Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q2 2026 Earnings Presentation
20 slides from Harmony Biosciences's earnings presentation, Aug 4, 2026
Slide 1: Q2 2026 Financial Results and Business Update
Q2 2026 Financial Results and Business Update August 4, 2026 Copyright © 2026 Harmony Biosciences. All rights reserved.
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statements,
Slide 3: Two Defining Stories This Quarter
TWO DEFINING STORIES THIS QUARTER G R O W I N G A D V A N C I N G R E C O R D C O M M E R C I A L Q UA R T E R B E S T- I N - C L A S S OX 2 R P O T E N T I A L $261.3M BP-205 • Record quarterly net product revenue for WAKIX • Encouraging single ascending dose (SAD) data; potential for once-daily do
Slide 4: Executing Against Four Value Creation Priorities
EXECUTING AGAINST FOUR VALUE CREATION PRIORITIES G R O W I N G A D V A N C I N G T R A N S A C T I N G P R O T E C T I N G GROW THE A D VA N C E EMPHASIS ON PROTECT THE WA K I X ® BP-205 AND THE BUSINESS PITOLISANT FRANCHISE N E X T W AV E O F DEVELOPMENT FRANCHISE I N N O V AT I O N Continued WAKIX
Slide 5: WAKIX Differentiation and Strong Execution Drive Performance
WAKIX® Differentiation and Strong Execution Drive Performance Average Patients on WAKIX 450 9,000 400 0 DIFFERENTIATED • A record $261M in 500 8,000 400 PRODUCT net sales in 2Q26 300 100 7,000 250 150 250 6,000 350 350 • Up 30% percent year over year in 350 200 5,000 300 EXPANDED TEAM year 7 on mark
Slide 6: Growth Opportunity Across the Narcolepsy Market
Growth Opportunity Across the Narcolepsy Market People Living With Narcolepsy in the U.S.1 • ~170K total narcolepsy Undiagnosed patients Narcolepsy Population LARGE • <50% diagnosed 80,000 MARKET patients ~170,000 OPPORTUNITY 90,000 Diagnosed • ~20% brand Narcolepsy penetration Patients in polypharm
Slide 7: Reiterating 2026 Net Revenue Guidance
Reiterating 2026 Net Revenue Guidance $1.00B-$1.04B WAKIX Net Revenue Growth 2020–2025 $1,000 $1B+ 2026 NET REVENUE GUIDANCE $800 $869 Net Revenue ($M) $715 $600 $582 $400 $438 $200 $305 $160 $0 2020 2021 2022 2023 2024 2025 2026 Guidance On Track to Achieve $1B+ in Net Sales 7 Harmony Biosciences |
Slide 8: Advancing BP-205 and a Catalyst-Rich Pipeline for Long-Term Growth
Advancing BP-205 and a Catalyst-Rich Pipeline for Long-Term Growth PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING BP-205 (Orexin-2 Multiple CNS Indications Receptor Agonist) Pitolisant Gastro-Resistant (GR) in Narcolepsy Prader-Willi Syndrome (PWS) Pitolisant Pitolisant Hig
Slide 9: BP-205: Most Potent OX2R Agonist in Clinical Development
BP-205: Most Potent OX2R Agonist in Clinical Development Select DMPK HRMY/BP1 Takeda2 Alkermes3 Centessa/Lilly4 Eisai5 parameters BP-205 TAK-861 2680 ORX750 E2086 Potency 0.015 nM 2.5 nM Not reported 0.11 nM 2.3 nM (hOX2R, EC50) Selectivity for hOX2R > 600x 3000x Not reported 9800x > 2000x vs hOX1R
Slide 10: BP-205: Single Ascending Dose (SAD) Phase Study in Healthy Volunteers
BP-205: Single Ascending Dose (SAD) Phase 1 Study in Healthy Volunteers RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, HEALTHY PARTICIPANTS Males, women of childbearing potential and post-menopausal females BP-205 SAD DOSES EVALUATED Study: Wide BP-205 0.2mg to 6.0mg Range of 9 DIFFERENT COHORTS OF 8
Slide 11: BP-205: Single Ascending Dose (SAD) Phase Study Data Highlights
BP-205: Single Ascending Dose (SAD) Phase 1 Study Data Highlights ENCOURAGING DATA FOLLOWING SINGLE ORAL DOSES OF BP-205 FROM 0.2 TO 6.0 MG: • Rapid absorption and a short Tmax in the range of 30 to 75 minutes o Potential to observe rapid efficacy Supportive of • Mean T1/2 of approximately 25h acros
Slide 12: BP-205 Development Plan – Next Steps
BP-205 Development Plan – Next Steps BP-205 MAD DATA IN HEALTHY VOLUNTEERS EXPECTED IN Q4 Multiple BP-205 IND OPEN IN US Phase 2 INITIATING PHASE 1B STUDY IN SLEEP-DEPRIVED Studies in HEALTHY VOLUNTEERS IN Q3 Mid-2027 Data expected early 2027 INITIATING PHASE 2 TRIALS FOR BP-205 IN MULTIPLE CNS INDI
Slide 13: Next-Generation Pitolisant Programs
Next-Generation Pitolisant Programs PITOLISANT GR – NDA ACCEPTED FOR FULL REVIEW PDUFA date anticipated April 1, 2027 PITOLISANT HD – ONGOING PHASE 3 REGISTRATIONAL STUDIES IN NARCOLEPSY AND IH Positioned TLD expected in 2027; Anticipated PDUFA in 2028 to Extend UTILITY PATENTS FILED FOR BOTH GR AND
Slide 14: EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs
EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs ESTABLISHED 5-HT2 (SEROTONIN) AGONIST MECHANISM OF ACTION Phase 3 ONGOING PHASE 3 TRIALS IN LENNOX-GASTAUT SYNDROME & DRAVET SYNDROME Topline Data Topline data anticipated 1H 2027 Expected in SAFETY: POTENTIAL TO OFFER A UNIQUE
Slide 15: Capacity & Conviction to Transact
Emphasis on Business Development KEY CRITERIA • Revenues in 2028-2032 • Assets in Phase 3, In-Registration, or On-Market LEVERAGE CORE COMPETENCIES Capacity & THERAPEUTIC AREAS OF INTEREST Conviction to • Sleep/Wake • Epilepsy Transact • Rare/Orphan CNS • Broader CNS indications AGNOSTIC TO DEAL TYP
Slide 16: Protect the Pitolisant Franchise
Protect the Pitolisant Franchise STRONG IP PROTECTS WAKIX TO MARCH 2030, INCLUSIVE OF PEDIATRIC EXCLUSIVITY Multi-layered IP estate – formulation, methods of use, next-gen applications UTILITY PATENTS FILED FOR NEXT-GEN PITOLISANT FORMULATIONS WAKIX Potential protection into the 2040s EXCLUSIVITY TO
Slide 17: Financial Summary Q2 2026
Financial Summary Q2 2026 • Cost of Product Sold increase due to new royalties related to Three Months Ended Six Months Ended Novitium License June 30, June 30, Agreement signed in Q1 2026 2025 % 2026 2025 % • R&D Expense: Totals may not foot due to rounding Change Change • Q2 lower primarily due Ne
Slide 18: Financial Summary Q2 2026
Financial Summary Q2 2026 Three Months Ended Six Months Ended June 30, 2026 June 30, 2026 • Record sales in Q2 of +30% +24% $261 million representing Net Product 30% growth Revenue $261.3 $200.5 $385.2 $476.7 Q2 2025 Q2 2026 Q2 2025 Q2 2026 • Continued strong Three Months Ended Six Months Ended unde
Slide 19: Executing Against Four Value Creation Priorities
EXECUTING AGAINST FOUR VALUE CREATION PRIORITIES G R O W I N G A D V A N C I N G T R A N S A C T I N G P R O T E C T I N G GROW THE A D VA N C E EMPHASIS ON PROTECT THE WA K I X ® BP-205 AND THE BUSINESS PITOLISANT FRANCHISE N E X T W AV E O F DEVELOPMENT FRANCHISE I N N O V AT I O N Continued WAKIX
Slide 20: 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 — Q2 2026 Earnings Presentation on 6ix