Heron Therapeutics, Inc. · NASDAQ:HRTX

Heron Therapeutics — Technical Presentation (September 2015)

24 slides from Heron Therapeutics's technical presentation, Sep 22, 2015

  1. Slide 1: A Phase 2 Study of HTX-011 in the Management of Post-Operative Pain

    A Phase 2 Study of HTX-011 in the Management of Post-Operative Pain Positive Top-Line Results September 22, 2015

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with the development, regulatory approval, manuf

  3. Slide 3: Heron Post-Operative Pain Program

    Heron Post-Operative Pain Program Objective: • Develop a best-in-class therapeutic for post-operative pain that can substantially reduce dependence on opiates Target Product Profile: • Maximal pain relief that lasts for 2-3 days • Maximal reduction of opioid use • Maximal reduction of length of hosp

  4. Slide 4: Heron Post-Operative Pain Program

    Heron Post-Operative Pain Program • Introducing HTX-011: – An injectable pain therapeutic that utilizes proprietary Biochronomer® polymer-based drug delivery platform technology – Contains bupivacaine and low concentration of meloxicam – Designed to deliver both drugs evenly over 2-3 days HTX-011 bu

  5. Slide 5: Post-Operative Pain Market

    Post-Operative Pain Market Opiate analgesics, the cornerstone of post-operative pain management, are associated with: • Harmful side effects • Longer hospital stays • Abuse • Addiction Sources: Centers for Disease Control and Prevention, 2015; Weiser et al, Lancet, 12;372(9633):139-44, 2008; Coley e

  6. Slide 6: Procedures Eligible for Long-Acting Local Anesthetic

    Procedures Eligible for Long-Acting Local Anesthetic Estimated Number of Procedures in the U.S. Eligible for Long-Acting Local Anesthetic 35.0 28.9 Number of Procedures (Millions) 30.0 25.0 22.5 20.0 15.0 10.0 5.0 0.0 2012 2021 Sources: Decision Resources, Commercial Market Assessment: Post-Operativ

  7. Slide 7: Superior Efficacy Would Address Major Unmet Medical Need

    Superior Efficacy Would Address Major Unmet Medical Need Target Product Profile Value Exparel (WAC $315) Ofirmev (WAC $426) Degree of Pain Relief and Opiate Sparing Source: PriceRx 7

  8. Slide 8: A Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study of HTX-011

    A Randomized, Placebo- Controlled, Double-Blind, Phase 2 Study of HTX-011 in the Management of Post-Operative Pain in 64 Patients Undergoing Bunionectomy 8

  9. Slide 9: Study Design

    Study Design Screening Treatment (96-hour evaluation) Primary Endpoint Part A - HTX-011 • SPI 0-24 hrs 200 mg bupivacaine (n=20) Secondary Endpoints • SPI 0-48 & 24-48 hrs Placebo - All subjects pooled • SPI 0-72 & 48-72 hrs Subjects for endpoint analysis • SPI 0-96 & 72-96 hrs requiring Part A (n=1

  10. Slide 10: Historical Context: Exparel Pivotal Bunionectomy Study

    Historical Context: Exparel Pivotal Bunionectomy Study Source: FDA Clinical Review of NDA 022-496, page 48 10

  11. Slide 11: Pain Intensity Difference at Low Dose

    Pain Intensity Difference at Low Dose 7.00 HTX-011 200 mg 6.00 Placebo Mean Pain Intensity Score* 5.00 4.00 3.00 2.00 SPID0-24 -25%, p=0.022 1.00 0.00 0 10 20 30 40 50 60 70 Hours *Standard LOCF method used to account for use of rescue medications from Golf et al, Adv 11 Ther, 28(9):776-788, 2011

  12. Slide 12: Pain Intensity Difference at High Dose

    Pain Intensity Difference at High Dose 7.00 HTX-011 400 mg 6.00 Placebo Mean Pain Intensity Score* 5.00 4.00 3.00 2.00 1.00 SPID0-24 SPID0-48 SPID0-72 -69%, p<0.0001 -52%, p<0.0001 -40%, p=0.0064 0.00 0 10 20 30 Hours 40 50 60 70 *Standard LOCF method used to account for use of rescue medications fr

  13. Slide 13: Summed Pain Intensity and SPID over Time

    Summed Pain Intensity (SPI) and Summed Pain Intensity Difference (SPID) over Time • Patients receiving HTX-011 had significantly lower pain scores for all three time periods of interest SPI SPI SPID Placebo HTX-011 400 mg -85.7 (-69%) 0–24 hours 124.2 38.5 p<0.0001 -117.9 (-52%) 0–48 hours 224.8 106

  14. Slide 14: Percent of Patients Pain Free

    Percent of Patients Pain Free 100 Percent of Patients Pain Free (PI ≤ 1) 90 HTX-011 400 mg 80 Placebo 70 60 50 40 p<0.0001 30 20 10 0 0 10 20 30 40 50 60 70 80 Hours 14

  15. Slide 15: Historical Context: Percent Pain Free, Cross-Study Comparison to Exparel

    Historical Context: Percent of Patients Pain Free, Cross-Study Comparison to Exparel 100 Percent of Patients Pain Free (PI ≤ 1) 90 HTX-011 400 mg 80 Placebo 70 60 50 40 30 20 10 0 0 12 24 36 48 60 72 Hours Source: Golf et al, Adv Ther, 28(9):776-788, 2011 15

  16. Slide 16: Mean Time to First Use of Opiate Rescue Medication

    Mean Time to First Use of Opiate Rescue Medication • 488% longer time to first use of rescue medications HTX-011 HTX-011 Placebo 200 mg 400 mg 20.8 hours 48.2 hours 8.2 hours p=0.15 p<0.0001 Cross-study comparison: Mean time with Exparel was 7.2 hours versus 4.3 hours on placebo Source: Golf et al,

  17. Slide 17: Percent of Patients Who Received No Opiate Rescue Medication

    Percent of Patients Who Received No Opiate Rescue Medication 100 Percent of Patients Who Received No 90 HTX-011 400 mg 80 Opiate Rescue Medication Placebo 70 60 50 p<0.0001 40 32% 30 20 10 5% 0 0 10 20 30 40 50 60 70 80 Hours 17

  18. Slide 18: Historical Context: No Opiate Rescue, Cross-Study Comparison to Exparel

    Historical Context: Percent of Patients Who Received No Opiate Rescue Medication, Cross-Study Comparison to Exparel 100 HTX-011 400 mg Percent of Patients Who Received No 90 80 Placebo Opiate Rescue Medication 70 60 50 40 30 20 10 0 0 12 24 36 48 60 72 Hours Source: Golf et al, Adv Ther, 28(9):776-7

  19. Slide 19: Pain Intensity Not Adjusted for Opiate Use

    Pain Intensity NOT Adjusted for Opiate Use: HTX-011 Significantly Better Than Unlimited Opiates* 7 HTX-011 400 mg 6 Placebo Mean Pain Intensity Scores 5 4 3 2 1 SPID0-24 SPID0-48 SPID0-72 0 p<0.0001 p=0.0001 p=0.0051 0 10 20 30 Hours 40 50 60 70 *Patients were permitted to take 5 mg oxycodone every

  20. Slide 20: Preliminary Safety

    Preliminary Safety • HTX-011 was generally well tolerated • The most common adverse events were: headache, nausea, vomiting, constipation, erythema, cellulitis, dizziness, and hypoxia, none of which were considered drug-related 20

  21. Slide 21: HTX-011b: Second Formulation with Distinct Properties

    HTX-011b: Second Formulation with Distinct Properties • HTX-011b is our second formulation • Designed to possess distinct properties that may be ideal in certain surgical procedures: – Greater volume – Slightly faster onset • Phase 1 study in healthy volunteers showed: – Therapeutic drug levels achi

  22. Slide 22: HTX-011b Provides Faster Onset and Greater Bupivacaine Levels

    HTX-011b Provides Faster Onset and Substantially Greater Bupivacaine Levels 600 Mean Bupivacaine Plasma Concentrations HTX-011 200 mg 500 HTX-011 400 mg HTX-011b 200 mg 400 (ng/mL) 300 200 100 0 0 20 40 60 80 100 120 140 160 Hours 22

  23. Slide 23: Pain Intensity: HTX-011b vs. HTX-011

    Pain Intensity: HTX-011b 200 mg vs. HTX-011 400 mg 7 HTX-011b 200 mg (n=5) 6 Mean Pain Intensity Scores* HTX-011 400 mg (n=22) 5 4 3 2 1 0 0 12 24 36 48 60 72 Hours *Not adjusted for use of rescue medications 23

  24. Slide 24: Summary and Future Directions

    Summary and Future Directions • Phase 2 results demonstrate unprecedented level of efficacy for a local anesthetic in the management of post- operative pain – Major reduction in pain intensity – True opiate-sparing activity – One-third of patients required no opiates at all over first 72 hours • Str

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