Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Ben Comer (00:04):
Welcome back to the
Business of Biotech.
I'm your host, Ben Comer, chiefeditor at Life Science Leader,
and I'm pleased to speak todaywith Sara Bonstein, Chief
Financial Officer at Insmed, acompany that is simultaneously
growing the commercial marketfor Arikayce, a drug used to in
(01:01):
combination to treatmycobacterium avium complex, or
MAC lung disease, and is alsoanticipating a potential FDA
approval for brensocatib, for adifferent non-cystic fibrosis
lung disease.
Some analysts are predictingblockbuster sales, that's sales
over $1 billion annually, forbrensocatib if it gets approved.
So it's a good time to chatwith Sara about how she helps
Insmed balance commercial scaleup with a continued focus on
pipeline progress and clinicaldevelopment, and what she sees
as the most important duties ofa CFO, and of course, how she
got to where she is today.
Welcome to the show, Sara.
Sara Bonstein (01:01):
Thanks so much,
Ben.
So glad to be here with you.
Ben Comer (01:04):
Yeah, really glad to
have you as well, and I thought
we could maybe start off withwhat I said at the very end of
my intro, which is what firstattracted you to the healthcare
industry and how did you getstarted in biopharma.
Sara Bonstein (01:17):
Yeah, no, it's a
great question and it's
something, you know, all youngpeople actually people of all
ages should reflect on, and Itruly believe that you should be
in an industry where you havepassion for it.
And so whatever drives you,whatever you have passion for,
regardless of your functionalarea, that's where you should
lead yourself.
And so throughout sort of myyounger years, I dabbled in all
(01:39):
different industries and Ireally learned that the
pharmaceutical, healthcare,biotech space is what I was
passionate about.
I'm not a scientist, I don'tpretend to be a medical
professional or a scientist, butI love that in a small way, in
my sort of G&A ability, Ican give back to patients.
I can hopefully, in some aspectof the work that I do, allow a
(02:02):
patient to live a longer life,aspect of the work that I do
allow a patient to live a longerlife, a higher quality of life,
and as you think about onepatient, I believe that touches
a hundred lives as you thinkabout sort of their circle of
the patient, their family, theirfriends, and you can't have a
more remarkable put your head ona pillow at night kind of
feeling to be able to helppeople live a longer or a higher
(02:22):
quality of life.
Ben Comer (02:24):
But I'm sure it was a
stretch.
You studied finance in school.
You probably had a choice of doI go into banking or do I go
into a separate industry?
You chose biopharma, not theeasiest or least complex
industry out there, I guess.
How did you choose it, and haveyou ever felt like it was a
(02:46):
mistake at any point?
Sara Bonstein (02:48):
Yeah.
So I it's funny, I, you know, Ilook back and I think about
freshman year of college and Istarted going to the events that
my first actual employer cameto college and recruited pretty
heavily.
And so I started going to thoserecruiting events freshman year
and I would go up and introducemyself at the ends and they
(03:09):
would be like, oh, what gradeare you?
And I'm like, oh, I'm afreshman.
And they're like, oh, thesearen't for you.
And I said, okay, well, I'll beat each one until they are for
me.
And it really helped me learnabout the industry.
But, like I said previously, Ialso saw what else was out there
.
I worked in banking while I wasin college and got a flavor of
what that looked like.
I've worked in, you know, sortof more like retail type
(03:31):
industries as well and I reallyloved this industry.
Like I said, I'm not ascientist, but what's most
important is you surroundyourself with people that could
teach you their trade, thatcould teach you their expertise,
and you hope that yourcontributions can also pay it
forward and help to teach themas well.
And so I very much appreciatethe other areas that need to
(03:53):
make this biopharma industry goaround right, I very much value
my bankers and if I didn't havethem we wouldn't be able to
raise the money and do what wedo and all that good stuff.
But for me, what drives me,what I'm most passionate about,
is to have that direct link to acertain indication, to a
certain group of patients, to acertain product, and be able to
(04:14):
drive that forward.
Ben Comer (04:15):
Yeah, and I don't
need to tell the listeners to
this call how resource intensiveit is to build a biotech
company, so the intersectionwith finance is perhaps even
more important in this industrythan some others.
You started out your career inbiopharma with some big
companies.
What did you learn in thoseearly experiences, Sara?
(04:39):
That has helped you get towhere you are today.
Sara Bonstein (04:42):
Yeah, I'm so
grateful that I had the
opportunity to start my careerat Big Pharma.
So my first 10-ish years was atBig Pharma and it really taught
me the business, thefoundational drug development
process, so from bench tocommercialization and everything
that goes along that journey,and what it takes to develop a
(05:03):
drug from FDA requirements, frommanufacturing, from commercial
organization.
There's so many components andmy belief is you cannot be a
good executive unless youunderstand the fundamentals of
the business.
And, again, you're not going tobe the expert, right?
I don't pretend to be theregulatory expert.
That's why we have regulatorypeople.
(05:23):
I don't pretend to be theclinical development expert.
That's why we have clinicaldevelopment people.
But in order to understand thebusiness and have a very robust
conversation and really be, Ikind of always viewed my role as
the voice of reason, voice ofbusiness in those conversations,
because you have thosetechnical people in their roles
for their technical capability,they might not think about it
(05:46):
sort of at that higher strategiclevel and that's where I was
able to meld both of those withmy financial backgrounds and
then understanding the corebusiness and then being able to
see the vision on how do youactually get impact to patient
as well as you appreciate, weare a for-profit company and you
need to drive the companytowards success from a balance
(06:08):
sheet perspective.
Ben Comer (06:11):
Yeah, and we've
mentioned the complexity, I
think you really do have tounderstand the business well to
be that voice of reason, right?
I'm curious, if there were any,maybe what struck you as the
most eye-opening when you werelearning the business what it
takes multiple years, millionsof dollars to get a drug from.
You know early stages ofdevelopment across the finish
(06:35):
line.
Was there anything that yourecall just kind of striking you
as like wow, this is somethingdifferent.
Sara Bonstein (06:39):
Yeah.
So a couple of thoughts maybeon that.
First is most pharma companies,biotech, big and small have you
can call them anything you wantsome global product teams.
It's a cross-functional teamglobally that oversees the
product or the indication.
So I still remember, early inmy career getting the
opportunity to sit on my firstglobal product team.
(07:02):
I was so passionate about thatproduct and then when that
product did not succeed out ofPhase 1 we went through Phase 1
and it was.
We got a you know no go to moveforward.
It was.
You know it was kind of likeyour baby right, you got really,
you got really really into the,into the product.
But it helped teach me young inmy career that you have to, you
(07:23):
know, give it your all.
But this is a tough industry andso you know we can, you know,
probably quote better statisticsthan this.
But it's well over a billiondollars to bring a drug from
bench to commercialization andmost drugs fail right, I think
it's 20% of drugs you know getto even move on into the pivotal
stage and then a lot of thosedon't fail, a lot of those don't
(07:49):
make it and get out to patient,and we do that for a lot of
good reason.
We do that because we want toensure that we're putting safe
and effective drugs and that iswhat is ultimately being
provided to patient.
But that takes 10 plus yearsfrom really from when you start
in the clinic tocommercialization, let alone the
bench time, and it takes wellover a billion dollars to do
that.
So that's really reallyintensive.
(08:11):
So to be able to kind of learnthat and see some almost you
know failures along the wayactually really helped me
understand the importance of thedrug development process and
making sure that the mechanismhas to work at the end of the
day.
Right, but did you build it toallow the mechanism to work?
Did you design the trial in away to give it its best chance
(08:35):
to work?
Did you resource it enough?
Did you ask the right questions?
Did you build your Phase 2program to ask the tough
questions then, versus waitingto your Phase 3?
And that's when you ask thetough questions and you see the
failure in Phase 3.
Could you have anticipated thatfailure if you designed your
Phase 2 differently?
So understanding thosecomponents and again, I don't
(08:58):
pretend I could sit here and goon a whiteboard and draw what
the schema needs to be for aclinical trial design.
But I was able to learn enoughof things that happened well and
sometimes, I think even moreimportantly throughout your
career, things that maybe didn'tgo that well, and then take
those learning and apply them tosort of the next time and be
like, well, you know how aboutwe think about it this way?
(09:20):
Could we do an extra arm orcould do a stratification, or
could we do a blinded look so wedon't, you know kind of
compromise alpha from astatistical plan and get some
answers?
Can we ask what's the endpointand pivotal, should we study
that in our Phase 2, those typesof things?
So that's the part that I findreally fun.
Ben Comer (09:42):
Yeah, and I want to
touch on that just in a little
while in terms of, you know, forour biotech builders out there,
what are some steps or that youcan take, or things that you
can think about, to set up yourbusiness, to be sustainable, to
get to that finish line of adrug approval.
But I'm curious, though, aboutyou know failure.
I want to follow up on what yousaid about you know the Phase 1
(10:02):
program.
Were there camps?
You know, were there peoplethat said that thought maybe
it'd be worth, you know, tryingit out in a Phase 2?
And you know, what can you sayabout the importance of fast
failure, of you know, eventhough you're, so you know,
invested in a specificdevelopment candidate having to
move on, you know, knowing whento kind of cut and run, as it
(10:25):
were.
Sara Bonstein (10:26):
Yeah, it's such a
great topic to bring up and I
think it's a pitfall that youactually see more probably the
smaller companies, but even thelarger companies fall into time
and time again where you need toset what does good look like
before you see the data right.
And so you have to say what inevery aspect of life what do you
want to achieve?
Give yourself goals, what doesgood look like before you see
(10:46):
the data right?
And so you have to say in everyaspect of life, what do you
want to achieve?
Give yourself goals, what doesgood look like, however you want
to phrase it and stay true tothat, because there are limited
resources and there are limitedpatients, and we also don't want
to be moving forward a drugcandidate that maybe isn't the
best drug candidate and exposemore patients to those clinical
(11:09):
trials.
Right, so it's setting thoseparameters right up front and
say, out of this, I want to seeX as the endpoint, I want to see
this amount of tumor shrinkage.
If it's oncology, I want to seethis amount of reduction of
whatever the symptom is, and soset those benchmarks and then,
(11:31):
when you get the data, if itdoesn't tell you that, don't
force the data to tell yousomething.
Of course you need to analyzeit.
If there's a subsection ofpatients, right, if you studied
all comers and the study islarge enough that you can then
subset it and say, okay, it didnot work for all comers, but it
worked for this subsection ofpatients and it did hit the
(11:52):
parameters that I set up front.
It's a different marketopportunity than I had
originally thought.
I thought the marketopportunity was this.
Now the market opportunity isthis.
Ask your first question Does itwork to the parameters that you
set for the smaller indication,yes or no?
If the answer is yes, then youneed to put the commercial lens
on and say the pathway to getthis to patients.
(12:17):
What does that look like?
What does the time look like?
What does the investment looklike?
Is that the best use ofresources for my patients more
broadly, across my portfolio,from a prioritization
perspective as well, as is thatthe right resources to use that
my investors entrusted in me?
So you have to think about itin those places as well.
So hopefully that helps.
Ben Comer (12:35):
No, that's great.
You started out in big pharma,as we mentioned.
Why did you decide to move outof big pharma into smaller
companies and what would you sayabout that transition?
Sara Bonstein (12:47):
Yeah.
So there's a couple of reasons.
There's professional andpersonal.
On the personal front, honestlyI didn't want to relocate.
I had two small children and wedid not see our family living
in a different state, and sofrom a personal perspective,
that was one of the drivingforces and I was traveling a ton
(13:10):
.
It was before COVID, where wedidn't fully appreciate all the
ability to be able to kind ofwork from different places, and
so I wanted to have a certainsort of lifestyle and certain
relationship with my childrenand certain amount of time with
them.
So that was kind of on thepersonal side.
On the professional side again,I love Big Pharma and I'm so
grateful for the foundationallearning that I've gotten from
(13:33):
them.
I was starting to lose, becauseit was so large, I was starting
to lose the connection to thepatient and so I was starting to
lose the can I go in every dayand at least see one action that
I'm doing today, have some sortof linkage on how it's going to
be five steps removed, right,but how that was going to have
(13:54):
an impact on patient life, and Iwas struggling with that a
little bit.
And so going back to sort ofthat passion on why do you go
into industry?
So, between those componentsand obviously the personal piece
was significance I'd said youknow it's probably time to
explore, and I at that pointtalked to a lot of you know
(14:16):
co-workers and colleagues aroundsome of their experiences and
you know I was grappling with doI stay in big pharma?
There is a sense of quoteunquote security with that,
right or wrong, but there's a,there's at least a perception of
security with that or do I goto this, this thing called
biotech, these small companies,and what does that look like?
(14:40):
And the coaching and feedbackthat I heard from some people
that I trusted I think it wasvery fair was biotech is great
but you cannot hide so biotechit's small, there's not a lot of
people, there's not a lot ofresources.
You'll get to wear a whole bunchof hats and do things that are
not in your subject matterexpertise and be challenged in
(15:01):
ways that are very different.
You won't know the exact boxyou're going to go into for,
what your next role is, all thatkind of stuff.
You're going to create that,but no one hides in biotech.
So some people love it and somepeople hate it, and that really
resonated with me because I'mlike I didn't go into this
industry to hide I don't work tohide, right and so then I had
(15:22):
my first opportunity to about 10years ago now to take my first
public CFO job, and so that wasreally my journey and how I got
there.
Ben Comer (15:35):
Yeah, you don't work
to hide.
I like that a lot.
Another interesting thing aboutyou, Sara, is that you are a
certified Six Sigma black belt,an achievement that is perhaps
not as in vogue as it once was,but I'm curious if you encourage
your direct reports to getcertified and, if not, what
(15:56):
aspects of Six Sigma do youcontinue to use in your work or
rely on?
Sara Bonstein (16:02):
Yeah, so my last
role at Big Pharma was a Six
Sigma Black Belt and Champion,so I got to run a whole bunch of
projects around the globe andit was really my first
professional experience where Istepped out of being subject
matter expert, stepped out ofknowing the ins and outs of the
(16:24):
role that I do and really kindof what I went to school for and
all that kind of stuff, and Iwas now in a role where I had to
learn a new set of tools andskills that were a little
uncomfortable, and I then neededto lead projects in things that
I didn't really know anythingabout, as well as lead teams
(16:45):
that I did not have authorityover, and so that was like check
one, two, three, right, likethat was a fair amount and I was
still pretty young in my career.
But I was so grateful for thatexperience because I think it
really set me up for thetransition into biotech, and so
what has stuck with me and whatI've learned from that
experience was leading throughothers is so critical, and
(17:09):
having people that are fivetimes smarter than you is what
you should be striving for andnever feel threatened on if your
direct reports or yourco-workers or colleagues you
feel like are smarter than you.
Embrace that, because that'sabsolutely amazing and that's
how you're going to learn andgrow and learn to listen and be
curious.
(17:29):
And so when I was able totransition over to my first CFO
role, as in many small companies, the CFO hat is not just the.
You're going to get your form10Qs and 10Ks filed if you're
public, or do your financialstatements and give them to your
board.
If you're private, you aregoing to oversee most likely
(17:53):
everything on the quote, unquote, g&a line, on the P&L.
So all your back office you'regoing to do all your finance,
accounting and treasury.
You're going to do yourinvestor relations, but then
you're also going to do IT.
You're going to do legal.
You're a lawyer.
All of a sudden You're going todo human resources.
All of a sudden you have toknow how to hire the right
people and build the rightculture and so facilities.
(18:14):
You have to build out the labsthat your departments need now
to get from bench to the humanright.
So you have to oversee allthese things that you're not a
subject matter expert in, and sothat Six Sigma role really
taught me how to lead throughothers and not be a subject
matter expert, so I'm foreverindebted to that.
And then as I think about howdo I bring that forward into my
(18:36):
teams today and every day,there's still tips and tricks
and kind of tools that I stilluse from that training.
I don't get too hung up on.
Is it called black belt or isit called a different sort of
process improvement?
What I challenge my guys withall the time is just challenge,
just ask like, why do you do itthat way?
Why do we do that In a curiousway, not in a accusatory or
(19:04):
doing something wrong way?
Right In a curious way on hey,why do we do that?
Do we do that because we didthat three years ago and that's
just how we have to do it?
Or do we do that because wedon't really know why we do that
and we need to evolve?
And so some of just thatcurious thinking and that
critical thinking I try and kindof weave into my everyday
conversations with my directreports.
Ben Comer (19:26):
Yeah Well, I think
two of those make a lot of sense
to me.
One is challenging the statusquo, which you just mentioned,
the other leading through othersand being able to exert
influence on teams that you maynot be leading, and I'm curious
if that is a skill, Sara, thatyou kind of always had, that
you've been able to do, or wasit one that you didn't have,
(19:48):
that you felt like you reallyhave developed over the course
of your career to this point?
Sara Bonstein (19:53):
Yeah, I think
I've hopefully developed it in a
positive way.
I will say, early in my careerI was at a company and for five
years and we went through fivedifferent CEOs, and so I learned
a ton about leadership good,bad and ugly right.
I learned a ton about differentleadership styles and different
(20:15):
ways to lead a team that I wasable to.
Like I was saying earlier, youtake the good and you also take
the learnings right.
So I was able to take pieces ofhow do I want to be as a leader
, what are things that I want toemulate and what are things
that are going to work for me.
Are things that aren't going towork for me as a leader it
might work for other people intheir leadership style, but not
going to work for me as a leaderand so that has helped me sort
(20:39):
of develop into my true,authentic self and how I lead my
teams, and so I think that hasbeen very helpful and has been
part of the success.
Ben Comer (20:52):
How would you
describe your leadership style?
If someone was to ask one ofyour colleagues or teammates
what's Sara's leadership style,what do you think they would say
?
Sara Bonstein (21:00):
Yeah, my goal and
hopefully this is what they
would say would be empowermentthat I empower my team but that
I'm very supportive of the team,that I'm approachable but that
I can be tough with if there'scertain things that are falling
(21:21):
off the rail or if I givesomeone you know I empower you
to make change and to run yourteam and all those good things.
But you can't fool me right,like I know if you're actually
kind of like doing it or notdoing it.
And I do lead with empathy.
I think that's important.
(21:41):
That's again a stylistic thing,that's not always how everyone
leads, but I do think empathy, Ido think getting to know your
team on a personal level isreally, really helpful because
it helps you get through toughertimes and I always try and be
my authentic self.
So bringing your authentic selfto work is really critical and
(22:02):
in your leadership you need togive people sort of the runway
to be their authentic self.
I don't want a whole bunch oflittle Saras that report into me
.
That's not going to be helpful.
I want them to be theirauthentic self.
I want to be my authentic selfand that's going to help us
really, really be true, to thebest outcomes.
Ben Comer (22:23):
So warts and all?
You don't want people showingup to the office and playing a
persona you know.
You want them to be themselvesbecause ultimately, in the long
run, they're going to be moresuccessful.
Is that what you're saying?
Sara Bonstein (22:36):
Absolutely.
If you're trying to hide,that's going to catch up to you
eventually, right and so if youcould be your authentic self and
bring all those differencestogether into the team setting,
you're going to be a better teamfor it.
Of the team setting, you'regoing to be a better team for it
.
Ben Comer (22:52):
What would you
describe as the most important
responsibilities of abiopharmaceutical CFO?
Sara Bonstein (23:05):
You know what's
the unique lens or perspective
that a CFO brings to thebusiness?
Yes, so you know it's aninteresting question because I
actually think about my role andI think company executive first
functions second.
So, yes, we all have at the Clevel right.
We all have our letter afterthe C, right.
So what area do we need tofocus on?
Are you the medical person, themarketing person, the operator,
(23:27):
the finance person?
But first and foremost, you'rea quote unquote chief of the
company.
So you need to be thinkingabout sort of company strategy
first, and that's how I sort ofapproach all different topics or
areas, financial related or not.
As we think about sort of theCFO role specifically, I think
(23:49):
it's a couple of things.
One, it really comes back tothe team.
So you need to make sure thatyou're building really strong
technical people.
The CFO role is there'sobviously a lot of very
technical components.
I'm not a CPA, I'm not anaccountant, so I learned again
very early in my career tosurround myself with really
smart, smart, technical people.
So I think that's absolutelyimportant.
(24:10):
We touched on the beingauthentic self and then
specifically on CFO for abiotech not profitable company
is obviously a little differentthan for a larger profitable
company, for a company that isstill needing to worry very,
very much about their balancesheet versus their income
statement, very, very much abouttheir balance sheet versus
(24:34):
their income statement.
It's cash dilution and how doyou put all those pieces
together?
So what I try and say toeverybody here is do the right
thing by the science.
We're going to make sure weprioritize correctly and not
overspend and all that kind ofstuff, but do the right thing
for the science.
If you can do the right thingfor the science, we can figure
out the balance sheet side.
We can figure out how do wemake sure we have the funding
(24:56):
for that?
So I try and take that burdenoff the rest of the company and
say we will make sure the cashis there when we need it as long
as the science is still tellingus that we should still invest
right, that it's an appropriateand good use of investment and
appropriate good use to continuethese drug candidates into
(25:19):
patients.
And so financing it's aninteresting piece.
Usually when someone raisesmoney the stock price goes down,
right.
That's just sort of simplesupply demand.
I think the piece that's superimportant is don't think about
it in that moment, reflect backthree months after you do the
(25:40):
financing, or three weeks or sixmonths or whatever the right
time frame is right.
But reflect on it afterwardsand see where the company's
health is at that point and thatwill help determine did you do
right by the company.
And so we try and reflect onall of those financings,
obviously in the moment wherewe're very cognizant of how we
structured it, the amount ofdilutions.
(26:00):
We bring the right amount ofcash.
You can never have too muchcash in this industry.
It always costs more than youthink it's going to.
But then also reflect on it sixmonths after or three months
after and say did I structurethat right?
Did I anticipate the interestrate environment correctly?
All those kind of things.
Ben Comer (26:17):
You became Insmed's
CFO in 2020.
What were your reasons forjoining Insmed?
Sara Bonstein (26:24):
Yeah.
So I'm really grateful that Iwas able to have the opportunity
to join this amazing team backin early 2020.
I came here for a couple ofreasons.
One was I really wanted acommercial product again.
So the first I guess now firsthalf of my career was in large,
(26:44):
established, big pharmacompanies that very much were
income statement focused and hadvery significant revenue, and
then my prior CFO roles were inpre-revenue companies and so I
wanted an opportunity to takesome of my earlier learning and
some of my more recent learningand kind of meld them into the
(27:04):
next stage of a CFO.
So that was obviously veryattractive to me to have a
commercial product.
The other piece is I love thedrug development space.
I love the pipeline and the hopethat that brings to patients
and their families, andsomething unique about InSmed is
I felt like they were buildingthe puzzle pieces and they had a
(27:25):
fair amount of them already tobe a self-sustaining biotech
company and to really be able tonot just have this one little
commercial product right, toreally be a self-sustaining
biotech company and have an eyeand a strategy to become
profitable.
So I saw those pieces.
And then third is who is Igoing to work with, right, who
(27:46):
is my boss going to be, andwhich is obviously super
important, and my boss and Iwork really well together but
also your colleagues, right?
Like, who are your peers goingto be?
And going back to sort of theearlier conversation, is you
want really smart people aroundyou?
So do you feel, like thecolleagues that are going to be
around you, you're going to beable to learn from them and are
(28:06):
you going to be able to pay itforward and teach them?
And so I saw all of those hereat Insmed, all grounded by an
amazing culture.
We spent a lot of our timeeither at work or thinking about
work and you wanted to have theculture and sort of who you are
as a person, ethically andmorally, and Insmed just really
fit all those bills.
Ben Comer (28:28):
Well, what was your
process for getting up to speed
as CFO after joining Insmed?
I mean in terms of getting toknow your team members, getting
to know the board, understandingthe full financial situation
and needs at Insmed.
How do you go about doing that?
Sara Bonstein (28:45):
Yeah, so my
experience was actually pretty
interesting, because I joinedand then five weeks later this
little thing called the globalpandemic hit us, and so it was.
Ben Comer (28:55):
I've heard of that,
yeah.
Sara Bonstein (28:56):
Yeah, it was an
interesting time because I was
in the office for three of thosefive weeks.
I was traveling at differentconferences the other two weeks,
but I had teams around theglobe and my trips planned.
So you know, go meet them inperson.
And I hadn't met most of myresearch analysts in person, I
hadn't met all my investors inperson, and so I had to do a lot
(29:19):
of that very differently thanwe've all sort of grown up and
we're used to.
And I think that there was somesignificant benefit because it
forced everyone to be just asclose, as it didn't matter if
you live five minutes from theoffice or if you were a five
hour plane ride from the officeor 12 hour plane ride from the
office, and so we all turned ourcameras on and we all got to
(29:42):
know each other, and so it was.
You needed to be morethoughtful and purposeful with
it.
But it goes back to sort ofleadership style on getting to
know the people on your team,getting to know your partners if
they're employees of InSmed orif they're other folks, and
building those relationships,and then I kind of know it in
(30:04):
the company for always.
Oh, Sara's going to say she hasone more question and then she's
going to have seven morequestions, right?
And so I'm that person whereI'm very curious.
And so on the science side oron the product side, is you know
, sitting with your chiefdevelopment officer and them
being like, why is she asking meso many questions?
(30:26):
But like, that's how you'regoing to learn, right?
And so ask the questions andnot be nervous to be like, oh
well, I'm the CFO, I'm notsupposed to ask these questions,
I'm supposed to know thatalready.
And it's like no, how are yousupposed to know that already?
You're not going to know thatunless you question and ask it.
And in a way, your questionsare probably going to help them
because they're going to be likeoh, that is kind of an
(30:47):
interesting question.
Maybe only one out of 10 isgoing to help them, but it's
going to potentially help them.
So that's a little bit about mystyle and how I got to speed.
Ben Comer (30:56):
Yeah, and you get to
know people by asking questions
and how they respond.
I think that's a very effectiveway to kind of quickly get a
sense of someone Innsmed hasbeen scaling up commercially.
You have one commercial product, potentially a second on the
way later this year.
How do you balance investing inthat scale up against the
(31:18):
uncertainty of late stageclinical data and regulatory
approval?
Sara Bonstein (31:23):
Yeah, yeah.
So it's a great question and itgoes to the.
This business costs a lot ofmoney and how do you make sure
that there are limited resources?
How do you make sure youappropriately prioritize those
resources across your portfolio?
The benefit of Insmed is wehave a portfolio right.
We get to be able to have thoseconversations about
(31:44):
prioritization, and so I'll giveyou an example.
Brensocatib, that's our product,that we put out positive,
pivotal data.
Last year.
We filed the NDA with FDA inDecember of 24.
And, assuming priority review,we would look to launch in third
quarter of this year in the USand followed in ex-US next year.
(32:05):
And so, as we sort of wentthrough the what do we invest at
risk before the data and allthose good things we had said,
well, we are building thiscompany to be a self-sustaining
biotech company.
We understand this piece of thescience.
We understand these would beour life cycle management, the
additional indications that wewould go after this one we have
(32:26):
chronic rhinosinusitis withoutnasal polyps.
That's our second indication.
This indication we have a highdegree of conviction is going to
work and strategically we thinkit's appropriate to have that
value built into the companybefore we turn over the data
card.
We are going to allocateresources to start that Phase 2
quote unquote at risk.
So we started that Phase 2 atrisk before we had the Aspen
(32:49):
data, our pivotal Phase 3 data,and that has turned out to be
the absolute right decision.
And now we will have that Phase2 data by the end of this year
and so that has really helpedfrom.
We validated the mechanism withthe data and now we have the
next indication sort of withinarm's reach we'll have
significant with the data.
And now we have the nextindication sort of within arm's
reach we'll have significantPhase 2 data.
(33:10):
In that same light, our thirdindication, HS.
We had said we need to balance,not putting all our eggs in the
brenso basket, right, we needto balance what happens.
A lot of drugs are notsuccessful, a lot of development
is not successful.
How do we balance that?
And so we waited on the thirdindication to start.
So we did sort of I call itblood, sweat and tears, right.
(33:34):
So we had some like human timeand energy spent on, you know,
writing things and all that kindof stuff, but we didn't write
any checks.
So we didn't write any checksto support that third indication
until the data was in hands.
But the team was ready becausethey spent sort of the internal
intellect time and the internalmind time to build out what
would that indication look like.
And we were able to start thatprogram last year and that is in
(33:59):
clinic now.
So that's just an example of howwe went through and we tried to
prioritize.
We did the same on thecommercialization side.
We had said we are going toinvest, quote unquote, at risk,
for certain functional areasmedical education.
So the medical science liaisons, the medical outcome liaisons.
We need to go out, first indisease, first in mechanism.
(34:19):
We need to go out and educatethe medical community.
That investment we will do atrisk, the commercial
infrastructure investment.
We would wait until sort of daytwo to start that journey on
investment and that has bodevery well for us and we will
continue to do that as we thinkabout our next indications and
(34:41):
programs branch For thoseat-risk investments?
Ben Comer (34:48):
was there a backup
plan to put the genie back in
the bottle if you had had to, orwere you so confident that you
felt that you could kind of goforward?
Sara Bonstein (34:54):
Yeah.
So we were super confident.
So I believed in the mechanism,and so much so that we started
research work on just themechanism of DPP-1 after our
positive Phase 2 data to be ableto have sort of lifecycle
management for the follow-onprogram not necessarily with
brensocatib, but that said, it'sappropriate and good
(35:16):
stewardship and I wouldn't bedoing my job unless we did all
the scenario planning.
So we had done the scenarioplanning on both sort of what do
we look like at Insmed, as wellas what is the balance sheet
transformation and what isneeded there for the scenarios
of the data is out of the park.
(35:37):
Positive, which we're reallyfortunate was where we landed if
the data was mixed, as well asif the data was negative.
So we were ready and had thoseconversations through the board,
ready to take whatever move weneeded to.
And that is again, I think,where some companies fall short
on.
They drink their own Kool-Aidand they get too into.
(36:00):
Well, of course, I'm going tocure this disease and that's
wonderful, we all have thatintention and that's what we all
want to do.
But we have to also balancethat.
Investors have entrusted uswith a significant amount of
capital.
They are intending to get alevel of return on that capital
and how are we making sure thatwe're building the company and
(36:21):
having the right scenarios to beable to do that?
And it goes back to thepipeline that we built, that we
were not just a brensocatibstory, right, we had a
commercial infrastructurealready in place.
We had additional things in ourpipeline.
So we would have been able tobe a different looking company
than we are today, right, but westill would have been able to
be, I think, a very successfulcompany if Aspen wasn't positive
(36:44):
but very grateful that it was.
Ben Comer (36:46):
Yeah and I mean I
assume that scenario exercise,
building those out to thosescenarios, helps to give you
confidence in making some ofthose at-risk commercial
investments.
Sara Bonstein (36:57):
Yeah, yeah.
And it also goes back to didyou design the program correctly
, right?
Like all the pieces are just socritical.
Did you give the mechanism thebest chance to be successful?
Did you design the clinicalprogram right?
Like all the pieces are just socritical.
Did you give the mechanism thebest chance to be successful?
Did you design the clinicalprogram right?
Do you have the tech ops pieceall in place?
So you have to give everyelement of the business the time
and attention.
Ben Comer (37:17):
You have an
opportunity at Insmed to shift
from a more uncommon, rare-ishpatient population to a larger
disease population.
Does that complicate thecalculus of commercial
investment versus progressingpipeline candidates and how you
manage that as CFO?
Sara Bonstein (37:37):
Yeah.
So our sort of litmus test ishow can we have impact on
patients with serious diseases?
Right, and so Arikayce, ourcurrent approved product with
the current label, is in the USabout 12,000 to 17,000.
We currently have a labelexpansion ongoing that would,
you know, increase that to about100,000 addressable patients.
(38:01):
Brensocatib and bronchiectasisassuming success in the US is
about 500,000 diagnosed patients, well over a million in the
three territories, so obviouslya much more significant patient
population.
But our litmus test in all ofour drugs is how can we have the
biggest impact if it's first inclass or best in class and have
high impact on patients?
(38:22):
So that is our limits test oneverything and what really
drives us to make sort of thestrategic decisions from a.
How do you commercialize thatsuccessfully?
There's a lot of amazinglearnings we could from Arikayce
.
We obviously need to do brensoa little bit differently, but
there's a ton that we can takefrom a learning perspective and
scale it and some will need to.
(38:43):
You know we obviously didn't dosomething like DTC for Arikayce
.
That's something we wouldobviously think about for
brensocatib.
Ben Comer (38:51):
Right Several.
I mentioned this at the top.
Several analysts have predictedpotential blockbuster sales for
brensoc atib.
That's certainly attractive toinvestors.
I'm curious about how you kindof manage the pressure that that
puts on the organization todeliver, assuming it's approved.
Does that factor into your dayjob?
(39:12):
Do you think about that?
How do you kind of manage thatidea that you may have a
blockbuster in the oven?
Sara Bonstein (39:19):
Yeah.
So our current approved product, what we've said publicly is we
believe that has the ability tobe a billion-dollar product,
assuming label expansion.
Brensocatib in non-cysticfibrosis bronchiectasis alone,
we have said we believe is a $5billion peak sales opportunity
and TPIP, we said again assumingsuccess, we believe will be a
(39:43):
$2 billion.
Ben Comer (39:45):
So 8 billion Big
numbers.
Sara Bonstein (39:47):
Yeah, big, big
numbers and we have follow-on
indications for brenso that thenext indication that I mentioned
earlier, CRS without nasalpolyps we think could be, you
know, potentially just as big asbronchiectasis.
So very significant numbers.
I obviously spend a lot of mytime on sort of external and
street and all the IR stuff, butfor the organization, similar
(40:11):
to the balance sheet, it's youguys stay focused on what you do
, right, that's how you're goingto drive success.
Let us manage externalexpectations appropriately and I
have a great, you know back toteam, a great investor relation
team that helps spearhead makingsure expectations are
appropriate externally.
Ben Comer (40:31):
Given your current
position at Intmed and your past
experiences at smallercompanies in earlier stages of
development pre-commercial, asyou mentioned what advice would
you give to biotech builders inthose earlier stages in terms of
setting up a business that cango the distance?
Sara Bonstein (40:49):
Yeah, no, it's a
great question, specifically
financially.
It's always going to cost moremoney than you think.
So get a budget and double itand still give yourself a
question it's going to costlonger and take longer.
Research is not linear.
It has a lot of sort of twistsand turns and it needs to have
(41:10):
those twists and turns.
You can't force some of itbecause that's how you're going
to get the best innovation.
So I think you just try andplan for that as best as you can
and make really great partnersinternally, building a great
culture within your company,putting really smart people
around you, and then the peoplethat you partner with externally
(41:32):
if it's your banks, if it'syour investigators, if it's your
research advisory folks, yourboard members just make sure
that everyone around you is alsonot going to drink the Kool-Aid
and give you the unfilteredkind of guidance and advice and
ask questions to learn, not askquestions to just hear people
(41:58):
talk and not accept it.
Ben Comer (42:02):
Right, yeah, I mean,
do you think for our biotech
builders, listening to thisinterview, get a budget and
double it?
Are they going to be able to dothat this year?
Sara Bonstein (42:13):
It's a tough
market, right, and so you need
to always be thinking aboutespecially for those smaller
companies as you're buildingthat sort of financing strategy
is, if you're asking investorsfor money, you need to make sure
that the money that they'regiving you they're going to get
an answer from it.
So if they're giving you Xamount in a raise, they know
(42:36):
you're going to need to go backto them.
Now you're not funded throughprofitability, right, but
they're going to want somethingfor that money.
They're going to want an answeron the Phase 1 trial, the Phase
2 trial.
They're going to want somethingtangible.
Having operational executionisn't going to be as interesting
to the investment community asactual data.
(42:58):
So, as you're thinking aboutyour financing plan and this is
where your banks can beabsolutely instrumental and you
should use them as thoughtpartners map out the clinical
catalyst that you have or thescientific catalyst that you
have, knowing that these are thetimelines you think they could
slip, so take that into accountand then you layer on your
(43:18):
financial piece and how much youneed to burn, how much you need
to raise, and ensure you havesort of those stage gates that
it's going to be really hard.
You're going to losecredibility, which is almost
impossible to regain in theinvestment community.
If you ask for money, you don'tgive them any answers and you
go back and ask for more.
So I guess that that that wouldbe my, my advice on that one.
Ben Comer (43:44):
Sage words.
That is Sara Bonstein, CFO atInsmed.
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 our new weeklyvideo casts of these
conversations, dropped everyMonday under the tab on Life
Science Leader Business ofBiotech.
We'll see you next week andthank you for listening.