Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q4 2021 Earnings Presentation
14 slides from Harmony Biosciences's earnings presentation, Feb 28, 2022
Slide 1: Q4 2021 Financial and Business Update
Harmony Biosciences Q4 2021 Financial and Business Update February 28, 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: Q4/FY 2021 WAKIX Revenue Performance
Q4/FY 2021 WAKIX® Revenue Performance Strong Sequential Growth QoQ, YoY Q4 2021 Revenue of $91.2M FY 2021 Revenue of $305.4M 4Q21 vs. 4Q21 vs. 2021 vs. 2020 4Q20 3Q21 4Q21 3Q21 4Q20 91% $56.3 $80.7 $91.2 13% 62% $91.2 $305.4 $80.7 $73.8 $59.7 $56.3 $45.6 $159.7 $38.0 $19.8 $6.0 $6.0 Q4 Q1 Q2 Q3 Q4 Q
Slide 5: Driving Growth Through Our Launch For WAKIX
Driving Growth Through Our Launch For WAKIX Q4 2021 Performance ~2/3 In-Person Access to HCPs Average # of ~3,800 WAKIX Patients Patient Outreach Programs & Support Continued Growth in Depth & Breadth of Prescriber Base Healthcare Professional Educational Initiatives Managed Care ~80% U.S. Covered L
Slide 6: Publications for WAKIX: Clinically Relevant Data
Publications for WAKIX®: Clinically Relevant Data 6
Slide 7: Phase 3 Clinical Trial of Pitolisant in Idiopathic Hypersomnia
Phase 3 Clinical Trial of Pitolisant in Idiopathic Hypersomnia: On Track to Initiate 1H2022 Open-Label Phase (N=~200) Double-Blind Randomized Withdrawal Phase Randomized Responders Screening Pitolisant Titration + Stable Safety + Dose Optimization Dose Placebo Follow-up Baseline Titration: Weeks 1-3
Slide 8: Clinical Development: COVID-19 Contingency Efforts
Clinical Development: COVID-19 Contingency Efforts Mechanism put in place for electronic signatures for ‘e-consent’ on Informed Consent Forms (ICFs); allows for remote screening Protocol amendments to allow for remote visits during the trial in both the PWS and DM1 Phase 2 trials; include teleme
Slide 9: Harmony Development Pipeline
Harmony Development Pipeline Regulatory Marketed Upcoming Product / Indication Pre-IND Phase 1 Phase 2 Phase 3 Filing1 Product Milestones WAKIX® EDS in Narcolepsy (Adults) Cataplexy in Narcolepsy (Adults) Pitolisant Pediatric Trial completed Narcolepsy2 Idiopathic Trial initiation Hypersomnia 1H2022
Slide 10: Historical Financials
a” OU'NF Historical Financials HW HARMONY BIOSCIENCES
Slide 11: Q4 2021 Financial Highlights
Q4 2021 Financial Highlights Three Months Ended Year Ended (In millions, USD) December 31,2021 December 31,2021 $100 $91.2 $400 Q4 ‘21 Net Product $80 $305.4 $300 Revenues $60 $56.3 $159.7 $91.2M $200 $40 $100 $20 62.0% vs prior year $0 $0 2020 2021 2020 2021 $40 $37.8 $150 Q4 ‘21 Non-GAAP Adjusted
Slide 12: Q4 2021 Financial Summary
Q4 2021 Financial Summary Three Months Ended Year Ended December 31, December 31, (In millions, USD) 2021 2020 2021 2020 Net Product Revenues $91.2 $56.3 $305.4 $159.7 Cost of Product Sold 17.8 9.9 55.5 27.7 Total Operating Expenses $44.8 $38.6 $162.4 $115.0 R&D Expense 7.5 7.6 30.4 19.5 S&M Expense
Slide 13: Q4 2021 GAAP vs Non-GAAP Reconciliation
Q4 2021 GAAP vs Non-GAAP Reconciliation Three Months Ended Year Ended December 31, December 31, (In millions, USD) 2021 2020 2021 2020 GAAP reported net income (loss) $22.7 $(0.2) $34.6 $(36.9) Interest expense / income 4.2 8.0 24.0 28.2 Taxes 1.8 - 2.8 - Depreciation 0.1 0.1 0.4 0.4 Amortization 4.
Slide 14: Thank You
HARMONY BIOSCIENCES Thank You February 2022
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