Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q1 2024 Earnings Presentation
16 slides from Harmony Biosciences's earnings presentation, Apr 30, 2024
Slide 1: Q1 2024 Financial Results
Q1 2024 Financial Results April 30, 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Hol
Slide 3: Harmony Accelerates Growth Strategy
Harmony Accelerates Growth Strategy Three CNS Franchises - Each With Peak Sales Potential of $1B-$2B Sleep/Wake Neurobehavioral Rare Epilepsy ▪ WAKIX potential $1B+ Net Revenue ▪ ZYN002 in Phase 3 RECONNECT study ▪ Establishes franchise through acquisition of opportunity in Narcolepsy alone with LOE
Slide 4: WAKIX Net Revenue Performance
WAKIX® Net Revenue Performance CONFIDENT IN WAKIX BEING A POTENTIAL $1B+ OPPORTUNITY IN ADULT NARCOLEPSY ALONE WAKIX Net Revenue ($M) HIGHLIGHTS ▪ Durable sales into year five on the market with 30% growth year-over-year ▪ Underlying demand drove continued revenue growth 30% – Strong patient interes
Slide 5: Solid Business Fundamentals Driving Growth
Solid Business Fundamentals Driving Growth 7000 ~Approximate Patient Counts Q1 24 Highlights ~6,300 +150 6000 +350 +350 +350 ~Average # of Patients on WAKIX 5000 +200 +300 On our way +300 to a $1B+ +400 4000 opportunity +100 +300 ~6,300 Average in adult +300 number of narcolepsy 3000 +400 patients o
Slide 6: Prescriber Dynamics Support Continued WAKIX Growth in Adult Narcolepsy
Prescriber Dynamics Support Continued WAKIX® Growth in Adult Narcolepsy HCPs enrolled in Depth of prescribing ~4,000 oxybate REMS in oxybate REMS enrolled HCPs HCPs not WAKIX Breadth of prescribing ~5,000 enrolled in oxybates REMS growth in HCPs not enrolled in oxybate REMS ~9,000 100% of HCPs surve
Slide 7: Building a Robust Late-Stage Pipeline
Building a Robust Late-Stage Pipeline Product / Indication Pre-IND Phase 1 Phase 2 Phase 3 Regulatory Filing Marketed Product Milestone WAKIX® EDS in Narcolepsy (Adults) Cataplexy in Narcolepsy (Adults) Pitolisant Pediatric Narcolepsy PDUFA June 21, 2024 Idiopathic Hypersomnia (IH) Submit sNDA 2H202
Slide 8: Extending the Pitolisant Franchise With Next-Gen Formulations (NG1)
Extending the Pitolisant Franchise With Next-Gen Formulations (NG1) Next-Gen Formulation 1 ▪ Description: Enteric coated tablet formulation of pitolisant HCI ▪ Clinical Development Objectives: ▪ Demonstrate bioequivalence (BE) to WAKIX; Abbreviated development program ▪ Dosing optimization ▪ Clinica
Slide 9: NG1 – Pilot Bioequivalence Study Data
NG1 – Pilot Bioequivalence Study Data Formulation Cmax (ng/ml) AUC0-t (h*ng/ml) AUC0-inf (h*ng/ml) Test formulation, NG1 15.29 242.27 256.62 (Enteric Coated Pitolisant Hcl) Reference formulation, 14.42 224.12 237.22 Wakix ( Pitolisant Hcl) ▪ Cmax and AUC, the two important parameters to establish Bi
Slide 10: Extending the Pitolisant Franchise With Next-Gen Formulations (NG2)
Extending the Pitolisant Franchise With Next-Gen Formulations (NG2) ON TRACK FOR DATA IN FIRST HALF OF 2024 Next-Gen Formulation 2 ▪ Opportunity: Extend franchise beyond 2040, with potential for new IP and opportunity to explore additional indications ▪ Formulation: Enhanced formulation designed to
Slide 11: ARGUS Study in Dravet Syndrome
ARGUS Study in Dravet Syndrome EPX-100 (n=50) 1.0 mg/kg BID Screening/ Randomization titrate every 7 days (80mg BID Baseline max) Placebo (n=50) 4-Week Period Titration Period 12- Week Week 4 to Week 8 Maintenance Period Trial Design: Objectives / Endpoints: ▪ Randomized, double-blind, ▪ Primary obj
Slide 12: Financial Highlights
Financial Highlights (In millions, USD) Three Months Ended March 31, 2024 30% HIGHLIGHTS ▪ Durable sales into year five on the market $154.6 Net Product $119.1 with 30% growth year-over-year Revenue ▪ Improved profitability Q1 2023 Q1 2024 ▪ Continued cash generation resulting in a strong balance sh
Slide 13: Financial Summary
Financial Summary (In millions, USD) Three Months Ended March 31, % Change Totals may not foot due to rounding 2024 2023 Net Product Revenue $154.6 $119.1 30% Cost of Product Sold 27.5 20.8 32% Total Operating Expenses $75.1 $57.9 30% R&D Expense 22.2 13.3 67% S&M Expense 27.2 22.6 21% G&A Expense 2
Slide 14: GAAP vs NON-GAAP Reconciliation
GAAP vs NON-GAAP Reconciliation (In millions, USD) Three Months Ended March 31, Totals may not foot due to rounding 2024 2023 GAAP net income $38.3 $29.5 Non-cash interest expense(1) 0.2 0.4 Depreciation 0.2 0.1 Amortization(2) 6.0 6.0 Stock-based compensation expense 10.4 6.6 Licensing fees and mil
Slide 15: Reiterates 2024 Net Revenue Guidance
Reiterates 2024 Net Revenue Guidance CONFIDENT IN WAKIX BEING A POTENTIAL $1B+ OPPORTUNITY IN ADULT NARCOLEPSY ALONE WAKIX ANNUAL NET REVENUE ($M) $700-$720 Reiterates $582 2024 Guidance $438 $700-$720M $305 $160 2020 2021 2022 2023 2024 Guidance 15
Slide 16: Harmony Biosciences
H3 HARMONY BIOSCIENCES
Harmony Biosciences Holdings — Q1 2024 Earnings Presentation on 6ix