DBV Technologies SA

PAR:DBV

Earnings Call Transcript

[Operator]

Welcome

to

the

DBV Full

Year

2021

Financial

Results.

My

name

is

Adrianne, and

I'll

be

your

operator

for

today's

call.

At

this

time,

all

participants

are

in

a

listen-only

mode.

Later,

we'll

conduct

a

question-and-answer

session.

[Operator Instructions]



Please

note

this

conference

is

being

recorded.

I'll

now

turn

the

call

over

to

Anne

Pollak. Anne,

you

may

begin.

[Anne Pollak, Head-Investor Relations, DBV Technologies SA]

Thank

you.

This

afternoon

DBV

Technologies

issued

a

press

release

that

outlines

our

financial

results

for

the

12

months

ended

December

31, 2021.

This

release

is

available

in

the

Press

Release

section

of

the

DBV

Technologies

website.

Before

we

begin,

please

note

that

today's

call

may

include

a

number

of

forward-looking

statements,

including,

but

not

limited

to,

comments

regarding

our

clinical

and

regulatory

development

plans,

the

timing

and

results

of

interactions

with

regulatory

agencies,

our

forecast

of

our

cash

runway,

and

the

ability

of

any

of

our

product

candidates,

if

approved,

to

improve

the

lives

of

patients

with

food

allergies.

These

forward-looking

statements

are

based

on

assumptions

that

are

subject

to

risks

and

uncertainties

that

could

cause

the

company's

actual

results

to

differ

significantly

from

those

suggested

by

these

statements.

Given

these

risks

and

uncertainties,

you

should

not

place

undue

reliance

on

these

forward-looking

statements.

Please

refer to

the

company's

filings

with

the

SEC

and

the

French

AMF

for

information

concerning

risk

factors

that

could

cause

the

company's

actual

results

to

differ

materially

from

expectations,

including

any

forward-looking

statements

made

on

this

call.

Except

as

required

by

law,

the

company

disclaims

any

obligation

to

publicly

update

or

revise

any

forward-looking

statements

to

account

for

or

reflect

events

or

circumstances

that

occur

after

this

call.

Joining

me

on the

call

today

are

Daniel

Tassé,

Chief

Executive

Officer

of

DBV;

Sébastien

Robitaille,

Chief

Financial

Officer;

and

Pharis

Mohideen,

Chief

Medical

Officer.

Daniel

will provide

an

update

on

Viaskin

Peanut

and

our

extended

cash

runway,

and

Sébastien

will

review

the

full

year

2021

financial

results.

Pharis

will

join

Sébastien

and

Daniel

for

questions

at

the

end.

I

will now pass the call over to Daniel.

[Daniel Tassé]

Thank

you,

Anne,

and

thank

you

all

for

joining

us

on

the

call

this

afternoon.

As

Anne

mentioned,

this

evening

I

will

provide

an

update

on

two

key

areas

of

focus

for

DBV;

the

first, the

clinical

and

regulatory

development

of

our

modified

Viaskin

Peanut

patch;

and

the

second, will

be

an

update

on our

cash

management

and

our

cash

runway.

Now,

let's

start

with Viaskin

Peanut.

During

our

last

corporate

update

in

December,

DBV

announced

that

we

will

initiate

a

pivotal

Phase

3

clinical

study

for

a

modified

Viaskin

Peanut

patch

in

children

in

the

intended

patient

population.

As

we

said

then,

we

still

believe

now,

this

data

from

the

pivotal

trial

will

further

strengthen

the

Viaskin

Peanut

label

if

approved

and

enhance

its

commercial

potential.

And

as

such,

initiating

this

trial

is

our

highest

priority.

Now

we

completed

the

pivotal

trial

protocol

at

the

end

of

February

and

prepared

it

for

submission

to

the

FDA

for

their

review.

Now,

in

parallel

to

finalizing

our

proposed

protocol,

we

also

have

had

timely

and

productive

exchanges

with

the

FDA.

We

very

much

appreciate

the

FDA's willingness

to

engage

with

us

during

this

critical

stage

of

protocol

alignment.

So,

we

believe

that

incorporating

any

feedback

from

those

collaborative

FDA

discussions

on

the

broad

strokes

of

the

protocol

will

facilitate

and

possibly

streamline

the

protocol

review

process.

We

intend

to

submit

the

full

protocol

following

that

further

alignment

from

ongoing

and

productive

exchanges

with

the

FDA.

And

now

turning

to

our

cash

management.

Through

our

continued

financial

diligence,

we

have

extended

our

cash

runway

from

the

third

quarter

of this

year

into

the

first

quarter

of

next

year.

So,

first

quarter

of

2023.

Based on

our

assumptions,

we

believe

our

cash

balance

and

significantly

reduced

monthly

run

rate

provide

us

with

sufficient

time

to

gain

alignment

with

the

FDA,

as

I

referred

to

earlier

on,

and

gaining

alignment

on

final

pivotal

protocol

for

Viaskin

Peanut.

Now,

as

you

know,

in

biotech,

there's

a

balancing

act,

extending

cash

runway

is

always

a

delicate

balance

between

cutting

expenses

now

and

obviously

our

ability

to

preserve

critical

research

and

development,

which

fuels

enterprise

value

and

growth

later.

I

surely

want

to

commend

DBV

employees

who

collectively

aim

to

do

more

with

less

and

preserve

their

ability

to

thoughtfully

advance

for

Viaskin

platform

in

the

coming

year.

And

I'm

looking

forward

to updating

you,

obviously,

on

our

progress.

At

this

point,

let

me

turn

the

call

over

to

Sébastien

for

a

review

of

our

full-year

2021

results.

Séb?

[Sébastien Robitaille, Chief Financial Officer, DBV Technologies SA]

Thank

you,

Daniel.

Earlier

today,

we

issued

a

press

release

with

our

2021

financial

results.

Cash

and

cash

equivalents

as

of

December

31, 2021,

were

$77.3

million,

which,

as

Daniel

stated

earlier,

we

believe

will

support

our

operations

into

the

first

quarter

of

2023.

When

we

initiated

our

global restructuring

initiative

in

June

2020,

we

aimed

to

reduce

our

average

monthly

cash

burn

by

40%

to

50%

in

the

second

half

of

2021

as

compared

to

the

first

half of

2020.

I'm

very

pleased

to

report

that

we

exceeded

our

goal.

Cash

used

in

operating

activities

in

the

second

half

of

2021

was

$41.7

million,

which

represents

a

54%

decrease

compared

to

the

first half

of

2020.

We

continue

to

maximize

the

efficiency

of

our

spend

and

remain

highly

disciplined

in

our

cash

management.

And

now,

I

would

turn

the

call

back

to

Daniel

for

some

closing

remarks.

[Daniel Tassé]

Thanks,

Sébastien.

So,

again,

I'm

very

pleased

by

the

progress

we've

made

since

we

last

talked

in

late

December,

when

we

announced

our

decision

to

now

initiate

the

pivotal

trial

for

the

modified

Viaskin

Peanut

patch.

Most

importantly,

since

then,

we

have

engaged

the

FDA

on

key

elements

of

the

Viaskin

Peanut

dossier

in

preparation

to

the

new

protocol

submission.

The

protocol

is

ready

to

go,

and

we

are

very

pleased

with

the

exchanges

we're

having

with

the

FDA.

Obviously,

finalizing

the

proposed

pivotal

trial

protocol

and

preparing

for

FDA

submission

was

our

top

priority,

and

I

want

to

thank

Pharis

and his

entire

team

for

their

hard

work

and

for

the

position

we're

in

right

now.

I

would

like

to

also

recognize

the extensive

review

of

our

plan

expenditures

and

financial

discipline

being

practiced

by

all

DBV

employees

led

nicely

by

Sébastien

and his

team.

DBV

employees

continue

to

demonstrate

the

creativity,

the

discipline,

the

resilience

that

is

needed

to

realize

the

full

potential

of

Viaskin

technology

for

patients,

for

families

and

for allergists

and

treating

physicians.

Now,

I

would

like

to

tackle

one

last

topic

before

we

open

the

line

for

questions.

It

is

not

a

secret

that

DBV will

need

to

raise

money

before

we

submit

the

modified

Viaskin

Peanut

BLA.

The

good

news is

that

based

on

our

current

assumption

we

just

shared

with

you,

we

have

sufficient

time

to

gain

[ph]



full

line with (08:20)

FDA

on

the

protocol

for

that

pivotal

mVP

trial.

Now, our

current

stock

price,

in

our

opinion,

does

not

reflect

the

significant

potential

of

the

Viaskin

platform, and

Viaskin

Peanut

specifically.

As

such,

exploring

a

number

of

tools

to

finance

the

company,

including

non-dilutive

financing

strategies

that

could

leverage

Viaskin

Peanut's

significant

commercial

potential

amongst all

other

options

that

are

worth

contemplating.

A

mix

of

financing

tools

done

incrementally are

amongst

the

potential

options

that

we

are

exploring.

Now I

want

to

thank

everyone

on

the phone

today

and

the

webcast

for

joining

us.

And

operator,

at

this

time,

we

would

like

to

open

the

line

for

questions.

[Operator]

Thank

you.

We'll

now

begin

the

question-and-answer

session.

[Operator Instructions]



And

our

first

question

comes

from

Jon

Wolleben

from

JMP Securities.

[Jonathan Wolleben, Analyst, JMP Securities LLC]

Hey,

good

afternoon,

and

thanks

for

the

update

and

taking

the

questions.

It

sounds

like...

[Daniel Tassé]

Hi,

Jon.

[Jonathan Wolleben, Analyst, JMP Securities LLC]

Daniel,

it

sounds

like

you've

already

had

some

interactions

with

FDA

on

the

protocol,

so I

was

hoping

you

could provide

a

little

more

color

on

that

back

and

forth

in

terms

of

what

you're

learning

that

they

want

to

see

in

this

protocol

and

kind

of

the

cadence

of

those

back

and

forths?

[Daniel Tassé]

The

cadence

has

been

very

good.

What

we

discuss

with

the

FDA

right

now

is what I call

the

basic

broad

strokes

and

core

principle

of

our

study.

As

you

know,

Jonathan,

we

have

a

pretty

unique

patch

that

has

no

analogs,

and

our

ability

to

have

this

rich discussion

with

the

agency

on

the

key

elements

in

principle

before

we

send

them

the

nitty-gritty

of

the

details,

we

felt,

was

the

right

approach

and the fact that

the FDA

is

engaged in

those

discussions,

obviously,

is

heart-warming

to

us.

I

don't

wish

to

provide

more

detail

at

this

point

in

time

because,

again,

I

would

be

providing

half

of that

conversation,

I think

the

FDA would

wish

to –

us

to

be

protective

of

that

discussion

here. But

I

can

certainly

tell

you

that

the

protocol

is

ready

to

go

and

the

fact

that

we

have

not

submitted

it

is

something

that

we're

pleased

with,

we're

happy

with,

because

we're

showing

good

progress

in

parallel.

[Jonathan Wolleben, Analyst, JMP Securities LLC]

Can you

give

us

any

sense

of

when

this

could

be

submitted

and

then

kind

of

next

steps

between

today

and

actually

starting

the

study?

[Daniel Tassé]

Yeah.

It

will

not

be

long

time.

The

next

discussion

[audio gap]



(11:18-11:27) towards...

[Pharis Mohideen, Chief Medical Officer, DBV Technologies SA]

Daniel,

you're

breaking

up.

We're

having

a

hard

time

hearing

you.

[Daniel Tassé]

Oh,

sorry.

What about

now?

[Pharis Mohideen, Chief Medical Officer, DBV Technologies SA]

That's

good.

[Daniel Tassé]

It's

better?

[Pharis Mohideen, Chief Medical Officer, DBV Technologies SA]

Yes.

[Daniel Tassé]

My

apologies.

So,

I

think,

Jonathan,

we

are

ready

to

send

this –

the

protocol.

The

interactions

with

the

agency

are

taking

place

frequently.

We

would

expect

to

be

sending

the

protocol

in

short

order.

But

again,

we

believe

that

getting

to

agreement

on

those

core

principles

will

make

for

a

faster,

more

expeditious

and

better

protocol

at

the

end

of

the

day.

So,

the

tradeoff

here

is

the

one

that

we're

very

comfortable

with.

[Jonathan Wolleben, Analyst, JMP Securities LLC]

Got

it

makes

sense.

And

maybe

one

last

one

for

me,

if

I

may.

Could

you

give

an

update

on

the

EPITOPE

program?

[Daniel Tassé]

Pharis,

you

want

to take

it?

[Pharis Mohideen, Chief Medical Officer, DBV Technologies SA]

Yeah.

So,

the

EPITOPE

study,

as

we've

said

in

the

past,

is

due

to

report

out

mid-year,

and

we're

looking

forward

and

excited

to

see

the

results

of

that

study.

Yeah.

[Jonathan Wolleben, Analyst, JMP Securities LLC]

And

have

you

set

any

internal

expectations

on

what

you'd

want

to see

to

warrant

moving

forward

in

the

younger

one,

the

three

year-olds?

Or

how

should

we

think

about

a

dual

path

forward

with

two

different

patches?

[Daniel Tassé]

Well,

that's

it.

If

I

may,

Pharis, and you

can

add

more

details.

EPITOPE

was

done

with

the

current

patch.

Obviously,

the

study

in

the

intended

population,

the

second

pivotal

we're

discussing

will

be

in

the

older

children.

We

have

a

number

of

options

of

what

it is

that

we

do

with

the

data.

As you

understand,

Jonathan,

until

we

see

the

data,

[ph]



how

would it

inform (13:11)

how

we

move

forward

is

difficult

to

forecast.

And

at

this

point

in time,

again,

I'd

rather

not

speculate.

It's

an

important

population,

as

you

know,

one

to

three

year-olds,

besides per

se

representing

an

epidemiology

of

about –

or

prevalence of

about

300,000

kids.

But

more

importantly,

it's

also

very

often

the

age

of

diagnosis

and

time

also

where

the

children

are

most

vulnerable,

obviously,

given

their

young

age,

the

ability

for

them

to

build

strategies

to

avoid

accidental

peanut

consumption

is

much

more

difficult

for

them.

So,

it's

a

very

important

market

for

us.

We

will

have

the

data

with

cVP

and

once

we

see

it,

is

it

on

the

path

we

can

take,

but

I'd

rather

reserve

judgment

until

we

see

the

data.

But

we're extremely excited

obviously by

the

potential

that

this

study

could

represent

in

adding

options

for

children

out

there.

And let's

be

clear,

the

one

to

three-year-olds,

nothing

is

approved

for

them,

right.

[Jonathan Wolleben, Analyst, JMP Securities LLC]

Yes,

makes

sense.

Okay.

Thanks

again

for

taking

the

questions.

[Daniel Tassé]

Welcome,

Jonathan.

Thank

you.

[Operator Instructions]

[Operator]

And

currently,

we

have

no

further

questions.

[Daniel Tassé]

Operator, if we

have

no

other

questions.

Can you go on there one more time? You don't? Okay.

[Operator]

No more – no questions in the queue.

[Daniel Tassé]

Okay. Again, I want to thank everyone

for joining this afternoon or this evening for our

colleagues in Europe. And as you know, we're always available for comment information. So thank you all for your attendance today

and wish you great evening.

Bye-bye.

[Operator]

Thank

you, ladies

and

gentlemen.

This

concludes

today's

conference

call.

Thank

you

for

participating.

You

may

now

disconnect.