Supernus Pharmaceuticals, Inc. · NASDAQ:SUPN
Supernus Pharmaceuticals — Debt Investor Presentation (March 2018)
35 slides from Supernus Pharmaceuticals's debt investor presentation, Mar 14, 2018
Slide 1: Supernus Pharmaceuticals Management March 2018 Presentation
Supernus Pharmaceuticals Management March 2018 Presentation © 2018 Supernus Pharmaceuticals, Inc. All Rights Reserved. 1
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation and other matters discussed today or answers that may be given to questions asked include forward-looking statements within the meaning of the federal securities laws. These statements, among other things, relate to Supernus’ business strategy, goals and expec
Slide 3: Summary of Offering
Summary of Offering Supernus Pharmaceuticals, Inc. SUPN / NASDAQ Global Market Convertible Senior Notes due 2023 144A Senior Unsecured $350 million $52.5 million 0.750% - 1.250% 32.5% - 37.5% April 1, 2023 (5 Years) Non-Callable To pay the costs of the convertible note hedge transactions, to acquire
Slide 4: Presenters
Presenters Jack Khattar President and Chief Executive Officer 30 years (18 years at Shire/Supernus, CIMA, Merck, Novartis) Greg Patrick VP, Chief Financial Officer 31 years (6 years at Supernus, Sopherion, Bionor Immuno) Merck, MedImmune, Ventiv Health, © 2018 Supernus Pharmaceuticals, Inc. All Righ
Slide 5: Investment Highlights
Investment Highlights Diversified & profitable pharma company with several “shots on goal” >$800 million in potential peak revenue for Oxtellar XR® and Trokendi XR® Late-stage psychiatry portfolio (SPN-810, SPN-812, Oxtellar XR®) Trokendi XR® and Oxtellar XR® have demonstrated strong sales growth Tr
Slide 6: Proven Execution: Ten Marketed Products Using Our Technologies
Proven Execution Ten Marketed Products Using Our Technologies Epilepsy Migraine All trademarks are the property of their respective owners. © 2018 Supernus Pharmaceuticals, Inc. All Rights Reserved. 6 Launch Year 201320142017 Trokendi XR® Trokendi XR® Oxtellar XR® Carbatrol®Adderall XR®Equetro®Intun
Slide 7: Robust Portfolio of CNS Products and Product Candidates
Robust Portfolio of CNS Products and Product Candidates *Oxtellar XR is indicated for adjunctive treatment of partial seizures. **Trokendi XR is indicated for treatment of Migraine Prophylaxis. © 2018 Supernus Pharmaceuticals, Inc. All Rights Reserved. 7 Product Indication Development NDA Launch Oxt
Slide 8: Profitable CNS Pharma Company: Strong Sales and Operating Income Growth
Profitable CNS Pharma Company Strong Sales and Operating Income Growth Total Net Product Sales ($ Millions) Total Operating Income ($ Millions) 2013 2014 2015 2016 2017 12 2013 2014 2015 2016 2017 © 2018 Supernus Pharmaceuticals, Inc. All Rights Reserved. 8 294 210 144 90 100 54 -5 21 -62
Slide 9: Trokendi XR and Oxtellar XR Solid Prescription Growth Since Launch
Trokendi XR and Oxtellar XR Solid Prescription Growth Since Launch 673 Annual Prescriptions (Thousands) 700 650 600 550 500 450 400 350 300 250 200 150 100 50 0 2013 Source: IQVIA Monthly Prescriptions © 2018 Supernus Pharmaceuticals, Inc. All Rights Reserved. 2014 2015 2016 2017 9 (Thousands) Troke
Slide 10: Non-Compliance – A Serious Problem in Epilepsy
Trokendi XR and Oxtellar XR Non-Compliance – A Serious Problem in Epilepsy 71% of patients report missing a dose at least once/month 45% reporting seizures after a missed dose1 Serious Quality of Life Issues Increased Healthcare Costs Worsening of Condition Non-compliance leads to breakthrough seizu
Slide 11: Extended-Release AEDs = Significant Patient Benefits
Trokendi XR and Oxtellar XR Extended-Release AEDs = Significant Patient Benefits Reduced Side Effects & Improved Tolerability Reduced Dosing Frequency & Precise Timing Smooth/Consistent PK ER IR Compliance Higher Effective Doses Reduced Breakthrough Seizures & Reliable Seizure Control Extended Relea
Slide 12: Oxtellar XR More Favorable Clinical Outcomes & Greater Adherence
Oxtellar XR More Favorable Clinical Outcomes & Greater Adherence Compared to OXC-IR1 Oxtellar XR (n=109) OXC-IR (n=91) Oxtellar XR (n=70) OXC-IR (n=46) 16 30 14 25 12 20 10 8 15 6 10 4 5 2 0 0 ED Visits Hospitalizations Missed Doses 1O’Neal W, et al., Adherence and Resource Utilization with Extended
Slide 13: Trokendi XR More Favorable Clinical Outcomes Compared to TPM-IR
Trokendi XR More Favorable Clinical Outcomes Compared to TPM-IR1 Side Effects with Trokendi XR vs. TPM-IR in Migraine Cohort (n=124) 28% Cognitive effect 12% Paresthesia 6% Somnolence TPM-IR Trokendi XR 3% Appetite decreased/weight loss *p<0.001 vs. TPM-IR †p<0.01 vs. TPM-IR % Gastrointestinal probl
Slide 14: Combined Target Market Opportunity of $13.5 Billion
Trokendi XR and Oxtellar XR Combined Target Market Opportunity of $13.5 Billion We believe we opportunity have the potential to capture a significant portion of this market >$500 Million1 >$300 Million2 Billion Epilepsy and Migraine Opportunity Oxtellar XR and Trokendi XR Bipolar Opportunity Oxtella
Slide 15: Trokendi XR Migraine Launch: Prescriptions and Market Share Trends
Trokendi XR Migraine Launch National Monthly Total Prescriptions and Market Share Trends 4.63 55,000 Migraine Launch 4.50 50,000 3.82 4.00 45,000 3.50 40,000 2.85 3.00 2.78 2.78 35,000 2.49 2.42 2.42 30,000 2.50 2.13 1.95 25,000 2.00 1.77 1.11 20,000 1.50 15,000 1.00 10,000 0.50 5,000 - 0.00 Source:
Slide 16: The Most Successful Anti-Epileptic Drug Launch Since 2010
Trokendi XR The Most Successful Anti-Epileptic Drug Launch Since 2010 Migraine Launch 50,000 40,000 30,000 20,000 10,000 - 1 3 5 7 911 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 Months after Launch Source: IMS NPA © 2018 Supernus Pharmaceuticals, Inc. All Rights Reserved. 16 Prescri
Slide 17: Psychiatry Pipeline
Psychiatry Pipeline Innovative SPN-810 SPN-812 Oxtellar XR Late Stage Portfolio First Treatment to be Developed for Impulsive Aggression Well Differentiated Novel Non-Stimulant Novel Product for Bipolar Disorder © 2018 Supernus Pharmaceuticals, Inc. All Rights Reserved. 17
Slide 18: SPN-810 Understanding Impulsive Aggression
SPN-810 Understanding Impulsive Aggression (IA) IA is a subtype of Maladaptive Aggression Impulsivity can be defined neurobiologically Impairment in self-control IA occurs across multiple disorders including ADHD, autism, bipolar disorder, schizophrenia, Alzheimer’s, PTSD and disorders of traumatic
Slide 19: SPN-810 Significant Market Opportunity
SPN-810 Significant Market Opportunity SPN-810 Market Sizing and Demand Study (April 2015); Assumes prevalence and demand from quantitative research are applicable to high ADHD pediatrician prescribers, and peak market share at 3–7 years post launch Figures in the table above reflect management’s es
Slide 20: SPN-810 Phase IIb Study in IA in ADHD Patients
SPN-810 Phase IIb Study in IA in ADHD Patients Extended release molindone Randomized, double-blind, placebo-controlled, multicenter 6–12 year old patients with IA co-morbid with ADHD Primary endpoint: change from baseline to endpoint (Visit 10) in R-MOAS* ratings. Optional six-month open-label exten
Slide 21: SPN-810 Phase IIb – Low and Medium Doses Met Primary Endpoints
SPN-810 Phase IIb – Low and Medium Doses Met Primary Endpoints Primary Endpoint: Change from Baseline at Visit 10 in R-MOAS# Score1 LOCF, ITT Population Improved Remission Rate at End of Study2 Improvement vs. Baseline 70% 60% 50% 40% 30% 20% 10% 0% (n=30) (n=27) (n=30) (n=31) * Placebo (n=30) Low d
Slide 22: SPN-810 Phase IIb – Well Tolerated by Patients
SPN-810 Phase IIb – Well Tolerated by Patients (Rep*orRtedebsyo>lv5%edof aSuftbejerctds iisn conoentinuation N (%) N (%) *There is no statistically significant difference in the rate of incidence of AEs between the placebo arm and all active treatment groups combined © 2018 Supernus Pharmaceuticals,
Slide 23: SPN-810 Phase III Study Design
SPN-810 Phase III Study Design *Primary Endpoint : Change in IA behavior frequency 1Predefined interim analysis of P301 completed September 2017 Both trials proceeding to completion with 1:1 randomization to 36mg dose and placebo Data expected in 1Q 2019 © 2018 Supernus Pharmaceuticals, Inc. All Rig
Slide 24: SPN-812 Novel Non-Stimulant ADHD Product Candidate
SPN-812 Novel Non-Stimulant ADHD Product Candidate Viloxazine hydrochloride Norepinephrine reuptake inhibitor New Chemical Entity (NCE) with potential for five year market exclusivity if approved Previously marketed outside the US as an antidepressant Building strong IP with expirations from 2029-20
Slide 25: SPN-812 Phase IIb Study in Pediatric ADHD Patients
SPN-812 Phase IIb Study in Pediatric ADHD Patients Objectives: Assess effect in reducing symptoms of ADHD children aged 6-12 years Evaluate safety and tolerability Primary Endpoint: Change from baseline to End of Study in the ADHD-RS-IV total score Design: Double-blind, placebo-controlled, multicent
Slide 26: SPN-812 Phase IIb – Three Doses Met Primary Endpoint
SPN-812 Phase IIb – Three Doses Met Primary Endpoint Primary Analysis Change from baseline in ADHD-RS-IV Total Score (ITT Population with LOCF) N=24 ITT = Intent To Treat LOCF = Last Observation Carried Forward © 2018 Supernus Pharmaceuticals, Inc. All Rights Reserved. 27 Statistics 400 mg N=44 300
Slide 27: SPN-812 Phase IIb – Well Tolerated by Patients
SPN-812 Phase IIb – Well Tolerated by Patients N=49 © 2018 Supernus Pharmaceuticals, Inc. All Rights Reserved. 28 Percentage of Patients with Related AEs, >5% SPN-812 ER Adverse Event (AE) Placebo N=24 100 mg N=48 200 mg N=48 300 mg N=48 400 mg Somnolence 0 14.6 20.8 20.8 24.5 Decreased appetite 8.3
Slide 28: SPN-812 Significant Market Opportunity
SPN-812 Significant Market Opportunity Source: IMS NPA, Company Research and Estimates – Assumes peak at 3-7 years post launch Figures in the table above reflect management’s estimates that are subject to several factors that are beyond our control and actual results may be significantly different f
Slide 29: Oxtellar XR Novel Product Candidate for Bipolar Market Opportunity
Oxtellar XR Novel Product Candidate for Bipolar Market Opportunity +53 Million Prescriptions Use of Oxcarbazepine in Psychiatry 50% Potential to Become Only Oxcarbazepine Product Approved to Treat Bipolar 1st 2018 Investigator-Initiated Trial Ongoing Source: IQVIA 2016 SSRI = Selective serotonin reu
Slide 30: Corporate Development Strategy
Corporate Development Strategy Focused corporate development strategy Late-stage neurology assets including adjacent Leverage current sales force Examples include: Parkinson’s, MS, Migraine therapeutic areas Psychiatry assets that could launch before SPN-810 & SPN-812 Establish presence in psychiatr
Slide 31: Financial Summary
Financial Summary 2017 Full Year Financial Results Net product sales of $294.1 million, up 40% over 2016 Operating income of $99.5 million, up 84% over 2016 Cash, cash equivalents, and investments at $273.7 million as of December 31, 2017 $165.5 million at December 31, 2016 © 2018 Supernus Pharmaceu
Slide 32: Positioned For Continued Strong Growth
Positioned For Continued Strong Growth Growth Potential for Existing Products >$800 Million in Potential Peak Revenue for Oxtellar XR® and Trokendi XR® Innovative Late SPN-810 SPN-812 Oxtellar XR Stage Portfolio in Psychiatry First Product to be Developed for Impulsive Aggression Well Differentiated
Slide 33: Appendix
Appendix © 2018 Supernus Pharmaceuticals, Inc. All Right s Reserved.
Slide 34: Oxtellar XR Improved Adverse Event Profile at Double the Dose of Trileptal
Oxtellar XR Improved Adverse Event Profile at Double the Dose of Trileptal® Dizziness Diplopia nuing ue to AEs Headache Somnolence 55% Reduction Vomiting Nausea Fatigue Asthenia 0 10 20 30 40 50 Trileptal 1200 mg/d (n=171) SPN-804O 2400 mg/d (n=123) Based on comparison of Oxtellar XR (SPN-804O) Phas
Slide 35: ADHD Market Opportunity in the U.S.
ADHD Market Opportunity in the U.S Projected Annual Prescriptions (Millions) 120 110 100 90 80 70 60 50 40 30 20 10 0 2017 2018 20192020 2021 2022 2023 2024 2025 2026 2027 2028 2029 Source - IMS NPA and Company Estimates Figures in the table above reflect management’s estimates that are subject to s
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