Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q3 2022 Earnings Presentation
14 slides from Harmony Biosciences's earnings presentation, Nov 1, 2022
Slide 1: Harmony Biosciences Q3 2022 Financial and Business Update
Harmony Biosciences Q3 2022 Financial and Business Update November 1, 2022
Slide 2: Legal Disclaimer
Legal Disclaimer 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 Holdings, Inc
Slide 3: Harmony's Strategy for Growth
Harmony’s Strategy for Growth Expand Optimize Acquire Clinical WAKIX ® New Utility of Performance Assets WAKIX 3
Slide 4: Q3 2022 WAKIX Net Revenue Performance
Q3 2022 WAKIX® Net Revenue Performance Q3 2022 Net Revenue of $117.2M ∆ 3Q22 ∆ 3Q22 45% 3Q21 2Q22 3Q22 vs. 2Q22 vs. 3Q21 $117.2 $80.7 $107.0 $117.2 10% 45% $80.7 Strong Revenue Growth ▪ 45% growth Q3 2022 vs. Q3 2021 ▪ 10% growth Q3 2022 vs. Q2 2022 ▪ Strong momentum in top line prescription Q3 2021
Slide 5: Driving Growth Through Our Launch For WAKIX
Driving Growth Through Our Launch For WAKIX® Q3 2022 Performance ~85% In-Person Access to HCPs Average # of ~4,600 WAKIX Patients Patient Outreach Programs & Support Continued Growth in Depth & Breadth of Prescriber Base Healthcare Professional Educational Initiatives Managed Care >80% U.S. Covered
Slide 6: Phase 2 Clinical Proof-of-Concept Trial of Pitolisant in PWS
Phase 2 Clinical Proof-of-Concept Trial of Pitolisant in PWS High-dose pitolisant (n=22) Open-Label Screening Randomization Low-dose pitolisant (n=20) Extension Placebo (n=23) -45D through -1D Titration Period Stable-Dose Period Week 1 to Week 3 Week 4 to Week 11 Trial Design: ▪ Randomized, double-b
Slide 7: PWS Phase 2 POC Study Topline Data: Primary Endpoint
PWS Phase 2 POC Study Topline Data: Primary Endpoint ESS-CHAD (Parent/Caregiver Version) Mean Change from Baseline to End of Treatment (Week 11) Low Dose Pitolisant High Dose Pitolisant Placebo Age (ESS-CHAD ∆ from BL) (ESS-CHAD ∆ from BL) (ESS-CHAD ∆ from BL) (n; pitolisant dose) (n; pitolisant dos
Slide 8: PWS Phase 2 POC Study Topline Data: Responder Analysis
PWS Phase 2 POC Study Topline Data: Responder Analysis Higher Responder Rate for Pitolisant vs. Placebo; Driven by High Dose Group Responder Rates at Visit 5 (Day 77) 70.0% 63.2% 55.6% 52.6% Pooled Pitolisant (N=42) Low Dose Pitolisant (N=20) High Dose Pitolisant (N=22) Placebo (N=23) Responder Resp
Slide 9: PWS Phase 2 POC Study Topline Data: Summary of Safety
PWS Phase 2 POC Study Topline Data: Summary of Safety Pooled Low Dose High Dose Pitolisant Pitolisant Pitolisant Placebo (N=42) (N=20) (N=22) (N=23) Category [n; %] [n; %] [n; %] [n; %] Any TEAE 24 13 11 15 57.1% 65.0% 50.0% 65.2% Any Treatment-Related TEAE 11 7 4 7 26.2% 35.0% 18.2% 30.4% Any Sever
Slide 10: Harmony Development Pipeline
Harmony Development Pipeline Regulatory Marketed Product / Indication Pre-IND Phase 1 Phase 2 Phase 3 Filing1 Product Milestone WAKIX® EDS in Narcolepsy (Adults) Cataplexy in Narcolepsy (Adults) Pitolisant Pediatric EMA decision Narcolepsy2 1Q2023 Idiopathic Trial initiated Hypersomnia 2Q2022 Prader
Slide 11: Financial Highlights
Financial Highlights (In millions, USD) Three Months Ended Nine Months Ended September 30, 2022 September 30, 2022 45% 45% $309.5 $117.2 $214.2 Net Product $80.7 Revenues Q3 2021 Q3 2022 YTD 2021 YTD 2022 102% 148% $123.9 Non-GAAP Adjusted Net $58.1 $61.2 Income(1) $23.4 Q3 2021 Q3 2022 YTD 2021 YTD
Slide 12: Q3 2022 Financial Summary
Q3 2022 Financial Summary (In millions, USD) Three Months Ended September 30, % Change Totals may not foot due to rounding 2022 2021 Net Product Revenues $117.2 $80.7 45% Cost of Product Sold 23.0 14.6 57% Total Operating Expenses $82.3 $45.1 83% R&D Expense 40.5 11.7 NM S&M Expense 20.5 16.5 24% G&
Slide 13: Q3 2022 GAAP vs Non-GAAP Reconciliation
Q3 2022 GAAP vs Non-GAAP Reconciliation (In millions, USD) Three Months Ended September 30, Totals may not foot due to rounding 2022 2021 GAAP net income $87.9 ($9.6) Non-cash interest expense(1) 0.4 0.5 Depreciation 0.1 0.1 Amortization(2) 6.0 4.6 Stock-based compensation expense 7.0 4.7 Licensing
Slide 14: Thank You
HARMONY BIOSCIENCES Thank You
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