Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Good morning, everyone.Thank you for joining our third day of our Piper Healthcare conference.Really excited to be featuring the team from Lexicon Pharmaceuticals.We've lots to cover over the next 25 minutes.And, first of all, congratulations on today's update on progress, enrollment, and start, and we'll talk about that, but just wanna acknowledge.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
The really great news as we kicked off.We'll start first sort of on INPEFA launch, right?Because a lot of our investors are paying close attention, and then we'll go to today's update.I guess the question that a lot of investors have is, at this junction, the year is ending, INPEFA got approved with a phenomenal label.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
You've done a great job winning formulary, and you're continuing to do that, and we'll talk about that-
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
... into 2024.How do you— why own now, right?Why is 2024 a very big inflection point for INPEFA that they need to not miss that -
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Yeah
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
and being ahead, and how do you foresee real growth?
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Yeah
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
- for the company?
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
So, yes, first of all, thanks for the question, and also thanks for acknowledging that the first patient has now been enrolled in LX9211 phase II-B study.So let me start with INPEFA.I think INPEFA is becoming a very important choice-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
for patients living with heart failure, especially those patients who have recent and worsening heart failure.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
What is so awesome about launching now is that you have a brand of heart failure market.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-that's growing 40% year-over-year.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Wow!
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
When you look in that class, you see the SGLTIs are growing-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-70% month-over-month.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
And so you see a remarkably expanding-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
and growing market.And my argument always is, taking the time this year to get access, when you get that.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
broad access, then I fully expect INPEFA will join.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-this growth.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
And so even with that growth that we see with SGLTs-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
You're only talking about 10, 12% penetration total.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
There's a green field of opportunities-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
still there, that we have an opportunity to get once we get broad access.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
And then get into a high-growing market.So, and then the second thing I will say about INPEFA, for those who want reasons to believe-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-is that INPEFA is not just an SGLT2.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
It's an SGLT2 in one.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Which means we've taken the time to mine our data-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
to try to figure out what other nuances we see
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
in our data that allows us to possibly expand to new indications, because we have a long patent life.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
with INPEFA.So we'll have a lot more to say as we finish-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-that evaluation going into 2024.When we get into the second half of 2024-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
I fully expect that we would have gotten the coverage that's necessary.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
The expansion of INPEFA and acceleration of INPEFA will be fully on its way.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
No, that's fantastic.I guess, you know, investors are tracking sort of every formulary win-
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
and market access.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Maybe just give us a perspective on where are we now?
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
How is that gonna change, sort of-
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
-over first half of 2024 going into the second half?
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Yeah.So, I'll take that one.Good morning, everyone.As we think about where we are in terms of access-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
and I think as we shared at the end of the third quarter.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... we had about 25% of covered lives-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
as we exited the third quarter, which, if you bear in mind, we didn't actually launch the product until the end of June.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
We've actually made some pretty encouraging progress there, even in a relatively short window, given that most bid processes for 2023-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
started the year before.So we've made some very nice progress there.Obviously, we announced-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-Express Scripts, which went live November first.So we would anticipate that that's gonna have a pretty big impact.What I can tell you is that since we last provided an update-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
We've improved access by double digits at least.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Right.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
So that's continuing to tick upwards.And I can tell you that our access team-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
are very heavily involved
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
In discussions with all of the major payers, as you'd expect.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
The great news is, just as the clinical data-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
is being well received by the clinical community.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
They understand that INPEFA does offer something.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-that's different to the other SGLT-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-only, SGLT2s, I should say.Those messages are also resonating-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
very strongly with payers.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
In particular, payers that are managing both the pharmacy benefit-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
and the medical benefit.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Because, you know, the challenge with a heart failure patient is, they're a bit like a boomerang.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
You know, they come into the hospital, they have an acute episode-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... they then get dried out-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Sent back into the community.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Unfortunately, they often come back very, very quickly.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
As we know with INPEFA, we're able to demonstrate very clear value for those patients, and in terms of stopping them-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
coming back into the hospital as well.So that message is resonating both with the hospital-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... cardiologists, but it's also resonating very well-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
With our community cardiologists.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
As we build access within the hospital setting, we would anticipate that our usage there is gonna accelerate only further.Further to what Lonnel said, you know, at the moment, only about one in ten patients leaves the hospital on an SGLT.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
With the 2022 guidelines-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
that were recently published, and the fact that AHA and ACC
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
are pushing these really hard now
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
We do anticipate that that number is gonna increase very, very rapidly, and we believe that INPEFA is perfectly positioned-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
to be the drug of choice for that, for that patient population.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Do you notice...I guess going back to the formulary, where do you hope to be, of how many lives are covered, sort of in the middle of 2024, and then going into the end of 2024?
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
So I mean, I would assume that we're probably gonna be exiting this year at, you know, close to 50%.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Our goal will be to obviously push that further throughout 2024.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Our push within the access team at the moment, I mean, obviously, we're in the 25, 26 bid cycle-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
We're offering appropriate value to the payer.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Obviously, we're trying to make sure that we have the long-term-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
- perspective in play for INPEFA, given-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
- the 10-year patent-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
that we have for this product, but at the same time, working with the payers to see how we could actually pull forward access-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
- into 2024.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
The great news is, again, with the value proposition-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
that we're going with
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
There seems to be plenty of opportunity to do that.So we do anticipate some off-cycle wins through 2024 and moving forward into 2025.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
No, that's helpful.Often we get this question from clients saying, now, as they recognize, right, that the market is open, like 10 patients with heart failure, and only one of them is on SGLT2, and there's plenty to go around between you and other SGLT2 class.But I guess the question here is, when you're out discussing, what do you emphasize the differentiation, where they can say, "Okay-
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
out of the different classes, we're in SGLT1 and SGLT2.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
- "Here's why your patient needs to be on our drug." Like, what, what are your talking points?
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Yeah.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Like, if you could just simplify that for our listeners, I think it could-
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
So I put it down to kind of three key factors.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
First off, our sales team is wholly focused on heart failure.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
You know, that, for us, is-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
- front and center.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
We are not talking about any other indication where the other SGLTs-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
are indicated.So I think that that focus and precision actually is a clear benefit-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
In terms of the message that we're conveying to customers.The second is just the breadth of the label that we have.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
I think you mentioned it yourself.You know-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
We do have a very strong label.Irrespective of any type of heart failure-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
- INPEFA works-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
and is indicated.And then the third piece is just the quality of the data, you know?
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
In particular, the NNT of four-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
that we talk about.I think when customers hear that number, it kind of hits them square between the eyes.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Because an NNT of four, I can tell you in my twenty-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
5+ years in the industry, especially in cardiology, is unheard of.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
The strength of the data, I think, really does kind of convey the belief.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Let's not forget, you know, INPEFA has been studied on over 20,000 patients.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
So, you know, SOLOIST is at the center.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
But we also have SCORED and other data-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
That's emerging, and I'm sure Craig will mention this.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
AHA, just recently-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
We had new data talking about impact on MACE.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
as well, and just speed of onset.Again, that is differentiated versus the other SGLTs.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
No, that's, that's helpful.I think, Jeff, you've done a really nice job on kind of giving all the metrics to kind of help us analysts, investors, kind of track the launch and get confidence in the launch.Do you foresee your disclosures and the way that you're going to share these items with us in 2024 to be very consistent with what we saw in 2023?Or are there other elements of things that you hope to share further with us that could help?
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
Yeah,
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
For the confidence.
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
they will be consistent.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
As Lonnel mentioned, one of the things we're focused on is-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
is coverage and
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- and access, and that's going to be one of the main topics-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
that we talk about-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- with investors.We will also be tracking scripts.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
As you know, the IQVIA and Symphony-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
and like, pick up
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- most of the retail scripts.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
But there are also scripts that are-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
... that are being filled-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
Through specialty pharmacy that are not being captured there, and so we'll provide that color and that additional information.So we'll update on the-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
same kind of metrics that we've been using so far to demonstrate the progress of our launch.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
How do you envision, sort of your expansion of the product in terms of whether it is partnering it outside of the U.S. or maybe even thinking of taking it to the community gastroenterologist, rather than just in the hospital setting?So, like, what type of sort of-
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
Yeah.So I can-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- talk about the partnering aspect.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
But also, I want to be sure that where we're focused really right now-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- is on cardiologists.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
Cardiologists practice in hospitals-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
and they have office practices.Generally, they do both.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
We're mostly focused on card...We reach cardiologists in their offices-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
Because that's the easiest place to get to them.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
So, community cardiologists are-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
are also the ones who are making-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
decisions frequently-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- for hospitalized patients.And, so we're addressing really all of the people that are the high prescribers-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
for heart failure generally.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
not just hospitalists
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Hospital
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
or people that are in the hospital.And so, I think we have a good sized field force to be able to do that.That's not something that we need-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Right
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
to partner to be able to, to do.We're not really calling on primary care physicians-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
but they're not really-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- driving heart failure treatment decisions.In terms of outside of the U.S.-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
We're having some discussions about some outside ex-US territories for INPEFA, as...Because that's not something-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
that we're going to do.It would be something we would do with a-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Uh
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- with a collaborator.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Is there a point, going back to the discussion you made, that your focus is on cardiologists?They practice both in community setting and hospital.Is there a way to actually track the scripts to see how much came from the patients that were, you know, hospitalized versus how many came from, you know, just heart failure, but not-
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
So what I can tell you is, if you look at the 5,000 claims-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
that we spoke about
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
At the end of Q3, given that for most new products in this category-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
there's a six-month new-to-market block-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah, yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
- in terms of hospital usage-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
the vast majority, in fact, all of that
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
- usage-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
- was in the community, which again, I think is actually a very encouraging picture for us.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Because, you know, if we think about the SOLOIST data in particular-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
- that's the hospitalized patient.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
The patient who's been in the hospital with an acute heart failure episode, and then they leave on Empa.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
...The fact that 5,000 prescriptions were already written-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-outside of the hospital is really encouraging.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Because it shows that the value for INPEFA is being seen both within-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
and without, or outside of the hospital, as the patient is discharged as well.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
So I think it clearly shows that the interest and utilization for the product is already there.And then, as we gain more formulary wins-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
We go through the P&T process, which I can tell you-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
-is happening in earnest now, we would anticipate that those numbers are only going to increase-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
as we see patients coming out of the hospital
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
discharged on INPEFA and moving into the community.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Uh-huh.Thank you.And before we transition into other...I get this question all the time, is you guys have done a phenomenal job in terms of the studies, getting the product approved, getting the broadest label possible, getting already a successful launch under your belt, you know, besides, you know, being on the market for a pretty very, very short period of time, not even a little bit over a quarter.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
So, the questions that always come up is, like, there are quite a bit of pharma partners that don't have an SGLT2 in their portfolio.What is now the gatekeeper, right?They have done all these steps, like, so, so I get this.I would love to hear your - how you answer this, and I'm sure this will come up in quite a bit of one-on-ones.But yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
Well, we think that we have, we're demonstrating value of INPEFA.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
I think that as we demonstrate the value of INPEFA over time-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
that may change.So-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
... we'll see.We'll see.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
But, you know, we're focused on really launching successfully, and that we think that's going to be the most important value driver here.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Yeah, I'm going to say something very controversial.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
If I was a large pharma company-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
...I wouldn't touch this at this point until I see the inflection on this launch.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Okay.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
When you see the inflection on this launch, then that sets up remarkable opportunity.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
For us, I've been very clear-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... this is not the year you're going to see that inflection.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
What you're going to see this year is the huffing and puffing and getting access.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Right?Because that's the long-term win.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Then, when you get into the second half of next year, you have the-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... the volume there.Then I think you'll start to see a real inflection point on the growth of this drug.That's when you - I think you'll lure in discussions around opportunities where we can partner in some ways.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
What I mean by that is, having a single product in your bag-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
is never efficient.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
And so where I see partnering opportunities is this vast cardiovascular space.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Could be an opportunity where we cross-promote-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... where we can be more efficient-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
-and use our capital better.And those are the areas where-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
...I think there's a better opportunity for us-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... than, say, a large company coming in, trying to do what we're already doing.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.No, that's very helpful.Bates, just want to make sure it's clear, the inflection point that you see that could present itself is more likely to be the second half of 2024.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Second half, yeah.We need to get access to the point that Tom's made this year-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... on the broad payer side.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
To Tom's point, also in hospitals-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... you have a six-month moratorium on new drugs.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.Right.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
We can't get in.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
That six months is now expiring.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
We have now knocked down three of the four GPO contracts.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
We have three of the four under our belts now.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Which means now we go into the IDNs-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... and we can start negotiating in earnest to get access into-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... the hospitals.The 5,000 scripts you've seen-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... has come into the community.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
We haven't touched yet where the real value proposition will be-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
... in those institutions.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Which is nothing but upside as we get into the second half of next year.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Yeah, and that, that's where I'd go back to the one in ten patients-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... actually leaving on an SGLT.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
That is going to be an area of considerable growth, especially as the guidelines are adopted.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... more broadly.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
No, that's great.And team, obviously, a lot of investors are also following the GLP-1 space, and the SELECT data became available.Could you maybe talk about...You know, obviously, they're going to file SELECT, but just sort of making sure people don't get confused on these two labels of-
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Mm-hmm
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
... the SELECT population versus the Empa population?Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
Yeah.Thanks for the question, Yas.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
I think the important thing-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
...to keep in mind is, as the guidelines, as Tom has mentioned, are changing-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
...I would move the SGLT class from a pillar-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
to the foundation.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
All patients with heart failure should be on an SGLT inhibitor.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
I think, like the other pillars, there'll be a subgroup of patients-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
... that would be candidates for GLP-1s-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
... or other analogs.I think the other important element is that the GLPs, in general, have demonstrated value in reducing stroke and MI, MACE events.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
... not heart failure events.In fact, there are data that show in patients with HFrEF-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
... use of a GLP actually might be associated with more risk in heart failure events.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
So I think if you're talking about a subgroup of obese patients with HFpEF-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
... which is where these trials have been done.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
... particularly to reduce MACE events-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
...not heart failure events.There could be and should be a role for those agents, but it's not going to displace-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
... at all the SGLT class.
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
Yeah.The only other point that I'd add to Craig's salient points there is just about the cost benefit side-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... of this as well.I mean, if you look at the cost comparison-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... of Empa versus a GLP-1-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... and especially in the Medicare patient, where at the moment, CMS-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... is obviously not covering these medications-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... you know, I think there's still some significant hurdles-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Tom Garner
SVP and Chief Commercial Officer, Lexicon Pharmaceuticals
... that are in the way for broad adoption of GLPs within this space in particular.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Great.Now I would love to transition into today's great news on PROGRESS.You know, announced the first patient enrolled.What did you disclose?You guys also had done a really nice job talking about the design of the studies ahead of time and the doses.Aside from the key milestone of dosing the first patient, was there any other elements of the trial that were disclosed that you want to talk about, that maybe you didn't get a chance to share with investors and analysts before, that you want to talk about?
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
...Yeah, yeah, as I think we've tried to take the approach to be really capital efficient-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
and de-risking the asset.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
I think that's the key takeaway, and I think the details are important to certain groups.I think for the overall investor-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
...We try to do things in a way that keep the timeline the same as they-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
would be if we were to go right into phase III.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
But de-risk and reduce costs significantly and sort of shift costs out-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- as we get more information.So by doing a phase two dose optimization-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
you take your phase III programs from a three- or four-arm study-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- with two arms.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
We've really zeroed in over this past year with the pharmacokinetics-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
and really looking at what are the doses that we think really bound, where the benefit risk will be.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
By taking down the induction arm, that first day dose-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
We already know that most of the adverse events were associated early in the dosing.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
So the benefit risk will be much better.We learned so much in the phase II study about how do we reduce screen fail?
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
How do we increase enrollment?
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
We have more academic sites.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
We have the president of the ADA as the PI of the study.So all of these things, having a long-term extension trial-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
not only shortens the timeline
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
but also is a great inducement for patients.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- to join the study.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
Everyone's gonna have access-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
to the product.So, you know, when you look at a time and capital allocation-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
We believe it is a much better way to go.We've already gotten feedback.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- from KOLs, from-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- FDA consultants, and from the FDA itself.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.Now, with the study being kicked off, have you guys thought about how soon you could...You know, this is a large market opportunity-
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
Mm-hmm
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Very limited competition and development.How soon could you get enrollment under your belt?How could you get data in 2024 or more like 2025?Like, how you're thinking about sort of the, the data, data release?
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
Well, we've done several things to increase-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- enrollment, so we're looking at getting over 400 patients-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- with moderate to severe pain.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
We're again being laser beam focused-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
so we can minimize a lot of the variability-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- that sinks so many pain studies.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
We significantly increased the number of sites, and we publicly-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
mentioned that, where we had about 45 sites in the pilot study.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
We're at 100 sites, all in the U.S.Again, we are qualifying and utilizing our best-performing sites in the first trial.And again, I think the overwhelming interest of them-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
to participate in this trial, again, is a reaffirmation of this is a-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
Good trial.This is an agent that-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
They're interested in.So we've taken all of that to try to increase enrollment.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
But, you know, right now, the numbers that we've committed to is finishing enrollment in about a year-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
is already a pretty, pretty heavy lift.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
But I think we feel confident in that.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
Based on what we've learned, and I think getting that screen fail.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
You know, we had a 60%-65% screen fail-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- in the first set of studies.We think we can manage that better.So again, we've had a-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
challenge internally of how can we go faster and-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
Certainly we have an upside.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
To be honest and to sort of give a conservative-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
but stretched target
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
of having data in second quarter of 2025 is
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Okay.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
I think, yeah, what I would add is, and I, I talked to this when we did the Phase II-A study.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
I appreciate speed.I really do.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
But I appreciate a successful trial better.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah, yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
And so we have to balance those two-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
to make sure all the elements that we learn in that II- A-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah, yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
that we are purporting that into
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
this II-B study.And then, to Craig's point, how do we do that and still stay on a timeline as we would in the phase III?
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
I think it's quite innovative and remarkable-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
What the team is doing, but my message really is, let's make sure the quality-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
that we want to bake into this-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
- gives us the confidence that we're gonna get a successful outcome-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Like we just did.This is important because you asked for reasons to believe.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
This is the first compound I put into the clinic-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Lonnel Coats
CEO, Lexicon Pharmaceuticals
- as a CEO when I came in 10 years ago.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
To nurture it out of the partnership with BMS-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
From discovery, and now have it in the late stage development.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
There's not been a new development in this area for over 20 years.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Equally important is, there hasn't been a successful neuropathic pain...
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
- study in Phase II in over 20 years.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
LX9211 has now broken that mold.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
It's now been successful in II-A
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
All that's left for us is to optimize this so we can-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
increase our confidence
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Got it
Lonnel Coats
CEO, Lexicon Pharmaceuticals
- in a Phase III and what we can deliver into-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Lonnel Coats
CEO, Lexicon Pharmaceuticals
a commercial market.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah.Given...No, thank you, Lonnel, and a lot of investors appreciate that, that meticulous, you know, taking risk off the table through each execution.The question comes up is, like, given the size of this phase II-B, and given the size of it's the phase II-A, is there-- have you negotiated or discussed with the FDA that maybe this could be deemed positive, be served as one of the registrational, or could maybe require a smaller size of the two pivotal studies in, in one way?Yeah.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
It's a great question, Yas, and actually it is.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Okay.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
That extension study, that is gonna be the long-term safety data already.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Okay.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
So that, at a minimum-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- is something that has already been discussed.I think it'll certainly be a very important-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
supportive trial of what we're-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- expecting now would be II parallel phase III-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- trials with a single dose.
Lonnel Coats
CEO, Lexicon Pharmaceuticals
Mm-hmm.
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
So it would certainly, if the study is positive-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
we all hope, that would be a supportive trial along-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
with the overall other two
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
phase three studies.But the long-term safety is gonna come-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Craig Granowitz
SVP and CMO, Lexicon Pharmaceuticals
- from this trial.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Thank you.And maybe this question is for you, Jeff.You know, I think, you know, reminding our investors of the current cash, cash runway, how to balance, you know, running, you know, phase IIF well-designed study, while also really building out really continued commercial success until really INPEFA has full access.So how do you foresee sort of, you know, cash, cash runway, cash events?
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
Yeah.Yeah.So at the end of this past quarter-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
we had a little over $218 million in cash and-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
in investments.We have a financial-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- arrangement with Oxford Finance-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- That gives us some additional capacity there.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
We are expecting to have that cash and cash runway to be able to get us into 2025.Part of what you're asking, I think that's one of the reasons why we were wanting-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
to be very capital efficient-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
with the LX9211
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
program and why we're taking the approach with that program
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- that we are.Because I think we can create a tremendous amount of value-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
but we need to be prudent-
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Yeah
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
with the way that we use our resources
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm
Jeff Wade
President and CFO, Lexicon Pharmaceuticals
- to be able to continue to invest appropriately in the launch of INPEFA as well.
Yasmeen Rahimi
Managing Director, Senior Research Analyst, Biotechnology, Piper Sandler
Mm-hmm.Perfect.Well, team, we have come to 25 minutes, flew by discussing this.You've had a phenomenal 2023, and really the best of luck and great things are happening in 2024.So just want to say thank you on behalf of all of us here at Piper Sandler.
