Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q3 2026 Earnings Presentation
22 slides from Harmony Biosciences's earnings presentation, Nov 4, 2026
Slide 1: Q3 2026 Financial Results and Business Update
Copyright © 2026 Harmony Biosciences. All rights reserved. Q3 2026 Financial Results and Business Update November 4, 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: Executing Against Four Value Creation Priorities
Multi-layered IP strategy across active legal proceedings reinforces confidence in WAKIX exclusivity to March 2030 PROTECT THE PITOLISANT FRANCHISE 5 Phase 3 registrational trials in 5 distinct rare CNS indications Led by BP-205, a potentially best-in-class OX2R agonist ADVANCE B P - 205 AND THE NE
Slide 4: Two Key Highlights for This Quarter
TWO KEY HIGHLIGHTS FOR THIS QUARTER STRONG COMMERCIAL QUARTER $269M • Third quarter net product revenue for WAKIX • 40% CAGR over past 5 years • 400 Net Patient Adds, 9,350 Average Patients POTENTIAL BEST-IN-CLASS OX2R BP-205 • Favorable multiple-ascending dose (MAD) data: 14 days of once-daily dosi
Slide 5: Executing Against Four Value Creation Priorities
Multi-layered IP strategy across active legal proceedings reinforces confidence in WAKIX exclusivity to March 2030 PROTECT THE PITOLISANT FRANCHISE 5 Phase 3 registrational trials in 5 distinct rare CNS indications Led by BP-205, a potentially best-in-class OX2R agonist ADVANCE B P - 205 AND THE NE
Slide 6: WAKIX Differentiation and Strong Execution Drive Performance
WAKIX® Differentiation and Strong Execution Drive Performance 6 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. KEY TAKEAWAY Average Patients on WAKIX Continued Demand-Driven Growth in Q3 '26 • $269M net revenue in Q3 '26 • 400 net patient adds, 9,350 average
Slide 7: Growth Opportunity Across the Narcolepsy Market
Growth Opportunity Across the Narcolepsy Market • ~170K total narcolepsy patients • <50% diagnosed patients • ~20% brand penetration in polypharmacy market People Living With Narcolepsy in the U.S.1 80,000 90,000 ~170,000 Diagnosed Narcolepsy Patients Undiagnosed Narcolepsy Population KEY TAKEAWAY L
Slide 8: Reiterating 2026 WAKIX Net Revenue Guidance
Reiterating 2026 WAKIX Net Revenue Guidance 8 Harmony Biosciences | Q3 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
Slide 9: Advancing BP-205 and a Catalyst-Rich Pipeline for Long-Term Growth
Advancing BP-205 and a Catalyst-Rich Pipeline for Long-Term Growth 9 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING Research collaboration with CiRC Biosciences. Innovative Clinical-Sta
Slide 10: BP-205: Multiple-Ascending Dose Phase Study in Healthy Volunteers
BP-205: Multiple-Ascending Dose (MAD) Phase 1 Study in Healthy Volunteers 10 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, HEALTHY PARTICIPANTS 14 days of repeated once-daily dosing DOSES EVALUATED BP-205 0.1 mg
Slide 11: BP-205: MAD Study Data Highlights
BP-205: Multiple-Ascending Dose (MAD) Phase 1 Study Data Highlights 11 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. PRELIMINARY DATA AFTER 14 DAYS OF DAILY DOSING (0.1 TO 3 MG): • Rapid absorption with a mean Tmax of ~60 minutes (range 30 to 90 minutes) o
Slide 12: BP-205 Development Plan
BP-205 Development Plan 12 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. Q3 2026: ENCOURAGING SINGLE-ASCENDING DOSE (SAD) DATA Q4 2026: FAVORABLE PRELIMINARY PHASE 1 MAD RESULTS Q1 2027: PHASE 1B DATA IN SLEEP-DEPRIVED HEALTHY VOLUNTEERS MID-2027: TO INITIA
Slide 13: Combination of BP-205 and Pitolisant: Synergistic Wake-Promoting Effects
Combination of BP-205 and Pitolisant: Synergistic Wake-Promoting Effects • In-vivo data in the narcoleptic mice model showed synergistic wake-promoting effects with BP-205 (OX2R agonist) and pitolisant (histaminergic) MoA • Pitolisant on top of BP-205 drove maximal histamine release (+205%) vs BP-20
Slide 14: Next-Generation Pitolisant Programs
Next-Generation Pitolisant Programs 14 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. PITOLISANT GR – NDA UNDER FDA REVIEW; ON TRACK TO LAUNCH IN 1H 2027 PDUFA date April 1, 2027 PITOLISANT HD – ONGOING PHASE 3 REGISTRATIONAL STUDIES IN NARCOLEPSY AND IH TLD
Slide 15: EPX-100: Advanced 5-HT2 Agonist Program in DEEs
EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs 15 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. ESTABLISHED 5-HT2 (SEROTONIN) AGONIST MECHANISM OF ACTION ONGOING PHASE 3 TRIALS IN LENNOX-GASTAUT SYNDROME & DRAVET SYNDROME TLD expec
Slide 16: Emphasis on Business Development
Emphasis on Business Development 16 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. TWO CATEGORIES OF OPPORTUNITY • Assets that can add near-term revenue in 2028 to 2032 to support our self-funded model • Innovative pipeline assets that drive long-term value
Slide 17: Protect the Pitolisant Franchise
Protect the Pitolisant Franchise 17 Harmony Biosciences | Q3 2026 Financial Results & Business Update | All rights reserved. WAKIX EXCLUSIVITY TO MARCH 2030, WITH PEDIATRIC EXCLUSIVITY STRONG IP PROTECTS WAKIX TO MARCH 2030, INCLUSIVE OF PEDIATRIC EXCLUSIVITY • Asserting pitolisant IP in active lega
Slide 18: Financial Summary Q3 2026
$0.87 $0.81 Q3 2025 Q3 2026 $2.32 $2.63 9M 2025 9M 2026 Financial Summary Q3 2026 18 • Continued sales growth in Q3 supported by strong underlying demand for WAKIX. • Reiterating full year WAKIX net revenue guidance of $1.0B - $1.04B for 2026. • Cash generation of $89M in Q3, sustaining our strong b
Slide 19: Financial Summary Q3 2026
Financial Summary Q3 2026 19 • Cost of Product Sold increase due to new royalties related to Novitium License Agreement signed in Q1 2026. • R&D Expense: • Q3 increase primarily due to $25.0M charge for MSN license milestone. • Partially offset by $15.0M charge for ZYN002 milestone in prior year qua
Slide 20: Executing Against Four Value Creation Priorities
Multi-layered IP strategy across active legal proceedings reinforces confidence in WAKIX exclusivity to March 2030 PROTECT THE PITOLISANT FRANCHISE 5 Phase 3 registrational trials in 5 distinct rare CNS indications Led by BP-205, a potentially best-in-class OX2R agonist ADVANCE B P - 205 AND THE NE
Slide 21: Jeffrey yo
Jeffrey yo , M. Daynd, Harmony Biosciences, LLE HARMONY
Slide 22: company/harmonybiosciences/ @harmonybio harmony_biosciences www.harmonybiosciences.com
company/harmonybiosciences/ @harmonybio harmony_biosciences www.harmonybiosciences.com
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