Supernus Pharmaceuticals, Inc. · NASDAQ:SUPN
Supernus Pharmaceuticals — Corporate Update (December 2018)
32 slides from Supernus Pharmaceuticals's corporate update, Dec 10, 2018
Slide 1: 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 2: SPN-812 Novel Non-Stimulant ADHD Product Candidate
Viloxazine hydrochloride Norepinephrine reuptake inhibitor, selective serotonin activity New Chemical Entity (NCE) with five year market exclusivity Previously marketed outside the U.S. as an antidepressant Building strong IP with expirations from 2029-2033 Clinical data point to a well-differentiat
Slide 3: SPN-812 Phase III Studies Status
SPN-812 Phase III Studies Status P301 N = 477 P303 N = 313 P302 N = 300 P304 N = 300 ADHD Patients 6-11 years 6-11 years 12-17 years 12-17 years Daily Doses 100mg 200mg 200mg 400mg 200mg 400mg 400mg 600mg Status Completed Completed Topline Data December 2018 Topline Data 1Q 2019 4
Slide 4: SPN-812 P301 Phase III Study Design
Randomized, double-blind, placebo-controlled, multicenter, parallel group, efficacy and safety study of SPN-812 100 mg and 200 mg Randomization Double-blind Treatment Period, Monotherapy Titration Maintenance Period SPN-812 200 mg/day (N=144) SPN-812 100 mg/day (N=144) Placebo (N=144) 5 D7 D42 Day -
Slide 5: SPN-812 P303 Phase III Study Design
Randomized, double-blind, placebo-controlled, multicenter, parallel group, efficacy and safety study of SPN-812 200 mg and 400 mg Double-blind Treatment Period, Monotherapy Titration Period Maintenance Period Randomization SPN-812 400 mg (N=100) Screening 300 200 SPN-812 200 mg (N=100) 100 Placebo (
Slide 6: SPN-812 P301/303 Phase III Studies Design
SPN-812 P301/303 Phase III Studies Design Primary Endpoint Change from baseline on the ADHD-RS-5 scale compared to placebo Secondary Endpoints Clinical Global Impression - Improvement (CGI-I) scale Conners 3rd edition - parent, composite T-score Weiss Functional Impairment Rating Scale - parent repo
Slide 7: SPN-812 P301/303 Topline Results Executive Summary
SPN-812 P301/303 Topline Results Executive Summary Two positive phase III trials in children 6-11 years old Met primary endpoint with robust statistical significance P-values ranging from <0.0001 to 0.0121 Sensitivity analysis confirms primary analysis Both trials showed strong efficacy on Hyperacti
Slide 8: SPN-812 P301/303 Topline Results Executive Summary
SPN-812 P301/303 Topline Results Executive Summary P301 met all secondary endpoints P303 met the CGI-I secondary endpoint Both trials showed favorable tolerability and safety profile Low incidence of AE’s across all doses (100mg, 200mg and 400mg) Overall, AE’s are mild leading to very low discontinu
Slide 9: SPN-812 P301 Study Topline Results
SPN-812 P301 Study Topline Results
Slide 10: SPN-812 P301: Met Primary Endpoint
SPN-812 P301: Met Primary Endpoint Visit Statistics Placebo (N=155) 100 mg (N=147) 200 mg (N=158) Baseline Mean 43.6 45.0 44.0 Week 6 (EOS) LS Mean -10.9 -16.6 -17.7 Effect Size 0.54 0.57 p-value 0.0004 <.0001 11 MMRM = Mixed Model for Repeated Measure ITT = Intent to Treat EOS = End of study Effect
Slide 11: SPN-812 P301: Met Primary Endpoint Efficacy Starting in Week 1
SPN-812 P301: Met Primary Endpoint Efficacy Starting in Week 1 Visit Statistics Placebo (N=155) 100 mg (N=147) 200 mg (N=158) Baseline Mean 43.6 45.0 44.0 Week 1 LS Mean -5.8 -9.5 -8.1 p-value 0.0004 0.0244 Week 2 LS Mean -7.9 -12.6 -12.3 p-value <.0001 0.0001 Week 3 LS Mean -9.9 -15.4 -15.7 p-value
Slide 12: SPN-812 P301 – Efficacy Starting in Week 1
SPN-812 P301 – Efficacy Starting in Week 1 LS Mean Change from Baseline over Time – MMRM (ITT Population) 13 ** ** ** * ** ** ** ** ** ** ** ** * p < 0.05 ** p< 0.01 MMRM = Mixed Model for Repeated Measure ITT = Intent to Treat -20 -18 -16 -14 -12 -10 -8 -6 -4 -2 0 Week 1 Week 2 Week 3 Week 4 Week 5
Slide 13: SPN-812 P301: Met Primary Endpoint (Sensitivity Analysis)
SPN-812 P301: Met Primary Endpoint Visit Statistics Placebo (N=155) 100 mg (N=147) 200 mg (N=158) Baseline Mean 43.6 45.0 44.0 Week 6 (EOS) LS Mean -11.1 -16.5 -17.8 p-value 0.0008 <.0001 14 ANCOVA = Analysis of Covariance ITT = Intent to Treat EOS = End of study Sensitivity Analysis of ADHD-RS-5 ba
Slide 14: SPN-812 P301: Met Secondary Endpoint (CGI-I)
Visit Statistics Placebo (N=155) 100 mg (N=147) 200 mg (N=158) Baseline Mean 4.8 4.8 4.8 Week 6 (EOS) LS Mean 3.1 2.7 2.6 p-value 0.0020 <.0001 15 SPN-812 P301: Met Secondary Endpoint EOS = End of study Analysis of Observed Global Improvement Score (CGI-I) at Week 6 (EOS)
Slide 15: SPN-812 P301: Met Secondary Endpoint (Conners 3)
Visit Statistics Placebo (N=155) 100 mg (N=147) 200 mg (N=158) Baseline Mean 75.9 77.4 75.5 Week 6 (EOS) LS Mean -4.8 -9.1 -9.5 p-value 0.0004 <.0001 16 EOS = End of study Analysis of Change from Baseline at Week 6 (EOS) in Composite T-score for Conners 3 - Parent Reported Scores SPN-812 P301: Met S
Slide 16: SPN-812 P301: Met Secondary Endpoint (WFIRS-P)
Visit Statistics Placebo (N=155) 100 mg (N=147) 200 mg (N=158) Baseline Mean 1.08 1.15 1.10 Week 6 (EOS) LS Mean -0.22 -0.36 -0.39 p-value 0.0019 0.0002 17 EOS = End of study WFIRS-P = Weiss Functional Impairment Rating Scale - Parent Report Analysis of Change from Baseline at Week 6 (EOS) in WFIRS-
Slide 17: SPN-812 P301 Significant Reduction in Hyperactivity and Inattention
Visit Statistics Placebo (N=155) 100 mg (N=147) 200 mg (N=158) ADHD-RS-5 Hyperactivity/Impulsivity Baseline Mean 21.1 22.2 21.1 Week 6 (EOS) LS Mean -5.5 -8.0 -8.7 p-value 0.0026 <.0001 ADHD-RS-5 Inattention Baseline Mean 22.5 22.8 22.9 Week 6 (EOS) LS Mean -5.7 -8.6 -9.2 p-value 0.0006 <.0001 18 An
Slide 18: SPN-812 P301 Well Tolerated
Placebo (N=159) 100 mg (N=154) 200 mg (N=161) Overall SPN-812 (N=315) Somnolence 3 ( 1.9) 16 (10.4) 15 ( 9.3) 31 ( 9.8) Headache 6 ( 3.8) 15 ( 9.7) 16 ( 9.9) 31 ( 9.8) Decreased appetite 0 8 ( 5.2) 14 ( 8.7) 22 ( 7.0) Sedation 0 3 ( 1.9) 9 ( 5.6) 12 ( 3.8) Vomiting 3 ( 1.9) 7 ( 4.5) 8 ( 5.0) 15 ( 4.
Slide 19: SPN-812 P301 Well Tolerated (Treatment Related AEs)
Placebo (N=159) 100 mg (N=154) 200 mg (N=161) Overall SPN-812 (N=315) Somnolence 3 ( 1.9) 14 ( 9.1) 14 ( 8.7) 28 ( 8.9) Headache 3 ( 1.9) 7 ( 4.5) 10 ( 6.2) 17 ( 5.4) Decreased appetite 0 7 ( 4.5) 12 ( 7.5) 19 ( 6.0) 20 Number (%) of Patients - Treatment Related AEs with > 5% incidence SPN-812 P301
Slide 20: SPN-812 P303 Study Topline Results
SPN-812 P303 Study Topline Results
Slide 21: SPN-812 P303: Met Primary Endpoint
Visit Statistics Placebo (N=97) 200 mg (N=107) 400 mg (N=97) Baseline Mean 43.5 43.8 45.0 Week 8 (EOS) LS Mean -11.7 -17.6 -17.5 Effect Size 0.46 0.49 p-value 0.0038 0.0063 22 Primary Analysis of ADHD-RS-5 Total Score based on MMRM (ITT Population) SPN-812 P303: Met Primary Endpoint MMRM = Mixed Mod
Slide 22: SPN-812 P303: Met Primary Endpoint Efficacy Starting in Week 1
Visit Statistics Placebo (N=97) 200 mg (N=107) 400 mg (N=97) Baseline Mean 43.5 43.8 45.0 Week 1 LS Mean -5.0 -7.9 -6.7 p-value 0.0268* 0.2058 Week 2 LS Mean -8.4 -11.6 -10.9 p-value 0.0398* 0.1141 Week 3 LS Mean -10.6 -13.7 -13.7 p-value 0.0668 0.0742 Week 4 LS Mean -11.8 -14.7 -15.3 p-value 0.1182
Slide 23: SPN-812 P303: Met Primary Endpoint Efficacy (Weeks 5-8)
Primary Analysis of ADHD-RS-5 Total Score based on MMRM (ITT Population) Visit Statistics Placebo (N=97) 200 mg (N=107) 400 mg (N=97) Week 5 LS Mean -11.6 -17.6 -16.5 p-value 0.0015 0.0114 Week 6 LS Mean -12.4 -17.7 -17.7 p-value 0.0050 0.0057 Week 7 LS Mean -12.9 -18.6 -17.3 p-value 0.0045 0.0325 W
Slide 24: SPN-812 P303 – Efficacy By Week
25 ** ** ** ** * ** ** * * * * p< 0.05; **p< 0.01 SPN-812 P303 – Efficacy By Week LS Mean Change from Baseline over Time – MMRM (ITT Population) MMRM = Mixed Model for Repeated Measure ITT = Intent to Treat -20 -18 -16 -14 -12 -10 -8 -6 -4 -2 0 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8
Slide 25: SPN-812 P303: Met Primary Endpoint (Sensitivity Analysis)
Visit Statistics Placebo (N=97) 200 mg (N=107) 400 mg (N=97) Baseline Mean 43.5 43.8 45.0 Week 8 (EOS) LS Mean -11.3 -17.0 -16.6 p-value 0.0058 0.0121 26 Sensitivity Analysis of ADHD-RS-5 based on ANCOVA at Week 8 (EOS) (ITT Population) SPN-812 P303: Met Primary Endpoint ANCOVA = Analysis of Covaria
Slide 26: SPN-812 P303: Met Secondary Endpoint (CGI-I)
Visit Statistics Placebo (N=97) 200 mg (N=107) 400 mg (N=97) Baseline Mean 4.8 4.8 4.8 Week 8 (EOS) LS Mean 3.1 2.6 2.6 p-value 0.0028 0.0099 27 Analysis of Observed Global Improvement Score (CGI-I) at Week 8 (EOS) SPN-812 P303: Met Secondary Endpoint EOS = End of study
Slide 27: SPN-812 P303 Significant Reduction in Hyperactivity and Inattention
Visit Statistics Placebo (N=97) 200 mg (N=107) 400 mg (N=97) ADHD-RS-5 Hyperactivity/Impulsivity Baseline Mean 21.0 21.2 22.0 Week 8 (EOS) LS Mean -5.1 -8.4 -8.3 p-value 0.0020 0.0039 ADHD-RS-5 Inattention Baseline Mean 22.5 22.6 23.0 Week 8 (EOS) LS Mean -6.2 -8.9 -8.6 p-value 0.0087 0.0248 28 SPN-
Slide 28: SPN-812 P303 Well Tolerated
Placebo (N=103) 200 mg (N=107) 400 mg (N=100) Overall SPN-812 (N=207) Somnolence 2 ( 1.9) 16 (15.0) 14 (14.0) 30 (14.5) Decreased appetite 0 10 (9.3) 9 (9.0) 19 (9.2) Fatigue 5 (4.9) 10 (9.3) 9 (9.0) 19 (9.2) Headache 5 (4.9) 13 (12.1) 6 (6.0) 19 (9.2) Vomiting 1 (1.0) 1 (0.9) 7 (7.0) 8 (3.9) Upper
Slide 29: SPN-812 P303 Well Tolerated (Treatment Related AEs)
30 Placebo (N=103) 200 mg (N=107) 400 mg (N=100) Overall SPN-812 (N=207) Somnolence 1 (1.0) 15 (14.0) 14 (14.0) 29 (14.0) Decreased appetite 0 8 (7.5) 8 (8.0) 16 (7.7) Fatigue 4 (3.9) 7 (6.5) 5 (5.0) 12 (5.8) Headache 1 (1.0) 9 (8.4) 5 (5.0) 14 (6.8) Upper abdominal pain 2 (1.9) 4 (3.7) 6 (6.0) 10 (
Slide 30: SPN-812 P301/303 Topline Results Executive Summary
SPN-812 P301/303 Topline Results Executive Summary Two positive phase III trials in children 6-11 years old Clinical data point to a well-differentiated ADHD product Strong efficacy with robust statistical significance Efficacy on both Hyperactivity and Inattention Fast onset of action Works as earl
Slide 31: Positioned For Continued Strong Growth
Growth Potential for Existing Products Potential Peak Sales for Oxtellar XR® and Trokendi XR® >$500M Innovative Late Stage Portfolio in Psychiatry SPN-812 Well Differentiated Novel Non-Stimulant SPN-810 First Product to be Developed for Impulsive Aggression SPN-604 Novel Product for Bipolar Disorder
Slide 32: Positioned For Continued Strong Growth
Positioned For Continued Strong Growth Growth Potential for Existing Products Potential Peak Sales for Oxtellar XR® and Trokendi XR® >$500M Innovative Late Stage Portfolio in Psychiatry SPN-812 Well Differentiated Novel Non-Stimulant SPN-810 First Product to be Developed for Impulsive Aggression SPN
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