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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2019 - Q4
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Operator

Welcome to the Lexicon Pharmaceuticals Fourth Quarter and Full Year 2019 Financial Results and Business Update Conference Call. At this time, all participants are in listen-only mode. Following management’s prepared remarks, we will hold a brief question-and-answer session. As a reminder, this call is being recorded today, March 12, 2020.

I will now turn the call over to Dr. Kimberly Lee, Head of Investor Relations and Corporate Strategy. Please go ahead..

Dr. Kimberly Lee

Thank you. Good morning and welcome to the Lexicon Pharmaceuticals fourth quarter and full year 2019 financial results and business update conference call. Joining me on today’s call are Lonnel Coats, Lexicon’s President and Chief Executive Officer; Alex Santini, Executive Vice President and Chief Commercial Officer; Dr.

Pablo Lapuerta, Executive Vice President and Chief Medical Officer; Dr. Praveen Tyle, Executive Vice President of Research and Development; and Jeff Wade, Executive Vice President of Corporate and Administrative Affairs and Chief Financial Officer. After our formal remarks, we will open the call for Q&A.

Earlier today, Lexicon issued a press release announcing our financial results for the fourth quarter and full year 2019, which is available on our website at www.lexpharma.com and through our SEC filings. A webcast of this call, along with the slide presentation, will be accessible in our Investor Relations section of our website.

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 and efficacy, and the therapeutic and commercial potential of XERMELO, Zynquista, LX9211 and our other drug candidates.

These statements may include characterization of the commercial performance of XERMELO, expected timing and results of clinical trials of sotagliflozin, telotristat ethyl, LX9211 and our other drug candidates, and a regulatory status and market opportunity for those programs.

This call may also contain forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of other drug candidates, strategic alliances and intellectual property as well as other matters that are not historical facts or information.

Various risks may also cause Lexicon's actual results to differ materially from those expressed or implied in such forward-looking statements.

These risks include uncertainties related to the success of our commercialization efforts for XERMELO; the timing and results of clinical trials and preclinical studies of sotagliflozin, telotristat ethyl, LX9211 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, development and commercialization activities.

For a list and description of the risks and uncertainties that we face, please see the reports we have filed with the Securities and Exchange Commission. With that, I'll now turn the call over to our President and CEO, Lonnel Coats..

Lonnel Coats

Thank you, Kim, and good morning to everyone, and thanks for joining us on the call. 2019 was marked by some meaningful milestones as well as some challenges for Lexicon. Let me start XERMELO. XERMELO achieved U.S. net sales of $8.5 million in the fourth quarter of 2019 and $31 million for the full year of 2019. In 2020, we expect U.S.

XERMELO net sales percentage growth in the high single digits in the first quarter and in the mid teens for the full year. We are also being very thoughtful about the lifecycle management of XERMELO, also known as the telotristat ethyl, and we're very excited about the development of telotristat ethyl and biliary tract cancer. Dr.

Lapuerta will be speaking about the broad program for telotristat ethyl in a little bit. In type 1 diabetes, as you all know, Zynquista, which is sotagliflozin, was approved by the European authorities last year.

In the meantime, we've been working diligently to find a path forward for sotagliflozin in the U.S., after receiving a complete response letter or a CRL, regarding our application for regulatory approval.

Toward the end of last year, we engaged in formal dispute resolution proceedings with FDA's Office of New Drugs, which ultimately denied the appeal of the previously issue CRL. We subsequently appealed the decision to the FDA Center for Drug Evaluation and Research, also known as CDER.

And just last night, we received the response from CDER confirming the Office of New Drugs previous appeal decision regarding CRL. We are evaluating the feedback they provided in their response, and we will provide an update on our plans for our next steps with type 1 diabetes by our first quarter earnings call.

We have reported preliminary top line results for the first four Phase 3 clinical trials of sotagliflozin in type 2 diabetes, and Dr.

Lapuerta will speak about the remainder of the type 2 diabetes program and the two outcome studies SCORED and SOLOIST that are designed to demonstrate benefits and support labeling for heart failure and chronic kidney disease.

We're engaged in discussions around potential partnerships with sotagliflozin, which will be necessary to complete those outcome studies. We continue to advance our earlier stage product candidate LX9211 in neuropathic pain. AAK1 is the therapeutic target for LX9211 and is a novel target with no association with the opioid pathway.

Preclinical data for LX9211 demonstrates excellent CNS penetration, and a reduction of pain behavior in models of neuropathic pain. Phase 1 data are consistent with the drug’s pre-clinical profile and reflects a favorable pharmacokinetic profile, which supports once daily dosing.

We expect to begin enrolling patients with diabetic peripheral neuropathic pain in a Phase 2 proof-of-concept study in the first half of this year. Before I close, let me touch on our cash position. We ended the fourth quarter with approximately $272 million in cash and short-term investments.

And we will continue to prudently manage our cash and expect our working capital will be sufficient to sustain our operations for at least the next year. With that, let me turn the call over to Dr. Lapuerta to review our pipeline..

Dr. Pablo Lapuerta

Thanks, Lonnel. Our confidence grows for telotristat ethyl. Gastrointestinal benefits, as seen on slide 6 here are documented in our product, XERMELO’s labeling. We also see opportunities to study the potential effects of telotristat on tumor growth in fibrosis. Early preclinical and clinical explorations are underway.

The next slide summarizes our clinical development program in patients with biliary tract cancer. The conduct of this open label Phase 2 study has been supported by preclinical evidence, and safety to-date has been satisfactory. We continue to anticipate data for our initial efficacy cohort will come in the fourth quarter of 2020.

And at the ASCO gastrointestinal conference this year, we presented TELEACE with real world data on XERMELO in patients with carcinoid syndrome and neuroendocrine tumors. This was a retrospective chart review of 200 patients, who are on standard background therapies and received telotristat ethyl for an average of 12 months in U.S. clinical practice.

Radiology reports indicated a mean tumor size reduction of 0.59 centimeters after initiation of telotristat. The P value was 0.006. In addition, there are numerous investigator initiated studies of telotristat ethyl that should help inform further development of the drug.

Results from one of them were disclosed in the fourth quarter of 2019 at the North American Neuroendocrine Tumor Society Conference. In that study, telotristat ethyl was studied in mice with valvular disease induced by hypertension. Telotristat reduced the progression of valvular disease, impacting several markers of valvular fibrosis.

Turning to sotagliflozin. In the fourth quarter of 2019, we published results for the study on its mechanism of action. Sotagliflozin led to a significant delay in radiolabeled glucose uptake, after a standardized meal. Here, sotagliflozin, canagliflozin or placebo, were given in the morning. This meal was administered about 5 hours later.

And you can see a higher rate of peak glucose absorption with placebo in red and canagliflozin in blue than with sotagliflozin in black. The study also provided data on urinary glucose excretion, which was significantly lower with sotagliflozin than canagliflozin. We believe this study establishes sotagliflozin as a dual inhibitor of SGLT1 and SGLT2.

And it points to the potential for lower glucose variability on sotagliflozin. In the fourth quarter, we also published results from patient interviews performed in a representative sample of participants from the sotagliflozin Phase 3 program in type 1 diabetes. The interview participants and the interviewer were all blinded to study treatment.

Here, you see the numbers of patients reporting different benefits overall and for sotagliflozin and placebo. The top five benefits were less hyperglycemia, more stable blood sugar, lower A1C, more effective insulin and less hypoglycemia.

They were all reported more often for sotagliflozin than placebo, and they were generally rated as very or extremely important to patients. The study was valuable because it demonstrated that glucose stability and control experienced day to day and the management of type 1 diabetes was very meaningful to these patients.

We are anticipating more results in the next quarter for our type 2 diabetes studies of sotagliflozin and we have recently received important feedback from the FDA on our strategy towards the long-term outcome studies. You may be aware that just this week the FDA issued new draft guidance for the development of drugs in treating type 2 diabetes.

The old guidance from 2008 required extensive data on cardiovascular safety. And we have enough cardiovascular events in our program already to support a type 2 diabetes filling. The new guidance emphasizes having a certain amount of two-year data plus extensive exposure of patients with older age kidney disease and heart disease.

We estimate that by June, we will have met all those requirements as well. Importantly, we have very recently asked the FDA about going beyond type 2 diabetes into SOLOIST study. The FDA response has been supportive. And this study is adequately designed to achieve a unique indication for the treatment of patients with worsening heart failure.

While other large programs have treated stable patients, SOLOIST enrolls patients with acute worsening of their disease, providing a new treatment at the time when patients need it the most. FDA recent feedback on the SCORED study has also been supportive.

The design of SCORED will allow for indications relating to both, heart failure and renal disease. Other SGLT programs have enrolled patients with high levels of microalbuminuria. SCORED in contrast enrolled a broader population with moderate and severe kidney disease without any albuminuria requirement. And SCORED is the largest study of its kind.

Both SCORED and SOLOIST can provide results in 2021. Of note, our FDA interactions support that these potential indications in heart failure and chronic kidney disease can be considered regardless of any indication in type 1 or type 2 diabetes. I will now turn the call over to Jeff to review our financials..

Jeff Wade

Thank you, Pablo. This morning I will discuss key aspects of our fourth quarter and full year 2019 financials. More financial details can be found in our Form 10-K, which will be filed shortly. Now, please refer to slide 14 of our presentation.

As indicated in our press release today, revenues for the fourth quarter decreased to $8.7 million from $17.1 million for the corresponding period in 2018, primarily due to lower revenues recognized under collaboration and license agreements.

Full-year 2019 revenues increased to $322.1 million from $63.2 million, primarily due to collaboration revenues recognized from amount received in connection with the termination of the alliance with Sanofi and recognition of the remaining amounts allocated to the performance obligations from the initial Sanofi collaboration agreement for development activities relating to sotagliflozin, as well as an increase from net product revenue.

Net product revenues for full-year 2019 included $31 million and $1.3 million, respectively, from net sales of XERMELO in the U.S. and the sale of bulk tablets to Lexicon’s collaborator, Ipsen. Cost of sales related to sales of XERMELO was $0.7 million and $0.6 million, respectively, for the fourth quarter of 2019 and 2018.

Full-year 2019 and 2018 cost of sales was $3.2 million and $2.5 million, respectively.

Research and development expenses for the fourth quarter increased to $40.6 million from $12.3 million for the corresponding period in 2018, primarily due to increases in external clinical development costs related to sotagliflozin subsequent to Lexicon regaining the rights and responsibilities for development and commercialization of sotagliflozin pursuant to the termination of the Sanofi alliance.

Full-year 2019 R&D expenses decreased to $91.9 million from $100.2 million, due to decreases in professional and consulting activities and lower external clinical development costs. Selling, general and administrative expenses for the fourth quarter were $14.6 million compared to $16.6 million for the same period in 2018.

Full-year 2019 SG&A expenses decreased to $56.8 million from $63.8 million, primarily due to lower marketing expenses and professional and consulting costs.

We recognized an impairment loss of $28.6 million in 2019 relating to an indefinite lived intangible asset associated with Lexicon’s 2010 acquisition of Symphony Icon, due to the decision to terminate research and development activities related to a program for irritable bowel syndrome that was among the assets quite acquired.

An income tax benefit of $6 million in 2019 was recognized in connection with the impairment loss, which resulted in a decrease to the deferred tax liability and created an income tax benefit. During 2018, there was no income tax benefit.

Net loss for the fourth quarter was $51.1 million, or $0.48 per share, as compared to a net loss of $16.8 million, or $0.16 per share, in the corresponding period in 2018. For the fourth quarter of 2019, net loss included non-cash, stock-based compensation expense of $3.5 million.

For the fourth quarter of 2018, net loss included non-cash, stock-based compensation expense of $2.8 million. Net income for the full-year 2019 was $130.1 million, or $1.16 per diluted share, as compared to a net loss of $120.5 million, or $1.14 per share, in 2018.

For the full-year 2019, net income included non-cash, stock-based compensation expense of $14.2 million. For the full-year 2018, net loss included non-cash, stock-based compensation expense of $11.7 million. We ended 2019 with $271.7 million in cash and long-term investments as compared to $160.1 million as of December 31, 2018.

We expect that our working capital will be sufficient to fund our operations for at least the next year. And we will continue to prudently manage our expenses and will seek further opportunities to extend our cash runway. Turning to our financial guidance for 2020, as Lonnel mentioned earlier, we expect U.S.

XERMELO net sales growth in the high single digit percentage in the first quarter and in the mid teens for the full year. As for operating expense guidance, including R&D and SG&A expenses, we expect total operating expenses to be in the range of $245 million to $275 million. We expect R&D expenses to be in the range of $190 million to $210 million.

We expect to incur a disproportionate share of our R&D expenses for the year, about a third in the first quarter as a result of activities relating to the completion of the type 2 diabetes glycemic control clinical trials and the wrap-up of the transition from Sanofi.

We expect SG&A expenses for the year to be in the range of $55 million to $65 million. Noncash expenses are expected to be approximately $22 million of our total operating expenses, consisting of $17 million of stock-based compensation and $5 million of depreciation and amortization.

As a reminder, under the terms of our settlement agreement, Sanofi committed to pay Lexicon $260 million. Of that total, the first installment in the amount of $208 million was paid in September of last year. The second installment in the amount of $26 million was payable in March of this year and has been received.

And the final installment in the amount of $26 million is payable this September. The $52 million in payments due this year will not affect this year's revenues because the full revenue impact of the settlement was recorded in 2019. But, they will obviously benefit our 2020 cash flow.

As Lonnel mentioned, we are engaged in discussion for potential partnerships for sotagliflozin, which will be necessary to enable completion of long-term outcome studies, SCORED and SOLOIST that are designed to demonstrate benefit to them and support leading for heart failure and chronic kidney disease.

I will now ask the operator to begin our Q&A session..

Operator

[Operator Instructions] Your first question comes from the line of Yigal Nochomovitz from Citi..

Samantha Semenkow

Hi. This is Samantha on for Yigal. Thanks very much for taking our questions. I wondered if you could sort of set expectations for data releases that we'll see in regards to type 2 diabetes in the first half, and you noted that we'll get top line disclosures in the first half and then we'll get Phase 3 presentations at ADA.

Can you discuss what expectations or what these top-line disclosures will include and what additional data we’ll see at ADA?.

Lonnel Coats

Well, we expect to provide top line data that would be generally consistent with what we've done previously, which is whether we met the primary endpoint and indications relating the overall safety profile.

And at ADA, we are making submissions to publish some of the data that came out towards the end of last year, those studies, and hope to have those presented in detail at ADA this year, and also subsequently at EASD. And we’ll continue to work towards publishing the full data from the program as we go forward..

Samantha Semenkow

And then, could you also confirm -- I think, your prior disclosure was for type 2 diabetes you would be filing in the first half of 2020.

Is that still something we should expect, or has that been satisfied for now?.

Lonnel Coats

So, a decision about filing really requires a partner for us. And so, it would be part of something that is involved in the partnership discussions. We wouldn't be in a position to file in the first half at this point, given the time that it's taken to get to a partnership, but would still be able to file in 2020..

Samantha Semenkow

Got it.

And then, just lastly, is there any read-through from the FDA’s position on type 1 diabetes that we should be considering for type 2, or are they just completely separate indications at this point from the FDA's perspective?.

Lonnel Coats

They're totally separate indications from the FDA's perspective.

The concern relating to Type 1 diabetes isn't really -- or has always been the inherent PK at risk that is involved in Type 1 diabetes that’s part of the disease and which we saw an imbalance in our clinical studies, and how that can be addressed and what's the appropriate way to address that best. And that’s not an issue in type 2 diabetes..

Operator

Your next question comes from the line of Kambiz Yazdi with Wedbush Securities..

Kambiz Yazdi

Good morning. This is Kambiz for Liana.

What are the growth drivers for XERMELO and carcinoid diarrhea?.

Lonnel Coats

What was the question, again? I'm sorry..

Kambiz Yazdi

Sorry.

Can you hear me?.

Lonnel Coats

Yes. Say, it again..

Kambiz Yazdi

What are the growth drivers for XERMELO and carcinoid diarrhea?.

Lonnel Coats

Let me turn it over to Alex..

Alex Santini

Yes. The main growth factor for our XERMELO brand is activating new patients on to drug and then holding on to them with good persistency and adherence over time. So, those are the 2 main drivers of our overall growth potential..

Operator

Your next question comes from the line of Jessica Fye from JP Morgan..

Unidentified Analyst

Hi. This is Daniel for Jessica. Thanks for taking our question.

Besides partnership, is there anything that will be a gating factor for filing SOTA in type 2 diabetes in the U.S.?.

Lonnel Coats

No. The reason it’s a gating decision is that Lexicon is in no position to commercialize type 2 on its own. So, we need to make sure that we carry all these conversations to their full conclusion relative to type 2. It's a fairly sizable and competitive market, and we will need a partner to be able to commercialize it. So, that is the gating decision.

In terms of the data and the quality of the data and the quality of the clinical program, I think Dr. Lapuerta has been consistently clear. We have a very strong program. And one of the requirements are to file we're in a very good position to file for type 2. But I think the overall value of this program goes beyond type 2, which I think Dr.

Lapuerta has talked to earlier. And that's how we are designing the program to have a unique position in heart failure as well as have a unique position with the drug for chronic kidney disease that goes beyond what the current class offers. That's where the real opportunity is.

And I think that's where most of the conversation is focused within the partnership discussions..

Unidentified Analyst

And then, in terms of partnerships, can you talk about the strategies that you're considering?.

Lonnel Coats

Strategies we're considering in terms of partnership?.

Unidentified Analyst

For SOTA in type I or…?.

Lonnel Coats

Yes. So, we always intend to -- Lexicon will participate in type 1 under any partnership arrangement because we believe that there's a lot of value we can create relative to both the continued development as well as the commercial development for type 1.

As for type 2 heart failure as well as chronic kidney disease, it definitely requires a partner that will have a global footprint or has a global footprint in order for us to realize the value in competitive markets.

And so, our strategy is to find a global partner with a footprint to allow us to seek uniqueness in all of the indications accordingly..

Operator

Your next question comes from the line of Stephen Willey from Stifel. .

Stephen Willey

So, I guess, SOLOIST and SCORED are both large multinational trials, and they're obviously enrolling in a variety of different countries that are presumably becoming a lot more restrictive with respect to patient hospital visits, et cetera, et cetera.

So, is there any impact at all that you can quantify maybe just as a result of some of all this coronavirus mayhem? And I guess, how confident are you in some of the previously stated timelines for the completion of those trials? And do you think that some of this kind of new complexity somehow changes the cadence of partnering discussions?.

Lonnel Coats

Steve, I don't think it changes the cadence of the partnership discussions, but I do think that anybody who has a program in development that’s global, will be at risk with the latest information that’s coming from the coronavirus and all the actions that are being taken globally to try to contain it.

So, without a doubt, I do believe it will have impact on everybody's timelines, if you have programs globally. To your point, patients need to go into institutions, they need to be able to go in and receive their medicines or so forth and so on.

With that I think all of the partners we have in terms of CROs and so forth, are going to other measures to make sure there's access. And how well they're able to do that we'll have to see, because I don't think anybody expected what we're seeing right now. And everybody's trying to make the appropriate adjustments.

So, to try to give you some quantifiable way would not be appropriate because we just don't know until we engage in and see how this thing continues to progress. It's also why we are being a little bit more conservative even around the XERMELO estimates.

A lot of our business is inside of academic institutions and hospitals that are now starting to close the doors and shut out reps. So, this is very -- we’re in our early days now, so it's best for us to be a little bit more conservative than aggressive in all of our forecasts..

Stephen Willey

Okay. That’s helpful. And maybe just lastly for clarification purposes, I was aware of the updated FDA guidance that was published last week. But, I guess, how does that directly impact, I guess, your filing timelines or your regulatory process? I know that you mentioned that you have enough CV events within the current trials, I guess, to file.

But, are timelines -- or is the ease with which you can pursue registration, somehow improved by the updated guidance?.

Lonnel Coats

The updated guidance is not going to directly improve registration, I think for anybody because it expands the time in which we have to do the work and it focuses on specialty populations.

Our message here is that regardless of the guidance, whether it's 2008 that they apply to SOTA or they try to apply the 2020 guidance, we will be ready in a position, particularly any discussions, we have with partners to be able to file the program.

So nothing is going to prevent us from being able to file the program and we're in pretty good shape with all of our data to do so..

Operator

Your next question comes from the line of Alan Carr from Needham..

Alan Carr

With respect to the partnership efforts around sotagliflozin, what's the strategy, if the discussions progressed longer than you'd like? What happens next? And what would Lexicon strategy be at that point? What would the company look like?.

Lonnel Coats

Yes. Alan, that’s a great question. And I'm going to answer that question for you in our first quarter earnings call. One of the things I promised is that we will not engage in this process forever. Because we have -- we're very blessed in many ways. We talked about 9211, we talked about expanding this the XERMELO program for BTC.

There's things that we still haven't talked about that can create value for Lexicon. And so, we can't drag this on too long where we began to not focus on the rest of our portfolio. So, I believe by the time we meet again for our earnings call, you'll have clarity of that question..

Alan Carr

And then, can you talk a bit more about the 4911, the trial design -- I'm sorry 9211.

Talk about the 9211 trial design, what do you expect to learn from this first cohort later this year?.

Lonnel Coats

Great question. I'll turn it over to Dr. Tyle..

Dr. Praveen Tyle

So, Alan, what we are starting is a randomized double-blind placebo-controlled, parallel-group, multicenter study. All the centers are in U.S. And we are going to evaluate efficacy, safety and pharmacokinetics of 9211 in the diabetic peripheral neuropathic pain population. We are not going to have any results this year.

This study is going to take approximately 18 months to enroll. So, we will probably have this Phase 2 study, proof-of-concept study finished by end of next year. We are estimating that we will enroll 282 patients. It will be all listed on clinicaltrials.gov. And we're going to study two doses of 9211 at this time..

Alan Carr

And then, one other one, around XERMELO and biliary tract cancer, that's the one that's going to have data later this year, I guess.

What do you expect to learn from this first cohort, and how much value you need building around the data from just that first cohort?.

Lonnel Coats

Dr.

Lapuerta?.

Dr. Pablo Lapuerta

In the first cohort, we want to look at the first 20 patients that are enrolled and look at their progression-free survival at six months. So, we hope that the majority of them will have achieved six-month progression-free survival. And I think that would encourage us to move forward. Unfortunately, this is a disease that advances very rapidly.

And to have a majority would be very encouraging..

Alan Carr

What would a subsequent cohort look like, second one?.

Dr. Pablo Lapuerta

It would be -- well, they have the same patient characteristics. There is no change in the population. It's just that if we don't see encouraging results in the first cohort, we can manage our resources and focus on other programs..

Lonnel Coats

Yes. This program is designed to succeed early or fail early..

Operator

Your next question comes from the line of Kevin Kedra from G. Research..

Kevin Kedra

Thanks for taking the questions. I just want to get a sense, with the partnership discussions, how critical is the type 2 indication to these discussions, given how long SGLTs have been out there for type 2? I think, they've been out there for roughly a decade, be fairly late coming in versus areas like heart failure and CKD.

You'd still be relatively early in the competitive landscape on that front.

So, how do you kind of balance that when having discussions with partners?.

Lonnel Coats

Kevin, you are spot on with that question. I'll give you Lexicon's view, and of course, we're very flexible in terms of wanting to achieve as much as we can in terms of indications.

But, we believe the net value where we can separate clearly from the -- not just within the class, but clearly create value across the portfolio is in heart failure, particularly the way we have designed our clinical program. We also believe that we can do it in kidney disease or chronic kidney disease.

And so, those are the two we believe will give the greatest value of separation and differentiation, which is why we need a partnership to complete them, because they are large trials and they are significant in terms of creating that evidence. But, once we have that evidence, I think we have a very unique position we can come to market with SOTA.

Also the interesting thing is when you break down the patient who has worsening heart failure, a huge percent of underlying that has type 2 diabetes. When you break down patients who have chronic kidney disease, a huge percent of them underlying their disease is type 2 diabetes. So, you're going to get a type 2 diabetes one way or the other.

But, if we focus and are able to shift our resources and be able to accelerate the long-term studies and bring them in line with the timelines that we just expressed, you have every chance to be able to have a differentiated product that seizes opportunity where there is a growing need.

So, you're absolutely correct, from our view, that is where the greatest opportunity is versus just type 2..

Operator

[Operator Instructions] You do have a follow-up question from the line of Kambiz Yazdi from Wedbush Securities..

Kambiz Yazdi

Hi.

Just one follow-up, how long do you expect cash runway are anticipated to last?.

Lonnel Coats

I think, as we noted that we expect the cash runway to run another year. And we're looking for ways to continue to extend that..

Operator

There are no further questions in queue. I will now turn the call over to Mr. Coats for his closing remarks..

Lonnel Coats

Well, thank you everybody for joining us this morning. We have a very busy year ahead, as always, here at Lexicon. And we expect top-line data from the remaining core Phase 3 studies for sotagliflozin in type 2 diabetes.

I think, as we've tried to communicate on the call, we’re greatly excited about -- really are those long-term studies, but they will require funding because we think separation will happen for this compound in a significant way, both focused on the SOLOIST program where we have a unique design for worsening heart failure, as well as the SCORED program that could lead to, as Dr.

Lapuerta said, that has been verified in our communication with the FDA to a unique label for renal disease, as well as for heart failure. So, we're very excited about advancing these partnership discussions to a point where we hope that we can get something done, and get these studies done and get the product available in market.

As for rest of our pipeline, we are making advances as we have outlined for LX9211, a remarkable program I think that could have even more acceleration as we begin to focus more on it. And for BTC, we look forward to calling out the data on progression-free survival by the end of this year on the first efficacy cohort that we will have completed.

So, a very busy year ahead. Look forward to engaging with you as we come into our first quarter earnings call. Thank you..

Operator

Thank you for participating. You may now disconnect..

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