Lexicon Pharmaceuticals, Inc. · NASDAQ:LXRX
Lexicon Pharmaceuticals — Investor Presentation (March 2024)
48 slides from Lexicon Pharmaceuticals's investor presentation, March 2024
Slide 1: Corporate Presentation
Corporate Presentation March 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements • This presentation, including any oral presentation accompanying it, contains “forward-looking statements,” including statements about Lexicon’s strategy and operating performance and events or developments that we expect or anticipate will occur in the future, such as pr
Slide 3: Lexicon's Evolution from a Unique Foundation in Mammalian Genetics
Lexicon’s Evolution from a Unique As Lexicon continues to evolve, we remain steadfast in our mission Foundation in Mammalian Genetics to bring new therapeutic solutions to patients in need. The resulting resource provides us with unique Advancing from perspective and In 2023 we took the next the fou
Slide 4: Leveraging Scientific Platform and Expertise to Build Strong Pipeline
Lexicon – Leveraging Scientific Platform and Expertise to Build Strong Pipeline Opportunities for Growth and Partnership Preclinical Phase 1 Phase 2 Phase 3 Registration Approved INPEFA® (sotagliflozin) Approved for Heart Failure Zynquista™ (sotagliflozin) Type 1 Diabetes (Preparation for NDA Resubm
Slide 5: INPEFA Approved and Commercially Launched for Treatment of Heart Failure
INPEFA® (sotagliflozin) Approved and Commercially Launched for Treatment of Heart Failure INPEFA granted broad INPEFA reduced the risk of total Recently adopted guidelines label in heart failure (HF), occurrence of cardiovascular death, support use of SGLT inhibitors across full range of left hospit
Slide 6: Sotagliflozin Inhibits Two Targets With Important Cardiometabolic Profiles
Sotagliflozin Inhibits Two Targets With Important Cardiometabolic Profiles Sotagliflozin is an oral inhibitor of sodium-glucose cotransporters -1 (SGLT1) and -2 (SGLT2), responsible for absorption (or reabsorption) of sodium and glucose Proximal convoluted tubule (S1) SGLT2 SGLT2 is expressed in the
Slide 7: Elevations of SGLT1 and SGLT2 Associated with Heart Failure and Cardiometabolic Diseases
Elevations of SGLT1 and SGLT2 are Separately Associated with Heart Failure and Other Cardiometabolic Diseases Left ventricle: Kidney: SGLT1 elevated in SGLT2 elevated in • Heart failure1-4 • Diabetic nephropathy6 • Dilated cardiomyopathy1 • Heart failure7,a • Ischemic heart disease with/without type
Slide 8: Human Genetics Provides Further Support for SGLT1 as a Target
Human Genetics Provides Further Support for SGLT1 as a Target for Heart Failure and Cardiometabolic Disease Naturally-Occurring SGLT1 Reduced Function Variant8 Adjusted HR (95% CI) P Value 0.81 Incident diabetes 0.006 (0.69–0.94) 0.74 Heart failure 0.0046 (0.60‒0.91) 0.80 Risk of HF or death 0.00089
Slide 9: Zynquista (sotagliflozin) for Type 1 Diabetes
01 Zynquista™ (sotagliflozin) for Type 1 Diabetes 9
Slide 10: Type 1 Diabetes: Substantial Opportunity in Area of High Unmet Need
Type 1 Diabetes: Substantial Opportunity in Area of High Unmet Medical Need – Up to $1B Opportunity US EPIDEMIOLOGY Type 1 diabetes is a form 1.7M 21% of diabetes mellitus with complete adults have Chronic insulin deficiency due to destruction with T1D1 Kidney Disease2 of beta cells in the pancreas
Slide 11: Preparing to Resubmit NDA for Type 1 Diabetes with CKD
Following FDA Feedback, Lexicon is Preparing to Resubmit NDA for Type 1 Diabetes with CKD • Sotagliflozin studied in largest-ever Phase 3 program for an oral agent in T1D • Since FDA filing for T1D, significant data has been generated demonstrating benefits of sotagliflozin in heart failure, MACE, a
Slide 12: Largest-Ever Phase 3 Program for an Oral Agent in Type 1 Diabetes
Largest-Ever Phase 3 Program for an Oral Anti-Diabetic Agent in Type 1 Diabetes Pivotal Studies 2,980 T1D Patients Optimized inTandem1 inTandem2 Insulin N=793 N=782 Placebo, 200 and 400 mg QD Placebo, 200 and 400 mg QD Global Study inTandem3 N=1,405 Placebo, 400 mg QD Confidential 12
Slide 13: Sotagliflozin Achieved Primary Endpoint, Improving A1C on Top of Optimized Insulin
Sotagliflozin Achieved Primary Endpoint, Significantly Improving A1C on Top of Optimized Insulin inTandem11 inTandem22 A1C, Baseline (%) 7.5 7.6 7.6 7.8 7.7 7.7 Week 24 (%) 7.5 7.2 7.1 7.8 7.4 7.4 N=268 N=263 N=262 N=258 N=261 N=263 0.5 0.5 LS Mean A1C Change from Baseline 0 0 (Absolute %) -0.02 [SE
Slide 14: Better Glycemic Control Important for People with T1D and CKD
Better Glycemic Control is Particularly Important for People with T1D Who Have Chronic Kidney Disease (CKD) Higher Glucose in People with T1D is Associated with More Rapid Progression of Chronic Kidney Disease Confidential Shah HS et al. J Clin Endocrinol Metab. Published online ahead of print Janua
Slide 15: SCORED Data Shows Reduction in Progression of CKD
SCORED Data in Type 2 Diabetes Patients Shows Evidence of Reduction in Progression of CKD Sotagliflozin Placebo HR Endpoint n/N (%) n/N (%) (95% CI) p-value eGFR ↓ 57%, ESKD, renal or CV death 215 (4.1) 273 (5.2) 0.78 (0.65, 0.93) 0.0061 eGFR ↓ 50%, ESKD, renal or CV death 239 (4.5) 306 (5.8) 0.77 (
Slide 16: Consistent Glycemic Control Benefits in T1D Population with CKD
Sotagliflozin Achieved Consistent Glycemic Control Benefits in T1D Population with CKD, with Similar Safety on Key Measures Pooled Data from inTandem1 and inTandem2 Entire Cohort CKD Cohort Sotagliflozin Sotagliflozin Sotagliflozin Sotagliflozin Placebo Placebo 200mg 400mg 200mg 400mg N=526 N=76 N=5
Slide 17: Potential Benefits for People with Type 1 Diabetes with CKD
Sotagliflozin Offers Important Potential Benefits for People with Type 1 Diabetes with CKD People with T1D and poor Improving A1C in people with glucose control have T1D is associated with reduced greater progression to CKD risk of CKD progression People with T1D and CKD Sotagliflozin reduced the ha
Slide 18: INPEFA for Heart Failure and Expansion Opportunities in Cardiovascular Medicine
02 INPEFA (sotagliflozin) for Heart ® Failure and Expansion Opportunities in Cardiovascular Medicine 18
Slide 19: Heart Failure: Substantial and Growing Public Health Problem
Heart Failure represents a Substantial and Growing Public Health Problem, with High Patient Burden and Costs Driven by Repeat Hospitalizations ~6.7 #1 1.3 million hospitalizations million heart failure cause of admissions to for heart failure annually prevalence in the U.S. hospital for Americans 65
Slide 20: Heart Failure is a Large and Fast-Growing Market with the SGLT Class
Heart Failure is a Large and Fast-Growing Market with the SGLT Class – including INPEFA – Positioned for Significant Growth 1 of 3 SGLT inhibitors SGLTs are recommended Despite guideline Strong Growth of SGLT indicated for heart foundation of HF endorsement SGLT use in heart failure1 is failure – an
Slide 21: First SGLT Inhibitor Labeled with Reduction of CV Death and HF Events
INPEFA is the First and Only SGLT Inhibitor Labeled with a Reduction of CV Death and HF Events in Patients Initiated on Therapy in the Hospital or Promptly Following Discharge 98 100 SOLOIST-WHF Primary Endpoint Data: Placebo INPEFA reduced the risk of total occurrence of CV death, hospitalization f
Slide 22: INPEFA Reduced CV Death and HF Events by 50% Over First 30 and 90 Days
INPEFA Reduced CV Death and HF Events by 50% Over the First 30 and 90 Days Post Discharge 20 Placebo Cardiovascular Death or HF-Related Event (%) 15 10 INPEFA is the Only SGLT Sotagliflozin Inhibitor to Demonstrate a Significant Reduction in 30-day Hospital 5 Readmissions 0 0 15 30 45 60 75 90 Days
Slide 23: INPEFA Total Prescribers Expanded Throughout Q4
INPEFA 2023 LTD Total Prescribers have Continued to Expand throughout Q4 to 1,313 from 686 in Q3 (91% growth QoQ) 2023 Cumulative LTD Total Prescribers Q2, Q3, Q4 1,313 686 8 Q2 Q3 Q4 Confidential 23 Source: Filled Rx data through Q4 2023 LTD. Company estimated from multiple Rx sources.
Slide 24: Submitted Rx's Accelerated Through Q4
Submitted Rx’s have continued to accelerate through Q4 demonstrating broadening adoption of INPEFA (64% growth QoQ) 2023 Cumulative LTD Submitted Rx’s LTD Through Q4 2023 12,184 Rx fill rate increased by a relative 22% Q4/Q3 4611 10 Q2 Q3 Q4 unique From 1,313 HCP’s in 2023 Confidential 24 *Submitted
Slide 25: INPEFA Coverage Continued to Expand Through Q4 2023
INPEFA Coverage Continued to Expand Through Q4 2023 Expected Expansion from Current Coverage and Reduction of Utilization Management Expected to Open Opportunity for Accelerating Growth in 2H 2024 % TOTAL LIVES COVERED Current INPEFA Formulary Coverage by Channel AS OF DECEMBER 31, 82% 2023* 69% ~42
Slide 26: Expected Expansion of Coverage Would Build on Early Successes
Expected Expansion of Coverage Would Build on Early Successes Already Achieved with Key Plans in Q3 and Q4 2023 Selected Accounts Current Market Access Status Plan Name/Formulary Channel Effective Date CVS/Aetna EQWP Medicare 12/1/2023 Express Scripts – Premier Access Medicare 11/1/2023 Express Scri
Slide 27: What Customers are Telling Us about INPEFA
What Customers are Telling Us about INPEFA Product Promise: The INPEFA product promise resonates strongly with Cardiologists in helping patients to feel better by improving symptoms while reducing events Product Differentiation: INPEFA can benefit from SGLT inhibitor class growth while also differen
Slide 28: Life-Cycle Management Opportunity for Sotagliflozin in HCM
Life-Cycle Management Opportunity for Sotagliflozin in HCM Hypertrophic Cardiomyopathy (HCM) Extended IP Protection for INPEFA Offers Runway for High Value Label ▪ Indication with strong scientific rationale and that would be Expansion Opportunities unique to sotagliflozin among SGLT inhibitors ▪ Si
Slide 29: Sotagliflozin Efficacy Data Across LVEF Points to Potential in HCM
To TOP Sotagliflozin’s Efficacy Data Across LVEF is Compelling for Heart Failure... And Points to Potential Life-Cycle Management Opportunity in HCM Treatment effect of sotagliflozin was observed in SOLOIST and SCORED patients, regardless of LVEF • Pooled analysis of all HR Treatment Effect vs LVEF
Slide 30: SCORED Data in Patients with LVH Without Hypertension
SCORED Data in Patients with Left Ventricular Hypertrophy without Hypertension Offer Perspective on Potential Application in Patients with HCM Sotagliflozin Reduces the Risk of Cardiovascular Events in Patients With Left Ventricular Hypertrophy Without Hypertension: A Post Hoc Analysis From SCORED •
Slide 31: FDA Feedback Supports Potential Sotagliflozin sNDA for HCM
FDA Feedback Supports Potential for Sotagliflozin sNDA for HCM Based on Single Successful Phase 3 Study with KCCQ Primary Endpoint Primary endpoint: Change from baseline in KCCQ Clinical Summary Scale (CSS) score Proposed indication: INPEFA is indicated to improve symptoms and physical limitations i
Slide 32: Significant Opportunities and Stakeholder Needs Remain in HCM
Despite Recent Advances for the Treatment of HCM, Significant Opportunities and Stakeholder Needs Remain as Disease Progresses Illustrative HCM Patient Journey Beta Blocker (BB) +/- Calcium Channel Cardiac Myosin Blocker (CCB) Inhibitor (CMI) INPEFA Surgical Intervention/Myectomy •Improve •Improve •
Slide 33: LX9211 for Neuropathic Pain
03 LX9211 for Neuropathic Pain 33
Slide 34: LX9211 Potential to Redefine Standard of Care for DPNP – Fast Track
LX9211 has the Potential to Redefine the Standard of Care for Patients Suffering with DPNP – Fast Track Designation by FDA HIGH UNMET MEDICAL PROOF OF CONCEPT NEED ACHIEVED LATE-STAGE CLINICAL POTENTIAL FOR DEVELOPMENT SIGNIFICANT UNDERWAY COMMERCIAL OPPORTUNITY Patient Data: Decision Resources Grou
Slide 35: DPNP: Potentially Significant Commercial Opportunity
DPNP represents a Potentially Significant Commercial Opportunity with High Unmet Medical Need Neuropathic Pain Market ~ 20 Million Patients in the U.S. • 20 million+ Americans experience neuropathic pain • Approximately 5 million DPNP patients in the U.S. • Current standard of care does not eliminat
Slide 36: Lexicon Identified AAK1 as Most Compelling Target for Neuropathic Pain
Lexicon Identified AAK1 as the Most Compelling Target for Neuropathic Pain among the Nearly 5,000 Targets Evaluated in the Genome5000 Program Genome5000 Supported Selection of AAK1 over Other Putative Genetic Knockouts of AAK1 Demonstrated Targets with Less Compelling Profiles for Neuropathic Pain R
Slide 37: Phase 2 Study of LX9211 in DPNP Designed to Demonstrate Effect Versus Placebo
Phase 2 Study of LX9211 in Diabetic Peripheral Neuropathic Pain was Designed to Demonstrate Effect Versus Placebo RELIEF-DPN-1: Efficacy, Safety, and PK of LX9211 in Patients with Diabetic Peripheral Neuropathic Pain (DPNP) Single-blind Screening Period Placebo Double-blind Treatment Single-blind Sa
Slide 38: LX9211 Achieved the Primary Endpoint in RELIEF-DPN-1
LX9211 Achieved the Primary Endpoint in RELIEF-DPN-1 Clinically and statistically significant reduction in average daily pain score (ADPS) at Week 6 compared to placebo* in the low dose arm with results that plateaued in the high dose arm Effect on ADPS consistent across age, sex, use of baseline DP
Slide 39: Benefits Demonstrated in Burning Pain and Pain Interference with Sleep
Significant and Clinically Meaningful Benefits Demonstrated in Both Burning Pain and Pain Interference with Sleep Both are commonly reported challenges experienced by DPNP patients LS MEAN CHANGE FROM BASELINE LS MEAN CHANGE FROM BASELINE IN BURNING PAIN IN INTERFERENCE IN SLEEP Confidential 39
Slide 40: PROGRESS Phase 2b Study – Enrollment Underway
PROGRESS Phase 2b Study – Patient Enrollment Underway, First Topline Data Read-out Expected in Q2 ‘25 Patient Safety Follow-up Treatment Period Population LX9211 10 mg • Adult patients with a LX9211 20 mg diagnosis of T1DM or T2DM with moderate R LX9211 20 mg for 7 days/10 mg thereafter to severe di
Slide 41: LX9211 Has Entered Late-stage Development for DPNP
LX9211 Has Entered Late-stage Development for DPNP • Potential first-to-market opportunity with very few novel treatments in development for DPNP or neuropathic pain generally • DPNP represents the largest and fastest growing neuropathic pain market opportunity • FDA feedback obtained in Q2 2023 and
Slide 42: Summary and 2024 Areas of Focus
04 Summary and 2024 Areas of Focus 42
Slide 43: Lexicon in 2024 – Key Business Objectives
Lexicon in 2024 – Key Business Objectives Progress Further Accelerate Resubmit NDA for Opportunities for Launch of INPEFA T1D with CKD & Partnership, for Heart Failure Advance LX9211 for Growth and DPNP Expansion Confidential 43
Slide 44: Leveraging Scientific Platform and Expertise to Build Strong Pipeline
Lexicon – Leveraging Scientific Platform and Expertise to Build Strong Pipeline Opportunities for Growth and Partnership Preclinical Phase 1 Phase 2 Phase 3 Registration Approved INPEFA® (sotagliflozin) Approved for Heart Failure Zynquista™ (sotagliflozin) Type 1 Diabetes (Preparation for NDA Resubm
Slide 45: Financial Summary & Upcoming Catalysts
04 Financial Summary & Upcoming Catalysts 45
Slide 46: Q4 2023 Financial Summary
Q4 2023 Financial Summary Q4 2023 Q4 2022 As of Dec 31, 2023 As of Dec 31, 2022 Total revenues $0.67M $0.00M Cash, cash equivalents and short-term $170.0M $138.4M Operating expenses investments Total assets $229.4M $194.3M R&D1 $14.8M $14.0M SG&A1 $32.6M $16.3M Long-term debt $99.5M $48.6M Total ope
Slide 47: Planned Catalyst Calendar 2024 – 2025
Planned Catalyst Calendar 2024 – 2025 Key Program Planned Catalyst 2024 – 2025 INPEFA Heart Failure Launch inflection in back half of 2024 INPEFA & Sotagliflozin Hypertrophic Cardiomyopathy Phase 3 study commencement mid-2024 Type 1 Diabetes with Chronic Kidney Resubmit NDA mid-2024; 6 month Disease
Slide 48: Thank You
u Lexicon pharmaceuticals Thank You PRECISION SCIENCE. PIONEERING MEDICINE. PATIENT DRIVEN. COMMON
Lexicon Pharmaceuticals — Investor Presentation (March 2024) on 6ix