Episode Transcript
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Ben Comer (00:04):
Welcome back to the
Business of Biotech.
I'm your host, Ben Comer, ChiefEditor at Life Science Leader,
and today I'm speaking withMardi Dier, Executive Vice
President and Chief FinancialOfficer at Madrigal
Pharmaceuticals, a company thatreceived approval for Rezdiffra
in March of 2024.
The first drug approved forpatients with MASH, formerly
(00:26):
known as NAS, and MAG andMadrigal's first approved
product.
That approval came about amonth after Marty joined the
company, and I'm excited tospeak with her today about her
current and prior experiences inthe life sciences industry,
working with investors, raisingcapital, and driving growth as
CFO and chief business officer,as well as how to transition an
(00:50):
RD organization into afull-scale commercial
enterprise.
And finally, we'll end with herplans for the future.
Marty, thank you so much forbeing here.
Mardi Dier (01:00):
Thanks for having
me, Ben.
Yeah, I'm really excited totouch all those topics and uh
thank you for the invite.
Ben Comer (01:05):
Yes, absolutely.
Um I want to start uh as we dowith a little bit on your
background.
I I think you started off uhin-house in the life sciences
industries as uh VP of investorrelations at Chiron.
And I wonder, you know, how,you know, maybe what your
interest was uh in investorrelations uh initially and you
(01:28):
know what that first job waslike.
Mardi Dier (01:30):
Yeah, well, actually
that was part two of my career.
The the first part of my careerwas um in public accounting and
then almost a decade ininvestment banking.
So I had, yeah, it's been a lotof years in my career so far.
But uh so I I came out ofundergrad with a biology degree,
not really knowing which way Iwas gonna go.
So I decided I'd learn aboutbusiness.
(01:52):
And that's what landed me at uhKPMG at the time, a big four
accounting firm.
So anyway, I got the um ABCs ofbusiness, uh, went to business
school and then into investmentbanking for the next decade,
where I kind of recircled backto um working with life sciences
companies as an investmentbanker.
Then I transitioned intoinvestor relations.
(02:14):
And that made um, you know, thestory make a little bit more
sense, which is I just spentalmost a decade really working
on Wall Street, uh understandinguh company growth, capital
formation, but most importantlyworking with analysts and uh
investors on the buy side.
So going into ChironCorporation, uh, for those
(02:36):
listeners who remember Chiron,Chiron and Genentech were
basically started at the sametime in the Bay Area.
Uh really high flyer at thetime.
I would say Genentech got thebetter of us, but Chiron at the
time was a big biotech, one veryfew of them in existence, had
over 3,000 employees andbillions in revenues, um,
multiple business units acrossthe world, et cetera.
(02:58):
So coming in to take myinvestment banking experience
and coming in to do investorrelations and into industry was
a huge transition for me, butalso in many ways felt natural.
Like being on the other side ofthe table and talking to
investors and analysts uh was alittle bit humbling, but also I
(03:21):
kind of know what they'relooking for, right?
So you could speak theirlanguage and you know, really
try to harness the story of agrowing biotech company trying
to get bigger and you know,trying to drive value for
shareholders.
So super exciting.
Ben Comer (03:36):
Yeah.
And so I guess give me a senseof how big of a crowd that is.
And, you know, were youencountering people, you know,
at at Chiron that you hadpreviously met?
I mean, there are a milliondifferent investment vehicles
nowadays, but I mean, do you andyou know, you talked about
being able to speak thelanguage, which uh I suspect is
(03:58):
is really a really importantskill in in managing and
handling investors.
But do you do you still find, Imean, even now that you're
running into some of the samelike big players in that space?
Mardi Dier (04:10):
That is very funny
you asked that question.
Um, you know, biotech wassmaller back then.
This was early 2000s.
Um, still, you know, hugeindustry, don't get me wrong.
Um, but there weren't as manycompanies, there weren't as many
investors, there weren't asmany funds, there weren't as
many investment banks andanalysts.
Um, some of my closestprofessional friends are from
(04:31):
that era, honestly.
Ben Comer (04:32):
Really?
Mardi Dier (04:33):
Um, and some of the
investors, some of the big
investors are still on WallStreet.
Of course, we've had a lot ofturnover over the over 20 years
or 19 years.
Um, but yeah, forming thoserelationships, and actually, it
was kind of a theme I wantedthroughout talking today, is
relationships matter still.
You know, you have always thetransactional side of whatever
(04:53):
you're doing in business, butthe relationships and picking up
the phone or getting feedbackor knowing how to talk to
someone across the table, themetaphoric uh table these days
is super important.
So, yes, I formed really deeprelationships.
Um, you know, we had 20, 25 umcell site analysts covering us.
(05:14):
Um, and then all the big andall the big firms were investors
at that time.
So um, yeah, it was formativefor me for sure.
Ben Comer (05:23):
And then after
Chiron, you worked at Portola
Pharmaceuticals beginning in2006.
Uh, so pretty early in thecompany's history.
I I I want to say they werethey launched in 2004, but
correct me if I'm wrong aboutthat.
But you you helped take thecompany public uh and you were
there through the 2020acquisition by Alexion for over
(05:45):
a billion dollars.
Um, can you talk a little bitabout your experience at Portolo
and maybe first, you know, whatwhat you learned from the IPO
process, you know, during aneconomic uh downturn in 2007,
2008?
Mardi Dier (06:01):
Well, yeah, this is,
I mean, we could talk all day
about my 14 years at Portola.
Um, it was, in a word, amazing,but there were a lot of twists
and turns along the way.
And so um in 2006, uh yes, in2006, Chiron was sold to
Novartis.
So they had already owned about50% of the company and they
came in and took the other theremaining uh remaining uh piece
(06:24):
of the company.
So that was that was great.
So Chiron is no more.
So I was looking for a job andI really wanted to kind of
package my experiences withaccounting, investment banking,
and investor relations at a bigbiotech at the time and become a
CFO.
And uh Portola was aventure-backed um high flyer
company at the time, founded byum uh Charles Homsey and David
(06:46):
Phillips in the cardiovascularspace.
Um we had a factor 10Ainhibitor uh called Patrix of
An.
Um, and it was in the earlystages.
It had just completed, it justinlicensed the technology, and
it was um just completed a phaseone study going into phase two.
So still early in the tenure,but the idea was bring in
(07:07):
somebody who had familiaritywith the street.
So you get a theme there withWall Street, the investors and
analysts, and take the companypublic.
So I got there late, late 2006,early 2007.
Um, we had done, I believe wehad done a series B already.
That's correct.
Um, and then it was, are weready to go public?
And 2007, as everyoneremembers, I'm sure, was sort of
(07:32):
the beginning of hmm, marketsaren't so stable.
We didn't know exactly what thefallout was gonna be, but
markets weren't so stable.
So maybe we should pivot andraise money privately until we
have a better view of what wasgonna go on in the public
markets, which we did and wewere successful.
We ran we raised um a bigSeries C, um, what at the time
(07:54):
was big.
Uh rounds have gotten bigger uhin the last 10 years, but at
the time it was quite big, itwas $75 million.
And um, we waited, we wanted towait out the markets.
What we didn't know was thatthe financial crisis was
happening in 2007 became 2013very difficult time for capital
(08:16):
formation and particularly forbiotech, which was really on the
you know the far end of therisk spectrum, and people were
not taking risk at that time.
So super challenging to thinkabout, hey, how are we going to
raise enough money for thiscompany?
Uh, we're about to enter reallybig studies.
These are cardiovascular,basically outcome studies, very
(08:39):
large um studies that we neededto um fundraise around and um
tackle these markets.
Um, so this, I mean, it'sreally kind of a long story.
We did do another financing.
Somehow we were able to do it,find great investors.
We did go um into the some ofthe sovereign wealth investors
at the time, but had a greatsyndicate, raised another
(09:01):
private round during that, Ithink it was 2009, at solid
valuations.
Um, and it was in 2013, wereally started preparing for an
IPO.
Like we're we gotta open themarket, right?
The market, there have been noum biotech IPOs up until that
time.
There was that big almostsix-year gap that companies were
(09:24):
not being formed.
Talk about innovation gettingstifled during that period.
But um we and Ironwood, Ibelieve, at the time were the
first to come out, biotechcompanies, to do an IPO post the
financial crisis.
And ours was in May or June,May of 2013.
Um, and you just had to haverealistic expectations, right?
(09:47):
We still were able to do an upround.
Um, we got great investorinterest, um, you know, and the
rest was kind of history.
We really had a very successfultenure at Portola Building
Value for the next seven yearsbefore we were sold to Alexion.
Um, but the actual mechanics ofthe IPO was, you know, you get
(10:09):
on a plane, you go city to city.
This was pre-COVID.
Everything was in person, youdid hour-long meetings, you tell
your story, tell your story,tell your story.
We had raised money privately,so we had a good set of
investors already who were goingto come in, but it was very
important to bring in newinvestors as well.
And we really just, I, for lackof a better word, pounded the
(10:30):
pavement and we got that dealdone.
Ben Comer (10:32):
There are a lot of
companies, small companies
sitting on the sidelines rightnow, looking for that window to
do an IPO.
Um, and I don't know how closeof a corollary there is to that
six-year period that that you'vebeen referencing, but were
there any specific cues that youwere kind of looking at or that
you would look at today if youwere in a similar position to
(10:54):
say, all right, now it's time,you know, to and and you, you
know, you referenced the factthat you know you and Ironwood
were one of the first couple ofcompanies out of the gate, which
must have been a little scary,but uh, you know, what what I
guess helped you decide to goahead and do it and and thinking
about today, you know, andthose companies that are sitting
on the sidelines, you know,what would you suggest that
(11:16):
those leaders that thosecompanies you know look to or
think about, you know, beforethey take the plunge?
Mardi Dier (11:23):
Yeah, really good
question.
Um, if there was a specificanswer, uh I mean I'd be here
talking to your It'd be on abillboard, yeah.
Yeah, yeah.
It's a little bit more of afeel, but but a little bit more
than that.
I mean, obviously, um goingback to those relationships you
form, um, you're get you'reyou're keeping your ear to the
(11:43):
ground on what's happening inthe marketplace.
You're working you at thispoint, you've selected your
investment banks.
You've probably had multi-yearrelationships with investment
banks giving you theinformation, you know, like, you
know, how are the markets?
If an investment bank um ishonest with you, there's times
when it's just like we can't doit.
This is not the right time todo it.
You know, um, there's sort ofyou need for capital, there's
(12:08):
patience.
You know, we waited sevenyears.
That was really a dry spell.
I mean, that's a really longtime.
Um, and there's just if there'sa will, there's a way, and you
kind of put that all togetherand decide, okay, we're gonna
go, we're gonna take a chance.
It's an educated guess becauseyou know where your investors
stand, right?
You keep talking to them.
You can't pre-sell a deal.
(12:30):
You can't say, hey, would youwould you put participate in our
IPO?
That's not the way it works.
But you have to understandthey're interested.
We're interested in your nextmilestone.
We think there's a lot of valuein the company.
Um, you know, you control whatyou can control from the company
standpoint.
And that we haven't reallytalked about that, but you know,
when you're coming out of asort of a dark space like we
(12:52):
have in post-COVID in terms ofIPOs and what we did in the
financial crisis, you know,opportunistic financings are far
and few between.
They're really morecatalyst-driven.
So the other, you know,decision, part of your rubric
and making that decision is hey,we're in front of or right
after key data that we think candrive value and get new
(13:14):
investors' interest.
That's what the company cancontrol.
Then you're keeping as a CFO orCEO or folks in charge of the
IPO process.
They're talking to all theoutside vendors, like, is it
possible?
We want this to be possible.
Okay, let's get ready.
Let's try.
And, you know, we did anexercise multiple times over the
(13:34):
years getting ready for an IPOis like, okay, we'll get to this
point.
We'll spend this amount ofmoney, you know, and then we'll
have a decision point.
We gated everything until wesaid, okay, we're we're doing
it.
Flip the switch, file that S1,and let's get on the road.
Um, so so I mean, there's a lotin that answer.
Um, but at the time there was alittle bit of lock arms too.
(13:57):
Like we knew our catalyst wascoming up, but let's lock arms
and get public.
We need the liquidity and wewant the capital um to raise
after the IPO, et cetera, etcetera.
So it just made a lot of timeand it and it worked.
And I guess I would say lastly,having reasonable expectations.
The IPO is not the finish line.
Ben Comer (14:17):
Right.
Mardi Dier (14:18):
Right.
It's the starting line in most,even though you've been slaving
for years already.
And at this point, it'd beenalmost 10 years at the company,
you know, with a board thatsupported us through that period
of time, um, and new investorscoming in, but you you had to
have reasonable expectations.
Like the market's not wideopen.
It's not crazy, you know, 2020,2021 uh type valuations.
(14:41):
So you just had to manageexpectations through the whole
process.
Ben Comer (14:45):
Well, fast forwarding
to the acquisition by Alexion,
um, what what could you sayabout getting, I mean, helping
to enable that acquisition tohappen?
I think this was uh almost abillion and a half dollars that
Alexion paid uh for uh forPortola.
You know, how do you thinkabout that in terms of you know
(15:07):
setting up the business uh to beready uh for a deal like that?
What what could you say there?
Mardi Dier (15:14):
Well, I mean,
there's there's the biotech
adage, of course, which uhbiotech biotech companies are
bought, not sold, right?
Ben Comer (15:21):
So you never you
never prepare for You're not
sitting around waiting forsomeone to call.
Mardi Dier (15:26):
Yeah, you you you
can't.
You you can't.
You know, maybe once in a whilethe lucky, you know, that luck
happens and and if that's whatyou want, then it works.
Um, you know, it's it's alittle bittersweet because we
had just launched our secondproduct, which was a uh reversal
agent for the factor 10inhibitors called a DEXO, a
(15:46):
product we really liked and hadgotten approved both in the US
and Europe.
So we had a lot of work thathad been done through the my
tenure at Portola to get twodrugs approved and on the
market.
Um, and but this goes back tomaybe another discussion that we
may have, which is how do youlaunch a drug?
Ben Comer (16:03):
Yeah.
Mardi Dier (16:04):
How do you launch a
drug in US and Europe and how do
you do that successfully?
We were we were a researchorganization who became a
commercial organization.
And um maybe maybe uh the uh wegot caught in the short the
(16:24):
launch thesis, which many hedgefunds have, which many investors
have, which means it's anunnatural transition generally
for a company to go from a verysuccessful research organization
to all of a sudden be able tohave all the experience to sell
the drug.
Ben Comer (16:39):
It's a huge shift.
Mardi Dier (16:40):
It's a huge shift.
And if you're not uh doing itperfectly, which is a tough
standard, investors can come inand short the launch, which is
exactly where Cortola was at thetime.
So the value we had actuallylost quite a bit of value as we
are trying to launch indexa intothe marketplace.
(17:02):
It's launches are hard andthey're not always linear, and
there is no margin for errorfrom the uh from the investor
community.
They, you know, instead ofsaying, well, there's gonna be
so much value for this product,but it's gonna take two or three
years to really gain ground,they kind of grade you on how
you do in those first couple ofquarters.
And, you know, we were graded,I think we were graded kind of
(17:24):
harshly.
And at that time, I thinkAlexion, it's a cool product, no
doubt.
And Alexion came in and tookadvantage of that.
It also was the start of COVID.
So there was a lot of thingsgoing on at once.
Um, but for the board and themanagement team at that time, it
didn't make sense to sell.
So to answer your question, wedidn't ready for sale at all.
(17:47):
We wanted to grow this uhproduct on our own in the US and
Europe.
Um, but you know, when somebodycomes calling, you you, you
know, you have a fiduciaryresponsibility to uh take that
into consideration, in which wedid.
Ben Comer (18:02):
Well, you got a
little taste of uh that
commercialization um struggle,you know, and the the trickiness
of a launch uh at Portola.
You're reprising that a littlebit with with Madrigal, and
we'll we'll talk about that injust a second.
But uh before we do, afterPortola, you went to Ultra
Genics at CFO, um, a uniqueultra-rare company.
(18:25):
You were there for a couple ofyears.
You were CFO and CBO, Ibelieve, um at um at Celerin.
Mardi Dier (18:32):
At Celerin, yeah.
Ben Comer (18:33):
At Celerin, right?
Um, what what were the whatcould you say about those
experiences, maybe how theydiffered?
Mardi Dier (18:40):
Oh, yes, opposite
ends of the biotech uh uh
experience.
So I did so uh after Portolawas sold, took a little break,
trying to think about what'snext.
I had joined some boards, so Ialso do board work, um, which is
really fun and exciting.
And uh was looking for my nextrole, and I knew I wanted a
(19:00):
little more critical mass in acompany.
Like I wanted to see again, Isort of have this itch.
It's like, how does acommercial launch work?
Like, how does it successfullywork?
And Ultra Genics is one of theum bigger biotechs in the Bay
Area that has commercialproducts.
They are in the rare diseasespace, which I thought was
actually very cool and I wantedto learn about it.
(19:22):
And they have a CEO, AmilCakis, who's a kind of a
stalwart in the biotech industryand is such a wonderful,
charismatic, interesting personand just so passionate about
rare disease.
Um, it just seemed to make alot of sense for me and where I
was in my career.
Um, and it was great.
(19:43):
You know, going to ultragenics.
I'm sorry it was only twoyears, but it was two great
years.
Um there was a lot of valuecreated there.
And they have a lead product,which is sold in many countries
all over the world, LatinAmerica, US, Canada, Europe, uh,
for it's what's called a raredisease called uh bone disease
called XLH.
(20:04):
And um actually it was a reallygood product.
And they were that we had agreat commercial team and able
to sell it.
And in addition to thecommercial organization, there's
just some cool research thatwas going on um on the rare
disease side that was kind offun to learn about and exciting.
Um and and so so ultradicts isgreat, remains great.
(20:28):
Um, I still am in touch withemail, but I I did get a phone
call a couple of years in froman old friend who had started a
Celerin.
And he just said, come help us.
You don't want to miss thisone.
Super exciting.
Um, and so I I did, I jumpedship.
I was like, oh, I have one morestartup in me, right?
(20:48):
It takes a lot of energy to doa startup.
It's like I have one more inme.
And uh, you know, Celerin, itwas a it was a brief stint, but
a really powerful stint.
We got there, basically noinfrastructure, acquired a
company and some technology, andthen decided we are gonna go
public based on some phase two Adata in the immunology space.
(21:11):
And we just kind of hit themarket right.
We did a huge IPO, over $600million IPO, one of the largest
clinical stages stage IPOs.
Um still a lot to be um proudof.
It was great.
Um and then I left shortlythereafter for for a lot of
reasons, but it made sense bothfor for me and the company.
(21:33):
Um, but at the time, that thatvery quick few months at
Accelerin, we we accomplished alot.
And it was very, very excitingum and fun.
But left Accelerin.
So it to answer your nextquestion, um, I still had this
itch.
Like, how do you really launch?
I'm a I kind of have biotech inmy blood.
(21:56):
How do you really launch aproduct in the US and elsewhere
successfully?
How do you not get the shortthe launch happen to you?
Yeah.
How do you drive value?
It's gotta be done.
You don't, it can't just bepharma.
And you know, most people callme crazy because it's like it
(22:16):
doesn't happen.
Like, you know, you just it's ahard lift.
Um, but um our chairman of ourboard is someone who I've known
from past investments.
Uh he's a one of a very largeinvestor in biotech, introduced
me to Bill Sibyl, our CEO atMagical.
Um, and even though the job ison the East Coast in Boston,
(22:40):
it's just he's experienced.
He's um, you could tell, justso talented.
He understood the space uh orthe opportunity of the space.
Not to say he was a mashexpert, he wasn't, but he
understood the opportunity.
And um, you know, he'd been histrack record speaks for itself
(23:01):
in terms of launching drugs.
So I kind of hitched my wagonto Madrigal and jumped in, kind
of like holding my nose, like,okay, what am I in for?
Um, and you know, we can we cango into that and the success
here.
Ben Comer (23:14):
Yeah, well, that was
uh, I think you joined in
February of 2024.
Madrigal was on the precipiceof its first FDA approval, uh,
which we now know was approved.
Um I I I assume you really hadto hit the ground running when
you when you joined the companya month away from from an
(23:35):
approval.
And I wonder what you could sayjust about kind of how you got
your legs under you.
Mardi Dier (23:40):
Uh are they under
me?
Ben Comer (23:44):
It appears so.
Mardi Dier (23:45):
Uh yeah, I am
standing actually.
Um oh yeah.
So, oh man, what what anamazing, oh God, how many months
has it been?
20 months and counting uh foreverybody, the whole, the whole
company.
So I joined February 2024,that's right.
And um I was, I think, employeein the 400 range, but we had
(24:06):
gone from like 200 to 400 just amonth before by putting the
sales force in place reallylate.
Meaning usually you do that,you know, 12 to 18 months before
you're gonna get approval ifyou're going at risk.
Um, but madrigal was aDyed-in-the-wool RD company
(24:29):
driven by our founder, BeckyTao, that brought Res Difra
through and her team through theFDA and to be the first drug
out of I think there were 23, 26failures in Nash.
Ben Comer (24:43):
Yeah, there's a big
graveyard in NASH at the time.
Yeah, I remember covering it.
Yeah.
Mardi Dier (24:47):
And the whole
company was focused on res Difra
and getting it approved.
And they did, I mean,unbelievable.
And it was, you know, only theSeptember of 23, so just a few
months before approval, thatthey brought in Bill Sybil.
Like, oh wow, we gotta we gottacommercialize this puppy,
(25:07):
right?
Like we gotta bring in theexperience, and and we're gonna
launch in April.
I mean, that's only for sevenmonths from when he joined.
And there were probably ahundred people here when he
joined.
So luckily, you know, hisbackground and his experience
(25:29):
allowed him to recruit people heknew in the industry who have
commercial experience.
Carol Huntsman, our chiefcommercial officer.
Um the number of people havetouched Bill throughout his
career.
And he was able unbelievably,they were able to get a uh
commercial and medicalorganization up to speed for
(25:51):
commercial launch in the numberof months, all the while, all
the while, you know, workingwith the FDA, keeping the RD
going, making sure we get toapproval that we can make the
drug and actually launch it.
So from the GNA side, from myside, CFO side, et cetera,
(26:11):
again, the company was only setup and right-sized to get the
drug approved.
Nothing was really contemplatedor planned of, oh my gosh, what
happens once you go commercial?
Ben Comer (26:22):
I mean, and I I
assume the clock really like
you, you know, you you talkedabout the short investors going
back to your previousexperience.
I I assume the clock, once thatapproval is announced, there's
a clock that starts ticking,right?
Mardi Dier (26:35):
Yes.
Oh, yeah.
Can they do it?
Ben Comer (26:37):
Yeah.
Mardi Dier (26:38):
Who's who's Bill
Sibyl?
The investors ask, you know,for bio, he's not a biotech, he
wasn't a biotech person.
He certainly is now abiopharma, I would say.
But who is he?
Like, what's his experience?
Has he run a company before?
Who's the commercial team?
What happened to Becky?
Who's the CFO?
What team are they puttingtogether?
I mean, so many questions youcould see.
That's just on the team side.
But they also were putting allsorts of short theses out there
(27:01):
about what is what's the labelgoing to look like?
You know, is this really amarket?
Are the GLP ones gonna liketake the whole mash market away?
Like, really, what are theydoing?
Is there any value here?
And um, you know, so weobviously we got to the March
14th timeframe.
Not only did we get approval,we got a, you know, a best case
(27:24):
label and um, you know, andlaunched within weeks.
Honestly, it was like April inmid-April sometime that we
launched the drug.
And I would say then thatobjectively, which I'm not, but
objectively, it's been anexceptional launch.
I mean, really most excellent.
So back to your question abouthow'd you get your legs under
(27:48):
you?
Um we have we have a relentlessspirit here at Madrigal.
Like everybody on the executiveteam and surrounding the
executive team have years andyears of experience.
They may have known each other,a lot of them knew each other,
but not everybody knows eachother.
But they all know what to do.
They're pros, right?
So they're coming in here andit's just like we all know we
(28:09):
got to get our job done and wegot to work really well
together.
I've never been with a team,honestly, that works so well
together to making decisions andthey're hard decisions and
running and getting things doneand wanting to do well.
We really across the board havean exceptional team in Maduro.
Ben Comer (28:26):
I wonder if you could
say a little bit more about
that transition from, you know,as you describe it, dyed in the
wool, RD shop, turning into acommercial company from from a
leadership perspective, youknow, what what's in that
playbook?
You know, what what goes into,I mean, thinking like culturally
and not to mention just on akind of task level.
(28:48):
Yeah.
Mardi Dier (28:49):
Both, both, both,
both.
Um, so like I said, the thecompany was was fit for purpose
to get this drug approved, butthings like corporate culture or
corporate core values or thingswhen when you get bigger and
you have critical mass, youknow, that wasn't the priority.
And it I'm not being critical,it's just it's just factual.
That's that's what they theydid what they needed to do to
(29:11):
get this drug approved, and itwas monumental, huge lift.
You know, we're a leader inthis space for sure for the mesh
space.
Um so we really had to we hadto do all of it.
But in some ways, from aculture standpoint, we almost
have a blank slate.
Like because you're kind ofgoing from a hundred people a
few months ago to five, six,seven, eight hundred people.
(29:32):
So you had the chance to directthat culture.
And we worked with ourexceptional um head of
communications and put togetherour core values, uh, which are
very simple, easy to use.
Everybody understands them.
And um, you know, we we usethem when we interview, we use
(29:54):
them when we put slidestogether.
And it's just a little bit ofwow, we're here because.
We're mission driven and we'rereally focused on the patient.
You know, we collaborate.
We have to collaborate.
The minute you have silos,you're dead.
You have to collaboratecross-functionally.
You have to have an ownermindset, meaning we're running
(30:15):
so fast.
But you know what?
You can't wait really forsomeone to tell you what to do.
Like have an owner mindset,like pitch-in, come in and and
help, and then innovate.
You know, like innovate whereyou can because our
competitiveness in this space issuper important.
So being first mover, takeadvantage of it.
(30:37):
Getting the drug to patients,we have over 23,000 patients on
drug now is is vital.
How can we innovate in a in ahighly regulated industry to
make sure we can do thingsfaster and better?
So those are our core values,super easy, and it's really
what's driven us over the last20 months.
Ben Comer (30:56):
What what are some
and I I guess I'm I'm thinking
about, you know, um Madrigal'scommercial strategy.
I I think you're selling directin the US and Europe.
Um, I'm not sure what you'redoing beyond those markets, but
could you give me a sense of,you know, maybe in your view,
what were some of the keys to uhto having a successful launch,
(31:18):
to being as you know, assuccessful with the launch so
far as you have been?
Mardi Dier (31:23):
Yeah.
Um it it's pretty it'simportant.
And this was really governed byum, you know, the commercial
team and Bill reallyunderstanding how best to launch
into this market, meaning thisis a specialty product.
So we are targeting, we're nottargeting everybody.
We're not going to primary carephysicians and selling direct
(31:44):
and having an enormous salesforce.
We are focused on the 315,000patients that have been
diagnosed with moderate tosevere MASH that fit within our
target physician group.
And so that is our focus andour story.
And then we price the drugappropriately for exceptional
(32:08):
value, supported by ICER reportsand other ways.
And when you marry thespecialty population with the
value of the drug and then thesize of our sales force, it's
kind of a recipe for driving alot of revenue, getting the drug
to patients, which is soimportant, the ones that need it
and are diagnosed, and reallydriving value for the
(32:29):
organization.
So, you know, justexceptionally smart to say stay
disciplined on exactly howyou're gonna sell the drug, how
you're gonna get the most drugto patients efficiently, and and
increase your penetration bothon breadth and depth every
quarter.
That's our goal.
And that's what we've done.
(32:50):
So in the US, yeah, we sellthrough um our specialty
pharmacies as a specialty modelthat's working, doing the same
in the EU.
So that in the EU, a number ofthe big countries will be
selling direct if everythingmakes sense in those countries.
Um, access is always a littlebit more challenging in Europe.
Um, and then we'll also findcountries where it makes sense
(33:14):
for us to sell and maybe wepartner either with a
distributor partnership modeland/or you know, an outlicensing
in other countries.
So that's still unfolding as wedecide where our opportunity
is.
But in the in the main markets,and what the launch today has
been a specialty, specialty ummedicine launch.
Ben Comer (33:34):
Um, you mentioned uh
referencing ISA reports.
That's the Institute forClinical and Economic Review.
And I'm just curious, like inyour role as uh as CFO, are you
having input like on the price,on setting the price?
Does that fall within yourpurview?
Mardi Dier (33:51):
Well, we have a
pricing committee that, you
know, it's not certainly not me,but I'm part of a committee
that we discuss and and setprice wherever we are.
That's important.
It has to be committee driven,it has to be data driven.
ICER is just one element thathelps because it really shows um
it's a third-party independentresearch organization that uh
(34:11):
gives a range of where theclinical benefit, where the
value of the product is, and wefall within that value.
It's been a great story.
Um and it just, you know, priceand medicine, pricing medicine
is very tricky, of course, andwe understand the environment
now as well.
Um, having third-party valuevalidation is is really helpful.
Um, but honestly, you know,again, back to the strategy that
(34:36):
has not um, you know, so farbeen an issue, right?
We've had a very successfullot.
Ben Comer (34:42):
Yeah.
Mardi Dier (34:42):
Yeah.
Ben Comer (34:43):
Excellent.
Um uh Madrigal is a commercialcompany now, but that doesn't
mean you aren't still doingdevelopment work.
Um, what what would you sayabout Madrigal's current
pipeline right now?
Mardi Dier (34:56):
So our strategy is
really simple.
Drive top line, that's ResDifraright now, and build pipeline,
right?
We know to reach the mostpatients and continue to drive
value.
Uh, we're very focused on MASHright now, that it can't just be
a single product.
We really see ResDIFRA as thefoundational therapy for MASH.
(35:17):
And so, on top of that, how canwe even treat patients better?
Is it more of a selectivesubset of patients, or is it
adding a GLP one where you havesome weight loss where we've
actually shown that you can havejust 5% weight loss, that
ResDifra actually works betterin uh reducing uh liver fat and
(35:38):
reversing liver stiffness.
Um, so there's a lot ofdifferent strategies that are
going to play out here.
And if you think of sort ofanalogous industries, whether
it's rheumatoid arthritis orpsoriasis, when the first drugs
came out that are still verysuccessful, you since then have
seen 20 years of growth, right?
(35:59):
And a lot of different productscome in, a lot of different
combinations, but yet the stillthe pie is still continuing to
grow.
And we think very much this isgonna happen in the MASH market
too.
We are at the very beginning.
We're only 10%, 7, 8, 9%penetrated into our 315,000.
You know, that we believe thattop of that funnel is going to
(36:21):
continue to grow as morepatients are diagnosed and the
awareness of MASH continues.
So we'll take ResDiFra as thatfoundational therapy.
We have um IP out to 2045, andthen we're building a pipeline
to see how can we make maybecombinations, you know.
So ResDIFRA plus an oral GLP1,which we've been in licensed,
(36:41):
how will that look?
Are there other indicationsthat ResDifra can be good for?
Like we have our F4, which iscompensated uh cirrhosis study
ongoing.
So really important, going backall the way to the catalyst to
drive value, like clinicalcatalysts, really important to
have those catalysts to helpdrive value of the organization,
but also the data to continueto get ResDIFRA in whatever form
(37:06):
or any combination oradditional assets to patients.
Ben Comer (37:11):
Right.
And we've talked about um howdifficult it can be to launch a
drug successfully.
It's also exceedingly difficultto develop a drug all the way
through to approval.
And I wonder if there'sanything else, Marty, you might
say about balancing commercialexcellence with replenishing the
pipeline, you know, keeping thedevelopment engine running from
(37:33):
a financial perspective.
Mardi Dier (37:35):
Oh, yes, from a
financial perspective, and we
haven't talked a lot about that,about deal making.
Um, you know, in biotechbiopharma, cash is king, right?
No, we're we have the luxurythat we're getting to a point
where, you know, we're getting alot of revenue on the top line,
but you know, we're justgetting there.
So how do you manage that?
(37:55):
You know, particularly.
Ben Comer (37:56):
Yeah, like what
percentage do you pump right
back into RD?
unknown (37:59):
Yeah.
Mardi Dier (37:59):
Well, right now
we're kind of in this sweet
spot, meaning we want to buildpipeline.
It's super important.
We message that, we'reinvesting.
We've done one deal already, wetalked about additional BD
strategies.
So this is the time to comeback into RD.
Our big phase three studies,white, they're still ongoing to
an extent, but the big bulk ofthe spend um for ResDIFRA, uh,
(38:24):
we've already, you know, are inthe past.
So now we want to refill thatcopper.
So it's really two things,which is messaging to the
street.
It's building out the rightteam for the next level of
growth on the RD team.
You know, we're not going tojust have one product.
We may have, you know, a numberof products that they need to
bring forward.
Um, and then having the rightcapital in the bank, um, all the
(38:47):
while marrying RD with the restof the organization culturally.
So we have become one company,not commercial and RD, but how
do you operate as one company?
I think we're doing a prettygood job, but we're at that
sweet spot of forming all thatright as we speak.
From the street perspective,this is like I said, this is the
(39:08):
time to do it because peopleare only looking at our top line
really for now.
I mean, obviously they want tomanage spend, but we have
capitalized the company in a waythat we've taken any sort of
financial overhang off the tablefor now.
We manage that really well.
So now the questions from thestreet are more RD or commercial
focused, not about how you'regoing to capitalize the company
(39:31):
and what's your next deal andwhere's the dilution.
So um, from that perspective,or we I think we're doing a
pretty good job.
Ben Comer (39:38):
Yeah, that's a good
place to be in, no, no doubt.
Um, magical n-licensed uh,we've been you've mentioned
GLP1s.
You N-licens the GLP1 candidatefrom uh a Chinese company, CSPC
Pharmaceutical Group Limited.
Um, that's gonna be developedin combination, uh, as you
mentioned with your approved uhproduct ResDifra.
(39:58):
Uh, there have been a lot ofdeals uh with Chinese biotechs
recently.
It's a very hot area in theindustry, lots of conversations
about it.
I'm wondering if there were anyunique uh complexities that you
had to overcome or or will haveto overcome uh to bring that
drug in into U.S.
development?
Mardi Dier (40:20):
So uh it yes, very
good question.
You always have to look at thatand manage that.
And when you're going um doinga deal with any of those
companies, you know, some of thethings you look for, do they
have a US presence?
Did they run uh the studies?
Uh this is a preclinical study,so it doesn't quite uh have
rigor, but you know, have havethey done some of the work in
(40:41):
the US?
You know, so we have looked atlater stage assets as well.
You do want to kick the tireson that because you don't want
to, you know, uncover somethingthat, you know, was done on an
unfamiliar setting that makes nosense for what you're trying to
do.
In this case, also the company,CSPC is a very large company,
very large company, um, and umhad a lot of rigor.
(41:02):
We had a lot of great meetings,um, you know, easy, easy back
and forth in terms of the of thenegotiations for the deal.
But I would say, and this is apre-clinical asset um that will
go in the clinic later thisyear, um, you know, from in this
space, the GLP one space, youeverybody knows is huge, right?
Yeah.
A lot of competitors.
(41:24):
So you do have to tiptoethrough the minefield of IP, uh,
intellectual property, ofcourse.
It would do that Chinesecompany, US company, whatever
company, right?
Right to make sure that youhave freedom to operate.
And I would say our IP workhere at Madrigal is um
exceptional and top-notch.
And, you know, so we did a lotof work there on the IP and
(41:46):
really feel good about ourrelationship with CSPC.
Um, that said, you know, it'spre-clinical, we'll have uh
we'll transfer the work um afterearly phase one over to the US
and we'll take it from there.
But, you know, any try, anytimeyou're combining, you know,
even though GLP one's our knownmechanism, but anytime you're
(42:08):
combining two drugs, there's anit's biology, right?
You know, you there's anelement of the unknown.
Yeah, absolutely.
So um that's why we wantoptionality and a lot of shots
on goal.
Uh, because you can on paper,the academic exercise looks
really good, but in reality,you've got to run the experiment
and see if it works.
So there's lots of data on bothdrugs, obviously, uh on the
(42:31):
mechanism of GLP1, and then alot of data on ResDifra.
So we know what we know.
Um, so not going in thisblindly, but we think it could
be a really cool opportunity.
Ben Comer (42:41):
Great.
Well, um, looking forward,Marty, uh, what what are your
top priorities, I guess, throughthe end of this year and maybe
for the first quarter of 2026?
And you're coming up onearnings.
So I really especiallyappreciate you being here today.
Mardi Dier (42:54):
Yeah, yeah.
We're coming up on earnings, sowe won't talk anything about
you know specifics regardingearnings.
Um our top priority is, youknow, continue.
Well, we've kind of said it isto continue growth and uh of
resdifra, our top line.
Really important.
We think this is a majorblockbuster opportunity for us.
(43:16):
And we want to be smart,creative, agile in making sure
we get this medicine in the mostuh uh physicians' hands and
then to the right patients.
Top, top priority for the restof this year and next year.
Um, and then um, I thinkspecifically is really laying
out our catalysts to drive valuefrom the RD side.
So really putting together allour efforts and just continued
(43:40):
execution.
Um we're still building outinfrastructure and systems, uh,
which is exactly what we shouldbe doing, uh, because we really
want to build uh, you know, aworld-class top-notch
institution.
And I think we're on our way.
Things are going really well.
Ben Comer (43:56):
What's your next um
uh clinical milestone or next
kind of uh big, you know, bigthing in the clinical side?
Mardi Dier (44:03):
Yeah, well, so we
have, I'm glad you asked,
actually.
I mentioned our F4C study.
So this is what we call MaestroNash Outcomes Study, and it is
looking at more severe NASHpatients in that F4 relates to
um cirrhosis when you've tippedthe scale from you know fatty
(44:25):
liver, you know, progressingfatty liver disease, and then
you become cirrhotic.
And you can have compensatedcirrhotic and decompensated
cirrhotic, not an area where youwant to go because it's it's a
little bit hard to return fromthere.
But in this compensatedcirrhotic population, there's a
real opportunity for us to makea difference.
And there's no medicine therewith a label to uh treat these
(44:47):
patients.
And we had some early data thatwe showed last year at Easel,
and then we keep talking aboutthat was fantastic.
Um, but the phase three isongoing.
So that's our next data set in2027, and that's that's a big
one.
Ben Comer (44:59):
Okay, because res
difra is for non-cerrhotic, is
that correct?
Correct.
Mardi Dier (45:03):
It's for for
moderate to severe um um mash,
um, similar to F2 and F3patients, as they are graded in
certain ways.
This tips the scale into thecirrhosis side of things.
Ben Comer (45:18):
Got it.
All right.
Well, um, Marty, thank youagain so much.
Uh, right, you know, coming upon earnings for for taking the
time to be on the show.
I I really appreciate it.
Mardi Dier (45:28):
Yeah, Ben, thank
you.
I really enjoyed it.
Yeah.
Have a great day.
Ben Comer (45:32):
We've been speaking
with Marty Deere, Executive Vice
President and Chief FinancialOfficer at Magical
Pharmaceuticals.
I'm Ben Comer, and you've justlistened to the Business of
Biotech.
Find us and subscribe anywhereyou listen to podcasts, and be
sure to check out new weeklyvideo casts of these
conversations every Monday underthe Business of Biotech tab at
(45:53):
life science leader.com.
We'll see you next week, andthanks as always for listening.