Xeris Biopharma Holdings, Inc. · NASDAQ:XERS

Xeris Biopharma — Investor Day (June 2025)

58 slides from Xeris Biopharma's investor day presentation, Jun 3, 2025

  1. Slide 1: Investor and Analyst Day

    Investor and Analyst Day June 3, 2025 1

  2. Slide 2: Welcome and Agenda

    Welcome and Agenda Allison Wey SVP, Investor Relations and Corporate Communications 2 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  3. Slide 3: Important Disclosures

    Important Disclosures Forward-Looking Statements and Other Information Any statements in presentation other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xer

  4. Slide 4: Today's Agenda

    Today’s Agenda Topic Speaker - Welcome & Introductions Allison Wey, SVP, IR & Corporate Communications - Unlocking the Future of Xeris John Shannon, Chief Executive Officer - Recorlev®: Tremendous Growth Opportunities Mary Beth McNerney, Chief Commercial Officer Break Dr. Anh Nguyen Joshua Bennett -

  5. Slide 5: Key Opinion Leaders (KOLs) Joining Us Today

    Key Opinion Leaders (KOLs) Joining Us Today Eliza B. Geer, MD (Memorial Sloan Kettering Cancer Center), is the Medical Director of Memorial Sloan Kettering’s Multidisciplinary Pituitary & Skull Base Tumor Center and Professor of Medicine and Neurosurgery. She is an endocrinologist who specializes in

  6. Slide 6: Unlocking the Future of Xeris

    Unlocking the Future of Xeris John Shannon Chief Executive Officer 6 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  7. Slide 7: Xeris' Innovative Therapies Address Serious, Unmet Medical Needs

    Xeris’ Innovative Therapies Address Serious, Unmet Medical Needs and Make a Difference in Patient Lives Built on a strong foundation of proprietary formulation technologies and deep expertise in clinical development and commercialization 7 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights

  8. Slide 8: Proven, Experienced Team Confidence to Execute Our Strategic Vision

    Proven, Experienced Team Confidence to Execute Our Strategic Vision A seasoned team with a track record of operational excellence that is well-positioned to take Xeris to new heights Presenting Today John Shannon Steven Pieper Kevin McCulloch Mary Beth McNerney Anh Nguyen Josh Bennett Allison Wey Ch

  9. Slide 9: Strong Foundation with Multiple Drivers on Our Transformational Journey

    Strong Foundation with Multiple Drivers on Our Transformational Journey Revenue Growth Fueled by Recorlev Acceleration and Launch of XP-8121 2035 + Next Great Biopharmaceutical 2030 Company Exceptional Growth + Tremendous Value Pipeline Execution Unlocked 2025 • ~$750M Total Revenue • Multi-billion

  10. Slide 10: Our Path to Long-Term Value Creation

    Our Path to Long-Term Value Creation Proven Execution & Recorlev Fuels Tremendous Financial Strength Enables XP-8121 Propels the Know-How Growth Opportunities Self-Funding of Growth Future of Xeris 2035 Total Revenue 2022 U.S. Addressable Market: 3-5M patients Recorlev Net Revenue Peak Net Revenue:

  11. Slide 11: Recorlev: Tremendous Growth Opportunities

    Recorlev®: Tremendous Growth Opportunities Mary Beth McNerney Chief Commercial Officer 11 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  12. Slide 12: Recorlev is Our Growth Engine in an Expanding Hypercortisolism Market

    Recorlev is Our Growth Engine in an Expanding Hypercortisolism Market Our most significant growth driver, expected to approach $1 billion in annual net revenue Highest commercial priority for the company where further investment is expected to drive tremendous shareholder value Long expected runway

  13. Slide 13: Hypercortisolism is Implicated in a Multitude of Diseases and Comorbidities

    Hypercortisolism is Implicated in a Multitude of Diseases and Comorbidities2-7 Physical Impacts Neuropsychiatric Disorders Endocrine Cardiovascular Disease Musculoskeletal Sexual Dysfunction Infections Fatigue The physical and emotional impact of elevated cortisol in Cushing’s Syndrome is high8-9 13

  14. Slide 14: Current and Future Market Growth Driven by Evolved Awareness

    Current and Future Market Growth Driven by Evolved Awareness of Broad Hypercortisolism Impact Patient Presentation: Patient Presentation: Patient Presentation: Overt “cushingoid” physical signs Clinical impacts of Clinicians actively question role of and symptoms10-12 hypercortisolism seen, with or

  15. Slide 15: Recorlev Intervenes at Multiple Steps in the Cortisol Production Pathway

    Recorlev Intervenes at Multiple Steps in the Cortisol Production Pathway Cortisol production is the result of a multi-step process where enzymes convert steroid hormones to respective hormone by-products and cortisol precursors. Recorlev’s unique mechanism of action inhibits 3 key enzymes early, mid

  16. Slide 16: Recorlev Normalized Cortisol Levels and Improved Clinical Outcomes

    Recorlev Normalized Cortisol Levels and Improved Clinical Outcomes In clinical trials, Recorlev was proven to normalize cortisol levels. When cortisol levels were normalized, impact on important secondary comorbidities were seen14, 17-18. Sustained Cortisol Normalization Impact on Comorbidities Asso

  17. Slide 17: Recorlev is on its Way to $1 Billion in Revenue

    Recorlev is on its Way to $1 Billion in Revenue Recorlev is the right product at the right time. $1 Billion Stepwise investment in Recorlev leadership position by leveraging existing capabilities and expertise: • Seize current market opportunity Recorlev Net Revenue • Expand clinical role of Recorle

  18. Slide 18: Disciplined Investment in Recorlev Leadership Position

    Disciplined Investment in Recorlev Leadership Position in Rapidly Growing Hypercortisolism Market Seize current market opportunity through stepwise investment Seize • Invest heavily in promotional footprint • Expand patient support services • Generate incremental data Expand Clinical Role of Recorle

  19. Slide 19: Recorlev Investment Summary

    Recorlev Investment Summary Hypercortisolemia market is evolving and growing rapidly as physicians shift to 01 screening patients with less “cushingoid” presentations Mechanism of Action inhibiting cortisol production at multiple points is unique and allows 02 Recorlev to address the root cause of C

  20. Slide 20: Evolving Understanding of Cortisol, Cortisol Regulation, and Cushing's Syndrome

    Evolving Understanding of Cortisol, Cortisol Regulation, and Cushing's Syndrome Eliza B. Geer, MD 20

  21. Slide 21: Understanding Cushing's Syndrome

    Understanding Cushing’s Syndrome Cortisol excess due to a tumor producing ACTH or cortisol CORTISOL • Adrenal steroid hormone • Production & secretion regulated by HPA Axis • Homeostasis: mediates circadian rhythm & stress response • Metabolism: converts protein to glucose • Immune system: reduces i

  22. Slide 22: Unique Presentations of Cushing's Syndrome

    Unique Presentations of Cushing’s Syndrome Actual Patient Actual Patient • ADRENAL CUSHING’S SYNDROME • ADRENAL CUSHING’S SYNDROME • 13-YEAR DIAGNOSTIC JOURNEY • 2-YEAR DIAGNOSTIC JOURNEY; FOLLOWING IDENTIFICATION OF TUMORS ON KIDNEY SCAN 22

  23. Slide 23: Clinical Complications Cushing's Syndrome

    Clinical Complications Cushing’s Syndrome Arterial atherosclerosis Nervous and vascular disease Neuropsychiatric disorders Cardiac disease Endocrine Cardiovascular Diabetes Osteoporosis (spine) and Visceral obesity vertebral fractures Osteoporosis Reproductive/Sexual (femoral neck) Impaired reproduc

  24. Slide 24: Role of Guidelines in Advancing Clinical Considerations in Testing & Treatment

    Role of Guidelines in Advancing Clinical Considerations in Testing & Treatment 2008 Endocrine 2015 Endocrine 2021 Pituitary Society Guidelines1 Society Guidelines2 Society Consensus3 Testing: Treatment Goals: Testing: •Clinical judgement Widespread testing not •Normalize cortisol and suspicion for n

  25. Slide 25: Clinical Approaches to Normalizing Cortisol Levels

    Clinical Approaches to Normalizing Cortisol Levels Clinical Pathway Following Diagnosis Confirmation Surgery Radiation Medical Therapy 25 1. Hinojosa-Amaya JM, et al. Drugs. 2019;79(9):935-956.

  26. Slide 26: Clinical Approaches to Normalizing Cortisol Levels

    Clinical Approaches to Normalizing Cortisol Levels 26 1. Hinojosa-Amaya JM, et al. Drugs. 2019;79(9):935-956. 2. Fleseriu M, et al. Expert Rev Endocrinol Metab. 2021;16(4):159-174.

  27. Slide 27: Continued Efforts in Advancing Research, Medical Innovations, and Guidelines are Needed

    Continued Efforts in Advancing Research, Medical Innovations, and Guidelines are Needed to Address Cushing’s Syndrome & Holistic Burden of Illness Chronic Priority is to Continued Goal: hypercortisolism normalize education Optimize Patient can lead to cortisol levels needed to Outcomes & multisystem

  28. Slide 28: Break

    Break Please be back in 10-minutes 28 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  29. Slide 29: XP-8121 Building a Blockbuster in Hypothyroidism

    XP-8121 Building a Blockbuster in Hypothyroidism Clinical Anh Nguyen, MD, MBA Overview Chief Medical Officer Expert Panel on Anh Nguyen, MD, MBA Hypothyroidism Antonio C. Bianco, MD, PhD University of Texas Medical Branch Francesco S. Celi, MD, MHSc UConn Health Opportunity and Joshua Bennett Path t

  30. Slide 30: Thyroid Gland has a Critical Role in Regulating Bodily Functions

    Thyroid Gland has a Critical Role in Regulating Bodily Functions Thyroid hormones control metabolism and affect almost every part of the body19 Influences metabolism, growth, development, and bone maintenance19 Thyroid gland malfunction leads to thyroid hormone (T3, T4)* deficiency19 30 Copyright ©

  31. Slide 31: Hypothyroidism is a Common Disease with a Wide Range of Symptoms

    Hair thinning/loss Sleep disturbance Depression/mood disturbance Cognitive dysfunction Cold intolerance Hypothyroidism is a Menstrual Common Disease irregularities19 Fatigue with a Wide Range Weight gain Reduced libido 19 of Symptoms 31 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights re

  32. Slide 32: Hypothyroidism has Lifelong Challenges to Achieving Consistent Control

    Hypothyroidism has Lifelong Challenges to Achieving Consistent Control Lifelong, individualized therapy that Titration is burdensome for both patients and often changes providers. Obstacles are common. 22-24 Treatment Levothyroxine (LT4) hormone replacement20 Prevalence Prevalenceofofchallenges chal

  33. Slide 33: Hypothyroidism has Unmet Needs that Demand New Treatments

    Hypothyroidism has Unmet Needs that Demand New Treatments Patients live with chronic inconsistent control 20% with TSH not in range when tested once25-26 do not maintain 30-70% normal TSH across time26,28-29 referred to XP-8121 Phase 2 study 22% * as “in control” failed screening due to TSH out of r

  34. Slide 34: XP-8121: Definitive, New Approach to Treat Hypothyroidism

    XP-8121: Definitive, New Approach to Treat Hypothyroidism Consistent drug XP-8121 1200 µg (SC) exposure to optimize Oral levothyroxine 300 µg (PO) biochemical control 31 Designed to improve the patient experience and clinical outcomes32 Mechanism Product Design Benefits Proprietary high-concentratio

  35. Slide 35: XP-8121 Building a Blockbuster in Hypothyroidism

    XP-8121 Building a Blockbuster in Hypothyroidism Clinical Anh Nguyen, MD, MBA Overview Chief Medical Officer Expert Panel on Anh Nguyen, MD, MBA Hypothyroidism Antonio C. Bianco, MD, PhD University of Texas Medical Branch Francesco S. Celi, MD, MHSc UConn Health Opportunity and Joshua Bennett Path t

  36. Slide 36: XP-8121 Building a Blockbuster in Hypothyroidism

    XP-8121 Building a Blockbuster in Hypothyroidism Clinical Anh Nguyen, MD, MBA Overview Chief Medical Officer Expert Panel on Anh Nguyen, MD, MBA Hypothyroidism Antonio C. Bianco, MD, PhD University of Texas Medical Branch Francesco S. Celi, MD, MHSc UConn Health Opportunity and Joshua Bennett Path t

  37. Slide 37: Patients and Prescribers Motivated to Seek New Options

    Patients and Prescribers Motivated to Seek New Options DIAGNOSIS TO INITIAL CONTROL REQUIREMENT ROUTINE CHANGES MONITORING SIGNS & SYMPTOMS LIFELONG Many, non-specific symptoms THERAPY DIAGNOSIS Straightforward, based on labs TREATMENT ADJUSTMENTS Despite best efforts of patients and healthcare prof

  38. Slide 38: Large Addressable Market and Transformational Opportunity for Xeris

    Large Addressable Market and Transformational Opportunity for Xeris XP-8121 has multi-billion peak revenue Fueled by patient preference and physician intent potential in a large addressable market to prescribe $1 - $3 billion Peak net revenue 72% 75% 71% Patients who Healthcare Healthcare would pref

  39. Slide 39: Confidence to Execute Phase 3 for Target 2030 Approval

    Confidence to Execute Phase 3 for Target 2030 Approval 2026 2028 2029 2030 Study Start Last Subject Out Topline Results NDA* Approval Phase 3 Randomized, FDA approved molecule with decades of 01 Comparative Pivotal Study32 safe use and known effectiveness, now in a new route of administration and do

  40. Slide 40: XP-8121 Investment Summary

    XP-8121 Investment Summary Significant Unmet Need | Seminal Program | Transformational Opportunity Unmet need not resolved after 50+ years of oral levothyroxine availability Long-term health risks, symptom burden, healthcare practice burden First pivotal Phase 3 study evaluating clinical efficacy of

  41. Slide 41: Leveraging Our Strengths to Deliver Our Future

    Leveraging Our Strengths to Deliver Our Future Kevin McCulloch President and Chief Operating Officer 41 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  42. Slide 42: The Future of Recorlev and XP-8121 Build Upon Our Strong Foundation

    The Future of Recorlev and XP-8121 Build Upon Our Strong Foundation APPLIED INNOVATION Operational Experience Drug-Device Development XeriSol Formulation COMMERCIAL EXCELLENCE Launches Rare and Retail Continuous Growth Diabetes ENDOCRINE INSIGHT Pituitary and Adrenal Disorders Rapidly Expanding Pres

  43. Slide 43: Our Applied Innovation Leverages Existing Know-How

    Our Applied Innovation Leverages Existing Know-How Operational Experience Manufacturing, development, clinical, and regulatory leadership with more than 100 years of combined experience Our team has developed dozens of new products and indications NDA, sNDA, device, and drug-specific regulatory expe

  44. Slide 44: Commercial Excellence is Our Standard

    Commercial Excellence is Our Standard Management team with deep experience in the promotion of pharmaceutical Highly Successful Launches products of Gvoke and Recorlev Market preparedness expertise in research, medical affairs, payer management and business analytics Dedicated sales, patient support

  45. Slide 45: Aligned to Serve the Endocrinology Community

    Aligned to Serve the Endocrinology Community Protecting People with Delivering a Best-in-Class Investing in Research and Diabetes from Harm Therapy to Normalize Cortisol Disease Awareness 20-year history that created the FIRST in Cushing’s Syndrome Clinical development partnerships ONLY ready-to-use

  46. Slide 46: Positioned for Long-Term Value Creation

    Positioned for Long-Term Value Creation Steven Pieper Chief Financial Officer 46 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  47. Slide 47: Continuing to Deliver Significant Revenue Growth in 2025

    Continuing to Deliver Significant Revenue Growth in 2025 Record Q1 Driven by Sustained Momentum Across Portfolio Total Revenue ▪ Total Revenue of $60M; 48% growth Y/Y +32% √ 14 consecutive qtrs. of +20% product revenue growth √ Recorlev net revenue over $25M ▪ Gross Margin improved to 85% mid-point

  48. Slide 48: Xeris is a Fully Funded Biopharmaceutical Company with Rapid Organic Growth

    Xeris is a Fully Funded Biopharmaceutical Company with Rapid Organic Growth Revenue outlook on pace to be approx. $750 million by Strong revenue growth and improving 2030 with existing diversified product portfolio gross margin profile of at least 85% provides ample opportunity to: • Accelerate Reco

  49. Slide 49: Strong Foundation with Multiple Drivers on Our Transformational Journey

    Strong Foundation with Multiple Drivers on Our Transformational Journey Revenue Growth Fueled by Recorlev Acceleration and Launch of XP-8121 2035 + Next Great Biopharmaceutical 2030 Company Exceptional Growth + Multi-Billion Enterprise Pipeline Execution • Recorlev Net Revenue $1B • XP-8121 Net Reve

  50. Slide 50: Q&A

    Q&A 50 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved. 50 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  51. Slide 51: Closing Remarks

    Closing Remarks John Shannon Chief Executive Officer 51 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  52. Slide 52: Thank You

    Thank You XERIS INVESTOR RELATIONS Allison Wey awey@xerispharma.com 52 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  53. Slide 53: Important Safety Information about Recorlev

    IMPORTANT SAFETY INFORMATION about Recorlev Indication RECORLEV (levoketoconazole) is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Limitations of use: R

  54. Slide 54: Important Safety Information about Recorlev (continued)

    IMPORTANT SAFETY INFORMATION about Recorlev (continued) • RECORLEV is contraindicated in patients: – With cirrhosis, acute liver disease or poorly controlled chronic liver disease, baseline AST or ALT >3 times the upper limit of normal, recurrent symptomatic cholelithiasis, a prior history of drug-i

  55. Slide 55: Citations

    Citations 1. Fleseriu M, et al. Expert Rev Endocrinol Metab. 2021;16(4):159-174. 2. Dekkers OM, et al. J Clin Endocrinol Metab. 2013;98(6):2277-2284. 3. Limumpornpetch P, et al. J Clin Endocrinol Metab. 2022;107(8):2377-2388 4. Mancini T, et al. Clin Endocrinol. 2004;61(6):768-777. 6. 5. Nieman LK,

  56. Slide 56: Citations (continued)

    Citations (continued) 19. Patil N, Rehman A, Anastasopoulou C, Jialal I. Hypothyroidism. 2024 Feb 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan–2024 Feb 18. 20. Esfandiari NH, Papaleontiou M. Levothyroxine prescribing: why simple is so complex. J Clin Endocrino

  57. Slide 57: Appendix

    Appendix 57 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

  58. Slide 58: Reconciliation of Net Income (Loss) to Adjusted EBITDA

    Reconciliation of Net Income (Loss) to Adjusted EBITDA 58 Copyright © 2021-2025 Xeris Pharmaceuticals, Inc. All rights reserved.

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