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9,195 Posts.
808
22/05/19
15:48
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35:01
make sure that these valves are
35:02
functioning as they should and good
35:04
overall clinical status so means the
35:05
animals were very healthy meaning they
35:07
were getting the right blood flow and
35:08
these valves are doing what they should
35:09
do so more on the valves later but
35:15
suffice to say what was a thought an
35:18
idea or two years ago has morphed into
35:20
actual valves and products that are now
35:23
in animals and we will be moving to man
35:25
and once we do that we're off to the
35:27
races this wonderful individual is
35:29
professor needling if you don't
35:30
recognize him he is the inventor of the
35:32
adapt process he is a cardiothoracic
35:35
surgeon himself and well known to all
35:38
the global doctors and other folks that
35:39
we deal with but I want to say today to
35:44
understand what you're invested in it's
35:46
a single focused company we are a
35:47
structural heart company that puts us in
35:50
the same category as the starks a lot of
35:51
companies such as Edwards that John
35:53
mentioned earlier it's an important
35:56
distinction cuz the folks in Wall Street
35:57
also watch us and they want to know who
35:59
are when you would even if therapies
36:01
infusion whatever what is the company or
36:03
from today we are a structural heart
36:05
company and that really means delivering
36:06
on the vision this is actually one of
36:08
our valves to 3d valve it's in the frame
36:11
for the tab ah but it is actually a work
36:13
about I've said it before but when you
36:16
see these valves usually there's three
36:17
pieces of tissue sewn into the step none
36:20
of them as a single piece those tissues
36:22
can be uneven they have a lot of
36:23
problems over a period of time and they
36:25
have about 200 sutures to hold them into
36:27
the frame whereas ours has about 20
36:29
those sutures also act as a point of
36:31
contact for calcification or calcium as
36:33
well so there are many many benefits
36:35
the tissue beyond the adapt science to
36:39
our product now brand equity like I said
36:43
a couple years back no one knew what a
36:44
DEP was nobody really cared we came out
36:47
with the Einstein campaign is important
36:49
to see that there its shape matters
36:51
because nobody else can do shape it's
36:52
obviously a smart idea but we're the
36:54
first and only buying scaffold that has
36:56
actually anti calcification treatment
36:57
this has become a big thing because it's
36:59
clinically significant this is the thing
37:01
that stops most surgeons we're just
37:03
about to release our ten year data okay
37:06
folks are aware of this because nobody's
37:08
got tenure data a couple of years ago we
37:10
had a new data that was significant here
37:12
we go attend but beyond that we keep
37:14
generating data in our last couple of
37:16
years we put out a lot of papers there
37:18
is another one right now that's about to
37:21
be published in a very prestigious
37:22
Journal it's the first time for us I
37:24
can't name the journal until they
37:25
publish but it's been accepted
37:26
it's a 600 patients study across multi
37:29
centers in UK and Australia and again
37:33
600 patients no calcification when that
37:35
hits the the wire when it comes out the
37:37
journal will release it but it's in one
37:39
of the most prestigious medical journals
37:41
in the space that's a first
37:43
and obviously doctors and competitors
37:44
notice that these kind of data do drive
37:47
business by the way we have zero DNA all
37:50
of these scaffolds when you when you
37:52
look at them under the microscope have
37:53
its DNA and what's important about that
37:57
Sina graft it's a foreign material you
37:59
put it into the patient and there'll be
38:01
the normal reactions to that
38:04
inflammation calcification other things
38:06
that go on as a result generally of DNA
38:08
people use it because you want the
38:10
physical characteristics that come with
38:12
this collagen now we have zero DNA
38:15
that's again proven fact and I believe
38:17
that's a strong marker for why we don't
38:19
calcify you have less reaction there are
38:22
other things that go on with calcium but
38:23
certainly zero DNA is critical no one
38:25
will ever achieve this in my opinion in
38:27
the materials that we use it's Leon's
38:29
invention it's very you can
38:31
reverse-engineer it it's obviously a
38:32
trade secret and it's no one's been all
38:36
the copy that forever and
38:38
anyone can but also as a result of the
38:41
adapt process and the cross linking that
38:43
we achieve we're able to make these 3d
38:45
shapes including the valves again
38:47
nobody's been able to do that at least
38:48
to our knowledge nobody's published that
38:50
information that's for sure
38:52
and that's a significant step forward in
38:53
the valve space we're not we're a lot
38:56
more widely known by doctors and as I
38:57
said competitors are actually saying
38:59
they're as good as us now so it we're at
39:01
a tipping point again driving data
39:04
moving forward the growth is coming from
39:06
US and Europe pricing is stable we do
39:08
have a premium price product because we
39:09
have a premium or we have clinical
39:10
benefits that are significant and it's
39:13
important to maintain that price and not
39:15
get caught up in the price wars with the
39:16
other folks we're growing it at a
39:18
significant rate is still holding price
39:19
because at a point doctors say well it's
39:21
worth the money as clinically
39:22
significant the rest you'd expect we're
39:26
following this vision and strategy for
39:28
last two years particularly this there
39:29
are other areas where we can review I
39:32
mean we need to focus obviously on the
39:33
structural heart as you can see the
39:34
adult space is much bigger in the
39:36
pediatric space and this is the market
39:38
just generally in the valve setting and
39:40
other settings available to us
39:41
not including TEVAR which is about
39:43
talked billion dollars vascular it's
39:45
still a big space we're moving forward
39:47
there these other areas are areas we can
39:49
compete in quite easily actually
39:51
particularly soft tissue Lunia we're
39:53
looking at it we're not obviously going
39:55
to defocus ourselves and try and jump in
39:56
there at the moment we need to nail this
39:57
first but these are things that are
39:59
available to us in the future and pretty
40:01
straightforward it's not a huge leap of
40:02
faith for us to get in there so what's
40:05
driving the the markets obviously we
40:06
started here the pediatric stuff we're
40:09
very quickly now moving on this you can
40:11
actually visualize real valves and in
40:13
animals that are working the tab our
40:15
project and we started to look at
40:17
conduits which is also a big big market
40:20
my friend here in the audience was
40:21
talking about this earlier that you know
40:24
basically tubes that are treated with
40:26
adapt are going to be important moving
40:28
forward particularly in cases like
40:32
coronary artery bypass graft cabbage
40:34
procedures where they currently use
40:36
vessels from patients there is some of
40:39
this stuff floating around of it none of
40:40
none of its adapt treated from other
40:42
companies it is quite a big market
40:44
professor dealing is now adapting
40:45
several corridors jugulars and other
40:47
things to see what they turn out like
40:49
and once we get that right we will be
40:52
able to enter the conduit market as well
40:54
nothing on the radar but I can put a
40:55
date on quick update on Terra or what's
40:58
driving tab where I want everyone to
40:59
focus on this it's really important this
41:00
future of our companies the reason we
41:02
started doing valves the tower space
41:05
John mentioned earlier is significantly
41:06
big a company our size would never dream
41:09
to play in a space that could be worth
41:11
12 billion dollars by 2025 I know a lot
41:14
of companies claimed to have something
41:16
that they can access a market for we
41:18
actually do the Tavor space has started
41:22
to grow because there's been some data
41:23
that came out recently John mentioned it
41:26
to big companies that spread the only
41:28
two companies in the space Edwards
41:29
Medtronic in March of ACC launched
41:32
patient data that they've been studying
41:34
for a couple of years in a low-risk
41:35
patients now if you look at the patient
41:37
continue it's a pyramid patients who
41:39
used to get TAV are at the top they were
41:40
the high-risk patients patients in their
41:42
mid 80s who probably couldn't tolerate
41:43
surgery would get it ever remember it's
41:45
our oyster catheter that takes about 12
41:47
minutes to place a valve or the care
41:49
that you know now drop it it takes about
41:51
six hours to do open our cracker chest
41:53
and put a valve here so there's a big
41:54
difference in your recovery time and the
41:55
operation time that's all fine medium
41:59
risk patients were on the fence whether
42:02
the hospitals would allow them to get to
42:05
have our it's more expensive than having
42:06
surgery low risk patients patients in
42:08
their 50s maybe were definitely getting
42:11
surgery now this data came out and
42:12
showed basically what you'd expect
42:14
patients who get tab are in the low risk
42:17
group the 55 year olds and upwards
42:18
actually do better than if they have
42:20
surgery now that's compelling because
42:22
it's clinically important credit Swiss
42:24
came out and said the double the the
42:26
addressable market ammo just doubled
42:28
this was much right we recognized this
42:30
two years ago by the way because one
42:31
thing about younger patients is these
42:33
valves have to last longer if you put a
42:35
valve on an 85 year old patient and it
42:37
lasts five years that's pretty good
42:38
innings if you put a valve on a 55 year
42:41
old patient and it calcifies it after
42:42
five years that's not good you've got to
42:44
go back and do it again one of the
42:46
reasons we went into the valve space is
42:48
that very reason that we thought the
42:50
properties in the valve would be
42:51
important and we knew the patients were
42:53
coming down to be younger perfect storm
42:55
for us this coming on the back of that
42:59
data just a quick update on what's
43:01
happening with these valve to
43:03
deteriorate one of the physicians at a
43:05
80s this year said the calcification of
43:07
the first sign of structural valve
43:09
deterioration okay therefore if you ever
43:11
valve that doesn't calcify it's kind of
43:13
last longer and that's the theory we
43:15
don't have a lot of data in the valve we
43:17
have it in other settings but it does
43:19
translate we understand why we don't
43:20
calcify so when I talk about access to a
43:23
space that's twelve billion dollars it's
43:27
we actually have technology that nobody
43:30
has and we're moving that technology
43:31
forward in clinical trials now
43:34
durability is so when you hear me talk
43:36
about durability and announcements of
43:38
whatever wants you just to be clear what
43:40
that means durability means a valve that
43:42
lasts longer think about yourself you'll
43:44
get it and durability is a function of
43:47
calcification as you just saw valves
43:49
will calcify therefore we have to take
43:51
them out but it's not the only thing so
43:53
we have calcification we have anti
43:54
calcification that's really important
43:56
but we also have structural elements
43:58
that are helping us with longevity as
44:01
well the the other valves right now out
44:04
there in this in this very big space are
44:06
made of three pieces of tissue as I said
44:07
sewn into a stent they may not be even
44:10
they may not coapt join properly and
44:12
they slap really hard so they wear out
44:14
our valve however ours a single piece
44:18
when you see it in time-lapse
44:19
photography it goes like that instead of
44:22
so it's rolling we have about 80 percent
44:25
less stress on the commissure on the
44:28
leaflet pop there then a conventional
44:30
valve we have tested them against
44:31
Medtronic valves so we know that this is
44:33
a fact because of the design because
44:36
this is one piece of tissue all around
44:38
here so not only do we not calcified but
44:40
we don't wear out there's a lot less
44:41
stress on these leaflets again the
44:44
doctors on our advisory board they're
44:46
all tab our doctors they represent the
44:48
biggest centers in the US in fact one of
44:50
my Advisory Board doctors dr. Reardon
44:52
was the key author on that other data I
44:54
for Medtronic so these guys are right up
44:56
there sir valve design plays a role we
44:59
have that manufacturing inputs up to
45:01
sutures we have about 20 searches around
45:03
here versus about 200 for Leela valves
45:05
right the searches are a point of
45:06
connection for calcium isolette sutures
45:09
the better so we've got that left foot
45:11
structure I just mentioned our because
45:13
of this design you have a lot less wear
45:15
and tear I guess is look at the point of
45:17
the leaflet and of course then you have
45:18
the adapt tissue properties zero DNA no
45:20
calcification on the scaffold and I just
45:23
reiterate again it's not a pipe dream
45:24
this stuff is the real deal here's a
45:28
picture these are you've seen some of
45:31
these before but these are our valves
45:33
over what's called a cycles cycle
45:36
testing is a machine it's a bench test
45:38
before you go to animals you run them
45:39
through these machines what you're
45:41
looking at is accelerated aging so 100
45:43
million cycles we've run some up to 400
45:46
400 is 10 15 years of human like this is
45:49
viscous fluid in here is about the same
45:51
viscosity as blood so you're emulating
45:53
basic flow but you're flapping the deck
45:55
opening and closing a lot quicker in
45:57
this machine so it's accelerated the
45:59
valves here is the first time you would
46:01
have seen this the other bounds I showed
46:02
before have not been in the frame if you
46:04
can just pick up that metal there it's
46:06
called nitinol that's the tab our frame
46:08
around the stent usually we've run them
46:10
without that so obviously when you add
46:12
the frame you've got another area of
46:13
complex complexity that you want to make
46:17
so these ones at a hundred million were
46:19
run inside there to have our frames and
46:20
if you start here at four obviously very
46:22
early days come over here bit hard to
46:24
tell but that is just a beautiful piece
46:26
of valve if you show that to anyone who
46:28
is in the space the doctors they love to
46:32
look at this because you don't normally
46:33
see a valve looking this good after a
46:35
hundred million cycles so here's just on
46:39
that test you know zero to suture tears
46:41
at 100 million that means that they're
46:42
sitting in their sutures right
46:44
the fatigue looks good and the ear way
46:48
which is the opening opening and closing
46:52
diameter the effective orifice area it's
46:54
called we've got better EOS and we've
46:56
seen and we release that with a cheap
46:58
data if you saw that airway number in
47:00
that announcement it was 2.5 the market
47:04
to now to a point you'd only go too far
47:07
but to a point that AOA size is
47:09
important the more blood flow up to a
47:12
point the better the patient's doing to
47:14
point 5 is the magic number so when you
47:18
put that in context again I want to
47:19
restate that it's not a pipe dream we
47:22
talk to a lot of doctors it's only two
47:24
years in we have a lot of attention from
47:26
Edwards from Medtronic these guys all
47:28
know who we are now and doctors tell we
47:31
will win the durability race and what
47:33
that means is valves that last longer as
47:35
this space has gone down into the
47:37
younger patients now a lower risk these
47:39
valves have to last longer the analysts
47:41
are saying there's only ever going to be
47:42
two players in this market every two
47:44
Medtronic the reason for that is that
47:46
the doctors know how to drive those
47:48
catheters in and out 12 minutes the only
47:51
thing that's going to change this market
47:52
is valves if it valve was more durable
47:55
people will use it so we're on this path
47:56
here these are the first gen stuff we've
47:59
worked up a very nice tab own advice but
48:02
the the star attraction here of course
48:03
is the is the valve and that's what's
48:07
going to drive us into this space like I
48:09
said the big guys know who we are I talk
48:10
to them they understand where we are in
48:12
terms of our development we are going to
48:14
go first in man that's a significant
48:16
breakthrough for our company you get
48:17
these into man the planning has already
48:20
started the doctors involved in this
48:22
have been so impressed with the early
48:24
results from the sheep study that
48:25
they're confident enough to now progress
48:27
to human patients in a limited study so
48:30
that's being planned more on that when
48:31
we get there but in conclusion I just
48:34
want to finish here and say you know
48:36
it's been a couple of years it's been
48:37
bumpy for Cheryl's I get it it's been
48:39
bumpy for stuff you've got a lot of
48:40
folks in that company is so dedicated to
48:42
the mission and so passionate about the
48:44
science we have in the difference it
48:45
makes the patients but also knowing that
48:47
it's going to win they know that when we
48:49
break through that we will compete and
48:51
alka Pete and everybody wants success
48:53
commercial sales obviously still growing
48:55
no matter how you turn at 55 percent is
48:58
not bad growth with regards to the adapt
49:00
portfolio the clinical data just keeps
49:03
coming I just talked about ten-year data
49:05
but also we're publishing now that 600
49:06
patient study that's only over three
49:08
years so it's very recent and we've got
49:09
many studies in the works right now that
49:11
continue to add to that and clinical
49:13
data is important you've got to have
49:15
to be competitive feasibility study is
49:18
concluding so the sheep study is is
49:20
coming to an end as we were explaining
49:21
that I showed your picture those valves
49:23
are looking very good and will make a
49:24
lot of progress on how to have our
49:25
project obviously with the valves now
49:27
moving into man but the perfect storm
49:30
has started because of this discussion
49:31
around the low risk patients younger
49:33
patients that's driven by other
49:34
companies not by us that what it's
49:36
opened up the door to is durability
49:37
younger patients have valves must last
49:40
longer we've got the answer of that
49:41
perfect storm and you know two years ago
49:45
people didn't know who we were honestly
49:46
in the states in the markets we are
49:49
globally recognized you can talk to
49:50
doctors everywhere now they've read
49:52
journals they've read our publications
49:53
the big companies know who we are
49:55
because we're focused on the adapt
49:58
message and the adapt science I'm
49:59
developing from a flat patch into a 3d
50:01
valve so on that note I'll put that up
50:03
there I'll close my remarks sorry I went
50:06
a little bit over time Teagan is
50:08
gesturing towards me to hurry up but I'd
50:12
like to thank you all for your time and
50:13
thank you for coming along the
50:19
leadership you've been showing and the
50:21
long hours you've been putting in over
50:23
the last number of years I'd like now to
50:27
present the results of the poll and I'm
50:31
going to move quickly through this by
50:34
each resolution number one the
50:37
reelection of John Seabrook his director
50:39
asked by 96.3% the election of ms Alicia
50:44
and John is director passed by 97.6%
50:48
election of mr. Yan hang was director
50:51
passed by 98 percent election of Wendy
50:55
gu as director passed by 97.6% election
51:00
of Steve the Nara is director asked by
51:03
96.6% and the ratification of approval
51:09
of placement for shares to Starbright
51:14
and the ratification and approval of
51:17
placement of shares to Starbright on 4th
51:19
of September asked by 53.7% approval to
51:30
approval of the ten percent placement
51:32
facility passed by 98.4% the adoption of
51:38
remuneration report asked by 91.3% with
51:45
that then we have one residual issue
51:48
here votes for the given that thoughts
51:53
for the remuneration report were 75
51:55
percent the resolution adopting the rent
51:58
report has asked for the 91 percent
52:01
injury item number 13 which is the board
52:04
spill meeting is conditional on at least
52:07
25% of the votes cast on the report
52:10
being against the adoption of the Graham
52:12
report therefore there is no strike
52:15
against the remuneration report at this
52:17
annual general meeting therefore there
52:19
will be no requirement to vote on a
52:21
resolution for a board still meeting and
52:29
then last is the motion to spill the
52:32
board has not been passed no changes to
52:34
the board will be made and I'll ask the
52:39
audience is there any other business
52:42
that can lawfully be brought forward and
52:47
I'm not seeing the audience of it Steve
52:50
if you could let me know nothing jump
52:55
very good I'd like to thank declare the
53:04
meeting closed both management and the
53:06
board are committed to the future of
53:08
your company and we look forward to your
53:10
continued support thank you
-
(20min delay)