Heron Therapeutics, Inc. · NASDAQ:HRTX

Heron Therapeutics — Investor Presentation (August 2017)

35 slides from Heron Therapeutics's investor presentation, August 2017

  1. Slide 1: Company Update

    Heron : Developing Best-in-Class Medicine. Improving Lives.” Company Update August 2017

  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

  3. Slide 3: Status of Product Portfolio

    Status of Product Portfolio CINV Pain Preclinical Clinical NDA Approved SUSTOL® (granisetron) extended- Now Approved by U.S. Food and Drug Administration release injection CINVANTI™ PDUFA Date: (HTX-019) aprepitant IV NK1 for CINV Prevention November 12, 2017 for injection HTX-011 bupivacaine + • Eo

  4. Slide 4: Postoperative Pain Program

    Postoperative Pain Program HTX-011: Proprietary Extended-Release Combination of Bupivacaine + Meloxicam

  5. Slide 5: Market Is Large and Local Anesthetic Use Is Common, but Long-Acting Anesthetics Have Not Fulfilled the Promise

    Market Is Large and Local Anesthetic Use Is Common, but Long-Acting Anesthetics Have Not Fulfilled the Promise Procedures Requiring Postoperative Local Anesthetic Usage Across Key Limiters of Liposomal Pain Relief, 2015-20201 Key Surgeries, 20151* Bupivacaine Market Penetration • Perceived inability

  6. Slide 6: Surgeons Expect to Use More Long-Acting Local Anesthetics as Better Options Become Available

    Surgeons Expect to Use More Long-Acting Local Anesthetics as Better Options Become Available Future Pain Market Outlook 73% of surgeons expect to use more 72% of surgeons expect to use 62% of surgeons expect to use more Chart Title long acting local anesthetics fewer opioids local anesthetics (e.g.,

  7. Slide 7: Reducing Pain at the Source Can Eliminate the Need for Opioids and May Decrease the Development of Chronic Pain

    Reducing Pain at the Source Can Eliminate the Need for Opioids and May Decrease the Development of Chronic Pain HTX-011 directly blocks transmission of the pain signal, Acting on opiate receptors in the brain, opioids can reduce the sensation of potentially reducing the chance of chronic pain. pain,

  8. Slide 8: HTX-011 Designed to Produce Marked Analgesia Through the First 72 Hours After Surgery

    HTX-011 Designed to Produce Marked Analgesia Through the First 72 Hours After Surgery Pig Postoperative Pain Model1 Saline Control Liposomal Bupivacaine 2 Biochronomer Bupivacaine Biochronomer Meloxicam HTX-011 (Biochronomer Bupivacaine + Meloxicam) Percentage of Maximal Force (60 gm) Tolerated 100.

  9. Slide 9: HTX-011 Clinical Experience Shows It Has the Potential to Transform Postoperative Pain Control

    HTX-011 Clinical Experience Shows It Has the Potential to Transform Postoperative Pain Control Phase 2 data has demonstrated: Product attributes of HTX-011 optimized in Phase 2 for Phase 3 efficacy studies:  Statistically significant reductions in  Formulation, where the product has both pain and

  10. Slide 10: End-of-Phase 2 Meeting Agreements with FDA

    End-of-Phase 2 Meeting Agreements with FDA • Two Phase 3 adequate and well-controlled efficacy studies and a Phase 3 safety study of approximately 200 subjects in multiple surgical models are adequate to support an NDA for a broad indication for reduction in postoperative pain for 72 hours – Primary

  11. Slide 11: Phase 3 Program Has Been Initiated

    PHASE 3 PROGRAM HAS BEEN INITIATED 11

  12. Slide 12: Study 301: Phase 3 Bunionectomy Study Design

    Study 301: Phase 3 Bunionectomy Study Design Study 301 HTX-011 60 mg Endpoints Instillation Randomization (3:3:2) Primary: Pain Intensity AUC0-72 vs. placebo N = 150 1st Key Secondary: Pain Intensity AUC0-72 vs. bupivacaine Bupivacaine 50 mg 2nd Key Secondary: Opioid use vs. placebo Injection N = 15

  13. Slide 13: Study 302: Phase 3 Herniorrhaphy Study Design

    Study 302: Phase 3 Herniorrhaphy Study Design Study 302 HTX-011 300 mg Endpoints Instillation Randomization (2:2:1) Primary: Pain Intensity AUC0-72 vs. placebo N = 160 1st Key Secondary: Pain Intensity AUC0-72 vs. bupivacaine Bupivacaine 75 mg 2nd Key Secondary: Opioid use vs. placebo Injection 3rd

  14. Slide 14: HTX-011 Study 208: Phase 2 Bunionectomy

    HTX-011 STUDY 208: Phase 2 Bunionectomy Updated Results With the Phase 3 Dose Analyzed by the FDA Requested Methodology (wWOCF) (5 Clinical Sites Enrolled Subjects) 14

  15. Slide 15: HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine After Bunionectomy

    HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Bunionectomy Increasing Pain 15

  16. Slide 16: HTX-011 Produces 24-Fold Greater Reduction in Pain Compared to Bupivacaine in Bunionectomy

    HTX-011 60 mg Produces 24-Fold Greater Reduction in Pain Compared to Bupivacaine 50 mg Through 72 Hours in Bunionectomy Bupivacaine 50 mg (n=25) HTX-011 60 mg (n=52) Greater Pain Reduction vs. Placebo 0-24 hr 0-48 hr 0-72 hr 0 AUC LSMD vs. Placebo -20 -40 -60 p=0.0020* -80 p=0.0020* -100 p=0.0166* -

  17. Slide 17: HTX-011 Has Demonstrated Significantly Greater Pain Reduction Than ER Bupivacaine or Meloxicam

    HTX-011 Has Demonstrated Significantly Greater Pain Reduction Than Extended-Release Versions of Bupivacaine or Meloxicam Using the Same Formulation HTX-002 60 mg (ER Bupivacaine) HTX-009 (ER Meloxicam) HTX-011 60 mg Study 208 0-24 hours 0-48 hours 0-72 hours 10 0 AUC Least Squares Mean -10 Differenc

  18. Slide 18: HTX-011 Study 202: Phase 2 Hernia Repair

    HTX-011 STUDY 202: Phase 2 Hernia Repair Updated Results With the Phase 3 Dose Analyzed by the FDA Requested Methodology (wWOCF) (3 Clinical Sites Enrolled Subjects) 18

  19. Slide 19: HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine After Herniorrhaphy

    HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Herniorrhaphy Increasing Pain 19

  20. Slide 20: HTX-011 Produces 4-Fold Greater Reduction in Pain Compared to Bupivacaine in Hernia Repair

    HTX-011 300 mg Produces 4-Fold Greater Reduction in Pain Compared to Bupivacaine 75 mg Through 72 Hours in Hernia Repair Bupivacaine 75 mg (n=32) HTX-011 300 mg (n=16) Greater Pain Reduction vs. Placebo 0-24 hr 0-48 hr 0-72 hr 0 AUC LSMD vs. Placebo -20 -40 -60 -80 p=0.0052* -100 -120 p=0.0128* -140

  21. Slide 21: HTX-011 Study 203: Phase 2 Abdominoplasty

    HTX-011 STUDY 203: Phase 2 Abdominoplasty Updated Results Using wWOCF (8 Clinical Sites Enrolled Subjects) 21

  22. Slide 22: HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine After Abdominoplasty

    HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Abdominoplasty Increasing Pain 22

  23. Slide 23: HTX-011 Produces 5-Fold Greater Reduction in Pain Compared to Bupivacaine in Abdominoplasty

    HTX-011 400 mg Produces 5-Fold Greater Reduction in Pain Compared to Bupivacaine 100 mg Through 72 Hours in Abdominoplasty Bupivacaine 100 mg (n=17) HTX-011 400 mg (n=25) Greater Pain Reduction vs. Placebo 0-24 hr 0-48 hr 0-72 hr 0 AUC LSMD vs. Placebo -20 -40 p=0.0985* -60 -80 p=0.0460* -100 -120 p

  24. Slide 24: Summary: HTX-011 Is Poised to Fulfill the Promise of a Long-Acting Local Anesthetic

    Summary: HTX-011 Is Poised to Fulfill the Promise of a Long-Acting Extended-Release Local Anesthetic Large, growing market opportunity  Differentiated, synergistic mechanism addresses inflammation – a key inhibitor of both  generic and long-acting local anesthetics Demonstrated superiority vs. gen

  25. Slide 25: CINV

    Heron : Developing Best-in-Class Medicine. Improving Lives.” : CINV

  26. Slide 26: CINV Prophylaxis Requires Two Complementary Mechanisms of Action

    CINV Prophylaxis Requires Two Complementary Mechanisms of Action • EMEND® IV is currently the only intravenous NK1 receptor antagonist on the US market and has >90% of the total NK1 market • Infusion reactions (predominately infusion site pain) and hypersensitivity reactions observed with EMEND ® IV

  27. Slide 27: CINV Franchise Commercial Update

    CINV FRANCHISE COMMERCIAL UPDATE 27

  28. Slide 28: SUSTOL Launch Performance Aligns Closely With Buying Process Insights From Market Research

    SUSTOL Launch Performance Aligns Closely With “Buying Process” Insights From Market Research Q4 2016: 56% of MDs said they would evaluate SUSTOL as their Q2 2017: 37% of PMs said they have completed trial or are in the potential branded agent of choice over a period of several quarters process of tr

  29. Slide 29: Since Launch, SUSTOL Has Delivered Triple-Digit Unit Growth Quarter-Over-Quarter

    Since Launch, SUSTOL Has Delivered Triple-Digit Unit Growth Quarter-Over-Quarter 30,000 SUSTOL Units by Quarter Purchasing Accounts by Quarter 26,430 120 105 accounts 25,000 (291 affiliated sites) 88 accounts 100 (252 affiliated sites) 74 accounts 20,000 (167 affiliated sites) 156% 80 unit growth 60

  30. Slide 30: Account Growth and Penetration Has Enabled SUSTOL to Outperform Recent CINV Launches

    Account Growth and Penetration Has Enabled SUSTOL to Outperform Recent CINV Launches Branded 5-HT3 Unit Share In Key Accounts CINV Launches Since 2008 (~460K Eligible Annual Units) Administrations in First 9 Months 100% 45,000 90% 97% 93% 40,000 80% 40,038 35,000 70% 80% 30,000 60% 50% 25,000 40% 20

  31. Slide 31: Market Insights Suggest SUSTOL May Decline Modestly Through the Arbitrage and Grow Thereafter

    Market Insights Suggest SUSTOL May Decline Modestly Through the Arbitrage and Grow Thereafter – Consistent With Aloxi Analogue Unit Sales Recent Market Insights 700,000 • Practices that are converting to SUSTOL are likely to maintain use1 600,000 • ~67% of current “dabblers” likely to stop or reduce

  32. Slide 32: CINVANTI Gives Heron a 2-Product CINV Franchise With Little Incremental Investment

    CINVANTI Gives Heron a 2-Product CINV Franchise With Little Incremental Investment 30,000 NK-1 Units • Significant market opportunity 25,000 20,000 – Emend ® IV accounts for 80% (~1.2M 15,000 units) of NK-1 market 10,000 5,000 • Potential for significant growth as NK-1s 0 are underutilized particula

  33. Slide 33: 2017 CINV Franchise Outlook

    2017 CINV Franchise Outlook Building on the strong momentum built by Heron, we expect steady but measured growth in SUSTOL® trial and adoption • We are raising our guidance to $25M - $30M in SUSTOL net sales in 2017 CINVANTI™ (HTX-019) program advancing • PDUFA date November 12, 2017 • Anticipate la

  34. Slide 34: Financial Summary

    Financial Summary Cash, cash equivalents and short-term investments of $109.3 million plus accounts receivable of $18.6 million at June 30, 2017, along with collections from SUSTOL sales after June 30, 2017 provides enough funding to complete the HTX- 011 pivotal Phase 3 efficacy studies in the firs

  35. Slide 35: Key Catalysts in Pain & CINV Franchises

    Key Catalysts in Pain & CINV Franchises HTX-011 for Postoperative CINVANTI™ (HTX-019) for SUSTOL® for CINV Pain CINV  Top-line results 2017 net sales guidance  NDA submission abdominoplasty increased: $25M - $30M  Phase 2 program in nerve NDA PDUFA Date Nov. 12, block initiated 2017  TKA study i

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