Slides
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1 First Quarter 2025 Earnings Presentation May 13, 2025
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2 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 projections of our future results of operations or of our financial condition, the potential therapeutic and commercial potential of pilavapadin (LX9211), LX9851, sotagliflozin and our other drug programs, the success of our commercialization efforts with respect to INPEFA® (sotagliflozin) and any other approved products, the results of and expected timing of the completion of ongoing and future clinical trials, the expected timing and outcome of discussions with regulatory authorities regarding such trials and any applications for approval based on such trials, our other research and development efforts, and the anticipated trends in our business. • These forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by such forward-looking statements. • Information identifying such important factors is contained in our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, including the sections entitled “Risk Factors,” as well as our current reports on Form 8-K, in each case filed with the Securities and Exchange Commission. • Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
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3 Mike Exton, PhD Director and Chief Executive Officer Business Overview
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4 Significant strategic objectives achieved in 2025 Company Overview Exclusive worldwide licensing agreement with Novo Nordisk for LX9851 Pilavapadin (LX9211) PROGRESS readout identified de-risked dose to move into Phase 3 trials (10mg) Reduced debt and strengthened financial position Well-positioned to continue advancing and investing in innovative R&D pipeline
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5 Pilavapadin 10 mg has consistently delivered clinically meaningful pain reduction *Pilavapadin (LX9211) 100/10 mg : included 100 mg as day 1 loading dose **Pilavapadin (LX9211) 20 mg for 7 days and then 10 mg thereafter PROGRESS Phase 2b ADPS Reduction Time Series -2.0 -1.5 -1.0 -0.5 0.0 LS Mean Change from Baseline Phase 2 results suggest clinical development plan de -risked for Phase 3 PLACEBO Pilavapadin RELIEF Phase 2a ADPS Reduction Time Series -2.0 -1.5 -1.0 -0.5 0.0 LS Mean Change from Baseline PLACEBO RELIEF 100/10mg** PROGRESS 10mg PROGRESS 20/10 mg*
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6 9M people living with diabetes suffer from DPNP1 1 in 4 people living with Diabetes suffer from DPNP . By 2035, there will be 13M DPNP patients in the U.S.1 70% of patients with neuropathic pain do not achieve partial pain management2 Neuropathic pain has a significant impact on quality of life for patients and caregivers 60% of DPNP patients treated go on to switch or add on therapies3 Most patients are stuck in a cycle of trial and failure with current treatment options 1 Includes diagnosed patients only, CDC National Diabet es St atistics Report 2024. Source: prevalence rate of DPNP in diabetic s is based on primary and secondary research; Source: Clearview Analysis. 2. Rosenberger DC, Blechschmidt V, Timmerman H, Wolff A, Treede RD. Challenges of neuropathic pain: focus on diabetic neuropathy. J Neural Transm (Vienna). 2020 Apr;127(4):589 -624. doi: 10.1007/s00702 -020-02145-7. Epub 2020 Feb 8. PMID: 32036431; PMCID: PMC7148276. 3. Veeva Compass data; based on internal Lexicon claims analysis 9M people in the U.S. living with diabetes suffer from DPNP1 1 in 4 people in the U.S. living with diabetes suffer from DPNP . By 2035, projected that there will be 13M DPNP patients in the U.S.1 70% of patients with neuropathic pain do not achieve partial pain management2 Neuropathic pain has a significant impact on quality of life for patients and caregivers 60% of DPNP patients treated go on to switch or add on therapies3 Most patients are stuck in a cycle of trial and failure with current treatment options Pilavapadin Neuropathic pain: A highly prevalent chronic condition with significant unmet need
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7 HCM: A significant and underpenetrated market Sotagliflozin HCM 30% Diagnosed with nHCM 70% Diagnosed with oHCM ~1% Market penetration ~1.1 million people in the U.S. have either obstructive or non-obstructive HCM1 43% Progressive heart failure 1. CVrg Market Strategies. Cardiovascular Resource Group, Oct. 2023.
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8 Sotagliflozin in HCM Broad proposed indication for both nHCM and oHCM with potential for use alone or in combination Once-daily oral dosing enables broad adoption with no REMS Approved for heart failure with no observed increased risk of AFIB to date Recent understanding of HCM market underscores potential for sotagliflozin Sotagliflozin HCM Sotagliflozin is well-positioned with potential for broad use in HCM if approved
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9 SONA T APhase 3 study for oHCM and nHCM Sotagliflozin 400 mg* (N = 250) Placebo (N = 250) R 1:1 Up to 14 days screening 4-week Follow-up26-week double-blind treatment period Global Phase 3 SONATA Trial Inclusion Criteria • Adults with HCM (obstructive/non-obstructive) • LVEF ≥50% • KCCQ23 CSS <85 • NYHA Class II or III Primary Endpoints • Change from baseline in KCCQ Clinical Summary Scale (CSS) score Enrollment underway Only ongoing trial to evaluate both obstructive and non-obstructive HCM Potential for supplemental new drug application (sNDA) with broad label Sotagliflozin HCM
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10 Strategic deal with Novo Nordisk allows LX9851 to "enter the majors" LX9851 Exclusive, worldwide license to develop, manufacture and commercialize LX9851 in all indications Lexicon/LX9851 positioned to benefit from Novo Nordisk size, scale and capabilities $75 million in upfront and near -term milestone payments; up to $1 billion in total upfront and milestones; tiered royalties Potential differentiation in the obesity market with shift in focus to orals, combinations and improved weight -loss maintenance First in class, potent, selective, orally bioavailable, investigational small molecule ACSL5 inhibitorLX9851
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11 Innovative and flexible partnership approach unlocks long-term value by augmenting Lexicon’s capabilities Partnering Exclusive licensing agreement for sotagliflozin in cardiometabolic and all other indications All markets outside of the U.S. and Europe $25M upfront; eligible for up to almost $200Min milestone payments Exclusive licensing agreement for LX9851 in obesity and all other indications Global markets $75M in upfront and near-term milestones; eligible for up to$1B in aggregate upfront and milestone payments Geographical expansion through Viatris’ global capabilities Maximizing asset value with Novo’s leadership position in obesity Pilavapadin Partnership approach focused on complementing Lexicon’s leading clinical development capabilities in the neuropathic pain space with a commercial footprint that can maximize value globally, and an R&D engine that can fully realize the “pipeline in a pill” Unlock value globally and across multiple indications
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12 Scott Coiante Chief Financial Officer Financial Overview
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13 Q1 2025 Financial Summary 1. Includes stock-based compensation expenses Q1 2025 Q1 2024 T otal revenues $1.3 $1.1 R&D $15.3 $14.4 SG&A $11.6 $32.1 T otal operating expenses $26.9 $46.5 Net loss ($25.3) ($48.4) Net loss per common share ($0.07) ($0.20) Confidential As of March 31, 2025* As of December 31, 2024 Cash, cash equivalents and short-term investments $194.8 $238.0 T otal assets $297.7 $298.4 T otal debt $58.6** $100.3 $ (in millions except per share amounts) Financials *Cash balance as of March 31, 2025 includes impact of severance payments from fourth quarter ($7.5 million) ** Excludes current portion of $42.1 million which was repaid in April of 2025.
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14 YTD 2025 Key Financial Highlights Full Year 2025 Operating Expenses* • First quarter included the impact of severance payments related to the restructuring and repositioning announced and accrued in 4Q 2024. • First quarter did not include cash impact of $45 million upfront payment (received in April) under licensing agreement with Novo Nordisk, which was used to improve balance sheet by reducing our long-term debt. • No change to operating expense guidance • Total 2025 operating expenses expected to be between $135 - $145 million • R&D expected between $100 - $105 million • Excludes clinical trial costs related to Phase 3 pivotal studies of pilavapadin • SG&A expected between $35 - $40 million 2025 Guidancereflects significantly lower operating expenses *As of May 13, 2025 Financials
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15 Summary Mike Exton, PhD Director and Chief Executive Officer
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16 Well-positioned with a portfolio of potential “pipelines in a pill” Exploring opportunities across multiple therapeutic areas Sotagliflozin Heart Failure expansion ex-US Hypertrophic Cardiomyopathy (HCM) Pilavapadin (LX9211)* Diabetic Peripheral Neuropathic Pain (DPNP) LX9851 Obesity/Weight Management Postherpetic Neuralgia (PHN) Additional differentiation data MS Spasticity 2025 2026 2027 2028 2029 Regulatory Approval Ph3 Planning / Execution Ph2 Planning / Execution ex-US, ex-EU Launches IND-Enabling Studies Regulatory Approval Regulatory Approval Regulatory Approval Ph3 Initiation Timelines are illustrative and represent potential scenarios aligned to Lexicon’s overall strategy *Execution of trials and subsequent regulatory support would require partnership or additional funding ** IIS: Investigator-initiated studies IIS** Studies Underway Ph3 Ongoing Exclusive license for all indications Conclusion
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17 L E AD TO S U CC E E D S T RAT E GY Large markets with significant need First or only in therapy or class Leading clinical and medical expertise Driving value and growth for Lexicon with opportunities for the most impact for patients Conclusion Lexicon Lead to Succeed strategy Designed to drive value for all stakeholders
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18 Pilavapadin (LX9211) • Full PROGRESS data anticipated in Q3 • End of Phase 2 meeting planned in Q3 • Data at upcoming medical meetings • Partnership discussions ongoing • Diabetic Peripheral Neuropathic Pain LX9851 • Obesity and Weight Management • Ongoing collaboration withNovo Nordisk on IND- enabling studies Significant number of planned catalysts through 2025 Conclusion Sotagliflozin • EU and LATAM sites enrolling • All Phase 3 study sites running by Q3• Hypertrophic Cardiomyopathy INPEFA® (sotagliflozin) • Regulatory submissions by Viatris ex-U.S. • Regulatory process related to recent MACE data• Heart Failure ZYNQUISTA® (sotagliflozin) • End of review meeting held in Q2 • Patients continue to strongly advocate for approval • Type 1 Diabetes (with CKD)
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19 Q&A Mike Exton, PhD Director and Chief Executive Officer Craig Granowitz, MD, PhD Senior Vice President and Chief Medical Officer Scott Coiante Chief Financial Officer
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20 Thank You