Lexicon Pharmaceuticals, Inc. · NASDAQ:LXRX
Lexicon Pharmaceuticals — Investor Presentation (August 2023)
26 slides from Lexicon Pharmaceuticals's investor presentation, August 2023
Slide 1: Corporate Presentation August 2023
Corporate Presentation August 2023 Lonnel Coats – Chief Executive Officer Jeffrey Wade – President and Chief Financial Officer Craig Granowitz, MD, PhD – Senior VP and Chief Medical 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: Our Mission
OUR MISSION Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives 3
Slide 4: Taking Flight – Our Story
TAKING FLIGHT – OUR STORY PIONEERING THE FUTURE Pioneering the future with a unique application of gene science, Lexicon discovers and develops Our approach to defining target proteins has so far 5. This year, we are taking the innovative and precise medicines for people next major step in our led t
Slide 5: Newly-Approved Drug and Lead Clinical Program Discovered Using Gene Science
Newly-Approved Drug and Lead Clinical Program Both Discovered Using Lexicon’s Unique Approach to Gene Science INPEFA™ NOW APPROVED FOR HEART FAILURE LX9211 NEUROPATHIC PAIN • INPEFA™ (sotagliflozin) is an oral drug that inhibits two • LX9211 is a potent, orally delivered, selective small molecule pr
Slide 6: Now Approved: INPEFA (sotagliflozin) for Treatment of Heart Failure
Now Approved: INPEFA™ (sotagliflozin) 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 hospitalization for HF, and
Slide 7: Cycle of Heart Failure Hospitalizations Presents an Increasingly Costly Challenge
Cycle of Heart Failure Hospitalizations Presents an Increasingly Costly Challenge ~6.7 #1 cause of hospitalizations 1.3 million hospitalizations million heart failure for Americans 65+ for heart failure annually prevalence in the U.S. (in is heart failure in the US 2019) ~8 million heart failure 25%
Slide 8: New Guidelines Recommend SGLT Inhibitors for all Heart Failure Patients
New Guidelines Recommend SGLT Inhibitors for all Heart Failure Patients – Regardless of Left Ventricular Ejection Fraction HFrEF HFpEF 2021 2022 2023 ESC Guidelines recommend SGLT AHA/ACC/HFSA Joint Guideline for ACC Expert Consensus Decision Pathway on inhibitors with other pharmacological the Mana
Slide 9: Updated Guidelines and Clinical Data Fueling Growth of HF-indicated SGLT Inhibitors
Updated Guidelines and Clinical Data Are Fueling Growth of the HF- indicated SGLT Inhibitors, with Substantial Opportunity Ahead SGLT use in Heart Failure As of early 2023, INPEFA is 1 of 3 SGLT In 2022, about 1 in 10 overall has more than fewer than 1 in 10 heart inhibitors currently patients recei
Slide 10: INPEFA Studied in Two Pivotal Trials with High-risk Patient Populations
INPEFA™ was Studied in Two Pivotal Trials with Unique and High-risk Patient Populations The SOLOIST study evaluated the efficacy and safety of INPEFA™ The SCORED study evaluated INPEFA™ in patients with in patients with worsening HF, regardless of EF comorbidities and CV risk factors, regardless of
Slide 11: Patient Journey: Hospitalization to Discharge
Patient Journey: Hospitalization to Discharge SEVERIT Y Acute Decompensation Hospital Discharge • Normalize hemodynamics • Perform diagnostic workup • Treat reversible triggers Clinical Stabilization • Introduce sequential GDMT • Discuss adherence/lifestyle • Set up outpatient care Outpatient Optimi
Slide 12: Primary Efficacy: Reduced Risk of CV Death, HF Hospitalization and Urgent HF Visits
Primary Efficacy: Reduced the risk of total occurrence of CV death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to placebo 98 100 Placebo 80 70 Events Per 100 Patients 60 Sotagliflozin 40 HR 0.67 (95% CI 0.52-0.85), P=0.0009 20 ARR: 25 Events Per 100 Patient-Ye
Slide 13: CV Death and HF Events Reduced by 50% Over First 90 Days Post Discharge
CV Death and HF Events Reduced by 50% Over the First 30 and 90 Days Post Discharge 20 Placebo Cardiovascular Death or HF-Related Event (%) 15 10 Sotagliflozin 5 0 0 15 30 45 60 75 90 Days Post - Discharge Pitt B et al. AHA 2022. 13
Slide 14: Generating Demand Post Launch with Targeted Initiatives
Generating Demand Post Launch with Targeted Initiatives LAUNCH FOCUS GOAL EXECUTION Generate demand Establish INPEFA as Drive urgency and need to initiate HF with heart failure the standard of care Guideline Directed Medical Therapy experts, high-volume for hospitalized heart both in and out of the
Slide 15: Available at Launch: Patient Support Offerings
Available at Launch: Patient Support Offerings Lexicon is committed to helping eligible patients who have been prescribed INPEFA gain appropriate access by offering various programs and resources through our INPEFA Together platform. 15
Slide 16: Significant Commercial Opportunity for INPEFA
Significant Commercial Opportunity for INPEFA™ Updated Heart Focused Commercial Failure Treatment Strategy Guidelines Transition of Care Heart Failure Patients Growing Unmet Highlighting Medical Clinical Data in Unique Need Patient Population 16
Slide 17: AAK1 is a Novel Target for Neuropathic Pain
AAK1 is a Novel Target for Neuropathic Pain AAK1: AP2-associated protein kinase 1 AAK1 Knockout Mice ▪ AAK1 regulates clathrin-mediated endocytosis Spinal Nerve Ligation Model ▪ AAK1 knockout mice were resistant to development of neuropathic pain ▪ Mechanism of action: – does not involve the opioid
Slide 18: RELIEF-DPN-1: Efficacy, Safety, and PK of LX9211 in DPNP
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 Safety (Up to 2 Weeks) Run-in Period Period (6 Weeks) Follow-up Period (5 Weeks) (2 Weeks) Patients with LX9211 100
Slide 19: LX9211 Achieved the Primary Endpoint in RELIEF-DPN-1
LX9211 Achieved the Primary Endpoint in RELIEF-DPN-1 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 DPNP medications,
Slide 20: Significant Benefits in Burning Pain and Pain Interference with Sleep
Significant Benefits Demonstrated in Both Burning Pain and On Pain Interference with Sleep LS MEAN CHANGE FROM BASELINE LS MEAN CHANGE FROM BASELINE IN BURNING PAIN IN INTERFERENCE IN SLEEP 20
Slide 21: Positive FDA Feedback on Late-Stage Development Program
Positive FDA Feedback on Late-Stage Development Program Alignment on: Potential for inclusion of “early Plans for dose Phase 3 Study Use of ADPS as onset of pain selection for Designs primary endpoint relief with Phase 3 persistent effect” in label ADPS= average daily pain score 21
Slide 22: LX9211 Late-Stage Development Plan in DPNP
LX9211 Late-Stage Development Plan in DPNP Launch of new Phase 2b study is the 1st step towards approval Strategy of employing Phase 2b study with open- label extension running in parallel with Phase 3 is Phase 2b Start-up Enrollment Open Label Extension designed to enable satisfaction of regulatory
Slide 23: LX9211: Promising Profile and Substantial Opportunity
LX9211: Promising Profile and Substantial Opportunity UNMET MEDICAL NEED PROOF OF CONCEPT ACHIEVED • More than 20 million Americans • The RELIEF-DPN-1 and experience neuropathic pain RELIEF-PHN-1 studies • Approximately 5 million DPNP patients in support AAK1 inhibition the U.S. in 2022 as a potenti
Slide 24: Q2 2023 Financial Summary
Q2 2023 Financial Summary Q2 2023 Q2 2022 As of June 30, 2023 As of Dec 31, 2022 Total revenues $0.32M $0.035M Cash, cash equivalents and short-term $256.7M $138.4M Operating expenses investments Total assets $316.7M $194.3M R&D1 $14.5M $13.4M SG&A1 $30.0M $10.7M Long-term debt $98.8M $48.6M Total o
Slide 25: Q2 2023: A Productive Quarter
Q2 2023: A Productive Quarter Advancement of AAK1-inhibitor LX9211 into Launch of INPEFA into large and fast-growing late-stage development in neuropathic pain heart failure market • Supported by data from Phase 2 proof-of-concept • INPEFA received FDA approval for the treatment of studies in both d
Slide 26: Thank You
u Lexicon Pharmaceuticals Thank You PRECISION SCIENCE. PIONEERING MEDICINE. PATIENT DRIVEN. COMMON
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