Supernus Pharmaceuticals, Inc. · NASDAQ:SUPN

Supernus Pharmaceuticals — Corporate Update (March 2019)

14 slides from Supernus Pharmaceuticals's corporate update, Mar 28, 2019

  1. Slide 1: Safe Harbor Statement

    Safe Harbor Statement This presentation includes forward-looking statements within the meaning of the federal securities laws. These statements, among other things, relate to Supernus’ business strategy, goals and expectations concerning its product candidates, future operations, prospects, plans an

  2. Slide 2: SPN-812 Novel Non-Stimulant ADHD Product Candidate

    Viloxazine hydrochloride Serotonin norepinephrine modulating agent (SNMA) 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-differentiated ADHD product

  3. Slide 3: SPN-812 Phase III Studies Status

    SPN-812 Phase III Studies Status P301 N = 477 P303 N = 313 P302 N = 310 P304 N = 297 ADHD Patients 6-11 years 6-11 years 12-17 years 12-17 years Daily Doses 100 mg 200 mg 200 mg 400 mg 200 mg 400 mg 400 mg 600 mg Status Completed Completed Completed Completed 4

  4. Slide 4: Topline Results Executive Summary

    SPN-812 P304 Topline Results Executive Summary Data confirm positive results from P301, P302, and P303 Phase III studies 400 mg reached statistical significance on: Change versus baseline in ADHD Rating Scale 5, p-value = 0.0082 Effect size of 0.66 CGI-I secondary endpoint, p-value = 0.0051 Hyperact

  5. Slide 5: Topline Results Executive Summary

    SPN-812 P304 Topline Results Executive Summary Data confirm positive results from P301, P302, and P303 Phase III studies 400 mg shows fast onset of action Statistical significance as early as 2 weeks Higher dose of 600 mg did not reach statistical significance Narrowly missed on primary endpoint wit

  6. Slide 6: Phase III Topline Results

    SPN-812 P304 Phase III Topline Results Visit Statistics Placebo (N=96) 400 mg (N=99) 600 mg (N=97) Baseline Mean 38.8 41.2 39.8 Week 7 (EOS) LS Mean -13.2 -18.3 -16.7 p-value 0.0082 0.0712 8 MMRM = Mixed Model for Repeated Measure ITT = Intent to Treat EOS = End of Study Primary Analysis of ADHD-RS-

  7. Slide 7: Phase III Topline Results: Efficacy Starting in Week 2

    SPN-812 P304 Phase III Topline Results Efficacy on 400 mg starting in week 2 Visit Statistics Placebo (N=96) 400 mg (N=99) 600 mg (N=97) Baseline Mean 38.8 41.2 39.8 Week 1 LS Mean -5.0 -6.7 -7.7 p-value 0.2460 0.0664 Week 2 LS Mean -7.8 -12.1 -10.9 p-value 0.0063 0.0456 Week 3 LS Mean -9.7 -14.7 -1

  8. Slide 8: Phase III Topline Results: Sensitivity Analysis

    SPN-812 P304 Phase III Topline Results Visit Statistics Placebo (N=96) 400 mg (N=99) 600 mg (N=97) Baseline Mean 38.8 41.2 39.8 Week 7 (EOS) LS Mean -13.4 -17.9 -16.5 p-value 0.0191 0.1002 10 ANCOVA = Analysis of Covariance ITT = Intent to Treat EOS = End of Study Sensitivity Analysis of ADHD-RS-5 b

  9. Slide 9: Analysis of Observed Global Improvement Score (CGI-I) at Week 7

    Visit Statistics Placebo (N=96) 400 mg (N=99) 600 mg (N=97) Baseline Mean 4.5 4.8 4.6 Week 7 (EOS) LS Mean 2.9 2.4 2.6 p-value 0.0051 0.0995 11 CGI-S was used as baseline; EOS = End of study Analysis of Observed Global Improvement Score (CGI-I) at Week 7 (EOS) SPN-812 P304 Phase III Topline Results

  10. Slide 10: Analysis in ADHD-RS-5 Subscales

    Visit Statistics Placebo (N=96) 400 mg (N=99) 600 mg (N=97) ADHD-RS-5 Hyperactivity/Impulsivity Baseline Mean 16.4 18.7 17.5 Week 7 (EOS) LS Mean -6.4 -8.3 -7.6 p-value 0.0484 0.2084 ADHD-RS-5 Inattention Baseline Mean 22.4 22.5 22.3 Week 7 (EOS) LS Mean -7.1 -10.1 -8.7 p-value 0.0042 0.1392 12 Anal

  11. Slide 11: 400 mg and 600 mg Well Tolerated

    13 Number (%) of Patients - Treatment Related AEs with > 5% incidence Placebo (N=97) 400 mg (N=100) 600 mg (N=99) Somnolence 3 (3.1) 13 (13.0) 17 (17.2) Fatigue 4 (4.1) 11 (11.0) 10 (10.1) Headache 3 (3.1) 9 (9.0) 7 (7.1) Decreased appetite 2 (2.1) 6 (6.0) 6 (6.1) Nausea 2 (2.1) 5 (5.0) 8 (8.1) Disc

  12. Slide 12: Phase III Program Executive Summary

    SPN-812 Phase III Program Executive Summary Final Phase III data package for the NDA is robust on 100 mg, 200 mg and 400 mg doses in more than 1,000 children and adolescent patients. P304 Fourth Phase III trial Consistent with and confirms results from three successful Phase III trials (P301, P302 a

  13. Slide 13: 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

  14. Slide 14: Positioned For Continued Strong Growth

    Positioned For Continued Strong Growth Growth Potential for 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 I

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