Q4 2020 Lexicon Pharmaceuticals Inc Earnings Call
Good afternoon, My name is shantou and ill be your conference operator today at this time I would like to welcome everyone for lexicon Pharmaceuticals fourth quarter 2020 earnings call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.
If you'd like to ask a question. During this time starved for number one on your telephone keypad, if you'd like to withdraw your question press the turnkey.
For today's conference is being recorded I would now like to hand, the conference over to your Speaker today Channel Executive director of corporate Communications and Investor Relations. Thank you.
Thank you Sean good afternoon, and welcome to the Lexicon Pharmaceuticals fourth quarter 2020 financial results Conference call.
Joining me today are Lanell coats lexicons, President and Chief Executive Officer, Dr for being tile Lexicons Executive Vice President of research and development.
And Jeff Wade Lexicons, Executive Vice President of corporate and administrative affairs, and Chief Financial Officer.
Earlier today lexicon issued a press release announcing our financial results for the fourth quarter of 2020, which is available on our website at www Dot Lex pharma dot com and through our SEC filings a webcast for this call along with a slide presentation is available on our website.
Yeah.
During this call we will review the information provided in the release provide an update on our clinical programs and then use the remainder of our time to answer your questions.
Before we begin let me remind you that we will be making forward looking statements, including statements relating to the safety efficacy and the therapeutic and commercial potential of <unk> 91, one set of good flow them and other drug candidates.
These statements May include characterizations of the expected timing and results of clinical trials, one for Alex 91, one so to close them and other drug candidates and the regulatory status and market opportunity for those programs.
This call May also contain forward looking statements relating to our growth and future operating results discovery and development of our drug candidates.
Strategic alliances and intellectual property as well as other matters that are not historical facts or information.
Various risks may cause our actual results to differ materially from those expressed or implied in such forward looking statements.
These risk include uncertainties related to the timing and results of clinical trials and preclinical studies of Alex 91, one circles Watson and our other drug candidates our dependence upon strategic alliances and other third party relationships.
Our ability to obtain patent protection for our discoveries limitations imposed by patents owned or controlled by third parties and the requirements of substantial funding to conduct our research and development activities.
For a list and description other risks and uncertainties that we face. Please see the reports we have filed with the Securities and Exchange Commission.
I will now turn the call over to Leno coats.
Thank you Chad good afternoon, everyone and thank you for joining us on the call.
We welcome the opportunity to discuss what was a very busy quarter for lexicon, and which we've made significant advancements with our two lead compounds, Alex now to one one and so to the closing.
During the fourth quarter, we commenced patient enrollment for relief ph and won a phase II clinical study of Alex non tier one one for the treatment of post herpetic Neuralgia. This is our second phase II clinical study for <unk> 201, which we have initiated in neuropathic pain patient.
Patient enrollment in our other phase II clinical study relief VPN, one in diabetic peripheral neuropathic pain is ongoing and.
In December we were very pleased to announce that we received fast track designation from the FDA for the development of Alex non two <unk> and diabetic peripheral neuropathic pain.
This designation is indicative of a serious unmet medical need of this patient population.
Also in the fourth quarter, the soloist and scored phase III outcome studies a soda good flows in heart failure. Both achieved their primary end points. The results of those studies were presented by Dr. Deepak Bhatt during the late breaking science session of the American Heart Association scientific sessions and were simultaneously published.
In two separate articles in the New England Journal Medicine.
Based on the strong results from these studies in our some subsequent discussions with FDA. We made the decision to move expeditiously with a new drug application for an indication to reduce the risk of cardiovascular death hospitalization for heart failure and urgent visits for heart failure in adult patients with type two diabetes.
Bt's for either worsening heart failure for additional risk factors for heart failure, we expect a new drug application to be filed in the second half of the year.
We also closed out the year by raising $70 million of net proceeds from sales of our common stock.
Combined with our decision to strengthen our balance sheet by eliminating 95% of our debt we entered into 2021 and a solid financial position with cash sufficient to fund our planned operations for two years.
On the next slide.
Looking ahead to 2021, we anticipate a number of events during the year, we expect both of our proof of concept studies for Alex non to one one to read out by the end of the year.
We're very enthused by what we have seen from Alex non to one one and our preclinical and phase one studies and are looking forward to obtaining the phase two results.
We plan to share more about the data from these earlier, Alex non two <unk> studies and the upcoming publications.
As I mentioned, we are moving full steam ahead with an NDA filing for soda good flows in and heart failure and expect to submit the NDA during the second half of the year, we will need to establish a strategic alliance with soda. Good flows in order to achieve the best long term value for the asset as well as for millions of people suffering from heart.
Worldwide and those business development discussions are moving ahead in earnest.
Important data from soloist and scored was presented at <unk> and in the New England Journal Medicine articles and there are more analysis ongoing which we expect to.
To release results in additional publications throughout the year.
Now onto type one diabetes.
We continue to believe the historical flows on demonstrated a positive benefit risk in a largest phase III development program ever conducted in type one diabetes and that it has the potential to become an important new treatment option as an adjunct to insulin for type one diabetes, we have requested an opportunity for an administered.
Net of the hearing with the FDA on whether there are ground force previous denial of our NDA for type one diabetes and the FDA issued a public notice of opportunity for hearing just last week.
We look forward to continuing these discussions with the FDA.
Now, let me start I'll start out by providing an update on Alex not 201, which we are developing for neuropathic pain.
Despite neuropathic pain affecting millions of people there remains a high level of unmet need for those suffering from the condition. The current approved therapies are limited by lack of efficacy compounded by debilitating side effects. As a result, many people turn to opioids to experience some level of relief.
Which of course carries our own risk or potential abuse and addiction.
We feel that Alex non two <unk> through its inhibition of a K one independent from the opioid pathway has the potential to overcome many of the shortcomings of current therapies and could become a welcome new innovation for those suffering from neuropathic pain on a daily basis.
I'm going to pause here and turn things over to Dr. Tile to provide an update on <unk>, one and to take you through the data from stellar so scorched studies and share a little more on why we think our day to maybe especially compelling because of solid flows inhibition of <unk> one.
<unk> style.
Lasalle.
<unk> nine to one one is a potent orally delivered selective small molecule inhibitor of <unk>.
One which is the pathway. We believe may have utility in reducing neuropathic pain, while avoiding the addictive non sites of the opioid abstinence.
It looks like the one one was discovered by scientists working but then our drug discovery Alliance with Bristol Myers Squibb, and we now wholly own all of the price to Alex nine to one one as well as any additional compounds acting too hey, Okay. One that we may develop.
As Lynn mentioned earlier, we received fast track designation Inc.
According to <unk> from the FDA for the treatment of diabetic peripheral neuropathy.
Let me show you some of the preclinical data supporting our view that Alex nine to one one maybe beneficial for people suffering from diabetic peripheral neuropathic.
Patrick team.
With diabetic peripheral neuropathic pain in people living with diabetes, often develop no damage, which causes painful debilitating symptoms most often in their legs and feet.
On this slide you can see the effect of <unk> nine to one one in the GAAP.
For standard diabetic peripheral neuropathic pain models.
And this model Streptozotocin is used to induce diabetes and racks and then Tessa performed to evaluate the reps sensitivity to mechanical allergy anyhow, we had even a slight touch 10 calls a painful sensation and drugs for diabetes.
This guy for his book under the Brown and Purple lines. The Brown lines are presented for Rux Enbridge diabetes was induced while the purple lines per centers to control that the dog diabetes and with normal sensitivity to touch.
The rocks along the blown lineup feeling the full effect of neuropathic pain from their diabetes and they feel pain with any type of touch as shown by zero percentage inhibition of mechanical allodium.
The rocks along the purple line are not feeling any effects from neuropathy ban for sensitivity to touch has shown by 100% inhibition of mechanical allo Danielle.
The lines in between these two extremes so the effect of <unk> nine to one one on diabetic rats.
You can see there is a clear dose response to Alex 90 to one one that enables those diabetic rats to call for at a significantly higher degree of touch without pain at the one milligram and three milligram per kilogram levels.
Vyvanse comparison in the same experiment and copper mountain was that from a store to a 100 milligram per kilogram and resulted in a similar response as the one milligram and pay milligram per kilogram levels of <unk> nine to one one.
So if you were able to achieve a similar level of efficacy at a much lower dose with Alex 901.
More importantly at this level of dosing, we saw non motor impairment and the rights and no impairment of performance and cognition model, which are the two significant side effects of novel patented.
In addition to the PMT preclinical studies, we also studied Alex nine to one one for you.
Clinical drive model for post Herpetic Neuralgia Mitchell.
Which is the focus of our other phase two proof of concept for clinical studies.
And this model for sellers voice, which is the lightest that causes shingles is introduced to <unk> total by nature and prefer to stay in the Doc usually only on king for life and under duress.
In this model, we looked at the time that last.
Spend in the dark horse for the light over five minute intervals are 300 seconds.
When stimulated with a 60 Gram filament every 15 seconds.
On this slide.
Head to head test of Alex Nigel one one milligram per kilogram versus Gaba Pam.
Milligram per kilogram.
On the left you can see the results from our single dose over the next nine to one one and carboplatin with both arms, providing a statistically significant improvement in the time spent in the dark as compared to the untreated <unk> represented by the dotted line.
And the multiple dose administration on the REIT involving seven daily doses of <unk> nine to one one and Gaba printing we saw further separation.
When comparing Gaba and can treat interest to Alex nine to one one treating back pain response was significantly better than that.
<unk> nine to one one treated racks.
So as in the case for <unk> model with Alex nine to one one in these doses, we saw no motor impairment and the rugs and no impairment of performance and the cognition model, which are two significant side effects of Gaba Brendan.
Okay.
Our preclinical data for <unk> time for one one has demonstrated excellent CNS penetration and reductions in pain behavior in animal models of neuropathic pain.
Very importantly, we have conducted several preclinical tests to confirm my lifetime to one once independence from the opioid pathway and so far we have found no concerns around addiction with Alex nine to one one.
We have conducted single and multiple ascending dose phase one studies in healthy volunteers to study the safety Tolerability and pharmacokinetics of <unk>.
<unk> nine to one.
The studies supported the preclinical profile.
Alex lined to one one was well tolerated with dose proportional pharmacokinetics that are supportive of once daily dosing.
There were no drug related serious adverse events and the most common adverse events were headache and dizziness.
Overall, we feel that <unk> nine to one.
<unk> represents an innovative potential approach to treat neuropathic pain without addictive potential of many of the current therapies and treatments.
We have two phase II proof of concept studies ongoing.
One is in the diabetic peripheral neuropathic pain and another one in post herpetic neuralgia.
For both double blind placebo controlled parallel group Multicenter studies.
The <unk> study is a three arm study, while PHN studies at two arm study.
They both share the same primary endpoint, which is the change from baseline to week six and the average daily pain score.
The <unk> study because diabetic peripheral neuropathic pain is a more heterogeneous condition.
Sounds like it was important to have a relatively large study.
So we anticipate enrolling approximately 300 patients.
Over at least over 30 U S sites.
The agenda is a more homogeneous disease and so we can do a smaller study.
Anticipating enrolling approximately 75 patients in this study.
Patient enrollment and dosing is ongoing in both studies and we expect results from both studies towards the end of this year.
I would like now to turn our attention to sort of the closing.
And the recent data from our two studies soloist and scored in heart failure.
The soloist and scored phase three outcome studies have been completed and involved approximately 210500 patients respectively.
Both studies were recently presented during the late breaker session of the American Heart Association in November 2020, and.
Country concurrently published in two separate articles in the New England Journal of Medicine.
Before delving into the data from soloist and scored I want to describe the reasons why we believe our data, especially compelling and maybe differentiate it from selective <unk> inhibitors.
There is a growing body of evidence that highlights the potential cardiovascular benefits for <unk> inhibition.
Including a number of recent publications that suggest the potential cardiovascular benefits.
<unk>, one and lower glycemic variability.
It has been reported in the literature that lower glycemic variability is linked to less left ventricular dysfunction and less risk of myocardial infarction and stroke.
Benefits of lower glycemic variability to a surety bond and I mentioned that also supported by human genetics studies in which people with loss of function mutations in the <unk> one gene.
<unk> decreased postprandial glucose level, which has been linked to decrease the incidence of heart failure.
Kris and obesity and debt.
As a result, we feel.
There is a solid scientific support that <unk> inhibition is providing much other cardiovascular benefits that we absorbed but sort of the flows in a dual <unk> inhibitor and soloist and scored studies.
The clearest evidence that surgical flow and is providing <unk> inhibition is represented on this slide.
Looking at the impact of hemoglobin <unk> in patients with moderate and severe chronic kidney disease.
<unk> inhibitors work through the kidney and so their effectiveness diminishes as kidney function decline.
Cash you'll be one inhibition works total cut and therefore it is a non.
Not independent it is not dependent on kidney function. So it is independent of kidney function.
In this slide you can see on the left that patients who have had severe chronic kidney disease or.
Egfr less than 30 milligram per minute pillar.
173 meters acquire experienced a very clear and significant reduction in <unk>.
There has never really been any evidence of even see benefit from any SCL keto inhibitor in this patient population.
Highly significant reduction in <unk> was also observed in patients with moderate chronic kidney disease or egfr between 30 and 60.
The soloist study was conducted in patients who had recently been admitted to the hospital for worsening heart failure, and who have type two diabetes.
They were treated with sort of a closing at placebo violent the hospital all within a couple of days of discharge from the hospital.
And number of heart failure studies have been conducted with <unk> inhibitors for those studies have primarily evaluated patients who are stable and have returned home from the hospital net.
<unk> patient population presented at the time of the highest unmet need for those patients suffering from heart failure in a hospital setting.
This graph is showing the primary endpoint of total eventual cardiovascular death.
Hospitalization for heart failure, and urgent heart failure visits a.
Data from the study shortly clearly noticeable effect net separated early between sort of the closing and placebo arms.
The hazard ratio was <unk> six settlement, meaning there was a 33% reduction in the risk of cardiovascular debt re hospitalization for heart failure or urgent heart failure visit.
What makes the results even more profound as debt.
Call out in the first months of the right of this slide.
<unk> separated very early and we saw statistical significance by 28 days that hazard ratio of <unk> six one.
We believe that this early effect could provide an important benefit to the health.
Health care system by reducing near term hospitals readmissions of these patients.
The score study was conducted in patients with type two diabetes severe.
Moderate kidney disease and cardiovascular risk factors.
The design of this study was more akin to some of the other cardiovascular outcome studies that have been conducted with selective as Cherokee two inhibitors.
The primary endpoint for the scored study was the same as soloist.
Other of cardiovascular death hospitalization for heart failure and heart failure visits.
In this case.
I'm Mary endpoint Hasnt had a hazard ratio of <unk> seven for all.
A 26% risk reduction once again and other highly significant P value and really compelling suppression that started early and continue to under study.
Now, let's look at a post talk analysis of total fatal or non fatal myocardial infarction and fatal or non fatal stroke, we saw very favorable hazard ratio of <unk>, 6% and six 6% respectively.
<unk> results have not been observed with selective <unk> inhibitors.
One of the most interesting findings from these two studies is shown on this slide.
We took a look at the hazard ratio across the entire spectrum of left ventricular ejection fraction and heart failure patients in both scored and soloist studies.
You can see from this graph there is a trend showing debt as the ejection fraction increases the hazard ratio actually decreases.
This trend has not been seen in any study and makes clear that our <unk>, one inhibitor sort of our flows and provide a benefit across both reduced and preserved ejection fraction patients in those studies, we are especially excited about the robust for risk reduction.
So total flows in the entire spectrum of preserved left ventricular ejection fraction patients who currently have limited treatment options.
The similar data also holds true for mace events, which include cardiovascular death, non fatal stroke on non fatal myocardial infection, where we see same trend as a function of ejection fraction.
Based on very encouraging data from these two studies, which I just reviewed the FDA agreed.
Results of soloist and scored can support.
New drug application submission for an indication to reduce the risk of cardiovascular death hospitalization for heart failure and urgent visits for the heart failure in adult patients with type two diabetes with either worsening heart failure.
Additional risk factors for heart failure.
We are very excited about the broad spectrum of cardiovascular benefit that our dual <unk> inhibitor. So total flows in demonstrator and board soloist and scored trials, including differentiation and rapid benefit in a hospital setting the benefit in both Houston preserved left.
<unk> took a little ejection fraction and the substantial reductions in myocardial infarction stroke.
These are all unique outcomes from what has been seen to date that selective <unk> two inhibitors.
We are very pleased with our regulatory feedback we received from food and drug administration, and we plan to move expeditiously forward without partnering discussion and for their NDA filing this year.
With that I'd like to turn the call back to <unk> to discuss the potential market opportunity for.
For sort of our flows and in heart failure Lasalle. Thank you Praveen concurrently with our partnership discussions we actually had to take a step back a bit and do a little work to build our own understanding of the overall heart failure market and we're sort of closing might strategically fit in that market some of which I'll share with you now.
Based on our market assessments, we feel distorted the flows and may have a differentiated product profile. We have unique advantages in the treatment of heart failure. We believe the data from the scored and soloist studies support a label for solar could flow them to treat worsening heart failure or risk factors for heart failure in patients with type two diabetes.
We take a moment and say the Entresto just received.
A label expansion from the FDA to include a more general range of chronic heart failure with a preference for patients with a left ventricle ejection fraction below loan.
We believe this approval.
<unk> represents or presents a significant opportunity for solid flows since data from the scored and soloist studies have shown heart failure benefits across the full range of the left ventricular ejection fraction spectrum, we feel that data supports a broad label for the treatment of heart failure that does not distinguish on.
Instance to have reps and have passed the.
For heart failure market has seen consistent growth that has the potential to accelerate tremendously in the next few years as new innovations into the market to treat the sizable population with a high burden of disease, especially in the larger half past population.
And we go to the next slide.
We said there are nearly a million hospitalizations per year in the United States, which is exactly for for heart failure, which is exactly where our solar study look to see the impact of soda. Good flows in this patient population. This was a big risk for the design of this study.
There has been a lot of literature around the convergence of heart failure in type two diabetes.
And in <unk> 2016 publication looking at 160000 hospital admissions across the United States for heart failure. They found that approximately 44% of the patients presented with type two diabetes.
When you look at the overall heart failure population.
The proportion of the patients and are hospitalized setting has been increasing over time.
Theres been a number of new entrants into the half Rep Arena.
But only started to flow has shown clear clinical benefit across the full range of more difficult to treat.
<unk> population.
Overall, we believe that the clinical data for silica flolan supports an indication to treat across the full spectrum of left ventricular ejection fraction and would be and especially welcome new entrants from the larger half per population.
Now on the next slide.
The heart failure market is quite large and rapidly growing occur.
According to global data the current market for chronic heart failure is approximately $4 $2 billion in the United States and is expected to grow at 18% per year and the upcoming decade to reach 16 $6 billion in 2028.
As you can see we feel that the overall market potential for surgical flow is very substantial and is a primary reason we are prioritize accelerating to file the NDA in heart failure in the second half of the year.
There is a great value in an urgent need for a treatment like soda good flows and we do not want to lose a day.
Now with debt without I'll turn this call over to Jeff to walk you through our financial results for the fourth quarter, and then give some financial guidance for 2021, Jeff.
Thank you Bruno.
To begin that will discuss key aspects of our fourth quarter financials.
For financial details can be found in the press release that we issued earlier today and our upcoming 10-K SEC filings.
As indicated in our press release, we had minimal revenues from the fourth quarter of 2020, primarily due to the elimination of product revenues as a result of our sale observed mellow during the third quarter of 2020.
Research and development expenses for the fourth quarter decreased to $1 million from $40 $6 million for the corresponding period in 2019.
This was primarily due to a reduction in external clinical development cost estimates related to physical flows.
This was a onetime adjustment and not indicative of our expected research and development expenses moving forward.
Selling general and administrative expenses for the fourth quarter decreased to $6 4 million from $14 6 million.
For the same periods in 2019, primarily due to reductions in personnel and elimination of marketing expenses. Following the sale of <unk> Mellon.
In total we had a net loss for the fourth quarter of $5 $5 million for per share as compared to a net loss of $51 1 million or <unk> 48 per share in the corresponding period of 2019.
Our net loss for the fourth quarter of 2020 in 2019 included noncash stock based compensation expense of $2 7 million and $3 $5 million respectively.
We ended 2020 with $152 3 million in cash and short term investments as compared to $271 $7 million as of December 31, 2019.
We eliminated 95% of our debt during the year, reducing our overall indebtedness from $245 $3 million at mid year to $11 6 million at the at the end of the year end December 31 2020.
Now I will turn to our financial guidance for 2021.
We expect our 2021 operating expenses to be in the range of $85 million to $100 million.
Which is a sizable decrease from the 200 for $4 million.
And operating expenses, we had in 2020.
We expect non cash expenses to be approximately $11 million of our total operating expenses.
Research and development expenses are expected to be in the range of $60 million to $70 million.
This estimate includes the expected spend for our ongoing two phase III clinical studies will expand to one one the.
The remaining closeout of our set of closing studies and the expected cost to submit a new drug application for heart failure.
As well as investments in preclinical and discovery stage programs.
We expect G&A expenses to be in the range of $25 million to $30 million.
Overall, we expect that our current cash and investments will be sufficient to fund our operations.
Through 2022 and into 2023.
I will now turn the call back to one off.
Just thank you I think less and less.
Open the lineup for questions.
And we'll go from there.
A reminder to ask a question.
Star one on your telephone to fly.
For calendar question. Please.
Please go on while we compile the Q&A roster.
Our first question comes from.
That's true.
Your line is open.
Hi, This is carly on for Yigal, Thanks, very much for taking our question.
Alex 91, one can you talk about the rationale for running a larger three arm study in diabetic neuropathic pain, where you're testing two different doses.
<unk> is running a smaller study.
Yeah, that's true and then I guess.
And the second part for the question based on the mechanism of action is there reason to think debt.
Alex 91, one should work better.
Indication okay.
Thanks for the question I'll turn that question over to Dr. Todd.
So currently the.
Let me separate your question into two parts. The first part is why larger trial of it.
<unk> compared to PHN.
What other indications of other indications potentially 90 to one one cookbook and correct those are the two questions.
So the first question is.
When you look at the <unk> study.
As I said in my remarks.
Heterogeneous disease and different.
<unk> present themselves for different etiologies. So we figured that we better study two different doses because different patient population many different.
Doses number one and number two because of the heterogeneous behavior of the disease. We wanted to make sure that we're not missing the positive signal by doing a very small study, hence the number of patients to be 300, now compared to PHN, which is more or less a very homogeneous disease and when you.
Look at the preclinical data the study.
30 milligram per kilogram dose, which motor less translates to where we are at 200, Slash 20, and dosing, which we are studying in the clinical study.
As for your second question, which is what are the other indications of 90 to 101 may work on I think besides these two indications. We are also doing preclinical work and various other CNS diseases and.
What we did not mentioned today, because we have not finalized yet.
What other disease areas, we may be studying in this compound. We believe this compound is very versatile and could be very useful in other neuropathy pain indications and other CNS diseases.
Yes.
Thank you for being.
Great.
Helpful. Thank you and then.
Just switching over to technical closing for heart failure.
You probably characterize.
Interest you are receiving from potential partners, there and maybe just talk a little bit about what you see the characteristics of an ideal partner program.
Yes, I mean, I think the number one characteristic you got to find someone who believes as you believe.
We took a step back.
I alluded to this at the Jpmorgan conference, we need to step back a little bit to make sure that we.
We can get the right kind of deal it.
It was important to do that because we haven't done any market research when we got the data in.
Net interest starting to show up.
It's not a good idea to entertain that so dramatically before you have your own research done for you have your own Kols engagement. So we took the time to do that and I think as we did debt our enthusiasm.
About what we had in hand grew quite remarkably.
You can only imagine that been shifts conversations that you have in partnership discussions I would say overall we have.
Had fairly robust conversations with a number of parties and we continue to have conversation with number of parties I think now that we have the data in hand of our own market research Ronquil findings.
I think that puts us in a better position to do two things one is to know for ourselves with value looks like and two how do we influence others to see the world as we see it.
And that's what takes time.
<unk> I think the challenge is you have some players who will come in and just say theres. Another <unk> two.
And the results are not similar.
And we have to help people through that and help them through it not only with the science that we show them. What we have to also have to manage the standard when we go out to market and test it so.
So I think the conversations remain robust.
And we intend to do something with someone who believes as we believe that this is a remarkable opportunity and it needs to be approached as such and not approached us at me too and that takes a little bit more time, but nonetheless, I think thats the way I would characterize the discussions.
Okay, Great. That's helpful. Thank you for taking the question.
Our next question comes from.
People with them.
Yes. Good afternoon, thanks for taking my question.
So I.
I guess.
In showing kind.
The combined effect in the house have patient population between soloist and scored then.
Is it is it safe to assume that in India that you'll be filing will include.
Data.
From patients with preserved ejection fraction from both trials.
Yes.
Results, we saw were consistent in both studies.
Just when you look at the.
Spectrum of patients, who had a history of heart failure, which is everybody in the list and the patients who had scored.
It's a very clear and really kind of a unique perspective across that entire ejection fraction, but the results were consistent in both of those studies.
Yes, Stephen I think the agency is going to want to see all of that data.
I think we're pretty confident at this point when we look at I think where the confidence comes from to some degree is true.
Entresto, how does that com.
And we looked at the questions that came from net ad com.
We looked at where the FDA was relative to how to define it.
We saw a lot of.
Of variability.
Variability in how people perceive have path for what they call have met that something thats just between reduced and preserved.
What I found about the filing with that conversation that we're having it because they were trying to figure out if you're going to label it where it was the real value.
And the.
The reason I say, it's a great opportunity for solid flows we don't need to have that conversation because whether you look at rep have met or path. The overall rate of reduction was quite substantial and statistically significant even you start to look at the confidence intervals you continue to see significant and so you just have a very robust.
<unk> across the entire spectrum.
It's very different from anything I think that was shared at the outcomes at the end of the year debt.
FDA was considering and the fact that day. They found a way to label Entresto gives me great confidence there should be a way to label us across the entire spectrum.
Understood.
I think you had previously suggested that a regulatory filing an NDA wood.
Unlikely occur in the absence of having a partnership a day so is.
<unk> is a partnership still a rate limiting steps for the regulatory filing or is that something that you guys feel that you can proceed with on your own.
As some of these partnering discussions continue to crystallize in the background.
Steve I reserve the right to change my mind.
So let me just changed my mind and part of that is because we went out and did the work we went out and spoke to two key opinion leaders, we went out and did the market research that.
Deepa, we went to more.
Amazed we were with our data.
And therefore, we learned very quickly we shouldn't waste anytime at this point waiting for a partnership to materialize before we make the decision to go forward.
We now have the advantage.
Other is going to have to show what we show in the best way to set that stage is to get it in front of the regulatory agency and set the stage and so we've made the decision not to wait for a partnership to materialize to create value.
One of the best ways to create the most substantial value is to move this for the NDA filing and so we have prioritized it because I think our confidence has grown about what we have in hand.
Understood.
Thanks for taking the questions and congrats on the credit.
Thank you.
Our next question comes from Joseph.
Morgan Your line is open.
Okay.
Hey, this is Luke on for Jeff Thanks for taking our question today.
So just real quick you guys.
What are you seeing as a potential read through from our upcoming data for jogging Src with.
And both are expected to readout data for ejection fraction.
In terms of how that would possibly impact business development for for soda.
Well this is kind of back to the answer I just gave Thats why you don't waste a day on getting your NDA and are setting the path for everybody else to follow.
I think these are two smart companies and they know how to develop.
I think there may be some degree of success that they are going to have but.
I think theres going to be very interesting to get antibody to match the data of.
So to get flows in and the reason, we believe that as debt fundamentally as we look at why do we see the results that we've seen is we believe that the <unk> is contributing it is making a contribution to the outcome that we see and as a result of that gear.
Given our unique mechanism. We think ultimately we will have uniqueness now that has to be seen when they call out their data.
We have to watch for is what we keep saying.
Don't just look at cutoff look at the entire spectrum when you start to look at.
<unk> is about 50% of the market.
And if you start doing cutoffs below 60 or somewhere in the neighborhood of 50, and so forth zone youre cutting off a substantial part of the market. Because you are not able to show benefit what we've been able to show whether it's the cutoff is 40 50 60 70, you still see a hazard ratio and you see you see statistical significance. So that's what.
You should look for from these other trials and if you don't see debt and the advantage will still be lexicon.
Okay, Thanks, and non that Youre seeing as you said moving right away.
On filing the NDA on your own.
Is there any potential for that to impact the commercialization strategy.
Our partners are still going to be gating to lab.
The commercial part that's where we need a partner there is not a question about debt are well positioned partner or a partner who has the.
The resources to be well positioned I would put it that way because we have had part of folks who come in with an interest.
That quite frankly see a substantial opportunity that may not be as positioned in heart failure today, but want to be.
And so therefore, we've taken those calls as well so the key is that you got to have somebody who comes in a fundamentally see the world the same.
We've come out of a significant alliance, where we diverged on our opinions.
We feel confident that our opinion was right.
Coming out of that alliance data now bears debt to be true, but we lost a lot of time. So we can't do that again, we really have to find someone who lines up with us that is willing to make the necessary investment to compete to compete to compete with confidence and conviction and launching the product in the Cogs failure market, there's not a lot of drugs.
This is why we remind folks when we talk to them how many drugs are available today with an indication for <unk>.
Don't exist.
Yes, I think Entresto is the closer that comes at smoothed into debt Pep arena with a broadening of their label for yet the benefit was seen below 57% of normal population and so there is still a massive need for more compounds and have passed and that is the fastest most significant.
Part of the market right now and right now we've shown it and so we'll have to wait and see if anybody else to match that but for now we have shown it and if we have a partner they want to come in and help us tell that story.
That's what we're going to sign up.
Alright. Thanks, Thank you for going over there I will turn it back.
You bet.
Our next question comes from Kevin Kendra G Research your line is open.
Hi, Thanks for taking the questions in the past few weeks there have been a few cases, we've seen it seems like the FDA and some companies for trucks under from you haven't really been on the same page so.
Surgical flows.
Can you speak to any dialogue you've had with the FDA since the update you gave in January and I know you mentioned interest for label, but anything else that.
Gives you confidence around your conversations with the agency and the filing pathway for.
For heart failure.
No great question I would say, we haven't had much more dialogue with the agencies subsequent to the last dialogue, we have with them. So what we've done is watch very carefully.
<unk> committees, they had to they have to one would entresto and the other one for <unk>.
Spinoffs spinal lactone and I think it was very clear the agency was looking for something.
They can make available to had some benefit for patients.
And this market given that there was no there are many options or choices I also believe the panel was looking very deeply and hard looking for data and mining the data that was in front of them to find some hope that there'll be a therapeutic option for patients in the <unk> arena.
So we've gained a lot of insight from those two advisory committees in terms of what the FDA is looking for and quite frankly is very consistent with what we what our.
<unk> had been and what we're planning to do relative to our filing so our confidence is really coming from debt more than anything else.
Great.
Switching to 91 one.
The timeline of data from both studies by year end, but in terms of enrollment have you seen any.
As for the pacing of enrollment or getting sites up and running now that COVID-19 is.
Declining to some degree and we have vaccines ramping up.
Same thing change day to give you kind of.
Greater level of.
Confidence in those timelines.
I think we've had to do is put risk mitigating strategies in place because we did start to see enrollment would be impacted by the last wave of COVID-19.
If you start to look at some states and how they were closing down and how they were trying to mitigate it it did have some impact so we.
We saw that and we saw the potential other than we started putting risk mitigating strategies in place to try to stay on time, but not compromise. The study. So I will say that it did have impact, but I believe the risk mitigating plan that we put in place.
Should keep us on track.
For the end of the year, we're very hopeful to the point that you just made as people confidence grow about the vaccine.
And as states start to let up a little bit on some restrictions.
Think people will get more comfortable coming out of their house.
And particularly people, who may have a chronic disease or chronic illness such as.
Diabetic peripheral neuropathic pain.
And when that happens I think are mitigating strategy will allow us to accelerate accelerate even faster, but for right now I will say that we did see risk to the study in terms of enrollment will put that plan in place and we're certainly hoping.
The environment would allow us to stay on track.
Great. Thanks.
Debt.
Again, if you would like to ask a question for star one on your telephone.
Next question comes from Joseph Stringer with one company.
Your line is open.
Hi, everyone. Thanks for taking our question.
I just wanted to follow up on that actually.
One one.
Looking ahead to the data readout.
Towards the end of this year what are the.
Sort of expectations around.
Eight EPS.
Change.
And placebo response rates between the.
The A&P and also the PHN trial.
Just.
In terms of any type of.
Rescue.
Paying rescue meds.
Included in the trial or not.
Additional color there would be helpful. Thank you.
Yes, I appreciate the question, but I'm not answering any of them.
A lot of the way, we're designing and running this trial is to try to be as proprietary as we can so that we maintain somewhat of an advantage relative to how we're conducting them. So I think these are all very good questions, but we havent disclosed how we're doing any of that.
As we as we make more progress in the future we may make a change in net stance, but right now we're not we're not getting very deep into those kind of details.
Okay fair enough. Thank you.
Yes.
But our analysis for your questions at this time I'll now turn the call back over to the presenters for closing remarks.
Well. Thank you I appreciate it for all of those who join us today.
Just wanted to say that.
2021.
Is off to a pretty terrific start for lexicon I think we ended the year very strong we recapitalize the company debt with our balance sheet restructured our company to be very much focused on the assets at hand.
So good flows in data.
Steve asked a question about do we file it with a partner without a partner.
Because we were able to capitalize the company we're in a position we can file that rigor.
Regardless of when a partnership comes along because the value will only go up.
And therefore, we've made the decision to prioritize following soda good flows and my confidence in this component is only growing every day.
And therefore, we need to make it a priority.
That being said, we are not taking our foot off the gas for Alex 9211, I believe this is the.
This is the the transformative brand.
Debt is going to be the future of lexicon and so we did see some issues that we needed to mitigate.
In terms of enrollment.
Given the environment, we're operating in I think we've put those plans in place to keep the program on track, but we haven't done anything that would.
Put our outcome at risk and that's what's most important.
And then lastly, I was I would say.
We hope as we come later into the year to share some of the other extraordinary work that we're doing on some of our discovery programs.
So we are returned we have returned back to our R&D routes and we're now starting to move things forward.
That we will start talking a little bit more about as we get towards the end of this year.
With that being said I.
I hope to see you all have a good evening.
Thank you.
For today's conference call you may now disconnect.
Okay.
Yes.
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