Ladies and gentlemen, thank you for standing by, and welcome to the Lexicon Pharmaceuticals First Quarter 2020 Financial Results and Business Update Call. [Operator Instructions] As a reminder, this call is being recorded today, April 27, 2020. I will now turn the call over to Dr. Kimberly Lee, Head of Investor Relations and Corporate Strategy.

Please go ahead..

Thank you. Good morning and welcome to the Lexicon Pharmaceuticals first quarter 2020 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 first quarter of 2020, 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 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 the 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 also cause our 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 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 a 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..

Thank you, Kim. Good morning, everyone, and thanks for joining us on the call today. In the first quarter, we continued to grow XERMELO at double digits and made progress on our pipeline, while effectively managing our resources and spending.

I will elaborate on some of the key achievements and will then turn the call over to Pablo and Jeff for updates on our pipeline developments and financial results, respectively. Starting with XERMELO. We achieved U.S net sales of $7.9 million in the first quarter of 2020, up 17% from the corresponding period in 2019.

We saw a continued strong demand, growth in dispenses and had stable inventory. For the year, we remain on track to see percentage growth in U.S. net sales year-over-year in the mid-teens. We're making good progress on the Phase 2 telotristat ethyl study in biliary tract cancer with the first efficacy cohort now fully enrolled.

In addition, we're gearing up to initiate a proof-of-concept study for LX9211 in diabetic peripheral neuropathic pain. Dr. Lapuerta will be speaking about these programs shortly. We continue to believe that the benefit/risk profile of sotagliflozin is positive for people with Type 1 diabetes.

With this in mind, we are evaluating next steps for sotagliflozin and pursuit of an approval in the United States. As announced last month, we are closing out the two sotagliflozin outcome studies, SCORED and SOLOIST in Type 2 diabetes, heart failure, and chronic kidney disease.

We continue to work closely with investigators to complete the near-term close out of these studies. Going forward, we will be in a better position to be able to prioritize and focus our investments on XERMELO in carcinoid syndrome diarrhea and biliary tract cancer and LX9211 in neuropathic pain as well as the advancement of our discovery pipeline.

We ended the first quarter with approximately $249 million in cash and short-term investments. We will continue to prudently manage our balance sheet. We expect that our working capital should be sufficient to support our operating expenses through 2021. With that, I'll turn the call over to Pablo to review our pipeline..

Thanks, Lonnel. We continue to make progress with our XERMELO life cycle management program. We’ve recently published additional data on gastrointestinal benefits in carcinoid syndrome, and we have presented more data consistent with our vision of a potential anti-tumor effect. We are also exploring the potential for XERMELO to address fibrosis.

The next slide covers our recent publications in carcinoid syndrome. We published data in the Journal of Gastrointestinal Cancer, describing the time to reduction in bowel movement frequency in our two randomized, double-blind, placebo-controlled Phase 3 trials of patients with carcinoid syndrome. Benefits developed over the course of about 12 weeks.

These data can help physicians and patients appreciate that 12-week of XERMELO should be considered in order to see the full response to treatment. We also published in the Journal of Pancreas, Observational Data on the use of XERMELO in actual practice.

Some patients receiving XERMELO do not have severe diarrhea, but they still have symptoms of carcinoid syndrome that deserve to be treated.

In this study, patients with relatively few bowel movements per day reported to nurses significant reductions in urgency, abdominal pain, nausea, and flushing with significantly better stool consistency when they used XERMELO. The safety of XERMELO in this population supported its use.

And that is relevant to safety for other patients with other cancer types, patients who do not have background diarrhea when enrolling in our studies. The next slide reviews our work with another cancer type, biliary tract cancer.

The conduct of this open-label, Phase 2 study has been supported by pre-clinical evidence, and safety to date has been satisfactory. Recently, we reached our goal of having 20 patients enrolled in the second quarter of 2020.

This should allow us to report efficacy data for the initial efficacy cohort of this study, 20 patients in this fourth quarter of 2020. On our last quarterly call, we described medical records data that were presented at ASCO GI.

These data show that patients with carcinoid syndrome on standard background therapies experienced a significant reduction in tumor size after receiving XERMELO. More recently in March, at the European Neuroendocrine Tumor Society or ENETS, we presented information on progression-free survival and other outcomes for the same patients.

Most patients had no tumor progression at 6, 12, and 18 months following initiation of XERMELO. The median time to tumor progression was 39.8 months. The majority of patients also experienced progression-free survival in the period following initiation of XERMELO with a median PFS of 23.7 months.

In addition, in a subset of 22 patients with recorded biomarker data, mean serotonin levels decreased significantly in the period following initiation of XERMELO. Patients improved on carcinoid syndrome symptoms and most were able to maintain or improve body weight and performance status.

The next slide presents an overview of the numerous investigator initiated studies of telotristat ethyl. They will help inform further development of the drug. Turning to LX9211. At the end of 2019, we announced positive top line data from the Phase 1 multiple ascending dose study of LX9211 in healthy volunteers.

The data demonstrated a favorable safety and pharmacokinetic profile supportive of once daily dosing.

We believe that AAK1 inhibition is a promising mechanism for treatment of neuropathic pain, and we expect to begin enrolling patients with diabetic peripheral neuropathic pain in a Phase 2 study mid-year, while continuing additional work in other areas of neuropathic pain. I will now turn the call over to Jeff to review our financials..

Thank you, Pablo. This morning, I will discuss key aspects of our 2020 first quarter financials. More financial details can be found in our Form 10-Q, which will be filed shortly. Now please refer to Slide 11 of our presentation.

As indicated in our press release today, revenues for the first quarter decreased to $8 million from $9.2 million for the corresponding period in 2019, primarily due to lower revenues recognized and our collaboration and license agreements, partially offset by higher net product revenues.

Net product revenues for the first quarter of 2020 were $7.9 million from net sales of XERMELO in the U.S., up 17% over the prior year quarter. Cost of sales related to sales of XERMELO was $0.6 million during each of the first quarters of 2020 and 2019.

Research and development expenses for the first quarter increased to $55.2 million from $12 million for the corresponding period in 2019, primarily due to increases in external clinical development costs relating to sotagliflozin subsequent to Lexicon regaining the rights and responsibilities for development and commercialization of sotagliflozin pursuant to the termination of the Sanofi alliance.

Selling, general and administrative expenses for the first quarter were $14.7 million compared to $14.1 million for the same period in 2019. Net loss for the first quarter was $66.6 million or $0.63 per share as compared to a net loss of $21.8 million or $0.21 per share in the corresponding period in 2019.

For the first quarter of 2020, net loss included non-cash stock-based compensation expense of $4.4 million. For the first quarter of 2019, net loss included non-cash stock-based compensation expense of $3.4 million.

We ended the first quarter of 2020 with $249.1 million in cash and short-term investments as compared to $271.7 million as of December 31, 2019. We expect that our current working capital, together with revenues expected from XERMELO net product sales, will be sufficient to support operating expenses through 2021.

We will continue to prudently manage our balance sheet and we'll seek further opportunities to extend our cash runway. Turning to our financial guidance for 2020. As Lonnel mentioned earlier, we continue to expect percentage growth of U.S. XERMELO net sales in the mid-teens for the full-year.

We are revising our 2020 operating and R&D expense guidance that was previously said on our last earnings call in light of the early close out of SCORED and SOLOIST. We are reducing total operating expenses to be in the range of $235 million to $255 million, down from $245 million to $275 million.

We expect R&D expenses to be in the range of $180 million to $190 million, down from $190 million to $210 million with a heavier weighting in the second quarter relative to the third and fourth as a result of the SCORED and SOLOIST close out. We continue to expect SG&A expenses for the year to be in the range of $55 million to $65 million.

As a reminder, our non-cash 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 an additional 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 paid in March of this year. In the final installment, in the amount of $26 million is payable for 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. I will now ask the operator to begin our Q&A session..

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

Hi. Good morning, guys. Thanks for taking the question. Lonnel you mentioned next steps in terms of pursuing an approval for Type 1 diabetes.

I'd be curious to know if you could expand a little bit on what those next steps might look like? And then secondly, for Jeff, regarding SOLOIST and SCORED, could you just give us a little bit more color on how much more you have to spend to wind down those two trials? Thanks..

Hi, Yigal. Thanks for the questions. Let me first start by saying that we have the feedback, we've analyzed the feedback that the agency has given us, and we still do not agree from our perspective as to the risk/benefit of sotagliflozin for patients with Type 1 diabetes. There are a number of different steps that we can take.

We've decided to hold for now under the COVID-19 environment because we essentially do not believe we'll make great progress until this settles down with the priorities of the agency, which I believe are absolutely correct to focus on COVID-19.

But as we get on the other side of this, then we will certainly inform our stakeholders as to what our next step of the process will be.

But at this point, we still believe the risk benefit swings to the favorability of sotagliflozin, and there are some additional steps that we can take inside of the agency to have our view heard on this matter and we intend to take those steps, but not at this moment until we get on the other side of COVID-19.

With that Jeff, I will turn it over to you..

Jeff, you may be on mute..

Sorry, I am on mute. Appreciate the reminder. Yigal, these are very large studies with a large number of patients. And so, there is a meaningful cost to wind these studies down appropriately.

Most of that cost will be incurred in the second quarter, and that's why I mentioned that the weighting of our expenses is likely to be more heavily in the second quarter. But the total of that is going to be included in the amount that we have reflected in our overall R&D expenses this year.

And we expect to be able to -- will incur most of the costs in the second quarter. There will still be some lingering cost in the third and fourth quarters as we wind down those studies and wind down the balance of the type 2 program, which is mostly complete at this point..

Okay. Thanks. And just one more for Pablo. Pablo, regarding the biliary study with the data expected in the -- at the end of this year, Could you just give us some sense as to what your expectations are in terms of the types of data we'll see and what the bar might be for sort of go, no go decision on taking that program forward? Thanks..

Yes, we hope to see good progression-free survival, and good would be over 50% of patients achieving progression-free survival at 6 months.

We also will be reviewing safety, and one of the things that we're doing is we're comparing our safety profile to the safety profile that's been well documented for gem cis and as first-line treatment of biliary tract cancer to see if the addition of XERMELO improves the safety, because that would be another indicator of success..

Right. Thanks so much..

Your next question comes from the line of Liana Moussatos with Wedbush..

Thank you for taking my question.

Any impact of COVID on XERMELO sales like new patients or enrollment of the Phase 2b/2c trial or even starting your peripheral neuropathic pain trial?.

Thanks, Liana. I think great question. We've been very fortunate we were able to get to the 20 patients that we had hoped to get to by this point. And so we're very pleased and really thank all of the PIs and the institutions that are doing this work that prioritize making it happen. And so, we're very pleased that that it actually did happen.

And so, I think we have a way to go forward with the biliary tract program. As for the commercial plan, I think we were a little concerned to be frank what we saw and at the end of January, early February, but the drug rebounded quite nicely in February and had an extraordinary month in March.

And what we watch very carefully is that you don't start to see inventory build where the retailers or the pharmacy start to build inventory because people start stocking up. So we haven't seen that, but we have seen quite remarkable sales in the second half of the first quarter, and we're very pleased with where that's going forward.

With that, we remain somewhat conservative in our estimates that we give for the full-year just because we don't know how the second quarter is going to play out with COVID-19 and patients continuing to stay with the program, stay with the product.

I will say one of the benefits that we have with sotagliflozin -- with XERMELO is that it's an oral, and that oral can be delivered to patients front door, and that's turning out to be a remarkable benefit in this environment. Patients do not have to go into institutions and so forth to get their meds, but those meds are delivered to their door.

So, that's turning out to be a very good benefit. And ultimately, it's sustaining our sales as we make progress. As for LX9211, we have delayed going into clinic. We have seen signs that it wouldn't be prudent to do that at this point, but what we are doing is preparing all the site initiation work and all the other work that’s necessary.

So when the environment does get to a point where we feel confident, we can go into clinic and make good progress relative to investments we're making, and then we'll probably do that. Our best estimate as Dr. Lapuerta said, we hope to be able to enter into the clinic in the second quarter here..

Thank you..

You bet..

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

Hey, good morning. Thanks for taking the questions. Maybe just one for Pablo. In the Phase 2 telotristat trial in biliary, are you conducting any kind of baseline genomic or expression analysis of a patient's tumors? And I only ask the question just because I know that there's some increased evaluation of targeted therapy in biliary.

I think there's a soon to start HER-2 trial. I know that there's an FGFR inhibitor that was just approved.

So just curious as to whether or not you're collecting that information in these patients now?.

We're trying to collect the information. It's not easy. We're trying to get -- the thing is we're not requiring prospective new biopsies to be conducted as part of the trial. So what we can do is try to get archival tissue in patients, but that's not been easy right now during the coronavirus epidemic.

So we'll continue working on that and we'll see what we can do. One biomarker that we are collecting in everybody at baseline is plasma 5-HIAA. And in patients with colon cancer, there's a study indicating that plasma 5-HIAA is an indicator of prognosis. So that may be an interesting plasma biomarker.

And we'll continue to work on seeing what we can do to get archival tissue in patients where it's available..

I mean, how do you think about what the next trial might look like, another, we still need to see data, but I guess presuming you're capable of making a go as opposed to a no decision based on the data that you get.

How do you think about the next trial design? Would it be something adaptive? Do you think this would be maybe something that can be upsized into registration, or do you just go right into a registrational trial if you surpass that internal efficacy threshold?.

We're thinking what would be registrational in terms of design, it all depends on biomarkers as you've suggested. So it could be something where the patient population is a subset of all patients with BTC based on plasma 5-HIAA or TPH staining of tissue, right? Or it could be a broader population with BTC..

Okay. Thanks for taking the questions..

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

Thanks for taking the questions. First, maybe start with sotagliflozin. Just wanted to get a sense of, if there's kind of any change in the way you're thinking about having discussions with potential partners.

I know COVID maybe interrupting that now, but given the wind down of the outcome studies, does this change the way you think about having those discussions, or you might have those discussions with in the U.S and around the world, given that this is a drug that is approved for type 1 outside the U.S?.

Jeff, I will turn that question over to you..

So we do, as you mentioned, we do have an approval for Zynquista in Europe and do intend to pursue a partnership there as you predict. I think it is disruptive what's going on with coronavirus. But it continues to be our intention to put together a partnership for Europe to be able to commercialize in Europe.

In the U.S., as Lonnel mentioned, we continue to believe there's an opportunity here and we are continuing to evaluate what's the right path forward with FDA.

I will say that by closing out the SCORED and SOLOIST studies, it does affect our partnership, how we would approach partnership in that we are not pursuing the heart failure and chronic kidney disease endpoints that we would have pursued in those long-term studies. So there is more of an impact is more focused on type 1 diabetes..

Okay. Thanks for the color. And then just want to ask on XERMELO. If you guys are seeing any -- has been consistent on kind of the level of patients maintaining therapy versus dropping off in new starts, trying to think about that given that new starts could be pressured with COVID? Thanks..

Great question. Alex, I'll turn it over you..

Yes. As Lonnel has indicated, fortunately for us, we continue to see new starts in the month of March, on the second half when the COVID plan went into effect, which was around the 16 of March. So we saw a continuation of new patients coming on the drug in that second half of the month, as well as new clinicians prescribing the medication as well.

And we'll keep a close eye on this going into the second quarter to see if the trend of new patients coming off the drug and the trend of new prescribers prescribing drug continues into the second quarter as well..

[Operator Instructions] Your next question comes from the line of Alan Carr with Needham & Company..

Thanks for taking my questions.

With -- I guess shelving the type 2 programs for now, are you revisiting the rest of the platform, the old transgenic platform, are there some other drugs that might be -- that maybe you can have the resources to pursue but now you might consider? And can you elaborate a bit on what you might be doing with XERMELO in fibrosis? Thanks..

So I'll hold the question on XERMELO and fibrosis for Dr. Tyle to speak to. In terms of the discovery pipeline, you're absolutely correct, Alan. I think we -- this opens up stopping those long-term trials frees up quite a bit of cash for Lexicon.

It also gives us the opportunity to take that look back at other things that we think we can do from our platform, which we have a lot of targets and a lot of compounds. And so I think we were already in a very good position to evaluate what was next. We are finishing up that work. And when we are ready to share that, we will share that out.

But you're absolutely correct. We do have an opportunity to bring forward a couple of the other Lexicon discovery programs and make that pretty much known to all stakeholders. So this gives us the opportunity, given that we have stopped the long-term programs to do some work around that and begin to bring that forward.

With that, I'll turn the second part of your question over to Dr. Tyle..

number one, is it viable with this mechanism of action to see some fibrosis effect; or number two, whether there are other potent inhibitors besides XERMELO in our pipeline, in our discovery pipeline, which would be better suited to take them into the clinic. So we should have like, Lonnel said, some of these results by the end of the year.

And then we can select, if warranted, based on preclinical data to take them into clinic..

Okay. Thank you. And then one last one.

What are the plans with 2761 in line of what you're doing with sotagliflozin? Is 2761 on the shelf, or maybe some other development opportunities for that?.

Yes. Alan, we put 2761 on the shelf for diabetes because our only focus on diabetes at this point will be type 1 and we believe sotagliflozin is most appropriate to continue to pursue type 1, not just in what we have in Europe with an approved indication, but also to get it here in the United States. So 2761 has been shelved for that purpose.

But we are looking at other applications for 2761. And Dr. Tyle is doing some preclinical work around that, but for diabetes most likely not..

Great. Thanks for taking my questions..

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

Hey, guys. Good morning. Thanks for taking my question. I was just hoping you could elaborate a bit on how you're thinking about OpEx later in 2020 and as we think about 2021? The question is driven by basically I think your previous runway guidance had been for cash taking you into '21, and now it's through 2021.

So a nice increase in the runway with a relatively modest $10 million or $20 million cut to 2020 OpEx guidance based on the closing out of the outcome studies.

So just curious how that magnitude of an OpEx cut gets you through '21 and what continued pipeline advancement in 2021 that outlook reflects?.

Great question, Jessica. I'll turn it over to Jeff..

So I think one of the key elements of this, Jess, is that not only are we having an impact on 2020 financials, but we're having a significant impact on 2021 financials when it comes to the close out of these studies. And so there's quite a meaningful impact as we look forward.

The overall outlook, I think is, we're confident that we're going to have cash that gets us through 2021 as it relates to our operating expenses. We see continued growth in XERMELO along the lines that we've had forecast for this year.

And we are looking very closely at our operating expenses and our R&D expenses to be sure that we're being prudent about how we spend those dollars. But I would say probably the biggest answer to your question is that the impact that we see is not only on this year, but also on next year in terms of the extension of our runway..

Okay.

And is there anything you can say about what continued internal pipeline advancement that runway reflects?.

Sure. And so, we’re -- we've highlighted some of the most significant elements of that. One is the biliary tract program, which we're continuing to forecast throughout this time period.

Also work around LX9211, executing and completing the first proof-of-concept study in diabetic neuropathic pain, but also doing additional proof-of-concept work with LX9211 during this time frame and doing some work on our early discovery pipeline is all included within that forecast..

Super. Great, thank you..

[Operator Instructions] At this time, presenters there are no further questions. And Mr.

Coats, do you have any closing remarks for us?.

Let me just thank everyone for joining us this morning. I hope everyone is remaining safe. These are very interesting times for sure under the COVID-19 environment. And we will continue to express to you as we go forward, anything that may impact our business in regards to COVID-19.

But this moment, we are managing through it and I'm very proud of the team for being where we are today. So stay safe and look forward to speak to everybody again in the future..

This concludes today's conference call. You may now disconnect..