Heron Therapeutics, Inc. · NASDAQ:HRTX

Heron Therapeutics — Technical Presentation (June 2018)

35 slides from Heron Therapeutics's technical presentation, Jun 25, 2018

  1. Slide 1: HTX-011 Postoperative Pain Program: Topline Results from Phase 2b Studies

    HTX-011 Postoperative Pain Program Topline Results from Phase 2b Studies June 21, 2018 Exhibit 99.3

  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. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this presentation and i

  3. Slide 3: Slide 3

  4. Slide 4: HTX-011 for Postoperative Pain Management Has Received Breakthrough Therapy Designation

    HTX-011 for Postoperative Pain Management Has Received Breakthrough Therapy Designation • Breakthrough Therapy designation designed to expedite development and review of drugs: – Intended to treat serious conditions; and – For which preliminary clinical evidence indicates substantial improvement ove

  5. Slide 5: Postoperative Opioids Are a Gateway to Addiction

    Postoperative Opioids Are a Gateway to Addiction AS MANY AS 2.6 MILLION patients that take opioids to manage pain after surgery may become persistent opioid users each year . MORE THAN 40 MILLION patients undergoing surgical procedures are prescribed opioids for pain management in the United States

  6. Slide 6: HTX-011 Achieved Statistically Significant Reductions in Pain and Need for Opioids

    HTX-011 ACHIEVED STATISTICALLY SIGNIFICANT REDUCTIONS IN PAIN AND THE NEED FOR OPIOIDS VS. BUPIVACAINE IN EVERY PHASE 2 STUDY AND BOTH PHASE 3 STUDIES

  7. Slide 7: Seven Positive Controlled Studies to Be Included in HTX-011 NDA

    Study Phase Surgical Model Tissue Type Significant for Pain Reduction vs. PBO Significant for Pain Reduction vs. BPV Significant Reduction in Opioid Use PK – PD Relation- ship Seven Positive Controlled Studies to Be Included in HTX-011 New Drug Application (NDA) Hernia Repair Soft Abdominoplasty Sof

  8. Slide 8: Recently Completed Phase 2b Studies

    RECENTLY COMPLETED PHASE 2B STUDIES

  9. Slide 9: Study 209: Phase 2b Total Knee Arthroplasty (TKA) Study Design

    HTX-011 400 mg Instillation N=58 HTX-011 400 mg Instillation + Ropivacaine Injection N=56 Saline Placebo Injection N=53 Cohort 1 HTX-011 200 mg Instillation N=20 HTX-011 200 mg Instillation + Injection N=22 Saline Placebo Injection N=11 Cohort 2 Study 209: Phase 2b Total Knee Arthroplasty (TKA) Stud

  10. Slide 10: Study 209: Subject Demographics (ITT)

    Saline Placebo (N=53) Bupivacaine Solution 125 mg (N=55) HTX-011 400 mg (N=114) Total (N=222) Study 209: Subject Demographics (ITT) Age (years) – mean (SD) 61.5 (8.3) 61.4 (9.4) 62.8 (9.0) 62.1 (8.9) Sex – n (%) Female 25 (47.2%) 35 (63.6%) 53 (46.5%) 113 (50.9%) Male 28 (52.8%) 20 (36.4%) 61 (53.5%

  11. Slide 11: 209: Phase 2b TKA Results Hierarchy

    Study 209: Phase 2b TKA Results Hierarchy AUC 0-48 HTX-011 400 mg vs. Placebo AUC 0-72 HTX-011 400 mg + Ropivacaine vs. Placebo AUC 0-48 HTX-011 400 mg + Ropivacaine vs. Placebo p < 0.0001 AUC 0-72 HTX-011 400 mg vs. Placebo p = 0.0002 p < 0.0001 p = 0.0004 HTX-011 via instillation achieved primary

  12. Slide 12: 209: Pain Reduction from HTX-011 at Rest Approximately Double that of Bupivacaine

    Study 209: Pain Reduction from HTX-011 at Rest Approximately Double that of Bupivacaine Windowed-worst observation carried-forward (wWOCF) for use of opioid rescue medication and last-observation carried-forward (LOCF) for missing pain data HTX-011 achieved primary endpoint for AUC 0-48

  13. Slide 13: 209: Both HTX-011 Arms Significantly Reduce Pain at Rest Compared to Placebo through 72 Hours

    Study 209: Both HTX-011 Arms Significantly Reduce Pain at Rest Compared to Placebo through 72 Hours wWOCF for use of opioid rescue medication and LOCF for missing pain data

  14. Slide 14: 209: Significant Separation between HTX-011 Arms and Placebo through 72 Hours

    Study 209: Significant Separation between HTX-011 Arms and Placebo through 72 Hours wWOCF for use of opioid rescue medication and LOCF for missing pain data

  15. Slide 15: 209: Both HTX-011 Arms Reduce Pain with Activity Significantly Better than Placebo and Bupivacaine

    Study 209: Both HTX-011 Arms Reduce Pain with Activity Significantly Better than Placebo and Bupivacaine through 48 Hours wWOCF for use of opioid rescue medication and LOCF for missing pain data

  16. Slide 16: 209: HTX-011 plus Ropivacaine Significantly Reduces Opioid Use vs. Placebo through 72 Hours

    Study 209: HTX-011 plus Ropivacaine Significantly Reduces Opioid Use vs. Placebo through 72 Hours Opioid consumption is presented in mean milligrams of morphine equivalents

  17. Slide 17: 209: Strong Correlation between Pain Reduction and Pharmacokinetics of HTX-011 in TKA

    Study 209: Strong Correlation between Pain Reduction and Pharmacokinetics of HTX-011 in TKA HTX-011 400 mg Via Instillation

  18. Slide 18: 209: HTX-011 Well Tolerated in TKA

    Study 209: HTX-011 Well Tolerated in TKA HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution: • No clinically meaningful differences in overall adverse events • No difference in the incidence of serious adverse events • No difference in premature disconti

  19. Slide 19: 209: TKA Summary

    Study 209: TKA Summary • HTX-011 achieved primary and key secondary endpoints • Both HTX-011 arms achieved significant reductions in pain at rest vs. placebo through 48 hours – Also significantly reduced pain at rest through 72 hours vs. placebo • Both HTX-011 arms achieved significant reductions in

  20. Slide 20: Study 211: Phase 2b Breast Augmentation Study Design

    HTX-011 60 mg Nerve Block N=12 Saline Placebo Nerve Block N=6 Cohort 1 Cohort 2 HTX-011 120 mg Nerve Block N=27 Saline Placebo Nerve Block N=12 HTX-011 240 mg Nerve Block N=25 Saline Placebo Nerve Block N=11 HTX-011 400 mg Nerve Block N=47 HTX-011 400 mg Instillation N=50 Saline Placebo Nerve Block

  21. Slide 21: Study 211: Subject Demographics (ITT)

    Saline Placebo (N=41) Bupivacaine HCL 50 mg (N=41) HTX-011 (N=161) Total (N=243) Study 211: Subject Demographics (ITT) Age (years) – mean (SD) 31.3 (9.0) 30.4 (7.8) 31.4 (7.8) 31.2 (8.0) Sex – n (%) Female 41 (100%) 41 (100%) 161 (100%) 243 (100%) Race – n (%) Asian 2 (4.9%) 2 (4.9%) 7 (4.3%) 11 (4.

  22. Slide 22: 211: Pain Reduction from HTX-011 at Rest Approximately Triple that of Bupivacaine

    Study 211: Pain Reduction from HTX-011 at Rest Approximately Triple that of Bupivacaine HTX-011 achieved primary endpoint for AUC 0-24

  23. Slide 23: 211: HTX-011 Instillation Shows Superior Reduction in Pain Intensity Early and Nerve Block Durable Response

    Study 211: HTX-011 Instillation Shows Superior Reduction in Pain Intensity Early and HTX-011 Nerve Block Shows Durable Response Notes: Pain intensity collected at rest wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing pain data

  24. Slide 24: 211: Raw Pain Scores in All Arms Drop Quickly; Difficult to Discriminate after 24 Hours

    Study 211: Raw Pain Scores in All Arms Drop Quickly; Difficult to Discriminate between Arms after 24 Hours Notes: Raw pain intensity collected at rest Scores not adjusted for opioid use

  25. Slide 25: 211: Both HTX-011 Arms Reduce Pain with Activity Significantly Better than Placebo

    Study 211: Both HTX-011 Arms Reduce Pain with Activity Significantly Better than Placebo through 24 Hours

  26. Slide 26: 211: Both HTX-011 Arms Significantly Reduce Opioid Use vs. Placebo through 24 Hours

    Study 211: Both HTX-011 Arms Significantly Reduce Opioid Use vs. Placebo through 24 Hours Opioid consumption is presented in mean milligrams of morphine equivalents

  27. Slide 27: 211: Strong Correlation between Pain Reduction and Pharmacokinetics in Breast Augmentation

    Study 211: Strong Correlation between Pain Reduction and Pharmacokinetics of HTX-011 Instillation in Breast Augmentation

  28. Slide 28: HTX-011 Well Tolerated in Breast Augmentation

    HTX-011 Well Tolerated in Breast Augmentation HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution: • No clinically meaningful differences in overall adverse events • No difference in the incidence of serious adverse events • No premature discontinuations

  29. Slide 29: 211: Breast Augmentation Summary

    Study 211: Breast Augmentation Summary • HTX-011 achieved the primary endpoint • Both HTX-011 arms achieved significant reductions in pain at rest vs. placebo through 24 hours • Both HTX-011 arms achieved significant reductions in pain with activity (the most conservative assessment) vs. placebo thr

  30. Slide 30: Consistent Pharmacokinetics

    CONSISTENT PHARMACOKINETICS

  31. Slide 31: HTX-011 Pharmacokinetics Across Diverse Surgical Models Are More Dose-Linear than Bupivacaine

    HTX-011 Pharmacokinetics Across 5 Diverse Surgical Models Are More Dose-Linear than Bupivacaine Solution R² = 0.8103 Bupivacaine C max (ng/mL) Bupivacaine Dose (mg) Bupivacaine C max Bunionectomy Herniorrhaphy Abdominoplasty Total Knee Arthroplasty Augmentation Mammoplasty R² = 0.0349 Bupivacaine C

  32. Slide 32: Phase 2b Conclusions

    Phase 2b Conclusions • HTX-011 plus ropivacaine was significantly superior to both placebo and bupivacaine in TKA • HTX-011 demonstrated significant activity via both instillation and nerve block in breast augmentation • Pharmacokinetics of HTX-011 remained consistent across 5 diverse surgical model

  33. Slide 33: Large US Market Opportunity

    ~15M procedures ~6M procedures ~7M procedures Large US Market Opportunity Target Market Opportunity Initial Targets Higher volume procedures across 4 major specialties ~6.5M Orthopedic procedures ~4.3M General Surgery procedures ~3.3 M OB/GYN procedures ~1.1M Plastic Surgery procedures Secondary Tar

  34. Slide 34: HTX-011 Has Demonstrated Significant Clinical Benefit in High-Value Procedures in Initial Target Market

    Procedure Annual Volume (‘000s, US, 2015) Overall % Local Anesthetic Use HTX-011 Significantly Superior to Bupivacaine Ortho Surgery HTX-011 Has Demonstrated Significant Clinical Benefit in Several of the High-Value Procedures in Initial Target Market Completed studies Claims Survey Knee arthroplast

  35. Slide 35: Positive Response by Physicians and Pharmacists to HTX-011's Target Product Profile

    Positive Response by Physicians and Pharmacists to HTX-011’s Target Product Profile 48% 55% 60% 60% 66% 67% 69% 73% 79% 80% 87% 88% 50% 43% 37% 38% 31% 31% 30% 23% 20% 19% 13% 11% 1% Phase 3 Procedures Dosing Regimen Overall Safety No Impact on Implantables Compatability with NSAIDs Indication No Im

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