Lexicon Pharmaceuticals (LXRX) Q1 2020 earnings call dated Apr. 27, 2020
Corporate Participants:
Kimberly Lee — Head of Investor Relations and Corporate Strategy
Lonnel Coats — President and Chief Executive Officer and Director
Pablo Lapuerta — Executive Vice President and Chief Medical Officer
Jeffrey L. Wade — Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer
Alex Santini — Executive Vice President and Chief Commercial Officer
Praveen Tyle — Executive Vice President of Research and Development
Analysts:
Yigal Nochomovitz — Citigroup — Analyst
Liana Moussatos — Wedbush Securities — Analyst
Stephen Willey — Stifel — Analyst
Kevin Kedra — G. Research — Analyst
Alan Carr — Needham & Company — Analyst
Jessica Fye — JPMorgan — Analyst
Presentation:
Operator
Ladies and gentlemen, thank you for standing by and welcome to the Lexicon Pharmaceuticals, First Quarter 2020 Financial Results and Business Update Call. All lines have been placed on mute to prevent any background noise. Following management’s prepared remarks, there will — we will hold a question-and-answer session. As a reminder, this call is being recorded today, April 27th, 2020.
I will now turn the call over to Dr. Kimberly Lee, Head of Investor Relations and Corporate Strategy. Please go ahead.
Kimberly Lee — Head of Investor Relations and Corporate Strategy
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 up 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 the 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 characterizations of the commercial performance of XERMELO, the expected timing and results of clinical trials of telotristat ethyl, LX9211 and our other drug candidates and the 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 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’d like to now turn the call over to our President and CEO, Lonnel Coats.
Lonnel Coats — President and Chief Executive Officer and Director
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 US 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 US net sales year-over-year in the mid-teens. We’re making good progress on the Phase II telotristat ethyl study and biliary tract cancer with the first efficacy cohort now fully enrolled. In addition, we are 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 the 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’ll 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 will turn the call over to Pablo to review our pipeline.
Pablo Lapuerta — Executive Vice President and Chief Medical Officer
Thanks, Lonnel. We continue to make progress with our XERMELO life cycle management program. We have 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 III 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 weeks 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 and 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 flatulence 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 II study has been supported by preclinical 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 six months, 12 months, 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 the median PFS of 23.7 months.
In addition, in a subset of 22 patients with reported 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 II study midyear while continuing additional work in other areas of neuropathic pain.
I will now turn the call over to Jeff to review our financials.
Jeffrey L. Wade — Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer
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 under 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 US up 17% over the prior-year quarter.
Cost of sales related to sales of XERMELO were $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 [Phonetic] [Technical Issues] 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 31st, 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 will 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 US 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 set 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 quarter and fourth quarter 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 payable in March of this year, 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.
I will now ask the operator to begin our Q&A session.
Questions and Answers:
Operator
[Operator Instructions]. Your first question comes from the line of Yigal Nochomovitz from Citigroup.
Yigal Nochomovitz — Citigroup — Analyst
Hi, good morning guys. Thanks for [Indecipherable]. 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.
Lonnel Coats — President and Chief Executive Officer and Director
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 have decided to hold it 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 can get on the other side of COVID-19.
With that, Jeff, I’ll turn it over to you.
Operator
Jeff, you may be on mute.
Jeffrey L. Wade — Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer
Sorry, I am on mute. I appreciate the reminder. Yigal, these are our very large studies, with large number of patients and so there is a meaningful cost to weighing these studies down appropriately. Most of that cost will be incurred in the second quarter. And that’s why, I mentioned that the weighing 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, we will incur most of the costs in the second quarter, yet there will still be some lingering cost in the third quarter and fourth quarter as we wind down those studies, and wind down the balance of the Type II program, which is mostly complete at this point.
Yigal Nochomovitz — Citigroup — Analyst
Okay, thanks. And just one more for Pablo. Pablo, regarding the biliary study with the data expected 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 a go, no-go decision on taking that program forward. Thanks.
Lonnel Coats — President and Chief Executive Officer and Director
Yes. We hope to see a good progression-free survival and good would be over 50% of patients achieving progression-free survival at six 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 GENESIS 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.
Yigal Nochomovitz — Citigroup — Analyst
Great. Thanks so much.
Operator
Your next question comes from the line of Liana Moussatos with Wedbush.
Liana Moussatos — Wedbush Securities — Analyst
Thank you for taking my questions. Any impact of COVID on XERMELO sales like new patient or enrollment of the Phase II BTC trial or even starting your peripheral neuropathic pain trial?
Lonnel Coats — President and Chief Executive Officer and Director
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 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 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 pharmacies 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 gave 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 — I think with XERMELO is that it is an oral, and that oral can be delivered to patient’s 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 doors. So that’s turning out to be a very good benefit and ultimately, it is 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 as necessary. So when the environment does get to a point where we feel confident, we can go into the clinic and make good progress relative to the investments we’re making, 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.
Liana Moussatos — Wedbush Securities — Analyst
Thank you.
Lonnel Coats — President and Chief Executive Officer and Director
You bet.
Operator
Your next question comes from the line of Stephen Willey with Stifel.
Stephen Willey — Stifel — Analyst
Yeah, good morning. Thanks for taking the questions. Maybe just one for Pablo. In the Phase II telotristat trial in biliary, are you conducting any kind of baseline genomic or expression analyzes of patients’ tumors, and I only asked the question just because I know that there is some increased evaluation of targeted therapy in biliary. I think there is a soon to start HER2 trial. I know that there is an FGFR inhibitor that was just approved. So just curious as to whether or not you’re collecting that information in these patients now.
Alex Santini — Executive Vice President and Chief Commercial Officer
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 is a study indicating that plasma 5-HIAA is an indicator of prognosis. So that may be an interesting plasma biomarker and we will continue to work on seeing what we can do to get archival tissue in patients where it’s available.
Stephen Willey — Stifel — Analyst
I mean, how do you think about what the next trial might look like? I know that 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 the registration or do you just go right into a registrational trial if you surpass that internal efficacy threshold.
Praveen Tyle — Executive Vice President of Research and Development
We are thinking it 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 patients with BTC based on plasma 5-HIAA or TPH staining of tissue, all right, or it could be a broader population with BTC.
Stephen Willey — Stifel — Analyst
Okay. Thanks for taking the questions.
Operator
Your next question comes from the line of Kevin Kedra with G. Research.
Kevin Kedra — G. Research — Analyst
Hi, thanks for taking the questions. First, maybe start with sotagliflozin, just want to get a sense 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 US and around the world given that this is a drug that is approved for type 1 outside the US?
Lonnel Coats — President and Chief Executive Officer and Director
Jeff, I’ll turn that question over to you.
Jeffrey L. Wade — Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer
Sure. 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 the coronavirus. But it continues to be our intention to put together a partnership for Europe to be able to commercialize in Europe. In the US, as Lonnel mentioned, we continue to believe there is 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, and that we are not pursuing the heart failure and chronic kidney disease endpoints that we would have proceeded in those long-term study. So there is more of an impact, just more focused on type 1 diabetes.
Kevin Kedra — G. Research — Analyst
Okay. Thanks for the color. And then, just wanted to ask on XERMELO. If you guys are seeing any — it has been consistent with kind of the level of patients maintaining therapy for strapping-off in new starts. Just trying to think about that given that new starts could be pressured with COVID. Thanks.
Lonnel Coats — President and Chief Executive Officer and Director
A great question. Alex, I’ll turn it over to you.
Alex Santini — Executive Vice President and Chief Commercial Officer
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 16th of March. So we saw a continuation of new patients coming on to 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 on with the drug and the trend of new prescribers prescribing drug continues into the second quarter as well.
Operator
[Operator Instructions]. Your next question comes from the line of Alan Carr with Needham & Company.
Alan Carr — Needham & Company — Analyst
Thanks for taking my questions. With I guess shelving the type two programs for now, are you revisiting the rest of the platform, the old transgenic platform, are there some other drugs that might be, that may be didn’t have the resources to pursue, but now you might consider? And can you elaborate a bit on what you might be doing with the XERMELO in fibrosis. Thanks.
Lonnel Coats — President and Chief Executive Officer and Director
So I’ll hold the question on XERMELO in 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 workaround that, and began to bring that forward.
And with that, I will turn the second part of your question over to Dr. Tyle.
Praveen Tyle — Executive Vice President of Research and Development
Alan, what we are doing is, we are not only looking at XERMELO, but we are also looking at cousins of XERMELO, which are in our discovery pipeline. When we selected XERMELO as the lead candidate for studying carcinoid syndrome diarrhea, we also had several other programs going on. And some of them may be more suited to study in whether it is IPF, idiopathic pulmonary fibrosis or NASH. So what we are doing is, we are studying several compounds including XERMELO in preclinical models to figure out whether, number one is it viable with this mechanism of action to see some fibrosis effect or number 2, 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.
Alan Carr — Needham & Company — Analyst
Okay, thank you. And then one last one. What is the plans with LX2761 in light of what you’re doing with sotagliflozin, just is LX2761 on the shelf or maybe some other development opportunities for that?
Lonnel Coats — President and Chief Executive Officer and Director
Yeah, Alan. We’ve put LX2761 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 LX2761 has been shelved for that purpose. But we are looking at other applications for LX2761 and Dr. Tyle is doing some preclinical work around that. But for diabetes, most likely not.
Alan Carr — Needham & Company — Analyst
Great, thanks for taking my questions.
Operator
Your last question comes from the line of Jessica Fye with JPMorgan.
Jessica Fye — JPMorgan — Analyst
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, for 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.
Lonnel Coats — President and Chief Executive Officer and Director
Great question, Jessica, I’ll turn it over to Jeff.
Jeffrey L. Wade — Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer
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 closeout of these studies. And so there’s quite a meaningful impact as we look forward. The overall outlook, I think as we are 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 have 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.
Jessica Fye — JPMorgan — Analyst
Okay. And is there anything you can say about what continued internal pipeline advancement that runway reflects?
Lonnel Coats — President and Chief Executive Officer and Director
Sure. And so, 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.
Jessica Fye — JPMorgan — Analyst
Super. Great, thank you.
Operator
[Operator Instructions]. At this time, presenters, there are no further questions. And Mr. Coats, do you have any closing remarks for us?
Lonnel Coats — President and Chief Executive Officer and Director
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 at 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 speaking to everybody again in the future.
Operator
[Operator Closing Remarks]