Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q4 2024 Earnings Presentation
18 slides from Harmony Biosciences's earnings presentation, Feb 25, 2025
Slide 1: Financial Results & Q4 & FY 2024 Business Update
Financial Results & Q4 & FY 2024 Business Update February 25, 2025 Copyright © 2025 Harmony Biosciences. All rights reserved.
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Bios
Slide 3: Innovation driving growth of the portfolio
NEURO SLEEP/WAKE BEHAVIORAL EPILEPSY Extending Our Leadership Next Major Clinical Catalyst Most Advanced 5-HT2 Position Development Program • Initiating Phase 3 registrational trials of • On track for topline data readout • EPX-100: validated MOA Pitolisant HD in narcolepsy & IH Q4 ‘25 of Phase 3 re
Slide 4: WAKIX Net Revenue Performance
WAKIX® Net Revenue Performance Q4 ‘24 WAKIX Net Revenue ($M) FY ‘24 WAKIX Net Revenue ($M) HIGHLIGHTS 23% Q4 ‘24 represented the highest quarter of Net Revenue in our history, $201.3M $714.7 FY ‘24 Net Revenue of $714.7M 20% $582.0 Durable double-digit sales growth continued through year five
Slide 5: Durable Growth in Patients on WAKIX
Meaningfully Differentiated Product Profile Key Driver in Strong Durable Growth in Patients on WAKIX® ~Approximate Patient Counts 8000 ~7,100 Q4 24 Highlights 7000 +300 +250 +250 +150 6000 +350 ~Average # of Patients on WAKIX +350 +350 5000 +200 On our way +300 +300 to a $1B+ 4000 +400 opportunity +
Slide 6: Pitolisant Franchise: Patient-Centric Drug Development
Pitolisant Franchise: Patient-Centric Drug Development Building Our Leadership Position in Sleep/Wake 75% Residual symptoms¹ Higher dose, enhanced efficacy 60% Report fatigue² Fatigue indication Products require Don’t achieve 100% 33% No titration No titration titration clinical benefit 1 in 5 Repor
Slide 7: Pitolisant Franchise Poised to Drive Durable Patient and Revenue Growth to the Mid-2040s
Pitolisant Franchise Poised to Drive Durable Patient and Revenue Growth to the Mid-2040s 2019 2026 2028 2030 2040 WAKIX® (LOE Q1 2030*) $1B+ foundation in narcolepsy alone PITOLISANT GR (TARGET PDUFA DATE 2026) Expands pitolisant patient base Potential $300–$500M Opportunity PITOLISANT HD (TARGET PD
Slide 8: Innovative Late-Stage Pipeline
Innovative Late-Stage Pipeline PRODUCT / INDICATION PRE-IND PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT Sleep/Wake WAKIX® EDS in Narcolepsy (Adults) Cataplexy in Narcolepsy (Adults) EDS in Narcolepsy (Pediatric) Pitolisant Prader-Willi Syndrome (PWS) Myotonic Dystrophy (DM1) Pitolisan
Slide 9: 2025 Anticipated Catalysts
2025 Anticipated Catalysts 2Q25 3Q25 4Q25 BP1.15205 (OX2R ZYN002 Pitolisant HD agonist) FXS Phase 3 Initiation of Phase 3 • Preclinical data Registrational Trial registrational trials in presentation at topline data readout narcolepsy and idiopathic SLEEP 2025 hypersomnia (IH) • IMPD submission Pito
Slide 10: BP1.15205: Potential Best-in-Class Orexin 2 Receptor Agonist
BP1.15205: Potential Best-in-Class Orexin 2 Receptor (OX2R) Agonist OREXIN CLASS Next wave of Sleep/Wake therapeutic innovation TEIJIN Tokyo-based Pharma; innovator of TPM-1116 (now BP1.15205) Preclinical Safety PRECLINICAL DATA PRESENTATION AT SLEEP IN JUNE Preclinical safety and efficacy data pres
Slide 11: ZYN002: Potential for First Approved Treatment of Fragile X Syndrome
ZYN002: Potential for First Approved Treatment of Fragile X Syndrome ZYN002: INNOVATIVE PRODUCT PROFILE Purely synthetic cannabidiol (CBD); devoid of THC; Permeation enhanced gel Topline Data LEAD PROGRAM IN FRAGILE X SYNDROME (FXS) Additional opportunity in related disorder, 22q deletion syndrome (
Slide 12: Pitolisant HD: Phase 3 Registrational Trials in Narcolepsy and IH in Q4 2025
Pitolisant HD: Phase 3 Registrational Trials in Narcolepsy and IH in Q4 2025 OPTIMIZED PK PROFILE AND HIGHER DOSE • Designed to address the need for greater efficacy in EDS and other symptoms in patients with central disorders of hypersomnolence Initiation of Phase 3 PROGRAMS TO PURSUE A DIFFERENTIA
Slide 13: EPX-100: Most Advanced and Differentiated 5HT2 Agonist Development Program
EPX-100: Most Advanced and Differentiated 5HT2 (serotonin) Agonist Development Program PROVEN MoA Established serotonergic mechanism of action – confirmed via highly predictive zebra-fish model PROVEN SAFETY • Clemizole was marketed for ~ 20 yrs with no significant safety and/or tolerability signals
Slide 14: Financial Highlights
Financial Highlights (In millions, USD) Three Months Ended Twelve Months Ended December 30, 2024 December 30, 2024 20% 23% $714.7 $201.3 $582.0 Net Product $168.4 Revenue Q4 2023 Q4 2024 2023 YTD 2024 YTD 47% 24% Non-GAAP $233.9 $63.0 $188.4 Adjusted $42.8 14 Net Income(1) Q4 2023 Q4 2024 2023 YTD 2
Slide 15: Financial Summary
Financial Summary (In millions, USD) Three Months Ended Twelve Months Ended December 31, % Change December 31, % Change Totals may not foot due to rounding 2024 2023 2024 2023 Net Product Revenue $201.3 $168.4 20% $714.7 $582.0 23% Cost of Product Sold 54.4 43.2 26% 156.8 121.2 29% Total Operating E
Slide 16: GAAP vs NON-GAAP Reconciliation
GAAP vs NON-GAAP Reconciliation (In millions, USD) Three Months Ended Twelve Months Ended December 31, December 31, Totals may not foot due to rounding 2024 2023 2024 2023 GAAP net income $49.5 $26.6 $145.5 $128.9 Non-cash interest expense(1) 0.2 0.2 0.7 3.2 Depreciation 0.0 0.2 0.3 0.5 Amortization
Slide 17: Deliver on Promise to Patients, Deliver Strong Value to Shareholders
DELIVER ON DELIVER PROMISE STONG VALUE TO PATIENTS TO SHAREHOLDERS Commitment to patients Innovative Addressing unmet medical needs Catalyst-rich pipeline Delivering meaningful treatment options Profitable biotech company Helping patients thrive Meaningful investment opportunity 17
Slide 18: company/harmonybiosciences/ @harmonybio harmony_biosciences
company/harmonybiosciences/ @harmonybio harmony_biosciences w w w. h a r m o n y b i o s c i e n c e s . c o m
Harmony Biosciences Holdings — Q4 2024 Earnings Presentation on 6ix