Slide 1: Management Presentation April 2013
Management Presentation April 2013
Slide 2: Safe Harbor Statement
Safe Harbor Statement 2 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 exp
Slide 3: Company Highlights
Company Highlights 4 Commercial stage CNS pharma with robust pipeline Strong execution since IPO Two epilepsy products in multi-billion dollar market Oxtellar XR™ launched in February 2013 Trokendi XR™ to be launched in 3Q 2013 SPN-810 for Impulsive Aggression in ADHD Positive Phase IIb data in Nove
Slide 4: Years of Successful Product Development
23 Years of Successful Product Development Former Division of Shire Note: All trademarks are the property of their respective owners. 5
Slide 5: Experienced Executive Team
Experienced Executive Team Jack Khattar, MBA President & CEO 28 years (Shire, CIMA, Merck, Novartis, Playtex, Kodak) Pad Bhatt, Ph.D SVP, Intellectual Property, CSO 22 years (Shire, Alza, Dow Corning) Woody Bryan, Ph.D VP, Business Development 18 years (Shire, Schering-Plough, AAI) Tami Martin R.N,
Slide 6: Two Product Launches & Exciting Mid Stage Pipeline
Product Indication Development NDA Launch Oxtellar XR™ Epilepsy Trokendi XR™ Epilepsy SPN-810 Impulsive Aggression in ADHD SPN-812 ADHD SPN-809 Depression February 2013 Tentative FDA Approval Two Product Launches & Exciting Mid Stage Pipeline 3Q 2013 Completed Phase IIb Completed Phase IIa IND 7
Slide 7: Outstanding Performance Since IPO
8 Outstanding Performance Since IPO Oxtellar XRTM Events Date of Achievement FDA Approval October 2012 Three Year Market Exclusivity November 2012 U.S. Launch February 2013 Trokendi XRTM Events Date of Achievement FDA Tentative Approval June 2012 Two U.S. Patents Issued October 2012 SPN-810 Events D
Slide 8: Non-Compliance – A Serious Problem in Epilepsy
71% of patients report missing a dose at least once/month 45% reporting seizures after a missed dose 9 Serious Quality of Life Issues Increased Healthcare Costs Worsening of Condition Non-Compliance – A Serious Problem in Epilepsy Non-compliance leads to breakthrough seizures that cost annually in e
Slide 9: Major Causes Of Non-Compliance
10 Major Causes Of Non-Compliance Multiple Medications Multiple Doses/ Day Timing of Dosing IR AEDs Significant Side Effects Lack of Tolerability Note: Immediate Release (“IR”) and Anti-Epileptic Drugs (“AEDs”).
Slide 10: Extended-Release AEDs = Significant Patient Benefits
11 Compliance Higher Effective Doses Reduced Side Effects & Improved Tolerability Reduced Dosing Frequency & Precise Timing Smooth/Consistent PK IR ER Reduced Breakthrough Seizures & Reliable Seizure Control Note: Extended Release (“ER”), Immediate Release (“IR”), Anti-Epileptic Drugs (“AEDs”) and P
Slide 11: Physicians, Patients & Managed Care Appreciate Benefits of Extended-Release AEDs
12 Physicians, Patients & Managed Care Appreciate Benefits of Extended-Release AEDs Switching from branded to generic AEDs can increase breakthrough seizures and healthcare cost Total healthcare costs 20% lower for use of branded topiramate compared to use of multiple generics 88% of physicians conc
Slide 12: Oxtellar XR: Launched in February 2013
Oxtellar XR™: Launched in February 2013 13 The only once daily oxcarbazepine XR product in the U.S. Adjunctive therapy in partial seizures in adults & children 6-17 years Phase III trial established efficacy and safety Multicenter, randomized, placebo-controlled in refractory partial onset epilepsy
Slide 13: Oxtellar XR: Significant Seizure Frequency Reduction
Oxtellar XR™: Significant Seizure Frequency Reduction 14 P=0.003 P=0.078 Oxtellar XR 2400 mg/d Oxtellar XR 1200 mg/d Placebo Reduction in Partial Seizure Frequency/28 Days (%) Reduction in Partial Seizure Frequency/28 Days (%) Oxtellar XR 2400 mg/d Oxtellar XR 1200 mg/d Placebo P=0.006 P=0.022 P val
Slide 14: Oxtellar XR: Critical Improvement in AE Profile
15 Number (%) of Patients With: Oxtellar XR 2400 mg/d (n=123) Oxtellar XR 1200 mg/d (n=122) Placebo (n=121) Any adverse event (AE) 85 (69) 69 (57) 67 (55) Treatment-related AEs 72 (58) 53 (43) 47 (39) AEs leading to discontinuation 37 (30) 20 (16) 15 (12) Discontinuations occurred on Trileptal® 2400
Slide 15: Oxtellar XR: Can Enable Higher Dosing
16 Based on comparison of Oxtellar XR Study 301 vs. Trileptal PI (adjunctive therapy study in adults); differences in trial design exist between the two studies. *Dizziness includes vertigo in Trileptal group. * Oxtellar XR™: Can Enable Higher Dosing Improved AE Profile at Double the Dose of Trilept
Slide 16: Trokendi XR: To Be Launched in 3Q 2013
Trokendi XR™: To Be Launched in 3Q 2013 17 Received Tentative Approval on June 25, 2012 Based on bioequivalence strategy Final Approval pending expiration of J&J data exclusivity June 22, 2013 Related to 1-24 months pediatric population Trokendi XR did not seek approval for this patient population N
Slide 17: Trokendi XR: Switch Study to Establish Bioequivalence
Trokendi XR™: Switch Study to Establish Bioequivalence 18 Design mimics dose switching in actual clinical practice Multicenter, open-label, 3-period conversion study Patients on other AEDs Established bioequivalence at steady-state of Trokendi XR™ to Topamax® Up to 28 Days 2 Weeks Treatment 2 Weeks
Slide 18: Overwhelming Patient Preference for Trokendi XR
19 Overwhelming Patient Preference for Trokendi XR™ Patient Preference (n=61) Impact on Compliance (n=61) Over 90% of patients preferred once-daily Trokendi XR™ over twice-daily Topamax® Over 90% of patients agreed that once-daily Trokendi XR™ helps with compliance Patients (%) Patients (%) Trokendi
Slide 19: A Proven and Efficient Commercial Strategy
A Proven and Efficient Commercial Strategy 20 Targeting Conversion of IR Epilepsy Patients to our XR Products Senior Commercial Expertise Relatively small population of neurologists Sales force of 75 reps building up to 100+ for two products Targeting top six deciles of prescribing physicians Synerg
Slide 20: Trokendi XR & Oxtellar XR Target Significant Markets
Trokendi XR™ & Oxtellar XR™ Target Significant Markets 21 Source: IMS NPA. U.S. Topiramate Market U.S. Oxcarbazepine Market (TRx’s in millions) Trokendi XR™ Oxtellar XR™ Topamax® Peak Sales: $2.7bn Trileptal® Peak Sales: $0.7bn 0.0 2.0 4.0 6.0 8.0 10.0 12.0 2001A 2002A 2003A 2004A 2005A 2006A 2007A
Slide 21: XR Products Perform Well When Effectively Promoted
XR Products Perform Well When Effectively Promoted 22 Note: Year 3 for Lamictal XR is based on 3 months of data (Jul-Sep 2011). % Of Molecule Prescriptions 12.5% 20.0% 27.5% 35.0% 40.0% 12.5% 21.5% 4.7% 12.3% 5.3% 2.6% 7.7% 22.0% 19.6% 11.0% 8.4% 1.8% 3.6% 5.6% 1.1% 2.3% 0.0% 10.0% 20.0% 30.0% 40.0%
Slide 22: A Significant Opportunity
Trokendi XR™ & Oxtellar XR™: A Significant Opportunity 23 Period Post Launch Year 1 Year 2 Year 3 Year 4 Year 5 Total Market (MM TRx) 10.0 10.4 10.8 11.2 11.6 Conversion Rate (%) 1 3 4 5 6 7 8 10 11 12 Potential Prescriptions (k) Trokendi XR + Oxtellar XR 100 300 416 520 648 756 896 1120 1276 1392 E
Slide 23: Oxtellar XR: Launch Update
Oxtellar XR™: Launch Update 24 More than 120 MM commercial lives covered Mainly Tier 3 unrestricted Additional 7 MM Medicaid lives covered with no PA or auto PA Reaching target physician audience Top 6 deciles Quality time with physicians Message delivered is well accepted Early patient cases very e
Slide 24: SPN-810: Novel Product for Impulsive Aggression in ADHD
SPN-810: Novel Product for Impulsive Aggression in ADHD 25 25% of children with ADHD have persistent conduct problems such as impulsive aggression Expected to be first product approved to treat this serious condition Co-morbidity in ADHD, schizophrenia, autism and bipolar disorder Molindone hydrochl
Slide 25: SPN-812: Novel Non-Stimulant for ADHD
SPN-812: Novel Non-Stimulant for ADHD 26 Note: * Investigator-Rated CAARS Total ADHD Symptom Scores. ADHD affects 6% to 9% of all school-age children and 3% to 5% of all adults Expected to have a better side effect profile than current therapies Norepinephrine reuptake inhibitor NCE for U.S. market
Slide 26: Balance Sheet & Capitalization
Balance Sheet & Capitalization Debt (millions) Senior Secured Credit Facility $23.2 — Senior Secured Convertible Debt — $75.0 First Principal Payment March 2012 May 2019 Cumulative Scheduled Principal & Interest 2013 – 2015 $26.6 $16.3 Capitalization (millions) Basic Shares Outstanding 30.9 30.9 Opt
Slide 27: Financing Designed to Take Company Through Cash Flow Break-Even
Financing Designed to Take Company Through Cash Flow Break-Even High Gross Margin Business Outsourced Manufacturing, with Gross Margins of 90+% EPS & Free Cash Flow Opportunity At Steady State, Business Capable of Sustaining Pre-Tax Margins of 30+% Use of Proceeds ($ millions) Strategy Commercializa
Slide 28: Company Highlights
Company Highlights Commercial stage CNS pharma with robust pipeline Strong execution since IPO Two epilepsy products in multi-billion dollar market Oxtellar XR™ launched in February 2013 Trokendi XR™ to be launched in 3Q 2013 SPN-810 for Impulsive Aggression in ADHD Positive Phase IIb data SPN-812 f
Slide 29: Appendix
Appendix 30
Slide 30: Low Detailing Limited Success of Keppra XR & Lamictal XR
Low Detailing Limited Success of Keppra XR & Lamictal XR 31 Source: IMS Health. Launch of Vimpat Number of Sales Calls (000’s) Keppra XR Lamictal XR Number of Sales Calls (000’s) 0.0 5.0 10.0 15.0 20.0 25.0 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09 2Q09 3Q09 4Q09 1Q10 2Q10 3Q10 4Q10 1Q11 Keppra Keppra XR Vimpat
Slide 31: SPN-810: Positive Phase IIb Data, Primary Endpoints
SPN-810: Positive Phase IIb Data Efficacy with Statistical Significance on Primary Endpoints at Low to Medium Doses 32 Primary Efficacy Endpoints (Treatment vs. placebo in ITT population) Low Dose Medium Dose High Dose R-MOAS Change All Patients P-value 0.071 0.115 0.943 Patients (>30kg) P-value 0.0
Slide 32: SPN-810: Positive Phase IIb Data, Secondary Endpoints
SPN-810: Positive Phase IIb Data Efficacy with Statistical Significance on Secondary Endpoints at Low Dose 33 Secondary Efficacy Endpoints (Treatment vs. placebo in ITT population) Low Dose Medium Dose High Dose CGI-Severity All Patients P-value 0.133 0.308 0.245 Patients (>30kg) P-value 0.007 0.117