Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q4 2023 Earnings Presentation
14 slides from Harmony Biosciences's earnings presentation, Jan 8, 2024
Slide 1: Q4 and Full Year 2023 Financial and Business Update
Q4 and Full Year 2023 Financial and Business Update February 22, 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: Strong Momentum in Execution of Our Growth Strategy
Strong Momentum in Execution of Our Growth Strategy ▪ FY 2023 WAKIX Net Revenue of $582.0M +33% Year-over-Year Growth Continued Strong Growth For WAKIX® ▪ ~6,150 average number of patients on WAKIX in Q4 2023 in ▪ Continued strong growth in average number of patients & WAKIX prescriber base Adult Na
Slide 4: WAKIX Net Revenue Performance
WAKIX® Net Revenue Performance CONFIDENT IN WAKIX BEING A POTENTIAL $1B+ OPPORTUNITY IN ADULT NARCOLEPSY ALONE WITH THE POTENTIAL TO CONTRIBUTE UP TO AN ADDITIONAL $1B, IF APPROVED IN OTHER CURRENT PITOLISANT LIFECYCLE MANAGEMENT PROGRAMS WAKIX NET REVENUE ($M) HIGHLIGHTS ▪ Q4 23 represented the hig
Slide 5: Solid Business Fundamentals Driving Growth
Solid Business Fundamentals Driving Growth Continued Strong Performance in 2023 - Year 4 of Commercialization ~Approximate Patient Counts 2023 Highlights ~Average # of Patients on WAKIX More unique prescribers of WAKIX than sodium oxybate Strong market access coverage (~84%) - even with the launch (
Slide 6: Prescriber Dynamics Support Continued WAKIX Growth in Adult Narcolepsy
Prescriber Dynamics Support Continued WAKIX® Growth in Adult Narcolepsy Depth of prescribing ~4,000 HCPs enrolled in oxybate REMS in oxybate REMS enrolled HCPs WAKIX Breadth of prescribing ~5,000 HCPs not enrolled in oxybates REMS growth in HCPs not enrolled in oxybate REMS ~9,000 Narcolepsy 100% of
Slide 7: Development Pipeline: Continues to Grow
Development Pipeline: Continues to Grow Regulatory Marketed Product / Indication Pre-IND Phase 1 Phase 2 Phase 3 Filing Milestone Product WAKIX® EDS in Narcolepsy (Adults) Cataplexy in Narcolepsy (Adults) Pitolisant Pediatric Narcolepsy (1) PDUFA Date June 21, 2024 Idiopathic Hypersomnia FDA Meeting
Slide 8: TEMPO: Global Phase 3 Trial of Pitolisant in PWS
TEMPO: Global Phase 3 Trial of Pitolisant in PWS Pitolisant (n=67) 1 Year Screening Randomization Open-Label Extension Placebo (n=67) -45D through -1D Titration Period Stable-Dose Period Week 1 to Week 3 Week 4 to Week 11 Trial Design: Objectives / Endpoints: ▪ Randomized, double-blind, ▪ Primary ob
Slide 9: DM1 Phase 2 POC Study Topline Data
DM1 Phase 2 POC Study Topline Data Change in Daytime Sleepiness Scale (DSS) from Baseline to Topline Data Highlights End of Treatment Period ▪ Clinically meaningful signal in EDS (DSS, ESS and CGI-S) ▪ Clinically meaningful signal in Fatigue (FSS) ▪ Mean change from baseline of -0.86 and -0.36 for h
Slide 10: Financial Highlights
Financial Highlights (In millions, USD) Three Months Ended Year Ended December 31, 2023 December 31, 2023 31% 33% $582.0 $168.4 $437.9 Net Product $128.3 Revenue Q4 2022 Q4 2023 FY 2022 FY 2023 3% -31% $183.5 $188.4 Non-GAAP Adjusted $61.9 $42.8 Net Income(1) Q4 2022 Q4 2023 FY 2022 FY 2023 $429.6 $
Slide 11: Financial Summary
Financial Summary (In millions, USD) Three Months Ended Year Ended December 31, % Change December 31, % Change Totals may not foot due to rounding 2023 2022 2023 2022 Net Product Revenue $168.4 $128.3 31% $582.0 $437.9 33% Cost of Product Sold 43.2 26.9 61% 121.2 83.5 45% Total Operating Expenses $8
Slide 12: GAAP vs NON-GAAP Reconciliation
GAAP vs NON-GAAP Reconciliation (In millions, USD) Three Months Ended Year Ended December 31, December 31, Totals may not foot due to rounding 2023 2022 2023 2022 GAAP net income $26.6 $48.5 $128.8 $181.5 Non-cash interest expense(1) 0.2 0.4 3.2 1.7 Depreciation 0.2 0.1 0.5 0.4 Amortization(2) 6.0 6
Slide 13: 2024 Net Revenue Guidance
2024 Net Revenue Guidance CONFIDENT IN WAKIX BEING A POTENTIAL $1B+ OPPORTUNITY IN ADULT NARCOLEPSY ALONE WITH THE POTENTIAL TO CONTRIBUTE UP TO AN ADDITIONAL $1B, IF APPROVED IN OTHER CURRENT PITOLISANT LIFECYCLE MANAGEMENT PROGRAMS WAKIX ANNUAL NET REVENUE ($M) $700 - $720 2023 $582M Net Revenue $
Slide 14: Thank You
H3 HARMONY BIOSCIENCES Thank You
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