Jazz Pharmaceuticals Plc · NASDAQ:JAZZ
Jazz Pharmaceuticals — Q2 2020 Earnings Presentation
38 slides from Jazz Pharmaceuticals's earnings presentation, Aug 4, 2020
Slide 1: 2020 Second Quarter Financial Results
2020 Second Quarter Financial Results August 4, 2020 © 2019 Jazz Pharmaceuticals all rights reserved.
Slide 2: Forward-Looking Statements
Forward-Looking Statements "Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995 This slide deck and the accompanying oral presentation contain forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals’ future financial and ope
Slide 3: 2Q20 Conference Call
2Q20 Conference Call Bruce Cozadd Overview Chairman and Chief Executive Officer Renée Galá Financial Update Executive Vice President and Chief Financial Officer Dan Swisher Commercial Performance President and Chief Operating Officer Rob Iannone, M.D., M.S.C.E. Research & Development Executive Vice
Slide 4: Business Updates
Business Updates © 2019 Jazz Pharmaceuticals all rights reserved.
Slide 5: On Track to Execute up to 5 Product Launches Through 2020 and 2021
On Track to Execute up to 5 Product Launches Through 2020 and 2021 2 Potential Approvals Xywav U.S. approval for • EMA approved • FDA accelerated • FDA approved July idiopathic January 2020 for approval June 2020 2020 for the hypersomnia1 EDS in adults with for treatment of treatment of narcolepsy o
Slide 6: Focused on Advancing Clinical Programs and Launch Execution
Focused on Advancing Clinical Programs and Launch Execution Jazz Expects Strong Durability of Oxybate Franchise and Long-term Growth of Neuroscience Business Neuroscience Xyrem Xywav Sunosi JZP-385 • Volume increased 5% • FDA approved for the • 12% increase in total U.S. • Developed modified in 2Q20
Slide 7: Xywav: A New Differentiated Standard of Oxybate Therapy
Xywav A New Differentiated Standard of Oxybate Therapy Xywav is indicated for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy1 • Xywav has a unique composition of cations resulting in 92% less sodium than Xyrem, which translates into a
Slide 8: Xywav for Idiopathic Hypersomnia Phase 3 Study Design
Xywav for Idiopathic Hypersomnia Phase 3 Study Design • Top-line data expected 4Q20 • Targeting supplemental sNDA submission as early as 1Q21 and launch late 2021 Open-label Treatment Titration and Double Blind Optimization Period Randomized Withdrawal Period (DBRWP) Randomization Xyrem Naïve Subjec
Slide 9: Idiopathic Hypersomnia and Narcolepsy Symptomatology
Idiopathic Hypersomnia and Narcolepsy Symptomatology Hypersomnolence Disorders that Share Similar Symptoms Narcolepsy Narcolepsy Idiopathic Symptoms Type 1 Type 2 Hypersomnia Excess daytime sleepiness ✔ ✔ ✔ Sleep paralysis and ✔ hallucinations Sometimes Occasionally Cataplexy ✔ ❌ ❌ Difficulty stayin
Slide 10: Focused on Advancing Clinical Programs and Launch Execution (Oncology)
Focused on Advancing Clinical Programs and Launch Execution Driving Significant Near-Term and Long-Term Value of Oncology Business Oncology Zepzelca JZP-458 Defitelio Vyxeos • FDA accelerated approval • Enrollment in pivotal • Top-line data in Phase 2 • 5-year OS data from the June 2020 Phase 2/3 st
Slide 11: Vyxeos 5-Year Overall Survival Data
Vyxeos 5-Year Overall Survival Data • Data supports Vyxeos’ ability to produce or contribute to durable remissions and survival in older patients with newly diagnosed high-risk/secondary AML • Kaplan-Meier (KM) survival at 5 years was 18% for Vyxeos compared to 8% for 7+3 Events/N Median OS (95% CI)
Slide 12: Financial Update
FINANCIAL UPDATE Confidential
Slide 13: Strong 2Q20 Total Revenues of $562 Million
Strong 2Q20 Total Revenues of $562 Million $ millions Δ Δ (unaudited) In millions, except % 2Q19 1Q20 2Q20 2Q20 vs 2Q20 vs (unaudited) 600 1Q20 2Q19 Xyrem® (sodium oxybate) oral $413 $408 $447 10% 8% solution 500 Defitelio® (defibrotide 46 47 43 (10)% (7)% sodium)/defibrotide 400 Erwinaze®/Erwinase®
Slide 14: $1.1 Billion Total Revenues 1H20
$1.1 Billion Total Revenues 1H20 2020 Total Revenue Guidance Increased to a Range of $2.225 Billion to $2.325 Billion $ millions (unaudited) In millions, except % Six Months Ended 1,200 Δ (unaudited) June 30, 2019 June 30, 2020 Xyrem $782 $855 9% 1,000 Defitelio 88 90 3% Erwinaze/Erwinase 89 70 (20)
Slide 15: 2Q20 Key Adjusted Line Items and Other Information
2Q20 Key Adjusted Line Items and Other Information1 Operating Expenses Support Growing Development Pipeline & Up to 5 Key Launches through 2020-2021 Adjusted Δ Δ In millions, except % 2Q19 1Q20 2Q20 2Q20 vs 1Q20 2Q20 vs 2Q19 (unaudited) Gross Margin 95.0% 94.9% 95.3% 0.4 pp 0.3 pp SG&A Expense $155
Slide 16: 1H20 Key Adjusted Line Items and Other Information
1H20 Key Adjusted Line Items and Other Information1 Operating Expenses Support Growing Development Pipeline & Up to 5 Key Launches through 2020-2021 Adjusted Six Months Ended In millions, except % Δ (unaudited) June 30, 2019 June 30, 2020 Gross Margin 94.4% 95.1% 0.7 pp SG&A Expense $303 $358 18% %
Slide 17: 2Q20 Financial Performance
2Q20 Financial Performance Adjusted Net Income1 Adjusted Net Income Per Diluted Share1 $ millions $ per share (unaudited) (unaudited) 300 4.50 4.00 250 3.50 200 3.00 2.50 150 2.00 $4.05 $233 $3.71 100 $207 1.50 1.00 50 0.50 0 0.00 2Q19 2Q20 2Q19 2Q20 Refer to the Appendix for reconciliations of GAAP
Slide 18: 1H20 Financial Performance
1H20 Financial Performance 1H20 ANI and EPS Impacted by $200M Payment to PharmaMar for Exclusive U.S. Rights to Zepzelca1 Adjusted Net Income Adjusted Net Income1 Per Diluted Share1 Cash Flow from Operations $ millions $ per share $ millions (unaudited) (unaudited) (unaudited) 500 8.00 500 450 450 7
Slide 19: Strong Cash Position and Borrowing Capacity
Strong Cash Position and Borrowing Capacity Well-Positioned to Execute on Our Near-Term and Long-Term Strategy In millions December 31, 2019 June 30, 2020 (unaudited) Cash, cash equivalents and investments $1,077 $1,696 Total long-term debt (principal)1 $1,768 $2,418 Undrawn revolving credit2 $1,600
Slide 20: 2020 Full-Year Revenue Guidance
2020 Full-Year Revenue Guidance Total Revenue Guidance Increased to a Range of $2.225 Billion to $2.325 Billion In millions, except % Prior 2020 Guidance1 Current 2020 Guidance2 Revenues $2,120 – $2,260 $2,225 – $2,325 Total Net Product Sales $2,105 – $2,240 $2,210 – $2,310 Neuroscience Net Sales $1
Slide 21: 2020 Full-Year GAAP Financial Guidance
2020 Full-Year GAAP Financial Guidance Prior 2020 Current 2020 In millions, except per share amounts and % Guidance1 Guidance2 Gross Margin 94% 94% SG&A Expense $785 – $843 $785 – $843 SG&A as % of Total Revenues 35% – 40% 34% – 38% R&D Expense $277 – $313 $302 – $338 R&D as % of Total Revenues 12%
Slide 22: 2020 Full-Year Non-GAAP Financial Guidance
2020 Full-Year Non-GAAP Financial Guidance Full-Year Adjusted Net Income and EPS Guidance Increased Current 2020 In millions, except per share amounts and % Prior 2020 Guidance1 Guidance2 Adjusted Gross Margin 94% 94%3,8 Adjusted SG&A Expense $700 – $750 $700 – $7504,8 Adjusted SG&A as % of Total Re
Slide 23: Strong Top-Line Growth Enables Continued Investments for Revenue Diversification and R&D
Strong Top-Line Growth Enables Continued Investments for Further Revenue Diversification and R&D Portfolio Expansion TOTAL REVENUES1 TOTAL ADJUSTED SG&A and R&D3 NON-GAAP ADJUSTED NET INCOME $ in millions $ in millions PER DILUTED SHARE3 (unaudited) (unaudited) $15.38 $2,225- $11.90– $2,3252 $13.54
Slide 24: Appendix
ies F i - °Y LIN e 2 | Ss 5 > ? oes. \ a : ae > , \ ®: Apa’ oi: % Ge Re ny Mate 4 g YANG WU f »" - & Jazz Pharmaceuticals
Slide 25: Robust Early- to Late-Stage Pipeline Fueled by Strong R&D Investment
Robust Early- to Late-Stage Pipeline Fueled by Strong R&D Investment PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 CombiPlex JZP-324 JZP-3854 Xywav Hem/Onc exploratory activities Oxybate extended-release formulation Essential tremor (Phase 2b) Idiopathic hypersomnia JZP-341 (Long-acting Erwinia Vyxeos Defite
Slide 26: Non-GAAP Financial Measures
Non-GAAP Financial Measures To supplement Jazz Pharmaceuticals’ financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the company uses certain non- GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this presenta
Slide 27: Reconciliation of GAAP Reported to Non-GAAP Adjusted Net Income
Reconciliation of GAAP Reported to Non-GAAP Adjusted Net Income In millions, except per share amounts 2Q19 1Q20 2Q20 (unaudited) GAAP reported net income (loss) $ 261.9 $ (157.8) $ 114.8 Intangible asset amortization 61.6 62.8 63.0 Share-based compensation expense 28.3 28.7 30.6 Impairment charge --
Slide 28: Reconciliations of GAAP Reported to Non-GAAP Adjusted Information Certain Line Items
Reconciliations of GAAP Reported to Non-GAAP Adjusted Information Certain Line Items Cost of Intangible Interest Income tax In millions, except % product Gross asset expense, provision Effective tax Quarter (unaudited) sales margin SG&A R&D amortization net (benefit) rate 2Q19 GAAP Reported $ 27.7 9
Slide 29: Reconciliations of GAAP Reported to Non-GAAP Adjusted Information Certain Line Items
Reconciliations of GAAP Reported to Non-GAAP Adjusted Information Certain Line Items Cost of Intangible Interest Income tax In millions, except % product Gross asset Impairment expense, provision Effective Quarter (unaudited) sales margin SG&A R&D amortization charge net (benefit) tax rate 1Q20 GAAP
Slide 30: Reconciliation of GAAP Reported to Non-GAAP Adjusted Net Income
Reconciliation of GAAP Reported to Non-GAAP Adjusted Net Income In millions, except per share amounts Six Months Ended June 30, (unaudited) 2019 2020 GAAP reported net income (loss) $ 347.1 $ (43.0) Intangible asset amortization 118.5 125.8 Share-based compensation expense 55.8 59.3 Impairment charg
Slide 31: Reconciliations of GAAP Reported to Non-GAAP Adjusted Information Certain Line Items
Reconciliations of GAAP Reported to Non-GAAP Adjusted Information Certain Line Items Cost of Intangible Interest Income tax In millions, except % product Gross asset Impairment expense, provision Effective Quarter (unaudited) sales margin SG&A R&D amortization charge net (benefit) tax rate 1H19 GAAP
Slide 32: Reconciliation of GAAP Reported to Non-GAAP Adjusted Net Income
Reconciliation of GAAP Reported to Non-GAAP Adjusted Net Income In millions, except per share amounts 2016 2017 2018 2019 (unaudited) GAAP net income1 $ 396.8 $ 487.8 $ 447.1 $ 523.4 Intangible asset amortization 102.0 152.1 201.5 354.8 Share-based compensation expense 98.8 106.9 102.4 110.6 Loss co
Slide 33: Reconciliation of GAAP SG&A and R&D to Non-GAAP Adjusted SG&A and R&D
Reconciliation of GAAP SG&A and R&D to Non-GAAP Adjusted SG&A and R&D In millions 2016 2017 2018 2019 2020G (unaudited) GAAP SG&A and R&D expense1 $ 665.2 $ 742.6 $ 910.1 $ 1,036.6 $ 1,087 – $ 1,181 Share-based compensation expense (94.3) (101.1) (95.8) (103.9) (112) – (126) Loss contingency -- -- (
Slide 34: Reconciliation of GAAP to Non-GAAP Adjusted 2020 Net Income Guidance
Reconciliation of GAAP to Non-GAAP Adjusted 2020 Net Income Guidance In millions, except per share amounts 2020 (unaudited) Guidance1 GAAP net income $190 – $270 Intangible asset amortization 250 – 270 Share-based compensation expense 120 – 135 Impairment charge 136 Loss on extinguishment of debt 4
Slide 35: Summary of Share Repurchases Under Current Program
Summary of Share Repurchases Under Current Program $431M Remaining Amount Authorized Under $1.52B Share Repurchase Program Dollar Amount Average Shares Share Repurchases Repurchased Purchase Repurchased (in millions) Price Per Share 2Q20 $7.5 70,000 $106.93 1Q20 $139.1 1,131,300 $122.91 2019 $301.4
Slide 36: APSS Abstracts, August 28-30, 2020
APSS Abstracts, August 28-30, 2020 Product First/Presenting Author Topic Abstract #0673: Effects of Solriamfetol on Driving Performance in Participants With Excessive Daytime Sleepiness Sunosi Vinckenbosch F Associated With Obstructive Sleep Apnea Sunosi Vinckenbosch F Abstract #0763: Effects of Sol
Slide 37: Glossary of Abbreviations
Glossary of Abbreviations aGvHD = Acute Graft-vs-Host Disease GTN = Gross-to-Net ALL = Acute Lymphoblastic Leukemia HSCT = Hematopoietic Stem Cell Transplantation AML = Acute Myeloid Leukemia HMA = Hypomethylating Agent AMLSG = AML Study Group HR = Hazard Ratio ANI = Adjusted Net Income HR-AML = Hig
Slide 38: Xywav Boxed Warning
Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution Boxed Warning WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. Central Nervous System Depression XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients tr