
was
performed
by
the
EU
consortium
and
our
Phase
2,
we
are
seeing
quite
compelling
data
that
we
see
very
strong
responses
to
all
the
variants
that
we've
tested
to-date.
Again,
we
haven't
tested
Omicron,
but
we
tested
all
the
other
variants,
including
Beta,
we
actually
know
has
very
low
responses
from
RNA-based
vaccines.
So,
it's
quite
compelling
already
that
we
seem
to
have
a
very
broad
protective
response,
which
of
course
we
need
to
build
on
in
the
Phase
3,
and
as
I've
mentioned
already,
continue
to
test
any
other
variants
that
come
through or
emerge through.
So,
those
are
the
main
differentiating
factors.
I said
a
third
one
could
possibly
also
be
the
safety
profile,
but
again, we
need
to generate
that
data.
We
have
too little data now to be
making
those
claims.
And
the
last
one
really
is
the
storage
and
shipment
temperature.
There
are,
as
you
know,
some
vaccines
that
have
a
very cold storage
and
shipment
that
I
think
will
be
a
disadvantage
when
other
vaccines
like
ABNCoV2
come
through
that
can
be
stored
at
room
temperature.
Okay.
So,
in the
value
proposition
you
are
speaking
of,
we
should
not
expect
you
to
include,
for
example,
a
more
competitive
pricing?
Yeah,
I
mean,
we
haven't talked
about
pricing.
I
mean,
the
pricing
right
now
is
pretty
stable
for
nearly
all
vaccines
that
are
emerging
in
terms
of
COVID-19.
How
that
pricing
will
change
as
the
market
changes?
Right
now,
it's
very
much
a
government
business.
Will
that
change
most
likely
to
more
of
a
private-type
market?
And
in
fact,
a
lot
of
people,
a
lot
of
analysts
are
predicting
actually
the
prices
to
increase. But
again,
we
will
keep
an
eye
on
price
as
and
when we
get
nearer
to
the
market.
And
I
think
the
good
thing
for
us
is
that
we
can
be
very
competitive
on
price
with
the
technology
that
we
have.
Okay. My
last
question.
Based
on
your
experience,
do
you
expect
there
will
be
a
need
for
a
tailored
Omicron
vaccine
booster
during
the
course
of
this
year?
Short
answer,
no.
And
if
I
give
the
explanation
for
that,
the
real-time
data
for
the
current
batch
of
vaccines,
which
we
know
generate
lower
titers
to
Omicron
than
compared
to,
for
example,
Wuhan,
have
shown
that
they've
been
very
effective
at
preventing
severe
disease
and
hospitalization
and
have
allowed
society
to
control
that
variant.
So,
that's
one
piece
of
evidence
that
would
suggest that
it
doesn't
make
a
lot
of
sense.
The
other
one
is
that,
of
course,
as
data
already
from
some
RNA-based
vaccines
with
Omicron-specific
constructs,
which
seem
to
be
not
any
more
immunogenic
than
the
original
Wuhan
strain,
which
again
argues
against
the
cost
of
developing
a
new
variant
when
in
fact
it
doesn't
look
like
there's
any
real
benefit.
Again,
there
could
be
differences
here
if
we're
talking
about
durability
or
if
a
new
variant
comes
with
even
more
mutations
than Omicron
that
seems
to
escape
the
Wuhan
immune
responses,
to-date
that
hasn't
happened.
Thank
you
so
much.
That
concludes
my
questions.
Thank
you.
Thank
you.
There
are
no
further
questions.
I
will
hand
the
call
back
to
you.
Thank
you.
And
thanks,
everyone,
for
taking
the
time
to
join
the
call
and
for
all
your
questions
and
interest.
So,
have
a
great
weekend.
Thanks
a
lot.
Thank
you.
This
concludes
today's
conference
call.
Thank
you
for
participating.
You
may
now
disconnect.