Lexicon Pharmaceuticals, Inc. · NASDAQ:LXRX
Lexicon Pharmaceuticals — Investor Presentation (November 2023)
27 slides from Lexicon Pharmaceuticals's investor presentation, November 2023
Slide 1: Corporate Presentation
Corporate Presentation November 2023
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: Recently-Approved Drug and Lead Clinical Program Discovered Using Lexicon's Approach
Recently-Approved Drug and Lead Clinical Program Both Discovered Using Lexicon’s Unique Approach to Gene Science INPEFA® 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 pro
Slide 6: INPEFA (sotagliflozin) for Heart Failure
INPEFA® (sotagliflozin) for Heart Failure 6
Slide 7: INPEFA Recently Approved and Commercially Launched for Treatment of Heart Failure
INPEFA® (sotagliflozin) Recently 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 le
Slide 8: 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. is heart failure in the US (in 2019) ~8.5 million heart failure 2
Slide 9: 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 2022 2023 AHA/ACC/HFSA Joint Guideline for the Management of ACC Expert Consensus Decision Pathway on Management Heart Failure specifically recommend SGLT inhibitors
Slide 10: Updated Guidelines and Clinical Data Are 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 As of August 2023, INPEFA is 1 of 3 SGLT SGLT use in heart failure has only ~1 in 10 heart failure inhibitors indicated for heart grown by 73% year over year prescriptions
Slide 11: INPEFA was Studied in Two Pivotal Trials
INPEFA was Studied in Two Pivotal Trials with Unique and High-risk Patient Populations The SOLOIST study evaluated the efficacy and safety of INPEFA in The SCORED study evaluated INPEFA in patients with patients with worsening HF, regardless of EF comorbidities and CV risk factors, regardless of EF
Slide 12: INPEFA Labeled with Reduction in CV Death and HF Events
INPEFA Labeled with Reduction in 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 for heart failure, and urgent heart fail
Slide 13: INPEFA Reduced CV Death and HF Events by 50% Over First 30 and 90 Days
INFEFA 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 Early effect of INPEFA Sotagliflozin demonstrated in reduction of 30-day Hospital Readmissions 5 0 0 15 30 45 60 75 90 Days Post - Discharge Pitt B
Slide 14: INPEFA Launch Scorecard
INPEFA Launch Scorecard: Q3 Has Seen a Significant Ramp in Commercialization Activity and Output Demand Generation Formulary Access ▪ Driving awareness and broad adoption of ▪ Focused on national and regional payer plans, INPEFA among prescribers who treat the most with all targeted plans actively e
Slide 15: Significant Commercial Opportunity for INPEFA
Significant Commercial Opportunity for INPEFA Updated Heart Focused Commercial Failure Treatment Strategy Guidelines Newly or Recently Hospitalized and Worsening Heart Failure Patients Growing Unmet Highlighting Medical Clinical Data in Unique Need Patient Population 15
Slide 16: LX9211 for Neuropathic Pain
02 LX9211 for Neuropathic Pain 16
Slide 17: LX9211 Has the Potential to Redefine the 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 NEED PROOF OF CONCEPT ACHIEVED • More than 20 million Americans • The RELIEF-DPN-1 and experience neuropathic pain RELIEF-PHN-1 studies support • Approximatel
Slide 18: 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 19: 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 20: 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 21: 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 21
Slide 22: LX9211 Advancing into Late-stage Development in DPNP
LX9211 Advancing into Late-stage Development in DPNP • DPNP represents the largest market opportunity indication within neuropathic pain • FDA feedback obtained in Q2 2023 and has been adapted into the development plan • Average Daily Pain Score (ADPS) will continue to be the primary endpoint of the
Slide 23: The PROGRESS Study – Enrollment Begins in December, Read-out Q2 '25
The PROGRESS Study – Patient Enrollment Will Begin in December, First Data Read-out Expected in Q2 ‘25 Safety Patient Open Label Follow- Blinded Treatment Period Treatment Period up Population Period LX9211 10 mg • Adult patients with a LX9211 20 mg diagnosis of T1DM or LX9211 10 mg T2DM with modera
Slide 24: Financial Information and Q3 Summary
03 Financial Information and Q3 Summary 24
Slide 25: Q3 2023 Financial Summary
Q3 2023 Financial Summary Q3 2023 Q3 2022 As of Sept 30, 2023 As of Dec 31, 2022 Total revenues $0.16M $0.039M Cash, cash equivalents and short-term $218.4M $138.4M Operating expenses investments Total assets $276.5M $194.3M R&D1 $17.6M $10.6M SG&A1 $32.2M $12.6M Long-term debt $99.3M $48.6M Total o
Slide 26: Lexicon Q3 2023: Meaningful Progress and Growth of INPEFA
Lexicon Q3 2023: Meaningful Progress and Growth of INPEFA Coupled with Significant Advancement of LX9211 Program Launch of INPEFA into large and fast- LX9211 moves into late-stage development growing heart failure market for DPNP – FDA Fast Track ❖ INPEFA granted a broad label across full range ❖ Su
Slide 27: Thank You
u Lexicon pharmaceuticals Thank You PRECISION SCIENCE. PIONEERING MEDICINE. PATIENT DRIVEN. COMMON
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