LXRX Lexicon Pharmaceuticals Inc.

1.94
-0.07  -3%
Previous Close 2.01
Open 2.02
52 Week Low 1.125
52 Week High 6.49
Market Cap $207,521,748
Shares 106,969,973
Float 28,766,135
Enterprise Value $211,094,645
Volume 547,079
Av. Daily Volume 962,284
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Telotristat ethyl - TELE-ABC
Biliary tract cancer (BTC)
Phase 2a
Phase 2a
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
Sotagliflozin
Type 2 Diabetes
Phase 3
Phase 3
SNY informed LXRX July 26, 2019 that it plans to terminate its agreement following insufficient efficacy across three Phase 3 trials. Phase 3 data noted 400 mg achieved the primary endpoint of superiority - December 20, 2019. Further trial data due 1H 2020.
LX9211
Neuropathic pain
Phase 2
Phase 2
Phase 2 trial to be initiated mid-2020.
Sotagliflozin
Type 1 Diabetes
CRL
CRL
CRL issued March 22, 2019. Appeal rejected by FDA - December 2, 2019.
Sotagliflozin
Type 1 Diabetes
Phase 3
Phase 3
Phase 3 data released September 9, 2016 met primary endpoint. Data from second trial released December 21, 2016 - primary endpoint met. Data from third trial also met primary endpoint - June 9, 2017.
Telotristat etiprate (XERMELO)
Carcinoid Syndrome
Approved
Approved
Approved February 28, 2017.
Sotagliflozin
Type 1 Diabetes
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint.

Latest News

  1. THE WOODLANDS, Texas, June 13, 2020 (GLOBE NEWSWIRE) --  Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today presented six posters for ZynquistaTM (sotagliflozin) at the virtual 80th American Diabetes Association (ADA) Scientific Sessions including additional efficacy and safety data patients with type 2 diabetes and moderate and severe renal impairment.

    Phase 3 CKD-3 Study

    In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-3 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and moderate (CKD Stage 3) renal impairment.

    The study met its primary endpoint, demonstrating that sotagliflozin 400 mg…

    THE WOODLANDS, Texas, June 13, 2020 (GLOBE NEWSWIRE) --  Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today presented six posters for ZynquistaTM (sotagliflozin) at the virtual 80th American Diabetes Association (ADA) Scientific Sessions including additional efficacy and safety data patients with type 2 diabetes and moderate and severe renal impairment.

    Phase 3 CKD-3 Study

    In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-3 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and moderate (CKD Stage 3) renal impairment.

    The study met its primary endpoint, demonstrating that sotagliflozin 400 mg significantly reduced A1C in the entire population of patients with moderate renal impairment compared to placebo at Week 26. The difference in least squares (LS) mean change in A1C from baseline for patients treated with sotagliflozin 400 mg compared to placebo was -0.24% (p = 0.0021). The change in A1C from baseline was not statistically different in patients treated with sotagliflozin 200 mg compared to placebo (p = 0.2085).

    The safety profile of sotagliflozin was generally similar to that of placebo. Incidences of symptomatic hypoglycemia (with documented blood glucose ≤70 mg/dL) were 20.4% on sotagliflozin 400 mg, 27.3% on sotagliflozin 200 mg, and 25.0% on placebo. The rates of symptomatic hypoglycemia (per 100 patient years of exposure) were 114.0 on sotagliflozin 400 mg, 140.5 on sotagliflozin 200 mg, and 175.4 on placebo.

    Phase 3 CKD-4 Study

    In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-4 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and severe (CKD Stage 4) renal impairment.

    The study did not meet its primary endpoint of demonstrating superiority of sotagliflozin versus placebo on A1C reduction after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and severe renal impairment compared to placebo. The placebo-adjusted difference in A1C from baseline for patients treated with sotagliflozin 400 mg compared to placebo was -0.29% (p = 0.0962) at week 26. For sotagliflozin 200 mg, the placebo-adjusted difference in A1C was 0.05% (p = 0.8124).

    Several findings indicated clinically meaningful glycemic control over time was achieved with sotagliflozin 400 mg. From baseline to Week 52, the placebo-subtracted A1C reduction for sotagliflozin 400 mg was -0.69% (95% confidence interval: -0.23, -1.15). At Week 52, achievement of A1C ≤ 7% was seen in 20.7% of patients on sotagliflozin 400 mg compared to 6.5% on placebo. Over 52 weeks, the incidence of rescue therapy to treat hyperglycemia was 7.6% on sotagliflozin 400 mg and 15.1% on placebo. Results were consistent with a dose related-response, as the 200 mg dose group at Week 52 had a placebo-subtracted A1C reduction of -0.32%, 19.6% of patients achieved A1C ≤ 7%, and 10.9% required rescue therapy.

    The safety profile of sotagliflozin was generally similar to that of placebo. This was a population at high cardiovascular risk, and the incidences of major adverse cardiovascular events (myocardial infarction, stroke, and cardiovascular death) were 4.4% on sotagliflozin 400 mg, 1.1% on sotagliflozin 200 mg, and 11.9% on placebo. Incidences of symptomatic hypoglycemia (with documented blood glucose ≤70 mg/dL) were 27.8% on sotagliflozin 400 mg, 28.7% on sotagliflozin 200 mg and 35.5% on placebo, and the rates (per 100 patient years of exposure) were 171.6 on sotagliflozin 400 mg, 226.9 on sotagliflozin 200 mg, and 269.8 on placebo.

    Additional poster presentations

    • Effects of sotagliflozin added to insulin therapy on beta-hydroxybutyrate in patients with type 1 diabetes. Peters, D. et al.
    • Efficacy and safety of sotagliflozin by baseline renal function in adults with type 1 diabetes. Handelsman, Y. et al.
    • Balancing the risk of DKA and severe hypoglycemia with sotagliflozin in adults with type 1 diabetes. Pettus, J. et al.
    • Impact of treatment with sotagliflozin on the incidence of severe hypoglycemia in patients with T1D. Pettus, J.

    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.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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 commercialize XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, 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 Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  2. THE WOODLANDS, Texas, May 13, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today additional data on XERMELO's® (telotristat ethyl) antiproliferative effects against cultured liposarcoma, colon cancer and cholangiocarcinoma cell lines that were published online in conjunction with the American Society of Clinical Oncology (ASCO) 2020 annual meeting (May 29 - June 2, 2020). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Tumor growth inhibition when exposed to telotristat ethyl was most pronounced in the liposarcoma cell line, followed…

    THE WOODLANDS, Texas, May 13, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today additional data on XERMELO's® (telotristat ethyl) antiproliferative effects against cultured liposarcoma, colon cancer and cholangiocarcinoma cell lines that were published online in conjunction with the American Society of Clinical Oncology (ASCO) 2020 annual meeting (May 29 - June 2, 2020). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Tumor growth inhibition when exposed to telotristat ethyl was most pronounced in the liposarcoma cell line, followed by the colon cancer and cholangiocarcinoma cell lines. 

    "We are pleased that this preclinical study demonstrated that telotristat ethyl has antitumor effect in various cancer types," said Praveen Tyle, Ph.D, executive vice president, research and development of Lexicon. "Today's data support the conduct of additional studies to examine telotristat ethyl's effect on tryptophan hydroxylase positive cancers."

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl). 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 commercialize XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, 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 Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

     

    Primary Logo

    View Full Article Hide Full Article
  3. THE WOODLANDS, Texas, April 07, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) will host its 2020 annual meeting of stockholders in a virtual format only due to the public health impact of the coronavirus pandemic and to prioritize the health and well-being of meeting participants.

    The virtual 2020 annual meeting of stockholders will be held at 8:00 a.m. CT on April 23, 2020.

    Stockholders at the close of business on the record date, February 24, 2020, are entitled to attend the annual meeting. The link to the meeting will be available at www.virtualshareholdermeeting.com/LXRX2020. Shareholders must enter the 16-digit voting control number found on their proxy card, voting instruction form, notice of internet availability…

    THE WOODLANDS, Texas, April 07, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) will host its 2020 annual meeting of stockholders in a virtual format only due to the public health impact of the coronavirus pandemic and to prioritize the health and well-being of meeting participants.

    The virtual 2020 annual meeting of stockholders will be held at 8:00 a.m. CT on April 23, 2020.

    Stockholders at the close of business on the record date, February 24, 2020, are entitled to attend the annual meeting. The link to the meeting will be available at www.virtualshareholdermeeting.com/LXRX2020. Shareholders must enter the 16-digit voting control number found on their proxy card, voting instruction form, notice of internet availability of proxy materials or email previously received.

    Please note that the proxy card and voting instruction form included with previously-distributed proxy materials will not be updated to reflect the change from an in-person meeting to a virtual-only meeting and may be used to vote shares in connection with the annual meeting.

    Whether or not shareholders plan to attend the virtual-only annual meeting, Lexicon urges shareholders to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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 commercialize XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, 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 Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  4. THE WOODLANDS, Texas, March 13, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today additional data on XERMELO's® (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome that were presented at the European Neuroendocrine Tumor Society (ENETS) meeting (March 11-13). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received telotristat ethyl for an average of 12…

    THE WOODLANDS, Texas, March 13, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today additional data on XERMELO's® (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome that were presented at the European Neuroendocrine Tumor Society (ENETS) meeting (March 11-13). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received telotristat ethyl for an average of 12 months in US clinical practice demonstrated that most patients had no tumor progression at 6, 12 and 18 months following initiation of telotristat ethyl, with a median time to tumor progression (TTP) of 39.8 months. The majority of patients also experienced progression-free survival (PFS) in the post-telotristat ethyl period, 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 post-telotristat ethyl period. Patients also improved on carcinoid syndrome (CS) symptoms, body weight and performance status.

    "We are pleased this observational study showed that use of telotristat ethyl was associated with not only neuroendocrine tumor control but also meaningful improvements in CS symptoms and clinical indicators of overall health in patients with advanced neuroendocrine tumors and carcinoid syndrome," said Pablo Lapuerta, executive vice president and chief medical officer of Lexicon. "Results of this observational study coupled with preclinical data support the conduct of clinical trials to examine telotristat ethyl's effect on neuroendocrine tumors."

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl). 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 commercialize XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, 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 Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421
     

    Primary Logo

    View Full Article Hide Full Article
  5. XERMELO® (telotristat ethyl) 2019 U.S. Net Sales Reached $31.0 Million

    THE WOODLANDS, Texas, March 12, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months and full-year ended December 31, 2019 and provided a business update.

    "In 2019, we achieved continued growth in our XERMELO (telotristat ethyl) business of nearly 25% year-over-year and made significant strides in advancing pipeline initiatives such as telotristat ethyl in biliary tract cancer and LX9211 in neuropathic pain," said Lonnel Coats, Lexicon's president and chief executive officer. "We expect initial clinical efficacy data for telotristat ethyl in biliary tract cancer by the end of this year. As for LX9211…

    XERMELO® (telotristat ethyl) 2019 U.S. Net Sales Reached $31.0 Million

    THE WOODLANDS, Texas, March 12, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months and full-year ended December 31, 2019 and provided a business update.

    "In 2019, we achieved continued growth in our XERMELO (telotristat ethyl) business of nearly 25% year-over-year and made significant strides in advancing pipeline initiatives such as telotristat ethyl in biliary tract cancer and LX9211 in neuropathic pain," said Lonnel Coats, Lexicon's president and chief executive officer. "We expect initial clinical efficacy data for telotristat ethyl in biliary tract cancer by the end of this year. As for LX9211, we are initiating a proof-of-concept study in diabetic peripheral neuropathic pain in the first half of this year."

    "We received a response yesterday from the Center for Drug Evaluation and Research (CDER) to our appeal of the FDA's complete response letter (CRL) for sotagliflozin in type 1 diabetes," continued Mr. Coats.  "The response confirmed the CRL decision, and we are now evaluating the feedback they provided in their response."

    "We are engaged in discussions around potential partnerships for sotagliflozin, which will be necessary to enable completion of the long-term outcomes studies, SCORED and SOLOIST, that are designed to demonstrate benefits in and support labeling for heart failure and chronic kidney disease."

    Fourth Quarter and Full-Year 2019 Product and Pipeline Highlights

    XERMELO® (telotristat ethyl)

    • XERMELO U.S. net sales were $31.0 million in 2019.
    • In December, Lexicon completed a safety review of the initial safety run-in cohort of The Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer. Safety analysis from the first six patients who completed at least a 21-day cycle of treatment with telotristat ethyl in combination with cisplatin and gemcitabine supported the continuation of enrollment with no adjustment in the telotristat ethyl 500 mg three times daily dosing regimen.

    Zynquista™ (sotagliflozin)

    • In December, Lexicon announced topline data from the Phase 3 SOTA-EMPA study of sotagliflozin in type 2 diabetes. Sotagliflozin 400 mg achieved the primary endpoint of superiority on A1C reduction versus placebo at Week 26 in patients with inadequate glycemic control while on a dipeptidyl peptidase 4 inhibitor, with or without metformin therapy. Sotagliflozin 400mg also achieved the key secondary endpoint of noninferiority versus empagliflozin on A1C reduction from baseline at Week 26. Sotagliflozin was generally well tolerated, with safety results comparable to previously reported safety results in patients with type 2 diabetes.
       
    • In December, Lexicon announced that the U.S. Food and Drug Administration's (FDA) Office of New Drugs had reiterated the FDA's prior position that the New Drug Application for sotagliflozin in type 1 diabetes cannot be approved in its present form and denied the appeal of the previously issued CRL. Lexicon subsequently appealed the decision to CDER. As indicated above, CDER yesterday reaffirmed the FDA's position.

    LX9211

    • Lexicon announced positive topline Phase 1 data for LX9211 in a multiple ascending dose study in healthy volunteers that demonstrated a favorable safety and pharmacokinetics profile supportive of once-daily dosing.

    Fourth Quarter and Full-Year 2019 Financial Highlights

    Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2019 compared to the fourth quarter and full year of 2018.

    Revenues: Revenues for the fourth quarter decreased to $8.7 million from $17.1 million for the corresponding period in 2018, primarily due to lower revenues recognized under collaboration and license agreements. Full-year 2019 revenues increased to $322.1 million from $63.2 million, primarily due to collaboration revenues recognized from the termination of the alliance with Sanofi and recognition of remaining amounts allocated to the performance obligations from the initial Sanofi collaboration agreement for development activities relating to sotagliflozin, as well as an increase from net product revenue. Net product revenues for full-year 2019 included $31.0 million and $1.3 million, respectively, from net sales of XERMELO in the U.S. and the sale of bulk tablets to Lexicon's collaborator, Ipsen.

    Cost of Sales: Cost of sales related to sales of XERMELO was $0.7 million and $0.6 million, respectively, for the fourth quarter of 2019 and 2018. Full-year 2019 and 2018 cost of sales was $3.2 million and $2.5 million, respectively.

    Research and Development (R&D) Expenses: Research and development expenses for the fourth quarter increased to $40.6 million from $12.3 million for the corresponding period in 2018, primarily due to increases in external clinical development costs 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. Full-year R&D expenses for 2019 decreased to $91.9 million from $100.2 million, due to decreases in professional and consulting fees and lower external clinical development costs.

    Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter were $14.6 million compared to $16.6 million for the same period in 2018. Full-year 2019 SG&A expenses decreased to $56.8 million from $63.8 million, primarily due to lower marketing expenses and professional and consulting costs.

    Impairment Loss on Intangible Asset: An impairment loss in 2019 of $28.6 million was recognized to an indefinite lived intangible asset associated with Lexicon's 2010 acquisition of Symphony Icon, due to the decision to terminate research and development activities related to a program for irritable bowel syndrome that was among the assets acquired.

    Income Tax Benefit: An income tax benefit of $6.0 million in 2019 was recognized in connection with the impairment loss on the indefinite lived intangible asset, which resulted in a decrease to the deferred tax liability and created an income tax benefit.  During 2018, there was no income tax benefit.

    Net Income (Loss): Net loss for the fourth quarter was $51.1 million, or $0.48 per share, as compared to a net loss of $16.8 million, or $0.16 per share, in the corresponding period in 2018. For the fourth quarter 2019, net loss included non-cash, stock-based compensation expense of $3.5 million. For the fourth quarter 2018, net loss included non-cash, stock-based compensation expense of $2.8 million. Net income for the full-year 2019 was $130.1 million, or $1.16 per diluted share, as compared to a net loss of $120.5 million, or $1.14 per share, in 2018. For the full-year 2019, net income included non-cash, stock-based compensation expense of $14.2 million. For the full-year 2018, net loss included non-cash, stock-based compensation expense of $11.7 million.

    Cash and Investments: As of December 31, 2019, Lexicon had $271.7 million in cash and investments, as compared to $160.1 million as of December 31, 2018.

    Anticipated Near-Term Milestones

    • H1 2020 – Initiation of a Phase 2 study for LX9211 in diabetic peripheral neuropathic pain
    • H1 2020 – Completion of patient enrollment in the first efficacy cohort of the Phase 2 study of telotristat ethyl in biliary tract cancer
    • H1 2020 – Topline results from core Phase 3 sotagliflozin studies in type 2 diabetes
    • June 2020 – Presentation of Phase 3 data for sotagliflozin in type 2 diabetes at the 80th Scientific Sessions of the American Diabetes Association (ADA)
    • September 2020 – Presentation of Phase 3 data for sotagliflozin in type 2 diabetes at the 56th Annual Meeting of the European Association for the Study of Diabetes (EASD)
    • Q4 2020 – Data from the first efficacy cohort of the Phase 2 study of telotristat ethyl in biliary tract cancer

    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 4187725. The live webcast and replay may be accessed by visiting Lexicon's website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. We are commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO. 

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Zynquista (sotagliflozin)

    Discovered using Lexicon's unique approach to gene science, Zynquista 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. Zynquista 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. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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 commercialize XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, 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, 2018, 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 December 31,   Year Ended December 31,
    (In thousands, except per share data)   2019   2018   2019   2018
        (Unaudited)       (Unaudited)    
             
    Revenues:                
    Net product revenue    $ 8,568     $ 7,521     $ 32,331     $ 26,583  
    Collaborative agreements     22       9,479       289,231       36,271  
    Royalties and other revenue      137       71       511       355  
    Total revenues      8,727       17,071       322,073       63,209  
    Operating expenses:                
    Cost of sales (including finite-lived intangible                
    asset amortization)     774       569       3,231       2,491  
    Research and development, including stock-based compensation                
    of $1,727, $1,488, $7,096 and $6,010, respectively      40,606       12,307       91,924       100,243  
    Selling, general and administrative, including stock-based compensation                
    of $1,752, $1,359, $7,122 and $5,686, respectively     14,564       16,562       56,835       63,754  
    Impairment loss on intangible asset     -       -       28,638       -  
    Total operating expenses      55,944       29,438       180,628       166,488  
    Income (loss) from operations      (47,217 )     (12,367 )     141,445       (103,279 )
    Interest expense      (5,191 )     (5,224 )     (20,676 )     (20,777 )
    Interest and other income, net     1,270       810       3,350       3,508  
    Net income (loss) before income taxes     (51,138 )     (16,781 )     124,119       (120,548 )
    Income tax benefit     -       -       6,014       -  
    Net income (loss)   $ (51,138 )   $ (16,781 )   $ 130,133     $ (120,548 )
                     
                     
    Net income (loss) per common share, basic   $ (0.48 )   $ (0.16 )   $ 1.23     $ (1.14 )
    Net income (loss) per common share, diluted   $ (0.48 )   $ (0.16 )   $ 1.16     $ (1.14 )
                     
    Shares used in computing net income (loss) per                
    common share, basic     106,272       105,920       106,218       105,830  
    Shares used in computing net income (loss) per                
    common share, diluted     106,272       105,920       116,747       105,830  
                     
    Consolidated Balance Sheet Data           As of December 31, 2019   As of December 31, 2018
    (In thousands)           (Unaudited)    
                     
    Cash and investments           $ 271,659     $ 160,052  
    Property and equipment, net             14,047       15,865  
    Goodwill             44,543       44,543  
    Other intangible assets             19,716       50,119  
    Total assets             417,715       284,136  
    Deferred revenue             -       25,990  
    Current and long-term debt             245,183       245,002  
    Accumulated deficit             (1,341,444 )     (1,471,577 )
    Total stockholders' equity (deficit)              117,101       (26,405 )

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
View All Lexicon Pharmaceuticals Inc. News