Harmony Biosciences Holdings, Inc. · NASDAQ:HRMY
Harmony Biosciences — Q3 2024 Earnings Presentation
22 slides from Harmony Biosciences's earnings presentation, Oct 29, 2024
Slide 1: Q3 2024 Financial Results and Business Updates
Financial Results Q3 2024 and Business Updates October 29, 2024 Copyright © 2024 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: Innovative, Patient Focused, and Catalyst-Rich Portfolio
Innovative, Patient Focused, and Catalyst-Rich Portfolio $1B+ $3B+ Proven commercial Establishing leadership product and growing position in CNS 13 5 Development programs; Anticipate 1 or more new 4 in Phase 3 by year end product or indication launches each year over next 5 years Catalyst-rich pipel
Slide 4: Innovation driving growth of the portfolio
SLEEP/ NEURO WAKE BEHAVIORAL EPILEPSY Extending Our Leadership Next Major Clinical Catalyst Most Advanced 5-HT2 Position Development Program • Compelling new data; conviction • Pivotal Phase 3 trial in Fragile X • EPX-100: validated MOA in IH - sNDA on track for Q4 2024 syndrome; topline data on tra
Slide 5: WAKIX Net Revenue Performance
WAKIX® Net Revenue Performance WAKIX Net Revenue ($M) HIGHLIGHTS 16% Durable double-digit sales growth continuing into year five on the market $186.0 Passed $2B in cumulative net revenue since launch $160.2 Underlying demand drove continued revenue growth – Strong patient interest – Continue t
Slide 6: Durable Growth in Patients on WAKIX
Meaningfully Differentiated Product Profile Key Driver in Strong Durable Growth in Patients on WAKIX® ~Approximate Patient Counts 7000 Q3 24 Highlights ~6,800 +250 +250 +150 6000 +350 +350 +350 5000 +200 ~Average # of Patients on WAKIX +300 +300 On our way +400 4000 to a $1B+ +100 +300 opportunity +
Slide 7: Unique Prescriber Dynamics Support Continued WAKIX Growth
Unique Prescriber Dynamics Support Continued WAKIX® Growth, Opportunity for Next-Gen Pitolisant Assets in Narcolepsy ~9,000 NARCOLEPSY TREATING HCPs MORE UNIQUE WAKIX growth PRESCRIBERS ~4,000 OF WAKIX THAN Enrolled in oxybate REMS Depth of prescribing SODIUM OXYBATE Unique feature as non- WAKIX gro
Slide 8: The Pitolisant Franchise: Patient-Centric Drug Development
The 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 R
Slide 9: Pitolisant Franchise Poised to Drive Durable 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 SEPT 2030*) $1B+ foundation in narcolepsy alone PITOLISANT-GR (PDUFA DATE 2026) Expands pitolisant patient base Potential $300–$500M Opportunity PITOLISANT-HD (PDUFA DATE 202
Slide 10: Harmony Biosciences: R&D Pipeline
Harmony Biosciences: R&D 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 Idiopathic Hypersomnia (IH) Prader-Willi Syndrome (PWS) Myo
Slide 11: Idiopathic Hypersomnia: Strong Benefit/Risk Proposition
Idiopathic Hypersomnia: Strong Benefit/Risk Proposition IH: DISORDER WITH REAL WORLD DATA FAVORABLE HIGH UNMET NEED Experience from BENEFIT/RISK PROFILE a large clinic & Compassionate Use program COMPELLING TOTALITY OF ESTABLISHED SAFETY DATA FROM INTUNE STUDY Non-scheduled and simple a Phase 3 pivo
Slide 12: OX2R Agonist BP1.15205: Potential Best-in-Class Asset
OX2R Agonist BP1.15205: Potential Best-in-Class Asset Potent on-target Highly desirable Potential approval effects QD dosing in early 2030s 24h High potency with Potentially better Potential for potential efficacy AE profile combination drug in various sleep development: disorders and other indicati
Slide 13: Epilepsy Franchise: Deliver Meaningful Treatment Options
Epilepsy Franchise: Deliver Meaningful Treatment Options to Patients with Serious Unmet Medical Needs ACQUISITION OF POTENTIAL FOR ON TRACK EPYGENIX FAVORABLE to initiate EPX-100 Phase 3 EPX-100 AND EPX-200 risk/benefit proposition study in Lennox-Gastaut syndrome (LGS) in Q4 2024 EPX-100 and EPX-20
Slide 14: Epilepsy Franchise: Most Advanced Development Programs in DEEs
Epilepsy Franchise: Most Advanced and Promising Development Programs in DEEs • EPX-100 (clemizole hydrochloride) • Established serotonergic (5-HT2) mechanism of action • Pre-clinical evidence for efficacy supporting broad utility in DEEs • BID dosing and liquid formulation: Clinically relevant for p
Slide 15: EPX-100 (Clemizole HCl): Overview and Clinical Development Programs
EPX-100 (Clemizole HCl): Overview and Clinical Development Programs EPX-100 or Clemizole HCl once marketed as a 1st generation antihistamine in the 1960s Sunsetted in 1970s with the introduction of newer antihistamines — no significant post-marketing safety signals Modulation of serotonin signal (5H
Slide 16: EPX-100: Preliminary Safety and Tolerability Data
EPX-100: Preliminary Safety and Tolerability Data Compared to Select Approved Drugs in DS and LGS Epidiolex1 Fintepla2 EPX-1003 Decreased appetite 16–22% 8% 0% Diarrhea 9–20% 6% 16% Somnolence 23–25% 11% 12% LFT monitoring Required n/a n/a REMS (CVD and PAH) n/a + n/a Echocardiography n/a Prior to i
Slide 17: EPX-200 (liquid lorcaserin): Overview
EPX-200 (liquid lorcaserin): Overview EPX-200: Safety and tolerability established in short- and long-term studies Selective 5HT-2C Agonist1 established MoA for DEEs Clinical data in DEEs3 Supported by published work from Pre-IND Liquid formulation and BID dosing Dr. Baraban et al. at UCSF, funded b
Slide 18: Financial Highlights
Financial Highlights (In millions, USD) Three Months Ended Nine Months Ended September 30, 2024 September 30, 2024 16% 24% $513.5 $186.0 $413.6 Net Product $160.3 Revenue Q3 2023 Q3 2024 2023 YTD 2024 YTD 1% 18% Non-GAAP 18 $170.9 $59.6 $145.4 Adjusted $58.8 Net Income(1) Q3 2023 Q3 2024 2023 YTD 20
Slide 19: Financial Summary
Financial Summary (In millions, USD) Three Months Ended Nine Months Ended September 30, % Change September 30, % Change Totals may not foot due to rounding 2024 2023 2024 2023 Net Product Revenue $186.0 $160.3 16% $513.5 $413.6 24% Cost of Product Sold 42.8 32.3 32.5% 102.4 78.1 31% Total Operating
Slide 20: GAAP vs NON-GAAP Reconciliation
GAAP vs NON-GAAP Reconciliation (In millions, USD) Three Months Ended Nine Months Ended September 30, September 30, Totals may not foot due to rounding 2024 2023 2024 2023 GAAP net income $46.1 $38.5 $96.0 $102.2 Non-cash interest expense(1) 0.2 2.2 0.5 3.1 Depreciation 0.0 0.1 0.3 0.4 Amortization(
Slide 21: Deliver on Promise to Patients
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 21
Slide 22: www.harmonybiosciences.com
company/harmonybiosciences/ @harmonybio harmony_biosciences www.harmonybiosciences.com
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