Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q1 2026 Earnings Presentation
26 slides from Harmony Biosciences's earnings presentation, May 7, 2026
Slide 1: Q1 2026 Financial Results and Business Update
Copyright © 2026 Harmony Biosciences. All rights reserved. Q1 2026 Financial Results and Business Update May 7, 2026
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 press release that do not relate to matters of historical fact should be considered forward-looking statements
Slide 3: Profitable Self-Funding Biotech
PROFITABLE SELF-FUNDING BIOTECH PROVEN COMMERCIAL ENGINE STRONG BALANCE SHEET ROBUST PIPELINE
Slide 4: Moving with Urgency on BD to Generate the Next Wave of Growth
Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT
Slide 5: Moving with Urgency on BD to Generate the Next Wave of Growth
Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT
Slide 6: Protect the Pitolisant Franchise
Protect the Pitolisant Franchise 6 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. WAKIX LOE INTO 2030 WITH PEDIATRIC EXCLUSIVITY PROTECTING GROWING ADVANCING TRANSACTING STRONG IP PROTECTION Multi-layered IP estate – formulation, methods of use, next-gen app
Slide 7: Moving with Urgency on BD to Generate the Next Wave of Growth
Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT
Slide 8: Continued Pitolisant Franchise Growth in an Evolving Market
Continued Pitolisant Franchise Growth in an Evolving Market 8 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PROTECTING GROWING TRANSACTING CONTINUE TO LEAD WITH WAKIX: ON TRACK FOR >$1B NET REVENUE IN 2026 PITOLISANT GR – NDA SUBMISSION 2Q26, PDUFA DATE ANT
Slide 9: Moving with Urgency on BD to Generate the Next Wave of Growth
Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT
Slide 10: Robust Pipeline Beyond Pitolisant Lifecycle Management
Robust Pipeline Beyond Pitolisant Lifecycle Management 10 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT EDS in Narcolepsy (Adult/Pediatric*) WAKIX® Cataplexy in Narcol
Slide 11: Moving with Urgency on BD to Generate the Next Wave of Growth
Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT
Slide 12: Renewed Emphasis on Business Development
Renewed Emphasis on Business Development 12 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PROTECTING GROWING TRANSACTING SIGNIFICANT CAPACITY TO TRANSACT RENEWED FOCUS ON BD OPPORTUNITIES WITH EMPHASIS ON: • Revenues in 2028-2032 • Assets in Phase 3, In-Reg
Slide 13: Moving with Urgency on BD to Generate the Next Wave of Growth
Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT
Slide 14: Reiterating 2026 Net Revenue Guidance
Reiterating 2026 Net Revenue Guidance 14 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. $1.00B-$1.04B 2026 NET REVENUE GUIDANCE WAKIX Net Revenue Growth 2020–2025 $160 $305 $438 $582 $715 $869 $1B+ $0 $200 $400 $600 $800 $1,000 2020 2021 2022 2023 2024 2025
Slide 15: WAKIX Differentiation and Strong Execution Drive Performance
WAKIX® Differentiation and Strong Execution Drive Performance 15 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. 1. https://narcolepsynetwork.org/accessed Feb 2024 • 17% Quarter over Quarter revenue growth: on track to achieve $1B+ in 2026 net sales • After 3
Slide 16: WAKIX Differentiation and Strong Execution Drive Performance
WAKIX Differentiation and Strong Execution Drive Performance 16 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. 80,000 90,000 ~170,000 Diagnosed Narcolepsy Patients Undiagnosed Narcolepsy Population People Living With Narcolepsy in the U.S.1 90K+ Undiagnosed
Slide 17: Robust Pipeline Beyond Pitolisant Lifecycle Management
Robust Pipeline Beyond Pitolisant Lifecycle Management 17 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT EDS in Narcolepsy (Adult/Pediatric*) WAKIX® Cataplexy in Narcol
Slide 18: BP-205: Potential for Best-in-Class OX2R Agonist
BP-205: Potential for Best-in-Class OX2R Agonist 18 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. BUILT ON NOVEL CHEMICAL SCAFFOLD Leads to differentiated product profile HIGH POTENCY Enables the potential for significantly lower dosing and target all 3 cen
Slide 19: Pitolisant GR (Gastro-Resistant): On Track To Extend Pitolisant Franchise Into 2040s
Pitolisant GR (Gastro-Resistant): On Track To Extend Pitolisant Franchise Into 2040’s 19 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PROTECTING TRANSACTING Q1 2027 ANTICIPATED PDUFA DATE NDA SUBMISSION ON TRACK FOR Q2 2026 Anticipated PDUFA date in Q1 202
Slide 20: Pitolisant HD: Opportunity To Expand Pitolisant Franchise With Differentiated Labeling
Pitolisant HD: Opportunity To Expand Pitolisant Franchise With Differentiated Labeling 20 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PROTECTING TRANSACTING 2027 ANTICIPATED PHASE 3 TOPLINE DATA PHASE 3 REGISTRATIONAL CLINICAL TRIALS ONGOING TOPLINE DATA
Slide 21: Robust Pipeline Beyond Pitolisant Lifecycle Management
Robust Pipeline Beyond Pitolisant Lifecycle Management 21 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT EDS in Narcolepsy (Adult/Pediatric*) WAKIX® Cataplexy in Narcol
Slide 22: EPX-100: One of Most Advanced 5-HT2 Agonist Programs in DEEs
EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs 22 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. ESTABLISHED 5-HT2 (SEROTONIN) AGONIST MECHANISM OF ACTION ONGOING PHASE 3 TRIALS IN LENNOX-GASTAUT SYNDROME (LIGHTHOUSE) & DRAVET SYNDR
Slide 23: Financial Summary Q1 2026
Financial Summary Q1 2026 23 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. • $32 million in expenses related to up-front payments for amorphous license agreements impacted diluted EPS by $0.45 a share after taxes. • Cash generation was muted in the quarter
Slide 24: Financial Summary Q1 2026
Financial Summary Q1 2026 24 •Cost of Product Sold as a percentage of Net Product Revenue increased due to new royalties related to Novitium License Agreement. •R&D Expense includes $32 million in IPR&D charges related to amorphous license agreements entered in Q1 2026 •Operating Expenses would have
Slide 25: Pillars of Value Creation
EMPHASIS ON BUSINESS DEVELOPMENT ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT CONTINUED PITOLISANT FRANCHISE GROWTH IN AN EVOLVING MARKET PROTECT THE PITOLISANT FRANCHISE PROTECTING GROWING ADVANCING TRANSACTING Well-positioned to deliver innovative treatments to patients while d
Slide 26: company/harmonybiosciences/ @harmonybio harmony_biosciences www.harmonybiosciences.com
company/harmonybiosciences/ @harmonybio harmony_biosciences www.harmonybiosciences.com
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