GlobeNewswire Inc | Jul 30, 2020 07:01AM EDT

July 30, 2020

THE WOODLANDS, Texas, July 30, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results and provided a business update for the three months ended June 30, 2020.

We achieved 21% growth in XERMELO net sales in the U.S. for the second quarter of 2020 compared to the prior-year period, underscoring the importance of our product to patients, said Lonnel Coats, Lexicons president and chief executive officer. In these unprecedented times of the COVID-19 pandemic, I am proud of the commitment and dedication of our employees to our mission to pioneer medicines to transform patients lives. We continue to make progress on our pipeline with initiation of screening of patients in the Phase 2 RELIEF-DPN-1 study for LX9211 in patients with diabetic peripheral neuropathic pain. We look forward to providing additional updates later this year.

Second Quarter Product and Pipeline Highlights

XERMELO (telotristat ethyl)

-- XERMELO U.S. net sales were $9.0 million in the second quarter of 2020. -- Telotristat ethyls antiproliferative effects observed in a preclinical study in liposarcoma, colon cancer and cholangiocarcinoma cell lines were published online in conjunction with the American Society of Clinical Oncology (ASCO) 2020 annual meeting (May 29 - June 2, 2020).

Sotagliflozin

-- Six posters for sotagliflozin were presented at the virtual 80th American Diabetes Association (ADA) Scientific Sessions (June 12-16, 2020) including additional efficacy and safety data in patients with type 2 diabetes and moderate and severe renal impairment.

Second Quarter 2020 Financial Highlights

Revenues: Revenues for the three months ended June 30, 2020 decreased to $9.2 million from $9.7 million for the corresponding period in 2019, primarily due to a decrease of bulk tablet sales of XERMELO to Ipsen and collaborative revenues, partially offset by an increase in U.S. net product revenue. Net product revenues for the three months ended June 30, 2020 consisted of $9.0 million from net sales of XERMELO in the U.S., up 21% from the prior year quarter.

Cost of Sales: Cost of sales related to sales of XERMELO for the three months ended June 30, 2020 and 2019 was $0.7 million and $1.3 million, respectively.

Research and Development (R&D) Expenses: Research and development expenses for the three months ended June 30, 2020 increased to $57.3 million from $12.6 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 June 30, 2020 were $14.1 million as compared to $14.3 million for the corresponding period in 2019.

Net Loss:Net loss for the three months ended June 30, 2020 was $69.1 million, or $0.65 per share, as compared to a net loss of $23.0 million, or $0.22 per share, in the corresponding period in 2019. For the three months ended June 30, 2020 and 2019, net loss included non-cash, stock-based compensation expense of $4.3 million and $3.8 million, respectively.

Cash and Investments: As of June 30, 2020, Lexicon had $201.9 million in cash and investments, as compared to $271.7million as of December 31, 2019.

Anticipated Near-Term Milestones

-- Q3 2020 Dosing of first patient in the Phase 2 LX9211 study in diabetic peripheral neuropathic pain -- Q4 2020 Initiation of a Phase 2 study for LX9211 in post-herpetic neuralgia

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 8:00 am EDT / 7:00 am CDT 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 4645277. The live webcast and replay may be accessed by visiting Lexicons 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 Lexicons 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 Sotagliflozin

Discovered using Lexicons 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 Lexicons 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), sotagliflozin, and LX9211. In addition, this press release also contains forward looking statements relating to Lexicons 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 managements current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicons 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 Lexicons 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 Lexicons 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 ConsolidatedStatements of Three Months Ended June 30, Six Months Ended June 30, Operations Data(In thousands,except per 2020 2019 2020 2019 share data) (Unaudited) (Unaudited) Revenues: Net product $ 8,985 $ 8,672 $ 16,862 $ 15,412 revenueCollaborative 25 860 33 3,299 agreementsRoyalties and 153 150 267 187 other revenueTotal revenues 9,163 9,682 17,162 18,898 Operating expenses:Cost of sales(including finite-livedintangible asset 728 1,327 1,296 1,880 amortization)Research anddevelopment, includingstock-based compensationof $1,949,$1,903, $4,125 57,301 12,637 112,482 24,659 and $3,671,respectivelySelling,general andadministrative, includingstock-based compensationof $2,309,$1,863, $4,565 14,113 14,263 28,801 28,373 and $3,506,respectivelyImpairment loss on 1,600 - 1,600 - buildingsTotal operating 73,742 28,227 144,179 54,912 expensesLoss from (64,579 ) (18,545 ) (127,017 ) (36,014 ) operationsInterest (5,125 ) (5,164 ) (10,256 ) (10,281 ) expenseInterest andother income, 633 691 1,591 1,480 netNet loss $ (69,071 ) $ (23,018 ) $ (135,682 ) $ (44,815 ) Net loss percommon share, $ (0.65 ) $ (0.22 ) $ (1.27 ) $ (0.42 ) basic anddiluted Shares used incomputing net loss per commonshare, basicand diluted 107,073 106,272 106,804 106,164 As of As of Consolidated December 31,Balance Sheet June 30, 2020 2019 Data(In thousands) (Unaudited) Cash and investments $ 201,866 $ 271,659 Property and equipment, net 11,524 14,047 Goodwill 44,543 44,543 Other intangible assets 18,833 19,716 Total assets 322,540 417,715 Current and long-term debt 245,264 245,183 Accumulated deficit (1,477,126 ) (1,341,444 ) Total stockholders' equity/(deficit) (10,687 ) 117,101

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