LXRX Lexicon Pharmaceuticals Inc.

1.56
+0.1  (+7%)
Previous Close 1.46
Open 1.48
52 Week Low 1.03
52 Week High 5.33
Market Cap $183,260,700
Shares 117,474,808
Float 39,270,970
Enterprise Value $89,163,456
Volume 1,932,453
Av. Daily Volume 3,184,899
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Upcoming Catalysts

Drug Stage Catalyst Date
LX9211 (RELIEF-DPN 1)
Diabetic Peripheral Neuropathy
Phase 2
Phase 2
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LX9211
Post-herpetic neuralgia
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Sotagliflozin
Heart failure
Phase 3
Phase 3
Phase 3 trial met primary endpoint.
Sotagliflozin
Type 1 Diabetes
CRL
CRL
CRL issued March 22, 2019. Appeal rejected by FDA - December 2, 2019.

Latest News

  1. THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.

    THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.

    In the SOLOIST study, the primary endpoint was achieved with a hazard ratio (HR) of 0.67 (p<0.001) in people with type 2 diabetes and a recent hospitalization for worsening heart failure. In the SCORED study, the primary endpoint was achieved with a hazard ratio of 0.74 (p<0.001) in people with type 2 diabetes and chronic kidney disease with an estimated glomerular filtration rate (eGFR) of 25 to 60 ml/minute per 1.73 m² of body-surface area.

    The key results from SOLOIST and SCORED were presented today at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: "Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure" and "Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease." The articles may be accessed at www.nejm.org.

    "Cardiovascular disease continues to be a leading cause of death in people with type 2 diabetes," said Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and a professor of medicine at Harvard Medical School and study chair and lead author for the NEJM publications of the SOLOIST and SCORED results. "SOLOIST demonstrates that early, in-hospital initiation of sotagliflozin in patients with worsening heart failure significantly reduces subsequent cardiovascular events, an effect that was consistent across groups with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). SCORED demonstrates that sotagliflozin significantly reduces heart failure events in a patient population with stage 3 and 4 chronic kidney disease and cardiovascular risk. Both studies add to the evidence that SGLT2 inhibition should be standard of care in heart failure, and the SCORED data reflecting a reduction in myocardial infarction and stroke and better glucose control in CKD patients suggest potential benefits from the dual SGLT1 and SGLT2 mechanism of this particular agent."

    Key SOLOIST Phase 3 Study Results

    SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients starting treatment with 200 mg sotagliflozin once daily compared with placebo, with dosing initiated either before or within 3 days of hospital discharge.

    The first dose of sotagliflozin or placebo was administered prior to hospital discharge in 48.8% of the patients and a median of two days after discharge in 51.2% of the patients, with the benefits of sotagliflozin being consistent between those prespecified subgroups of patients. The initial 200 mg once daily dose of sotagliflozin was increased to 400 mg once daily if unacceptable side effects did not occur.

    Treatment with sotagliflozin resulted in a significantly lower total number of cardiovascular deaths, heart failure hospitalizations and urgent visits as compared to placebo. A total of 600 primary endpoint events occurred in the study, with 245 events in the sotagliflozin treated group and 355 events in the placebo group. There were 51.0 primary endpoint events per 100 patient-years in the sotagliflozin treated group as compared to 76.3 events per 100 patient-years in the placebo group (HR=0.67; 95% confidence interval [CI]=0.52 to 0.85; p<0.001). There were 10.6 events of cardiovascular death per 100 patient-years in the sotagliflozin treated group as compared to 12.5 events per 100 patient-years in the placebo group (HR=0.84; 95% CI=0.58 to 1.22; p=0.36).

    Of note, effects on the primary endpoint were consistent among patients suffering from heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF), with a hazard ratio of 0.72 (95% CI=0.56 to 0.94) in patients with a left ventricular ejection fraction (LVEF) of less than 50% and a hazard ratio of 0.48 (95% CI=0.27 to 0.86) in patients with a LVEF of greater than or equal to 50%.

    Serious adverse events that led to discontinuation of study drug, as determined by investigators, occurred in 3.0% (n=18) of the patients in the sotagliflozin treated group and in 2.8% (n=17) of the patients in the placebo group. Based on investigator reported events, the most common adverse events of special interest included hypotension (6.0% on sotagliflozin versus 4.6% on placebo), urinary tract infections (4.8% on sotagliflozin versus 5.1% on placebo), acute kidney injury (4.1% on sotagliflozin versus 4.4% on placebo), and diarrhea (6.1% on sotagliflozin versus 3.4% on placebo). Among other adverse events of interest, in SOLOIST, genital mycotic infections (0.8% on sotagliflozin vs. 0.2% on placebo) were infrequent, severe hypoglycemia (1.5% on sotagliflozin vs. 0.3% on placebo) was more common in the sotagliflozin treated group and diabetic ketoacidosis (0.3% on sotagliflozin vs. 0.7% on placebo) was similar between treatment groups.

    The SOLOIST study was originally designed with a primary endpoint of the first occurrence of death from cardiovascular causes or hospitalization for heart failure, as determined by independent adjudication, but was modified in connection with the early close out of the study to include urgent heart failure visits and reflect the total number of events, as determined by investigators, in order to enhance the statistical power of the comparison. The specification of the primary endpoint based on total events was implemented without any awareness of the study outcomes or study-group assignments and without information from an interim analysis.

    The results for first occurrence of cardiovascular death or hospitalization for heart failure (HR=0.71; 95% CI=0.57 to 0.89; p=0.003) based on investigator reported events were consistent with those of the modified primary endpoint.

    Key SCORED Phase 3 Study Results

    SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m² of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo. The initial 200 mg once daily dose of sotagliflozin was increased to 400 mg once daily if unacceptable side effects did not occur.

    Treatment with sotagliflozin resulted in a significantly lower total number of cardiovascular deaths, heart failure hospitalizations and urgent visits as compared to placebo. A total of 930 primary endpoint events occurred in the study, with 400 events in the sotagliflozin treated group and 530 events in the placebo group. There were 5.6 primary endpoint events per 100 patient-years in the sotagliflozin treated group as compared to 7.5 events per 100 patient-years in the placebo group (HR=0.74; 95% CI=0.63 to 0.88; p<0.001). There were 2.2 events of cardiovascular death per 100 patient-years in the sotagliflozin treated group as compared to 2.4 events per 100 patient-years in the placebo group (HR=0.90; 95% CI=0.73 to 1.12; p=0.35).

    Of note, over the course of the study, the data showed an average reduction in hemoglobin A1c of 0.56% in the sotagliflozin treated group as compared to a reduction of 0.25% in the placebo group in patients with severe chronic kidney disease, eGFR less than 30 ml per minute per 1.73 m² of body-surface area (p<0.001). In patients with moderate chronic kidney disease, eGFR greater than or equal to 30 ml per minute per 1.73 m² of body-surface area, the data showed an average reduction in hemoglobin A1c of 0.60% in the sotagliflozin treated group as compared to a reduction of 0.17% in the placebo group (p<0.001).

    Serious adverse events that led to discontinuation of study drug, as determined by investigators, occurred in 2.1% (n=112) of the patients in the sotagliflozin treated group and in 1.8% (n=94) of the patients in the placebo group. Based on investigator reported events, the most common adverse events of special interest included urinary tract infections (11.5% on sotagliflozin versus 11.1% on placebo), diarrhea (8.5% on sotagliflozin versus 6.0% on placebo), volume depletion (5.3% on sotagliflozin versus 4.0% on placebo), bone fractures (2.1% on sotagliflozin versus 2.2% on placebo), and genital mycotic infections (2.4% on sotagliflozin versus 0.9% on placebo). Among other adverse events of interest, diabetic ketoacidosis (0.6% on sotagliflozin vs. 0.3% on placebo) was more common in the sotagliflozin treated group and severe hypoglycemia (1.0% on sotagliflozin vs. 1.0% on placebo) was similar between treatment groups.

    The SCORED study was originally designed with co-primary endpoints, assessed in time-to-event analyses, of the first occurrence of a major adverse cardiovascular event (defined as death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, or 3-point MACE) and the first occurrence of death from cardiovascular causes or hospitalization for heart failure, as determined by independent adjudication, but were modified in connection with the early close out of the study to include urgent heart failure visits and reflect the total number of events, as determined by investigators, in order to enhance the statistical power of the comparison. The specification of the primary endpoint based on total events was implemented without any awareness of the study outcomes or study-group assignments and without information from an interim analysis.

    In a time-to-event analysis, applying the original co-primary endpoints based on investigator reported events, the results for both the first occurrence of a MACE event (HR=0.84; 95% CI=0.72 to 0.99; p=0.035) and the first occurrence of death from cardiovascular causes or hospitalization for heart failure (HR=0.78; 95% CI=0.66 to 0.91; p=0.001) were consistent with those of the modified primary endpoint.

    About Sotagliflozin

    Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m², who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in diabetes and metabolism, neuropathic pain and other indications. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of sotagliflozin and the clinical development and therapeutic and commercial potential of sotagliflozin. In addition, this press release also contains forward looking statements relating to Lexicon's financial position, long term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211 and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  2. THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced its participation in the following conference:

    • Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020

    Lonnel Coats, Lexicon's president and chief executive officer, and Jeffrey L. Wade, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer, will participate in a live fireside chat on Wednesday, November 18, 2020 at 2:40 p.m. ET. A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is…

    THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced its participation in the following conference:

    • Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020

    Lonnel Coats, Lexicon's president and chief executive officer, and Jeffrey L. Wade, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer, will participate in a live fireside chat on Wednesday, November 18, 2020 at 2:40 p.m. ET. A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in diabetes and metabolism, neuropathic pain and other indications. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's financial position, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421

     



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  3. THE WOODLANDS, Texas, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months ended September 30, 2020 and provided an update of key milestones.

    "In the third quarter, we streamlined our operations to prioritize our focus on our advancement of LX9211, a promising drug candidate with potential to become a treatment option for the millions of people living with neuropathic pain. Most people suffering with neuropathic pain experience only limited success with available therapies while enduring substantial side effects," said Lonnel Coats, Lexicon's president and chief executive officer. "We have commenced our first Phase 2 study in diabetic peripheral neuropathic…

    THE WOODLANDS, Texas, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months ended September 30, 2020 and provided an update of key milestones.

    "In the third quarter, we streamlined our operations to prioritize our focus on our advancement of LX9211, a promising drug candidate with potential to become a treatment option for the millions of people living with neuropathic pain. Most people suffering with neuropathic pain experience only limited success with available therapies while enduring substantial side effects," said Lonnel Coats, Lexicon's president and chief executive officer. "We have commenced our first Phase 2 study in diabetic peripheral neuropathic pain and plan to commence our second Phase 2 study in post-herpetic neuralgia shortly with results for both studies expected by the end of next year."

    Third Quarter Highlights

    LX9211

    • Commenced patient dosing in RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain. Enrollment is expected to total approximately 300 patients at 30 U.S. clinical sites.
    • Preparing to commence an additional Phase 2 study of LX9211 in post-herpetic neuralgia later this year.

    Realignment and Debt Reduction

    • Realignment of the business around LX9211, sotagliflozin and other drug discovery and development programs.
    • Reduced outstanding debt by more than 90%, including the elimination of its $150 million secured term loan and $75.8 million principal amount of its 5.25% Convertible Senior Notes due 2021.

    XERMELO® (telotristat ethyl)

    • XERMELO U.S. net sales were $6.5 million in the third quarter of 2020, reflecting sales during the quarter prior to the completion of the sale of XERMELO and related assets to TerSera Therapeutics LLC on September 8, 2020.
    • Received $160.4 million in cash at closing of the sale and eligible to receive up to $65 million in additional milestone payments for the development and commercialization of XERMELO in patients with biliary tract cancer and mid-teens royalties on net sales of XERMELO in biliary tract cancer.

    Sotagliflozin

    • Announced topline data from four Phase 3 sotagliflozin studies in type 2 diabetes: SOTA-MONO, SOTA-SU, SOTA-GLIM and SOTA-INS with all four studies meeting their primary objectives of lowering A1C in patients with type 2 diabetes.

    Upcoming Milestones

    • Q4 2020: Initiation of a Phase 2 study for LX9211 in post-herpetic neuralgia.
    • Q4 2020: Presentation of data from the sotagliflozin SOLOIST and SCORED Phase 3 studies at the American Heart Association Scientific Sessions 2020.
    • Q4 2021: Phase 2 study results in diabetic peripheral neuropathic pain and in post-herpetic neuralgia.

    Third Quarter 2020 Financial Highlights

    Revenues: Revenues for the three months ended September 30, 2020 decreased to $6.6 million from $294.4 million for the corresponding period in 2019. The three months ended September 30, 2019 included collaborative revenues of $260.0 million from the termination of the alliance with Sanofi and recognition of the remaining amount of $23.5 million allocated to performance obligations from the initial agreement with Sanofi. Net product revenues for the three months ended September 30, 2020 consisted of $6.5 million from net sales of XERMELO in the U.S.

    Cost of Sales: Cost of sales related to sales of XERMELO for the three months ended September 30, 2020 and 2019 were $0.6 million.

    Research and Development (R&D) Expenses: Research and development expenses for the three months ended September 30, 2020 increased to $40.1 million from $26.7 million for the corresponding period in 2019, primarily due to increases in external clinical development costs related to sotagliflozin subsequent to the termination of the alliance with Sanofi.

    Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended September 30, 2020 decreased to $12.0 million from $13.9 million for the corresponding period in 2019.

    Gain on Sale of XERMELO: A gain of $132.8 million was recognized for the three months ended September 30, 2020 from the sale of XERMELO and related assets to TerSera.

    Net Income: Net income for the three months ended September 30, 2020 was $82.6 million, or $0.71 per diluted share, as compared to net income of $226.1 million, or $1.95 per diluted share, in the corresponding period in 2019. For the three months ended September 30, 2020 and 2019, net loss included non-cash, stock-based compensation expense of $1.9 million and $3.6 million, respectively.

    Cash and Investments: As of September 30, 2020, Lexicon had $111.4 million in cash and investments, as compared to $271.7 million as of December 31, 2019.

    Conference Call and Webcast Information

    Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is (888) 645-5785 (U.S./Canada) or (970) 300-1531 (international). The conference ID for all callers is 7787988. The live webcast and replay may be accessed by visiting Lexicon's website at http://www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target with a pain phenotype discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

    About Sotagliflozin

    Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in diabetes and metabolism, neuropathic pain and other indications. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's financial position, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.



    Lexicon Pharmaceuticals, Inc.
    Selected Financial Data
             
    Consolidated Statements of Operations Data Three Months Ended September 30, Nine Months Ended September 30,
    (In thousands, except per share data) 2020 2019 2020 2019
      (Unaudited) (Unaudited)
    Revenues:        
    Net product revenue $6,542  $8,351  $23,404  $23,763 
    Collaborative agreements  -   285,910   33   289,209 
    Royalties and other revenue  92   187   359   374 
    Total revenues  6,634   294,448   23,796   313,346 
    Operating expenses:        
    Cost of sales (including finite-lived intangible        
    asset amortization)  633   577   1,929   2,457 
    Research and development, including stock-based        
    compensation of $1,029, $1,698, $5,154 and $5,369, respectively  40,147   26,659   152,629   51,318 
    Selling, general and administrative, including stock-based        
    compensation of $875, $1,864, $5,440 and $5,370, respectively  11,997   13,898   40,798   42,271 
    Impairment loss on buildings  -   -   1,600   - 
    Impairment loss on intangible asset  -   28,638   -   28,638 
    Total operating expenses  52,777   69,772   196,956   124,684 
    Other operating income:        
    Gain on sale of XERMELO  132,818   -   132,818   - 
    Income (loss) from operations  86,675   224,676   (40,342)  188,662 
    Loss on debt extinguishments, net  (255)  -   (255)  - 
    Interest expense  (4,118)  (5,204)  (14,374)  (15,485)
    Interest and other income, net  301   600   1,892   2,080 
    Net income (loss) before income taxes  82,603   220,072   (53,079)  175,257 
    Income tax benefit  -   6,014   -   6,014 
    Net income (loss) $82,603  $226,086  $(53,079) $181,271 
             
    Net income (loss) per common share, basic $0.77  $2.13  $(0.50) $1.71 
    Net income (loss) per common share, diluted $0.71  $1.95  $(0.50) $1.59 
             
    Shares used in computing net income (loss) per common share, basic  107,309   106,272   106,974   106,200 
    Shares used in computing net income (loss) per common share, diluted  117,552   116,640   106,974   116,742 
             





       As of  As of
    Consolidated Balance Sheet Data Sept. 30, 2020  Dec. 31, 2019
    (In thousands) (Unaudited)  
    Cash and investments $111,446  $271,659 
    Property and equipment, net  11,106   14,047 
    Goodwill  44,543   44,543 
    Other intangible assets  -   19,716 
    Total assets  178,928   417,715 
    Current and long-term debt  20,320   245,183 
    Accumulated deficit  (1,394,523)  (1,341,444)
    Total stockholders' equity  87,639   117,101 

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421

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  4. THE WOODLANDS, Texas, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it has entered into separate, privately-negotiated exchange agreements with certain holders of its 5.25% Convertible Senior Notes due 2021 under which such holders have agreed to exchange an aggregate principal amount of $62.55 million of Notes in exchange for aggregate consideration consisting of $41.03 million in cash (including $1.07 million of accrued interest) and 8,746,117 shares of Lexicon's common stock, par value $0.001 per share.

    The transactions are expected to close by September 28, 2020, subject to customary closing conditions. Immediately following the closings, $24.95 million in aggregate principal amount…

    THE WOODLANDS, Texas, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it has entered into separate, privately-negotiated exchange agreements with certain holders of its 5.25% Convertible Senior Notes due 2021 under which such holders have agreed to exchange an aggregate principal amount of $62.55 million of Notes in exchange for aggregate consideration consisting of $41.03 million in cash (including $1.07 million of accrued interest) and 8,746,117 shares of Lexicon's common stock, par value $0.001 per share.

    The transactions are expected to close by September 28, 2020, subject to customary closing conditions. Immediately following the closings, $24.95 million in aggregate principal amount of the Notes will remain outstanding.

    The completion of the transactions will reduce Lexicon's remaining interest expense through 2021 on the exchanged Notes by approximately $3.9 million. Once completed, and together with other debt reductions, including the repayment of Lexicon's secured loan concurrent with the closing of its sale of XERMELO® (telotristat ethyl) and related assets to TerSera Therapeutics, LLC, Lexicon will have reduced the principal amount of its outstanding debt by approximately 90% since June 30, 2020, better aligning with its strategic focus on its LX9211 neuropathic pain program and other research and development assets.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company. The issuance of common stock has not been registered under the Securities Act of 1933 (the "Securities Act") or the securities laws of any other jurisdiction, and these securities may not be offered or sold in the United States absent registration or an applicable exemption from the Securities Act and applicable state laws.

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target with a pain phenotype discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, neuropathic pain and other indications. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's financial position, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211 and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

     

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  5. Lexicon Receives $160.4 Million at Closing

    Eligible for Up to $65 Million in Milestone Payments Plus Mid-Teens Royalties on Net Sales of XERMELO in Biliary Tract Cancer

    Substantial Debt Reduction with Full Repayment of Secured Loan

    THE WOODLANDS, Texas, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today the completion of the sale of Lexicon's rights, title and interest in XERMELO® (telotristat ethyl) to TerSera Therapeutics LLC. 

    Lexicon received $160.4 million in cash at closing, comprised of a $155 million upfront payment and additional payments for inventory and other closing considerations.  Lexicon may receive additional milestone payments of up to an aggregate of $65 million for the development…

    Lexicon Receives $160.4 Million at Closing

    Eligible for Up to $65 Million in Milestone Payments Plus Mid-Teens Royalties on Net Sales of XERMELO in Biliary Tract Cancer

    Substantial Debt Reduction with Full Repayment of Secured Loan

    THE WOODLANDS, Texas, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today the completion of the sale of Lexicon's rights, title and interest in XERMELO® (telotristat ethyl) to TerSera Therapeutics LLC. 

    Lexicon received $160.4 million in cash at closing, comprised of a $155 million upfront payment and additional payments for inventory and other closing considerations.  Lexicon may receive additional milestone payments of up to an aggregate of $65 million for the development and commercialization of telotristat ethyl in patients with biliary tract cancer.  Additionally, Lexicon will be eligible to receive mid-teens royalties on net sales of XERMELO in biliary tract cancer.  In connection with the transaction, TerSera offered employment to 28 Lexicon employees.  Lexicon plans to realign its business around its research and development assets, with a focus on its LX9211 neuropathic pain program, now in Phase 2 clinical development, while substantially reducing its debt by fully repaying its $150 million secured term loan.

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, neuropathic pain and other indications. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to the sale of XERMELO (telotristat ethyl) and Lexicon's long-term outlook on its business.  In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211 and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

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