THE WOODLANDS, Texas, March 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and full-year ended December 31, 2022 and provided an update on key corporate milestones.
“We are on track for the PDUFA action date in May of this year for our NDA for sotagliflozin for the treatment of heart failure, as confirmed during this week’s FDA late-cycle review meeting,” said Lonnel Coats, Lexicon’s chief executive officer. “We believe the uniqueness of our data from the SOLOIST-WHF trial provides a point of clinical differentiation and provides a strong opportunity to launch into a growing market with recently adopted medical treatment guidelines recommending the use of SGLT inhibitors as a key pillar of heart failure treatment.”
“We continue to advance the science across our portfolio with the upcoming presentation of sotagliflozin-related analyses at the American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress of Cardiology in New Orleans, Louisiana, including a featured presentation on the time to clinical benefit of sotagliflozin in people with worsening heart failure. In parallel, we are equally excited about the clinical progress of our AAK1-inhibitor, LX9211. We plan to advance LX9211 into late-stage development in neuropathic pain, supported by data from Phase 2 proof-of-concept studies in diabetic peripheral neuropathic pain (DPN) and postherpetic neuralgia (PHN), both completed in 2022.”
Fourth Quarter Highlights
Sotagliflozin
LX9211
Fourth Quarter 2022 Financial Highlights
Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2022 compared to the fourth quarter and full year of 2021.
Research and Development (R&D) Expenses: Research and development expenses for the fourth quarter of 2022 decreased to $14.0 million from $16.5 million for the corresponding period in 2021, and for the full-year decreased to $52.8 million from $55.0 million in 2021, primarily due to lower professional and consulting fees in 2022 related to the preparations for the submission of our application for regulatory approval to market sotagliflozin for heart failure.
Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter of 2022 increased to $16.3 million from $8.8 million for the corresponding period in 2021, and for the full-year increased to $48.1 million from $32.3 million in 2021, primarily due to increases in salaries and benefits, professional and consulting costs and marketing costs relating to preparations for the commercial launch of sotagliflozin in heart failure.
Net Loss: Net loss for the fourth quarter of 2022 was $30.5 million, or $0.16 per share, as compared to a net loss of $25.6 million, or $0.17 per share, in the corresponding period in 2021. For the fourth quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $3.3 million and $2.2 million, respectively. Net loss for the full-year 2022 was $101.9 million, or $0.62 per share, as compared to a net loss of $87.8 million, or $0.60 per share in 2021. For the full years of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $11.5 million and $10.6 million, respectively.
Cash and Investments: As of December 31, 2022, Lexicon had $138.4 million in cash and investments, as compared to $86.7 million as of December 31, 2021.
Conference Call and Webcast Information
Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-317-6003 and the conference ID for all callers is 8206864. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.
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 heart failure, neuropathic pain, diabetes and metabolism 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 and long-term outlook on its business, including the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin, LX9211 and its other potential 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, successfully commercialize any products for which it obtains regulatory approval, 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, 2021, 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, | Years Ended December 31, | |||||||||||||
(In thousands, except per share data) | 2022 | 2021 | 2022 | 2021 | |||||||||||
(Unaudited) | (Unaudited) | ||||||||||||||
Revenues: | |||||||||||||||
Royalties and other revenue | $ | 28 | $ | 14 | $ | 139 | $ | 298 | |||||||
Operating expenses: | |||||||||||||||
Research and development, including stock-based compensation of $1,184, $676, $4,253 and $4,284, respectively | 13,977 | 16,498 | 52,816 | 55,046 | |||||||||||
Selling, general and administrative, including stock-based compensation of $2,084, $1,552, $7,267 and $6,293, respectively | 16,329 | 8,846 | 48,083 | 32,342 | |||||||||||
Total operating expenses | 30,306 | 25,344 | 100,899 | 87,388 | |||||||||||
Loss from operations | (30,278 | ) | (25,330 | ) | (100,760 | ) | (87,090 | ) | |||||||
Interest expense | (1,103 | ) | (295 | ) | (2,780 | ) | (802 | ) | |||||||
Interest and other income, net | 887 | 14 | 1,596 | 134 | |||||||||||
Net loss | $ | (30,494 | ) | $ | (25,611 | ) | $ | (101,944 | ) | $ | (87,758 | ) | |||
Net loss per common share, basic and diluted | $ | (0.16 | ) | $ | (0.17 | ) | $ | (0.62 | ) | $ | (0.60 | ) | |||
Shares used in computing net loss per | |||||||||||||||
common share, basic and diluted | 188,726 | 148,897 | 165,733 | 145,652 | |||||||||||
As of | As of | ||||||||||||||
Consolidated Balance Sheet Data | December 31, 2022 | December 31, 2021 | |||||||||||||
(In thousands) | |||||||||||||||
Cash and investments | $ | 138,357 | $ | 86,743 | |||||||||||
Property and equipment, net | 2,071 | 1,176 | |||||||||||||
Goodwill | 44,543 | 44,543 | |||||||||||||
Total assets | 194,299 | 136,909 | |||||||||||||
Long-term debt, net of issuance costs | 48,579 | - | |||||||||||||
Accumulated deficit | (1,589,720 | ) | (1,487,776 | ) | |||||||||||
Total stockholders' equity | 117,124 | 113,595 | |||||||||||||
For Investor Inquiries:
Carrie Siragusa
Lexicon Pharmaceuticals, Inc.
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For Media Inquiries:
Alina Kolomeyer
Lexicon Pharmaceuticals, Inc.
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Last Trade: | US$0.81 |
Daily Change: | -0.05 -5.84 |
Daily Volume: | 5,268,320 |
Market Cap: | US$293.890M |
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