Slides
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AVADEL Pharmaceuticals plc (NASDAQ: AVDL) Fourth Quarter and Full Year 2024 Earnings
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2 TRANSFORMING MEDICINES TO TRANSFORM LIVES A BIOPHARMACEUTICAL COMPANY FOCUSED ON 2
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3 This presentation may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the potential therapeutic benefit of LUMRYZ; the success of the commercialization of LUMRYZ and expansion into additional patient populations; the anticipated market demand and sales opportunity of LUMRYZ; the potential for the Company to be a leader in the market; the Company’s idiopathic hypersomnia clinical study for LUMRYZ, including enrollment and timing related thereto; the potential development and related timing of a once-nightly, no-/low-sodium oxybate formulation; and the Company’s anticipated financial condition, expenses, uses of capital and other future financial results. In some cases, forward-looking statements can be identified by use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable). The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Safe Harbor Statements
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4 2,500 Patients on therapy* *as of December 31, 2024 Deep, wholly-owned pipeline with numerous expansion opportunities 30 Orange book listed patents with expirations to early-2042 Publicly traded on NASDAQ since 1996 Management team with extensive commercial experience in rare and orphan drug launches : AVDL Relentless Confidence with Humility Courageous Insights to Impact Togetherness O U R VA LU E S US Operations Dublin, Ireland St. Louis, Missouri Corporate Headquarters
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5 Since its launch in June 2023, LUMRYZ has seen consistent patient uptake Launch to Date1 1) Figures as of December 31, 2024 ~$197 2,500 Net revenue ($M) Patients on therapy ~3:1 LUMRYZ Net Patient Adds vs Twice Nightly Mixed-Salt Oxybates Since July 2023
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6 Over 50,000 oxybate-eligible patients with narcolepsy >14,000 patients treated with first generation oxybates >15,000 patients that discontinued first generation oxybates 25,000+ patients new to oxybates > 14 ,000 patients >15 ,000 patients 25,000+ patients >50,000 Oxybate market expanding to +$5B 8,000 reimbursed patients on therapy achieves $1B in sales LUMRYZ Peak Sales Opportunity is >$1B For Narcolepsy
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7 EARLY LAUNCH STRATEGY: Targeted and focused Represent 2/3 of total LUMRYZ patient starts Targeted initial launch strategy has resulted in meaningful penetration with early adopters Represent 1/3 of total LUMRYZ patient starts 2025 LAUNCH STRATEGY: Capitalize on momentum with early adopters to drive growth with broader provider base Remaining Prescriber Base (~75% of oxybate market) Early Adopters (~25% of oxybate market)
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8 Targeted investments to expand demand and optimize patient experience Market leadership in new-to-brand patients while generating growth from all patient segments Deliver positive cash flow generation in 2025 Our Launch Strategy Has Built a Strong Foundation for Continued Growth
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9 Expanding customer-facing teams to enable greater engagement with patients, providers, and caregivers Deploying higher-touch, more frequent, and more personalized support services to better aid patient transitions to LUMRYZ Bolstering our commercial leadership team with two industry veterans with competitive rare disease commercial experience and proven track-records Investment Strategy Builds on Positive Momentum LUMRYZ has Generated with Patients and Providers
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10 Idiopathic hypersomnia (IH) is a rare sleep disorder characterized by excessive daytime sleepiness (EDS) not attributable to any other medical conditions; 42,000 patients diagnosed with IH in US Initiated REVITALYZ Phase 3 trial to evaluate the efficacy and tolerability for LUMRYZ in IH; total target of ~150 patients participating for a 14-week period Enrollment completion date – H2 2025 <10% treated with the only FDA approved oxybate treatment
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11 PROGRAM INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY REVIEW COMMERCIAL MAJOR MILESTONES Sodium Oxybate Extended- Release Oral Suspension (LUMRYZTM) Narcolepsy – Excessive Daytime Sleepiness (EDS) and/or Cataplexy in Adults Received FDA approval and ODE in May 2023; launched in June 2023 Narcolepsy - EDS and/or Cataplexy in Pediatrics Age 7+ Received FDA approval and ODE in October 2024 Idiopathic Hypersomnia (IH) First patient dosed in REVITALYZTM Ph3 trial in July 2024 Extended- Release, No-/Low- Sodium Oxybate Formulation EDS and/or Cataplexy in Narcolepsy; IH Program update expected by end of 2025 Advancing Innovative and Transformative Sleep Medicine Pipeline
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Financials
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13 Product Revenue $19.5 $50.4 $28.0 $169.1 Operating Expenses $43.7 $48.9 $165.0 $196.2 Operating Loss ($24.9) ($3.3) ($137.8) ($42.4) Cash, Cash Equivalents & Marketable Securities $105.1 $73.8 Financial Summary 1 Q4 FULL YEAR 2023 2024 2023 2024 ($ in millions) 1 – Refer to Forms 10-K for the years ended December 31, 2023 and 2024 for full financial results.
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14 GAAP Operating Loss ($24.9) ($3.3) ($137.8) ($42.4) Stock Based Compensation $3.5 $4.1 $15.8 $20.4 Depreciation & Amortization 1 $1.1 $1.0 $4.3 $4.2 Transaction Costs 2 $ - $ - $ - $5.5 Non-GAAP Operating (Loss) Income ($20.3) $1.8 ($117.7) ($12.3) GAAP vs. Non - GAAP Reconciliation Q4 FULL YEAR 2023 2024 2023 2024 ($ in millions) 1) Includes depreciation of fixed assets and amortization of prepaid expenses 2) Expenses incurred for the mandatory exchange of the Company’s American Depository Shares for the underlying ordinary shares and the termination of the American Depository Receipt Program 3) Totals may not sum due to rounding
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15 Revenue $240 - $260M Cash Operating Expenses $180 - $200M Cash Flow $20 - $40M Patients on Therapy at 12/31/2025 3.3 – 3.5K 2025 Guidance
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16 A Leader in the Sleep Space With Substantial Growth Opportunities Focused on transforming medicines to transform lives Meeting Unmet Needs in Narcolepsy 94%1 of patients prefer LUMRYZ over first-generation oxybates due to once at night dosing; awarded Orphan Drug Exclusivity for major contribution to patient care Opportunity For Growth In Narcolepsy $5B future oxybate estimated market value represented by >50K patients; LUMRYZ represents a $1B+ peak sales opportunity LUMRYZ Beyond Narcolepsy Ongoing Phase 3 REVITALYZ trial evaluating LUMRYZ for use in Idiopathic Hypersomnia, a disease with over 40,000 patients diagnosed Strong Financial Position and IP Protection Existing capital + sales sufficient to support LUMRYZ launch; strong balance sheet with no debt; Multiple Orange Book-listed patents, 16+ years of Intellectual Property protection into 2042 1Roy A, Harsh J, Akinyemi AO, et al. Patient Preference and Nocturnal Experience With Oxybate Treatment for Narcolepsy: Interi m Analysis of Data From RESTORE. Chest 2022, Oct 16-19, 2022: Nashville, TN.