Lexicon Pharmaceuticals(LXRX) - 2024 Q1 - Quarterly Results

Corporate Highlights and Outlook Lexicon Pharmaceuticals reported Q1 2024 progress with INPEFA's launch, pipeline advancements, and strong capitalization - The commercial launch of INPEFA for heart failure is progressing, with an expected inflection in the second half of 2024 driven by expanded market access[1][3] - Planning to resubmit the New Drug Application (NDA) for ZYNQUISTA™ for type 1 diabetes with chronic kidney disease (CKD) around mid-year 2024[1][3] - A Phase 3 study of sotagliflozin in hypertrophic cardiomyopathy (HCM) is starting, with enrollment expected to begin mid-year 2024[1][3] - Enrollment is on track for the Phase 2b PROGRESS study of LX9211 for diabetic peripheral neuropathic pain, with topline data expected in Q2 2025[1][3] - Selected LX9851 as a new development candidate for obesity and weight management, now entering IND-enabling studies[3] - The company is well-capitalized following a recent successful financing, enabling targeted investments for growth[3] Pipeline Highlights Lexicon's pipeline demonstrated strong Q1 2024 momentum with significant progress across its key drug candidates INPEFA (sotagliflozin) for Heart Failure INPEFA's commercial launch progressed in Q1 2024, showing significant sales growth and anticipated market access expansion | Metric | Value | | :--- | :--- | | Q1 2024 Net Sales | $1.1 million | | QoQ Growth | 63% | | Current Market Access | ~40% | ZYNQUISTA (sotagliflozin) for Type 1 Diabetes Lexicon plans mid-2024 NDA resubmission for ZYNQUISTA as adjunctive therapy for type 1 diabetes with CKD - NDA resubmission for ZYNQUISTA is planned for mid-year 2024 as an adjunct to insulin for people with type 1 diabetes and CKD[5] - Chronic kidney disease (CKD) is estimated to impact 20% to 25% of people with type 1 diabetes[6] Sotagliflozin for HCM Lexicon is initiating a Phase 3 study of sotagliflozin for hypertrophic cardiomyopathy (HCM), expected mid-year 2024 - A Phase 3 study of sotagliflozin in HCM is being initiated, with study start expected mid-year 2024[7] LX9211 for DPNP Enrollment for LX9211's Phase 2b DPNP study is on track, with topline data anticipated in Q2 2025 - The PROGRESS Phase 2b study of LX9211 is on track, with topline data anticipated in Q2 2025[8] LX9851 for Obesity and Weight Management Lexicon selected LX9851, an oral ACSL5-inhibitor, as a development candidate for obesity, now entering IND-enabling studies - LX9851, an oral ACSL5-inhibitor, has been selected as a development candidate for obesity and is now commencing IND-enabling studies[9] First Quarter 2024 Financial Highlights Lexicon's Q1 2024 financials show $1.1 million revenue, a $48.4 million net loss, and a $355.6 million cash position | Financial Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total Revenues | $1.1 million | $0.02 million | | R&D Expenses | $14.4 million | $12.0 million | | SG&A Expenses | $32.1 million | $19.1 million | | Net Loss | $(48.4) million | $(31.9) million | | Net Loss per Share | $(0.20) | $(0.17) | | Cash and Investments (End of Period) | $355.6 million | N/A | Selected Financial Data This section provides Lexicon's unaudited consolidated statements of operations and balance sheet data for Q1 2024 Consolidated Statements of Operations Data (Unaudited, In thousands, except per share data) | | Three Months Ended March 31, | | :--- | :---: | :---: | | | 2024 | 2023 | | Total revenues | $1,130 | $24 | | Cost of sales | $31 | $— | | Research and development | $14,372 | $12,026 | | Selling, general and administrative | $32,060 | $19,140 | | Total operating expenses | $46,463 | $31,166 | | Loss from operations | $(45,333) | $(31,142) | | Net loss | $(48,397) | $(31,934) | | Net loss per common share | $(0.20) | $(0.17) | Consolidated Balance Sheet Data (Unaudited, In thousands) | | As of March 31, 2024 | As of December 31, 2023 | | :--- | :---: | :---: | | Cash and investments | $355,598 | $170,026 | | Total assets | $417,219 | $229,429 | | Long-term debt, net | $99,874 | $99,508 | | Total stockholders' equity | $288,867 | $93,110 | About INPEFA (sotagliflozin) INPEFA (sotagliflozin) is an oral SGLT1/SGLT2 inhibitor indicated for cardiovascular risk reduction in heart failure and type 2 diabetes, with safety warnings - INPEFA is an oral inhibitor of both SGLT1 (gastrointestinal tract) and SGLT2 (kidney), which regulate glucose and sodium[17] - Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes with CKD and other CV risk factors[18][21] - Key safety risks include ketoacidosis, volume depletion (especially in patients with impaired renal function or on loop diuretics), urosepsis, hypoglycemia (when used with insulin), necrotizing fasciitis of the perineum, and genital mycotic infections[20][22][23] - Common adverse reactions (≥5% incidence) include urinary tract infection, volume depletion, diarrhea, and hypoglycemia[26] About Lexicon Pharmaceuticals and Safe Harbor Lexicon Pharmaceuticals is a biopharmaceutical company leveraging its Genome5000™ platform, with a Safe Harbor statement on forward-looking statements - Lexicon's mission is to pioneer medicines using its unique Genome5000™ genomics target discovery platform[29] - The press release contains forward-looking statements based on current expectations, which are subject to risks and uncertainties that could cause actual results to differ materially[30]