Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — FY2020 Earnings Presentation
16 slides from Harmony Biosciences's earnings presentation, Mar 25, 2021
Slide 1: Q4 & FY 2020 Financial and Business Update
Exhibit 99.2 Harmony Biosciences Q4 & FY 2020 Financial and Business Update March 25, 2021Exhibit 99.2 Harmony Biosciences Q4 & FY 2020 Financial and Business Update March 25, 2021
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: Corporate Highlights
Corporate Highlights • Commercial-stage US Pharma company focused on treatments for patients living with rare, neurological disorders who have unmet medical needs • Opportunity to expand existing $2B narcolepsy market with WAKIX® (pitolisant) • First-in-class molecule with a novel mechanism of actio
Slide 4: 2020 Achievements on our Growth Strategy
2020 Achievements on our Growth Strategy 2020 Achievements Harmony’s Three Pillars of Growth Strategy þ Raised $147M in IPO þ Added to Russell 2000 and 3000 Indices þ WAKIX generated $160M in first full year of sales þ Received FDA approval for cataplexy indication þ Enrolled first patient in Phase
Slide 5: Significant Adult Narcolepsy Market Value Opportunity
Significant Adult Narcolepsy Market Value Opportunity 165,000 ~$2.1B People Living With Narcolepsy in the U.S. Net Sales 100,000 93,000 72,000 90,000 80,000 70,000 60,000 28,000 WAKIX 50,000 Patient 40,000 Opportunity 30,000 44,000 20,000 10,000 0 Undiagnosed Diagnosed Diagnosed & Treated Diagnosed
Slide 6: 2020 WAKIX Revenue Performance
2020 WAKIX Revenue Performance Continued Growth with Q4 Revenue of $56.3M +23.4% vs. Q3 $56.3 $45.6 $38.0 $19.8 $6.0 Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Quarterly WAKIX Net Revenue ($m) 62020 WAKIX Revenue Performance Continued Growth with Q4 Revenue of $56.3M +23.4% vs. Q3 $56.3 $45.6 $38.0 $19
Slide 7: Driving Growth Through Our Launch For WAKIX
Driving Growth Through Our Launch For WAKIX Q4 2020 Performance ~2,500 Average # of Patient Outreach WAKIX Patients Programs & Support Expanded Virtual Engagement Programs Unique HCP Prescribers >2,400 Since Launch Healthcare Professional Educational Initiatives U.S. Covered Lives With Formulary Acc
Slide 8: Multiple Opportunities for Pitolisant
Multiple Opportunities for Pitolisant 8Multiple Opportunities for Pitolisant 8
Slide 9: Prader-Willi Syndrome (PWS)
Prader-Willi Syndrome (PWS) Rare, genetic multi-system disease characterized by hypothalamic dysfunction; decreased 1,2 hypocretin levels in some patients ~15,000-20,000 patients in U.S. and more than 50% have Excessive Daytime Sleepiness 1 (EDS) due to sleep-wake state instability of central origin
Slide 10: Rationale for Pitolisant in Patients with PWS
Rationale for Pitolisant in Patients with PWS The hypothalamus Pitolisant increases Studies have A disorder of regulates sleep-wake histamine levels in suggested potential hypothalamic 1,2 state stability via the brain and has role of histamine dysfunction hypocretin and demonstrated and benefit of
Slide 11: Phase 2 Clinical Trial of Pitolisant in Patients with PWS: Trial Design
Phase 2 Clinical Trial of Pitolisant in Patients with PWS: Trial Design High-dose pitolisant (n=20) Open-Label Screening Randomization Low-dose pitolisant (n=20) Extension Placebo (n=20) -28D through -1D Titration Period Stable-Dose Period Week 1 to Week 3 Week 4 to Week 11 Trial Design: • Randomize
Slide 12: Phase 2 Clinical Trial of Pitolisant in Patients with PWS: Study Objectives
Phase 2 Clinical Trial of Pitolisant in Patients with PWS: Study Objectives Primary Objective: To evaluate the safety and efficacy of pitolisant compared to placebo in treating EDS in patients with PWS Secondary Objectives - Impact of pitolisant on: - Caregiver assessment of severity based on EDS -
Slide 13: Myotonic Dystrophy (DM)
Myotonic Dystrophy (DM) Rare, genetic multi-system disease; myotonia and progressive muscle weakness hallmark symptoms; EDS most common non-muscular symptom 1,2 (~80% - 90% of patients) Two forms: DM1 (~140,000 US patients) more common than DM2 (~3,000 - 29,000 US patients); earlier onset and more s
Slide 14: FY 2020 Financial Summary
FY 2020 Financial Summary (in millions, USD) Three Months Ended Twelve Months Ended December 31, December 31, 2020 2019 2020 2019 Net Product Revenues $ 56.3 $ 6.0 $ 159.7 $ 6.0 Total Operating Expenses $ 38.6 $ 38.1 $ 115.0 $ 150.3 R&D Expense 7.6 5.3 19.4 69.6 S&M Expense 17.5 16.8 55.8 44.3 G&A E
Slide 15: GAAP vs Non-GAAP Reconciliation
GAAP vs Non-GAAP Reconciliation (in millions, USD) Three Months Ended Twelve Months Ended December 31, December 31, 2020 2019 2020 2019 GAAP reported net loss $ (0.2) $ (36.4) $ (36.9) $ (152.0) Interest expense / income 8.0 2.7 28.2 6.1 Taxes Depreciation 0.1 0.1 0.4 0.4 Amortization 4.3 1.9 9.8 2.
Slide 16: Thank You
Thank You March 25, 2021Thank You March 25, 2021
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