Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Technical Presentation (March 2018)
35 slides from Heron Therapeutics's technical presentation, Mar 19, 2018
Slide 1: HTX-011 Postoperative Pain Program Topline Results From Phase 3
HTX-011 Postoperative Pain Program Topline Results From Phase 3 March 19, 2018 Exhibit 99.2
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
Slide 3: Status of Product Portfolio
Preclinical Clinical NDA Approved SUSTOL® (granisetron) extended-release injection CINVANTI® (aprepitant) injectable emulsion HTX-011 bupivacaine + meloxicam ER Local Administration HTX-011 bupivacaine + meloxicam ER Nerve Block Approved by U.S. Food and Drug Administration Status of Product Portfol
Slide 4: Postoperative Opioids: A Doorway to Addiction
Postoperative Opioids: A Doorway to Addiction $ As many as 2.6 MILLION PEOPLE that take opioids to manage pain after surgery may become persistent opioid users. . MORE THAN 40 MILLION patients undergoing surgical procedures are prescribed opioids for pain management in the United States every year U
Slide 5: Large US Market Opportunity
Large US Market Opportunity Theoretical and Target Market 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 Targets Higher volume procedures in non-core
Slide 6: High Procedure Volume in Target Markets Provides a Robust RoW Market Opportunity
High Procedure Volume in Target Markets Provides a Robust RoW Market Opportunity Country Total Surgical Procedures Total Procedures Requiring Postop Pain Management Initial Target Procedures Remaining Secondary, Lower Volume & Procedures Currently Not Using Local Anesthetics Germany 22,545,000 6,838
Slide 7: Inflammation Can Reduce the Activity of Local Anesthetics
Inflammation Can Reduce the Activity of Local Anesthetics HTX-011 is Different Because It Blocks Both Pain and Local Inflammation Surgical insult produces an immediate drop in pH As inflammatory cytokines are released and inflammation sets in, the acidic environment is maintained for many days The a
Slide 8: The Unique Mechanism of Action of HTX-011 Demonstrated in Pig Model
The Unique Mechanism of Action of HTX-011 Has Been Demonstrated in the Pig Postoperative Pain Model The normalization of pH starting at 8 hours with HTX-011 allows almost 10x more bupivacaine (BPV) to enter the nerve to block the pain signal % of un-ionized BPV available to enter nerve 7.94% 0.79%
Slide 9: Properties of HTX-011 Suited for Needle-Free Administration
The Properties of HTX-011 Are Ideally Suited for Needle-Free Administration to Coat the Affected Tissue HTX-011 is a single dose application of a viscous solution administered directly via needle free syringe to coat the affected tissue within the surgical site prior to suturing HTX-011 releases its
Slide 10: HTX-011 achieved all primary and key secondary endpoints in both phase 3 trials
HTX-011 achieved all primary and key secondary endpoints in both phase 3 trials
Slide 11: 301/EPOCH1: Phase 3 Bunionectomy Study Design
Study 301/EPOCH1: Phase 3 Bunionectomy Study Design Randomization (3:3:2) HTX-011 60 mg Instillation N = 157 Saline Placebo Instillation N = 100 Bupivacaine 50 mg Injection N = 155 Study 301 Endpoints Primary: Pain Intensity AUC0-72 vs. placebo 1st Key Secondary: Pain Intensity AUC0-72 vs. bupivacai
Slide 12: 301: Subject Demographics
Study 301: Subject Demographics HTX-011 60 mg (N=157) Saline Placebo (N=100) Bupivacaine HCl 50 mg (N=155) Total (N=412) Age (years) – mean (SD) 48.0 (14.47) 47.3 (12.83) 45.5 (14.79) 46.9 (14.22) Sex – % Female 87.9% 86.0% 85.2% 86.4% Male 12.1% 14.0% 14.8% 13.6% Race – % American Indian or Alaskan
Slide 13: 301: Results Hierarchy
Study 301: Results Hierarchy Primary and ALL Key Secondary Endpoints Significant 1st Key Secondary: AUC0-72 HTX-011 vs. Bupivacaine 2nd Key Secondary: Opioid Consumption HTX-011 vs. Placebo Primary: AUC0-72 HTX-011 vs. Placebo p < 0.0001 3rd Key Secondary: Opioid-Free HTX-011 vs. Bupivacaine p = 0.0
Slide 14: 301: HTX-011 Reduces Pain After Bunionectomy Significantly Better
Study 301: HTX-011 Reduces Pain After Bunionectomy Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) At All Time Periods Evaluated Source: Figure 14.2.7 wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing data Increasing Pain
Slide 15: 301: HTX-011 Significantly Reduces Total Opioid Use
Study 301: HTX-011 Significantly Reduces Total Opioid Use vs Bupivacaine and Placebo Source: Figure 14.2.2 Opioid consumption is presented in mean milligrams of morphine equivalents
Slide 16: 301: HTX-011 Significantly Increases Proportion of Opioid-Free Subjects
Study 301: HTX-011 Significantly Increases Proportion of Opioid-Free Subjects vs Bupivacaine and Placebo Source: Figure 14.2.3 Percent of Patients With Severe Pain at Any Time Through 72 hours HTX-011 53.5% Saline Placebo 83.0% p<0.0001 Bupivacaine 75.5% p<0.0001
Slide 17: Safety
Study 301 Safety
Slide 18: 301: Incidence of Treatment Emergent Adverse Events
Study 301: Incidence of Treatment Emergent Adverse Events Occurring in ≥ 5% in the HTX-011 Group Source: Table14.3.1.3 Preferred Term HTX-011 60 mg (N=157) Saline Placebo (N=101) Bupivacaine HCl 50 mg (N=154) Any TEAE 83.4% 78.2% 85.1% Nausea 37.6% 43.6% 45.5% Dizziness 21.7% 17.8% 23.4% Incision si
Slide 19: 301: HTX-011 Lowers the Incidence of Opioid-Related Adverse Events
Study 301: HTX-011 Lowers the Incidence of Opioid-Related Adverse Events Source: Table 14.3.1.8.1 Preferred Term HTX-011 60 mg (N=157) Saline Placebo (N=101) Bupivacaine HCl 50 mg (N=154) Any ORAE 43.9% 53.5% 50.6% Nausea 37.6% 43.6% 45.5% Vomiting 14.6% 18.8% 21.4% Pruritus 7.6% 9.9% 5.8% Constipat
Slide 20: HTX-011 Safety in Bunionectomy
HTX-011 Safety in Bunionectomy HTX-011 was generally well tolerated with: No drug-related serious adverse events No premature discontinuations due to drug-related adverse events No deaths (one death on BPV) Fewer opioid-related adverse events No evidence of drug-related LAST
Slide 21: 302/EPOCH2: Phase 3 Herniorrhaphy Study Design
Study 302/EPOCH2: Phase 3 Herniorrhaphy Study Design HTX-011 300 mg Instillation N = 164 Saline Placebo Instillation N = 82 Bupivacaine 75 mg Injection N = 172 Randomization (2:2:1) Study 302 Endpoints Primary: Pain Intensity AUC0-72 vs. placebo 1st Key Secondary: Pain Intensity AUC0-72 vs. bupivaca
Slide 22: 302: Subject Demographics
Study 302: Subject Demographics Number of subjects: HTX-011 300 mg (N=164) Saline Placebo (N=82) Bupivacaine HCl 75 mg (N=172) Total (N=418) Age (years) – mean (SD) 48.9 (13.29) 48.0 (14.59) 49.4 (11.26) 48.9 (12.75) Sex – % Female 7.3% 3.7% 4.7% 5.5% Male 92.7% 96.3% 95.3% 94.5% Race – % American I
Slide 23: 302: Results Hierarchy
Study 302: Results Hierarchy Primary and ALL Key Secondary Endpoints Significant 1st Key Secondary: AUC0-72 HTX-011 vs. Bupivacaine 2nd Key Secondary: Opioid Consumption HTX-011 vs. Placebo Primary: AUC0-72 HTX-011 vs. Placebo p = 0.0004 PBO: saline placebo; BPV: bupivacaine HCl 3rd Key Secondary: O
Slide 24: 302: HTX-011 Reduces Pain After Herniorrhaphy Significantly Better
Study 302: HTX-011 Reduces Pain After Herniorrhaphy Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) At All Time Periods Evaluated Source: Figure 14.2.7 wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing data Increasing Pain
Slide 25: 302: HTX-011 Significantly Reduces Total Opioid Use
Study 302: HTX-011 Significantly Reduces Total Opioid Use vs Bupivacaine and Placebo Source: Figure 14.2.2 Opioid consumption is presented in mean milligrams of morphine equivalents
Slide 26: 302: HTX-011 Significantly Increases Proportion of Opioid-Free Subjects
Study 302: HTX-011 Significantly Increases Proportion of Opioid-Free Subjects vs Bupivacaine and Placebo Source: Figure 14.2.3 Percent of Patients With Severe Pain at Any Time Through 72 hours HTX-011 48.8% Saline Placebo 81.7% p<0.0001 Bupivacaine 60.5% p=0.0372
Slide 27: Safety
Study 302 Safety
Slide 28: 302: Incidence of Treatment Emergent Adverse Events
Study 302: Incidence of Treatment Emergent Adverse Events Occurring in ≥ 5% in the HTX-011 Group Preferred Term HTX-011 300 mg (N=163) Saline Placebo (N=82) Bupivacaine HCl 75 mg (N=173) Any TEAE 73.0% 74.4% 73.4% Nausea 18.4% 34.1% 21.4% Constipation 17.2% 18.3% 23.7% Dizziness 14.7% 15.9% 24.3% He
Slide 29: 302: HTX-011 Lowers the Incidence of Opioid-Related Adverse Events
Study 302: HTX-011 Lowers the Incidence of Opioid-Related Adverse Events Preferred Term HTX-011 300 mg (N=163) Saline Placebo (N=82) Bupivacaine HCl 75 mg (N=173) Any ORAE 32.5% 43.9% 42.2% Nausea 18.4% 34.1% 21.4% Constipation 17.2% 18.3% 23.7% Vomiting 4.3% 4.9% 6.9% Pruritus 1.2% 1.2% 2.3% Urinar
Slide 30: HTX-011 Safety in Herniorrhaphy
HTX-011 Safety in Herniorrhaphy HTX-011 was generally well tolerated with: No drug-related serious adverse events No premature discontinuations due to adverse events No deaths Fewer opioid-related adverse events No evidence of drug-related LAST
Slide 31: Conclusions
THERAPEUTICS CONCLUSIONS ee
Slide 32: Overall Conclusions From Phase 3
Overall Conclusions From Phase 3 Phase 3 results show conclusively that HTX-011 is the first and only long-acting local anesthetic to demonstrate superior pain reduction and significantly reduce the need for opioids compared to the current standard of care, bupivacaine solution for the full 72 hours
Slide 33: HTX-011 NDA Filing Plans
HTX-011 NDA Filing Plans Goal is to file an NDA in 2H2018 requesting a broad label for reduction of postoperative pain and opioid analgesics for a full 72 hours after surgery NDA will contain data from 5 surgical models to support a broad label: Bunionectomy Herniorrhaphy TKA Abdominoplasty Breast a
Slide 34: Financial Summary
Financial Summary Cash, cash equivalents, short-term investments, accounts receivable plus cash from projected net sales of SUSTOL and CINVANTI are expected to be sufficient to fund operations for at least one year. Summary Statement of Operations and Net Cash Used in Operations (In thousands, excep
Slide 35: Key Catalysts in Pain Management & CINV Franchises
Key Catalysts in Pain Management & CINV Franchises HTX-011 for Postoperative Pain CINVANTI® and SUSTOL® for CINV Fast Track designation granted 2018 net sales guidance for CINV franchise: $60M - $70M Completed enrollment in Phase 3 pivotal trials Top-line Pivotal Phase 3 results 1H 2018 Topline resu
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