Lexicon Pharmaceuticals, Inc. · NASDAQ:LXRX
Lexicon Pharmaceuticals — Q1 2024 Earnings Presentation
48 slides from Lexicon Pharmaceuticals's earnings presentation, May 2024
Slide 1: 1Q24 Earnings Presentation
1Q24 Earnings Presentation Lonnel Coats – Chief Executive Officer Jeffrey Wade – President and Chief Financial Officer Craig Granowitz, MD, PhD – Senior VP and Chief Medical Officer Tom Garner – Senior VP and Chief Commercial Officer
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: Opening Remarks
Opening Remarks wlexicon HERE. NOW. NEXT...
Slide 4: Lexicon's Patient-Focused Mission Results in Significant YTD Accomplishments
Lexicon’s Patient-Focused Mission Results in Significant 2024 YTD Accomplishments for Lexicon • Continued progress in commercial launch of INPEFA® (sotagliflozin) in heart failure • Resubmission of NDA for ZYNQUISTA™ (sotagliflozin) in type 1 diabetes expected mid- year 2024 Start-up ongoing for Pha
Slide 5: INPEFA (sotagliflozin) for Heart Failure
01 INPEFA® (sotagliflozin) for Heart Failure 5
Slide 6: Burden of Heart Failure in the United States Projected to Increase
Burden of Heart Failure (HF) in the United States is Projected to Increase by 2030 to 8.5 Million Patients and $70 Billion in Costs US Heart Failure Cost Burden 75B Forecasted Increase $69.7B Future 60% 50B US Estimate 8.5 million with HF1 $43.6B HF Mortality2 Current US Normal 27% 1-year‡ mortality
Slide 7: Hospitalizations and Re-Admissions Drive the Majority of HF Costs
Hospitalizations and Re-Admissions Drive the Majority of HF Costs ~25% of patients hospitalized for 17% Heart Failure Costs (Estimated) Hospitalizations are estimated to account for ~80% HF are readmitted within 30 days post discharge 2-3% of total heart failure costs Outpatient HF-related drug 1 in
Slide 8: The SGLT Class Is Positioned for Significant Growth in HF
The SGLT Class – including INPEFA – is Positioned for Significant Growth for the Treatment of HF 1 of 3 SGLT1&2 ~11% >70% SGLTs are recommended 1 of 3 SGLT inhibitors Despite Strong growth of foundation of HF indicated for heart endorsement, SGLT SGLT use in heart treatment in guidelines failure – a
Slide 9: Newest ACC Expert Consensus Pathway Statement References SGLT Inhibitors
Newest ACC Expert Consensus Pathway Statement References SGLT Inhibitors in Recognition of Sotagliflozin’s SGLT1 and SGLT2 Mechanism HFpEF1 HFrEF2 2023 Consensus Statement 2024 Consensus Statement "We now have evidence that both SGLT2 and SGLT1 ACC expert consensus statement highlighted the inhibito
Slide 10: INPEFA Awareness, Intent to Prescribe and HCP Satisfaction Continue to Increase
INPEFA Awareness, Intent to Prescribe and HCP Satisfaction Continue to Increase as Promotional Efforts Expand across Target Customers INPEFA FUTURE INTENT TO INPEFA HCP AWARENESS PRESCRIBE SATISFACTION 88% n=70 91% n=43 93% n=43 Source: Lexicon Q1 internal market research 10
Slide 11: INPEFA Targeting: ~150 Cardiovascular Specialists
INPEFA Targeting: ~150 Cardiovascular Specialists Focused on Highest Volume HF Prescribers FOCUSED TARGETING ~9,200 Priority HCP targets at launch Segment A Prioritized executional focus: ~2200 Segments A&B ~60% HF TRx volume HCPs Segment B ~2700 HCPs Primary focus is Cardiologists specializing in H
Slide 12: Highest Volume HF Prescribers Contributing to INPEFA Uptake
Highest Volume HF Prescribers are Contributing Significantly to INPEFA Uptake with Significant Headroom for Rapid Growth VOLUME BY SEGMENT ADOPTION WITHIN HCP SEGMENT A 18%, 405 2,289 D Segment, 23% HCP SEGMENT A-C B 13%, 361 2,745 Segments, 77% C 6%, 244 4,192 Source: Filled Rx data through Q1 2024
Slide 13: Total Prescribers Continue to Expand
Total Prescribers Have Continued to Expand with ~ 2K Cardiologists Having Initiated INPEFA for their HF Patients CUMULATIVE LTD TOTAL PRESCRIBERS ~1,900 ~1,300 ~680 8 Q2 Q3 Q4 Q1 Source: Filled Rx data through Q1 2024 LTD. Company estimated from multiple Rx sources. 13
Slide 14: INPEFA TRx Volume Grew by 26% in Q1 2024
INPEFA TRx Volume Grew by 26% in Q1 2024 CUMULATIVE TRX BY QUARTER 6,060 2770 3,290 2200 2200 1,090 1080 1080 1080 10 Q2'23 Q3'23 Q4'23 Q1'24 Source: Filled Rx data through Q1 2024 LTD. Company estimated from multiple Rx sources. 14
Slide 15: INPEFA Coverage Expected to Accelerate through 2H '24
INPEFA Coverage Expected to Accelerate through 2H ‘24 as Active Dialogue Progresses with Priority Payers % TOTAL LIVES COVERED AS CURRENT INPEFA FORMULARY COVERAGE BY CHANNEL OF MARCH 31, 2024* 82% 69% ~40% 32% 22% 11% 13% 6% 5% Covered In Active Negotiation Commercial Medicare Medicaid Health Excha
Slide 16: Zynquista (sotagliflozin) for Type 1 Diabetes
02 Zynquista™ (sotagliflozin) for Type 1 Diabetes 16
Slide 17: Type 1 Diabetes: Substantial Opportunity in an Area of High Unmet Need
Type 1 Diabetes: Substantial Opportunity in an Area of High Unmet Medical Need 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 Clinical results sugg
Slide 18: 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 type 1 diabetes (T1D) • Since FDA filing for T1D, significant data has been generated demonstrating benefits of sotagliflozin in hear
Slide 19: Significant Unmet Needs in T1D Shared by Population with CKD
Significant Unmet Needs in Type 1 Diabetes are Shared by – and Often Have Particular Importance in – Population of T1D with CKD Reducing glycemic Controlling Reaching A1C goal variability and complications such as without hyperglycemia improving time blood pressure and and hypoglycemia in range redu
Slide 20: Sotagliflozin Has Potential to Improve Glycemic Control for People with T1D and CKD
Sotagliflozin Has Potential to Improve Glycemic Control for People with T1D and CKD Illustrative Patient Journey Managing T1D with CKD Sotagliflozin Insulin or insulin Treatment for serious analogues kidney disease, CVD, or other complications All people with T1D are on insulin and vast majority con
Slide 21: Concentration of Prescribers Supports Efficient Commercial Opportunity
Concentration of Prescribers Supports Efficient Commercial Opportunity 92% of T1D is treated by 3,000 endocrinologists T1D Treatment Concentration Among Endocrinologists Geographic Distribution of T1D Treatment 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Top 1,000 Top 3,000 Endocrinologists Endocrin
Slide 22: Numerous Studies Underway Utilizing Sotagliflozin in T1D
Numerous Studies Underway Utilizing Sotagliflozin in T1D Opportunities for increased clinical evidence following potential approval and launch JDRF Awards $9 Million for Phase 3 Type 1 Diabetes Sotagliflozin in Patients with Clinical trial that will test sotagliflozin, Multifactorial Intervention He
Slide 23: Summary and Next Steps
Summary and Next Steps • NDA resubmission anticipated mid–2024 with potential for 6-month review • Anticipate Q1 2025 launch • Pre-launch planning and activities underway • Additional investments including field force planned for time of approval • Unmet need supports potential for broad adoption •
Slide 24: Sotagliflozin for HCM
O3 Sotagliflozin for HCM _ Egan
Slide 25: HCM Represents a Significant Opportunity for Sotagliflozin
Hypertrophic Cardiomyopathy (HCM) Represents a Significant Opportunity for Sotagliflozin • Sotagliflozin has the potential to address key unmet needs across HCM with strong scientific Broad proposed rationale indication (alone or in • Timing of potential sNDA approval could come combination) when di
Slide 26: FDA Feedback Supports Potential Sotagliflozin sNDA with Broad Label in HCM
FDA Feedback Supports Potential Sotagliflozin sNDA with Broad Label in HCM Based on Single Phase 3 Study Primary endpoint: Change from Proposed indication: Sotagliflozin is indicated to baseline in KCCQ Clinical Summary improve symptoms and physical limitations in adults Scale (CSS) score with sympt
Slide 27: Remaining Opportunities and Stakeholder Needs in HCM
Despite Recent Advances in HCM Treatment, Significant Opportunities and Stakeholder Needs Remain that Sotagliflozin May Address Sotagliflozin Beta Blocker (BB) +/- Cardiac Myosin Surgical Calcium Channel Inhibitor Intervention / Blocker (CCB) (CMI) Myectomy Patient HCP Payer Improve QoL with limited
Slide 28: LX9211 for Neuropathic Pain
04 LX9211 for Neuropathic Pain 28
Slide 29: LX9211 Has Potential to Redefine Standard of Care for DPNP
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 30: DPNP Represents Significant Unmet Medical Need
DPNP Represents Significant Unmet Medical Need Neuropathic Pain – DPNP Represents ~25% • Current standard of care of Total Addressable Market does not eliminate neuropathic pain for ~20 Million Patients most patients, and many experience undesirable side effects • Potential for first drug with a new
Slide 31: PROGRESS Phase 2b Study
PROGRESS Phase 2b Study – Patient Enrollment Underway, First Topline Data Read-out Expected in Q2 2025 Patient Population Treatment Period Safety Follow-up LX9211 10 mg Study Enrollment: LX9211 20 mg Adult patients ~400 patients, with a diagnosis R LX9211 20 mg for 7 days/10 mg thereafter ~100 patie
Slide 32: 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 The PROGRESS Study neuropathic pain market opportunity is designed to enab
Slide 33: LX9851 for Obesity and Weight Management
05 LX9851 for Obesity and Weight Management ‹#›
Slide 34: Chronic Weight Management with an Oral Agent
Chronic Weight Management with an Oral Agent Opportunities beyond initial weight loss with a GLP-1 receptor agonist: • Oral agent for chronic weight management • Reduction in body fat that spares lean body mass • Improved metabolic profile, with reduced cholesterol Weight and triglycerides, improved
Slide 35: Compelling Knockout Mouse Phenotype for Metabolism
Compelling Knockout (KO) Mouse Phenotype for Metabolism Acsl5 KO Exhibited Phenotype Countering All Aspects of the Metabolic Syndrome • Lean and resistant to diet-induced obesity • Decreased atherosclerotic plaque • Glucose tolerance with lower insulin levels • Resistant to hepatic steatosis in NASH
Slide 36: Phenotypic Screen Identified ACSL5 as Potential Metabolic Syndrome Target
Phenotypic Screen Identified ACSL5 as Compelling Potential Metabolic Syndrome Target Much Lower Cholesterol and Triglycerides and Modestly Lower Body Fat on Standard Diet % Body Fat LBM Characteristics of Acsl5 KO Phenotype Compared to Genome5000™ Assessment of Nearly 5,000 Genes Cholesterol Triglyc
Slide 37: High Fat Diet Revealed Potential for Reduced Body Fat with Preserved Lean Mass
High Fat Diet (HFD) Revealed Another Important Characteristic of Target: Potential for Reduced Body Fat with Preserved Lean Body Mass Acsl5 KO Mice on HFD Have Substantially Less Body Fat with No Difference in Lean Body Mass Standard Diet (Chow) High Fat Diet (HFD) 37
Slide 38: LX9851 and Semaglutide Combination Reduces Body Weight in DIO Mice
Combination of LX9851 and Semaglutide Demonstrates Greater Reduction in Body Weight in HFD-fed DIO Mice 52 Semaglutide, LX9851 and Combination 50 48 46 ** *** 44 Body Weight (g) * 42 ** 40 * *** *** ** ** *** 38 36 ** Control #1: PBS 34 Control #2: HPMC Semaglutide Semaglutide + 345 32 LP-960345 30
Slide 39: LX9851 Helps Maintain Weight Loss after Semaglutide Discontinuation
LX9851 Helps Maintain Weight Loss after Semaglutide Discontinuation in HFD-fed DIO mice 52 Semaglutide Withdrawal After Initial Weight Loss 50 48 46 * * Body Weight (g) 44 ** 42 * 40 38 * 36 ** *** ** Control #1: PBS 34 Semaglutide treatment Semaglutide (0-14); w/o (15-28) withdrawn after day 14 32
Slide 40: LX9851 Has a Unique Profile for Chronic Weight Management
LX9851 Has a Unique Profile with Potential to Address the Most Important Needs and Opportunities for Chronic Weight Management Opportunities beyond initial weight loss with a GLP-1 receptor agonist: Unique opportunity • Oral agent for chronic weight management in projected $41 billion • Reduction in
Slide 41: Financial Summary
O06 Financial Summary ee
Slide 42: Q1 2024 Financial Summary
Q1 2024 Financial Summary As of March 30, As of December 31, Q1 2024 Q1 2023 2024 2023 Total revenues $1.1M $0.02M Cash, cash equivalents and short-term $355.6M $170.0M Operating expenses investments Total assets $417.2M $229.4M R&D1 $14.4M $12.0M SG&A1 $32.1M $19.1M Long-term debt $99.9M $99.5M Tot
Slide 43: Summary, Pipeline and Catalysts
07 Summary, Pipeline and Catalysts 43
Slide 44: Leveraging Scientific Platform to Build Strong Pipeline Opportunities
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: Significant Number of Planned Catalysts Through 2025
Significant Number of Planned Catalysts Through 2025 Pipeline Indication Planned Catalyst 2024 – 2025 • Potential launch inflection in second half of INPEFA® (sotagliflozin) • INPEFA Heart Failure 2024 Sotagliflozin • Hypertrophic Cardiomyopathy • Phase 3 study commencement mid-2024 • Type 1 Diabete
Slide 46: Q&A
u Lexicon pharmaceuticals Q&A PRECISION SCIENCE. PIONEERING MEDICINE. PATIENT DRIVEN. COMMON
Slide 47: Lexicon Commitment to Growth and Expansion
Lexicon Commitment to Growth and Expansion Targeted Capital Allocation Partnership Opportunities Seamless Execution to Support Near- to Maximize Value Term Return Recent successful capital raise supports plans for execution 47
Slide 48: Thank You
u Lexicon pharmaceuticals Thank You PRECISION SCIENCE. PIONEERING MEDICINE. PATIENT DRIVEN. COMMON
Lexicon Pharmaceuticals — Q1 2024 Earnings Presentation on 6ix