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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Lexicon Pharmaceuticals Inc | NASDAQ:LXRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.05 | 2.94% | 1.75 | 1.75 | 1.81 | 2.02 | 1.65 | 1.66 | 5,866,568 | 01:00:00 |
“We continue to make good progress on our XERMELO business, with XERMELO net sales growing more than 30% in the third quarter of 2019 versus the same period in 2018,” said Lonnel Coats, Lexicon’s president and chief executive officer. “We now have full rights for Zynquista. We expect to complete the core Phase 3 studies in type 2 diabetes in the near term and anticipate being in a position to file for regulatory approval for that indication in the U.S. and in Europe in the first half of 2020. We continue to have productive dialogue with the FDA on a path forward for Zynquista in type 1 diabetes in the U.S.”
Third Quarter Product and Pipeline Highlights
XERMELO® (telotristat ethyl)
Zynquista™ (sotagliflozin)
Third Quarter 2019 Financial Highlights
Revenues: Revenues for the three months ended September 30, 2019 increased to $294.4 million from $7.0 million for the corresponding period in 2018, primarily due to an increase of collaborative revenues of $260 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 and an increase in net product revenue. Net product revenues for the three months ended September 30, 2019 consisted of $8.4 million from net sales of XERMELO in the U.S., which were up 33% from the prior year quarter.
Cost of Sales: Cost of sales related to sales of XERMELO for each of the three months ended September 30, 2019 and 2018 was $0.6 million.
Research and Development (R&D) Expenses: Research and development expenses for the three months ended September 30, 2019 increased to $26.7 million from $13.8 million for the corresponding period in 2018, primarily due to an increase in external clinical development costs related to sotagliflozin subsequent to the termination of the alliance with Sanofi, in which Lexicon regained the rights and responsibilities for development and commercialization for sotagliflozin.
Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended September 30, 2019 decreased to $13.9 million from $15.6 million for the corresponding period in 2018, primarily due to decreased marketing costs.
Impairment Loss on Intangible Asset: An impairment loss for the three months ended September 30, 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 for the three months ended September 30, 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.
Net Income (Loss): Net income for the three months ended September 30, 2019 was $226.1 million, or $1.95 per diluted share, as compared to a net loss of $27.4 million, or a loss of $0.26 per share, in the corresponding period in 2018. For the three months ended September 30, 2019 and 2018, net income included non-cash, stock-based compensation expense of $3.6 million and $2.9 million, respectively.
Cash and Investments: As of September 30, 2019, Lexicon had $296.3 million in cash and investments, as compared to $160.1 million as of December 31, 2018. The cash position as of September 30, 2019 includes proceeds of $208 million in connection with the termination of the alliance with Sanofi.
Anticipated Near-Term Milestones
Conference Call and Webcast Information
Lexicon management will hold a live conference call and webcast today at 8:00 am EST / 7:00 am CST 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 8189178. 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
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 complete the transition from Sanofi of responsibility for ongoing clinical studies and other activities relating to sotagliflozin, 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 September 30, | Nine Months Ended September 30, | ||||||||||||||||
(In thousands, except per share data) | 2019 | 2018 | 2019 | 2018 | ||||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||||
Revenues: | ||||||||||||||||||
Net product revenue | $ | 8,351 | $ | 6,286 | $ | 23,763 | $ | 19,062 | ||||||||||
Collaborative agreements | 285,910 | 556 | 289,209 | 26,792 | ||||||||||||||
Royalties and other revenue | 187 | 124 | 374 | 284 | ||||||||||||||
Total revenues | 294,448 | 6,966 | 313,346 | 46,138 | ||||||||||||||
Operating expenses: | ||||||||||||||||||
Cost of sales (including finite-lived intangible asset amortization) | 577 | 551 | 2,457 | 1,922 | ||||||||||||||
Research and development, including stock-based compensation of $1,698, $1,472, $5,369 and $4,522, respectively | 26,659 | 13,763 | 51,318 | 87,936 | ||||||||||||||
Selling, general and administrative, including stock-based | ||||||||||||||||||
compensation of $1,864, $1,405, $5,370 and $4,327, respectively | 13,898 | 15,579 | 42,271 | 47,191 | ||||||||||||||
Impairment loss on intangible asset | 28,638 | - | 28,638 | - | ||||||||||||||
Total operating expenses | 69,772 | 29,893 | 124,684 | 137,049 | ||||||||||||||
Income (loss) from operations | 224,676 | (22,927 | ) | 188,662 | (90,911 | ) | ||||||||||||
Interest expense | (5,204 | ) | (5,252 | ) | (15,485 | ) | (15,552 | ) | ||||||||||
Interest and other income, net | 600 | 783 | 2,080 | 2,698 | ||||||||||||||
Net income (loss) before income taxes | 220,072 | (27,396 | ) | 175,257 | (103,765 | ) | ||||||||||||
Income tax benefit | 6,014 | - | 6,014 | - | ||||||||||||||
Net income (loss) | $ | 226,086 | $ | (27,396 | ) | $ | 181,271 | $ | (103,765 | ) | ||||||||
Net income (loss) per common share, basic | $ | 2.13 | $ | (0.26 | ) | $ | 1.71 | $ | (0.98 | ) | ||||||||
Net income (loss) per common share, diluted | $ | 1.95 | $ | (0.26 | ) | $ | 1.59 | $ | (0.98 | ) | ||||||||
Shares used in computing net income (loss) per | ||||||||||||||||||
common share, basic | 106,272 | 105,881 | 106,200 | 105,800 | ||||||||||||||
Shares used in computing net income (loss) per | ||||||||||||||||||
common share, diluted | 116,640 | 105,881 | 116,742 | 105,800 | ||||||||||||||
As of | As of | |||||||||||||||||
Consolidated Balance Sheet Data | September 30, 2019 | December 31, 2018 | ||||||||||||||||
(In thousands) | (Unaudited) | |||||||||||||||||
Cash and investments | $ | 296,304 | $ | 160,052 | ||||||||||||||
Property and equipment, net | 14,540 | 15,865 | ||||||||||||||||
Goodwill | 44,543 | 44,543 | ||||||||||||||||
Other intangible assets | 20,157 | 50,119 | ||||||||||||||||
Total assets | 444,588 | 284,136 | ||||||||||||||||
Deferred revenue | 1,117 | 27,046 | ||||||||||||||||
Current and long-term debt | 245,126 | 245,002 | ||||||||||||||||
Accumulated deficit | (1,290,306 | ) | (1,471,577 | ) | ||||||||||||||
Total stockholders' equity (deficit) | 164,712 | (26,405 | ) | |||||||||||||||
For Investor Inquiries:
Kimberly Lee, D.O.Head of Investor Relations and Corporate StrategyLexicon Pharmaceuticals(281) 863-3383klee@lexpharma.com
For Media Inquiries:
Chas SchultzExecutive Director, Corporate Communications and Patient AdvocacyLexicon Pharmaceuticals(281) 863-3421cschultz@lexpharma.com
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