Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (October 2017)
59 slides from Heron Therapeutics's corporate update, Oct 12, 2017
Slide 1: Company Update
Company Update October 12, 2017
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
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
Slide 4: Postoperative Pain Program
Postoperative Pain Program HTX-011: Proprietary Extended-Release Combination of Bupivacaine + Meloxicam
Slide 5: Market Is Large and Local Anesthetic Use Is Common
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
Slide 6: Surgeons Expect to Use More Long-Acting Local Anesthetics
Surgeons Expect to Use More Long-Acting Local Anesthetics as Better Options Become Available Future Pain Market Outlook 72% of surgeons expect to use 62% of surgeons expect to use more Chart Title 73% of surgeons expect to use more fewer opioids local anesthetics long-acting local anesthetics 100% 4
Slide 7: Risk of Chronic Opioid Use After Selected Surgeries
Risk of Chronic Opioid Use After Selected Surgeries Adjusted Odds Ratio for Chronic Opioid Use 0 1 2 3 4 5 6 Total Knee Arthroplasty 5.1 Open Cholecystectomy 3.6 Simple Mastectomy 2.6 Total Hip Arthroplasty 2.5 Open Appendectomy 1.7 Laproscopic Cholecystectomy 1.6 Cesarean Delivery 1.3 Based on data
Slide 8: Opioids Increase Healthcare Costs Due to Side Effects
In Addition to Potential Addiction, Opioids Increase Healthcare Costs Due to a High Rate of Side Effects Cost of Opioid-Related Adverse Drug Events1,2 Moderate to Severe Opioid- Cost per ADE Events in Induced ADE 2013 $ Ileus $6,141 Pruritus $502 Urinary Retention $1,867 Respiratory Depression $1,50
Slide 9: Reducing Pain at the Source Can Eliminate the Need for Opioids
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,
Slide 10: Inflammation Plays a Key Role in Pain Management
Inflammation Plays a Key Role in Pain Management (Current local anesthetics do not address this) BUPH+ BUPN + H+ • Inflammation produces an acidic environment Outside membrane Nerve Cell Membrane • Shifts the balance to Inside membrane ionized form, which is unable to penetrate nerve cell membrane B
Slide 11: Fixed-Dose Combination of Bupivacaine & Meloxicam Produced Complete Analgesia
Unique Fixed-Dose Combination of Bupivacaine & Meloxicam Delivered Into the Incision Produced Complete Analgesia1 Pig Post-Operative Pain Model1 Saline Control Liposomal Bupivacaine 2 Biochronomer Bupivacaine Biochronomer Bupivacaine + Meloxicam 6-Day Release Percentage of Maximal Force (60 gm) 100.
Slide 12: >72 Hour Duration of Action Seen as Ideal
>72 Hour Duration of Action Seen as “Ideal” Ideal Duration of Efficacy for Long- Minimally Acceptable Duration of Acting Local Anesthetic Efficacy for Long-Acting Local Anesthetic >5 days 2% 5 days 4% ≤ 24 hours 72 hours 4 days 11% 12% 9% ≤ 24 48 hours hours 27% 44% 48 hours 72 hours 45% 46% Source:
Slide 13: HTX-011 Designed to Produce Marked Analgesia Through 72 Hours
HTX-011 Designed to Produce Marked Analgesia Through the First 72 Hours After Surgery1 Saline Control Liposomal Bupivacaine Biochronomer Bupivacaine 2 Biochronomer Meloxicam HTX-011 (Biochronomer Bupivacaine + Meloxicam with 3-day release) Percentage of Maximal Force (60 gm) 100.0 90.0 80.0 Increasi
Slide 14: Activity of HTX-011 Cannot Be Replicated By Systemic Meloxicam
Activity of HTX-011 Cannot Be Replicated By Systemic Administration of Meloxicam Along With ER Bupivacaine Pig Post-Operative Pain Model Saline Placebo HTX-011 (Bupivacaine + Meloxicam) Biochronomer Bupivacaine With Simultaneous Injectable Meloxicam 100.0 90.0 80.0 Increasing Analgesia Percent of Ma
Slide 15: HTX-011 Clinical Experience 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
Slide 16: 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
Slide 17: Phase 3 Program Has Been Initiated
PHASE 3 PROGRAM HAS BEEN INITIATED 17
Slide 18: 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
Slide 19: 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
Slide 20: 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) 20
Slide 21: HTX-011 Reduces Pain Better Than Placebo or Bupivacaine After Bunionectomy
HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Bunionectomy Increasing Pain 21 wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing data
Slide 22: 24-Fold Greater Pain Reduction vs Bupivacaine in Bunionectomy
HTX-011 60 mg Produces 24-Fold Greater Reduction in Pain Compared to Bupivacaine 50 mg Through 72 Hours in Bunionectomy Greater Pain Reduction vs. Placebo p-values are from ANOVA using AUC of Pain Intensity with wWOCF for HTX-011 vs. bupivacaine 22 AUC, area under the curve; LSMD, least squares mean
Slide 23: HTX-011 Reduces Total Opioid Use in Bunionectomy
Bunionectomy Study: HTX-011 Significantly Reduces Total Opioid Use vs Bupivacaine and Placebo Source: Data on File, Heron Therapeutics, Inc. 23
Slide 24: HTX-011 Increases Proportion of Opioid-Free Subjects vs Placebo
Bunionectomy Study: HTX-011 Significantly Increases the Proportion of Opioid-Free Subjects vs Placebo 24 Source: Data on File, Heron Therapeutics, Inc.
Slide 25: Bunionectomy Study: Drug-Related Adverse Events
Bunionectomy Study: Drug-Related Treatment-Emergent Adverse Events* Pooled HTX-011 Bupivacaine 50mg Saline Placebo Preferred Term (N = 174) (N = 25) (N = 104) Any Drug-related 28.2% 28.0% 24.0% TEAEs Nausea 12.1% 8.0% 11.5% Erythema 8.0% 8.0% 1.0% Vomiting 3.4% 4.0% 11.5% Hypertransaminasaemia 1.1%
Slide 26: HTX-011 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 Study 208 Greater Pain Reduction vs. Placebo p-value from ANOVA, LSMD of area under the curve for HTX-011 vs. HTX-002 or HTX-009 AUC, area under the cur
Slide 27: 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) 27
Slide 28: HTX-011 Reduces Pain Better Than Placebo or Bupivacaine After Herniorrhaphy
HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Herniorrhaphy Increasing Pain 28 wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing data
Slide 29: 4-Fold Greater Pain Reduction vs 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 Greater Pain Reduction vs. Placebo p-values are from ANOVA using AUC of Pain Intensity with wWOCF for HTX-011 vs. bupivacaine 29 AUC, area under the curve; LSMD, least squares mea
Slide 30: Herniorrhaphy Study: Reduces Total Opioid Use vs Placebo
Herniorrhaphy Study: HTX-011 Significantly Reduces Total Opioid Use vs Placebo 30 Source: Data on File, Heron Therapeutics, Inc.
Slide 31: Herniorrhaphy Study: Increases Proportion of Opioid-Free Subjects
Herniorrhaphy Study: HTX-011 Significantly Increases Proportion of Opioid-Free Subjects vs Bupivacaine and Placebo Source: ESRA SEPT 2017. 31
Slide 32: Herniorrhaphy Study: Drug-Related Adverse Events
Herniorrhaphy Study: Drug-Related Treatment-Emergent Adverse Events* HTX-011 300/400 mg Bupivacaine 75 mg Saline Placebo Preferred Term (n = 99) (n = 32) (n = 85) Any Drug-Related 30.3% 28.1% 29.4% TEAEs Hypotension 8.1% 3.1% 3.5% Nausea 7.1% 0% 9.4% Bradycardia 5.1% 6.3% 7.1% Dizziness 5.1% 3.1% 1.
Slide 33: HTX-011 Study 203: Phase 2 Abdominoplasty
HTX-011 STUDY 203: Phase 2 Abdominoplasty Updated Results Using wWOCF (8 Clinical Sites Enrolled Subjects) 33
Slide 34: HTX-011 Reduces Pain Better Than Placebo or Bupivacaine After Abdominoplasty
HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Abdominoplasty Increasing Pain 34 wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing data
Slide 35: 5-Fold Greater Pain Reduction vs Bupivacaine in Abdominoplasty
HTX-011 400 mg Produces 5-Fold Greater Reduction in Pain Compared to Bupivacaine 100 mg Through 72 Hours in Abdominoplasty Greater Pain Reduction vs. Placebo p-values are from ANOVA using AUC of Pain Intensity with wWOCF for HTX-011 vs. bupivacaine 35 AUC, area under the curve; LSMD, least squares m
Slide 36: Abdominoplasty Study: Reduces Total Opioid Use
Abdominoplasty Study: HTX-011 Significantly Reduces Total Opioid Use vs Bupivacaine and Placebo Source: Data on File, Heron Therapeutics, Inc. 36
Slide 37: More HTX-011 Patients Were Opioid-Free by Day 3
Although Almost All Patients Took Opioids on Day 1, More HTX-011 Patients Were Opioid-Free by Day 3 37
Slide 38: Abdominoplasty Study: Drug-Related Adverse Events
Abdominoplasty Study: Drug-Related Treatment-Emergent Adverse Events* HTX-011 400 mg Bupivacaine 100 mg Saline Placebo Preferred Term (n = 25) (n = 17) (n = 32) Any Drug-Related 44.0% 41.2% 31.3% TEAEs Nausea 20.0% 29.4% 15.6% Headache 12.0% 5.9% 6.3% Vomiting 8.0% 5.9% 6.3% Constipation 4.0% 11.8%
Slide 39: HTX-011 Significantly Better Than ER Bupivacaine and Unique PK-PD
HTX-011 SIGNIFICANTLY BETTER THAN EXTENDED-RELEASE BUPIVACAINE (002) AND SHOWS A UNIQUE PK-PD RELATIONSHIP 39
Slide 40: PK-PD Assessment: 002 ER Bupivacaine Shows No PK-PD Relationship
Pharmacokinetic-Pharmacodynamic (PK-PD) Assessment Bunionectomy Study: 002 ER Bupivacaine 60 mg Was Significantly Better Than Placebo Through 24 hr, but Does Not Demonstrate a PK-PD Relationship 002 ER Bupivacaine No PK-PD Relationship Mean Pain Intensity vs Time 10 3 135 Change in Pain Score 9 002
Slide 41: PK-PD: Exparel Bunionectomy Study
PK-PD: Exparel® Bunionectomy Study Exparel Significantly Better Than Placebo Through 24 hr, but Does Not Demonstrate a PK-PD Relationship Exparel® (liposomal bupivacaine) No PK-PD Relationship Mean Pain Intensity vs Time 3 140 ∆ Pain Score Plasma Conc 120 Plasma Bupivacaine (ng/mL) ∆ Pain Score (Sal
Slide 42: HTX-011 Excellent PK-PD Relationship
PK-PD: Bunionectomy Study HTX-011 Significantly Better Than Placebo Through 72 hr With an Excellent PK-PD Relationship HTX-011 (bupivacaine + meloxicam) PK-PD Relationship Mean Pain Intensity vs Time Pain Score Plasma PK 4 50 45 3.5 Bupivacaine Concentation (ng/mL) 40 3 35 (Saline-HTX-011) 2.5 ΔPain
Slide 43: Cross-Study Comparison vs Two Forms of ER Bupivacaine
In a Cross-Study Comparison of a Standardized Bunionectomy Model, HTX-011 Demonstrated Superior Pain Reduction vs Two Forms of Extended-Release Bupivacaine Liposomal Extended-Release Bupivacaine (Exparel, 120 mg)* 002 Extended-Release Bupivacaine (60 mg) HTX-011 (60 mg) 10 Greater Pain Reduction vs
Slide 44: On-Going Phase 2b Studies
[TEEROWN THERAPEUTICS Developing Best-in-Class Medicine. Improving Lives.” On-Going Phase 2b Studies
Slide 45: Phase 2b Total Knee Arthroplasty Study Design
Phase 2b Total Knee Arthroplasty Study Design HTX-011 200 mg HTX-011 400 mg Instillation Instillation N = 20 N = 25 HTX-011 200 mg HTX-011 400 mg Instillation + Injection Instillation + Injection Cohort 1 Cohort 2 N = 20 N = 25 IRC Saline Placebo Saline Placebo Injection Injection N = 10 N = 25 Bupi
Slide 46: Phase 2b Nerve Block: Breast Augmentation Study Design
Phase 2b Nerve Block: Breast Augmentation Study Design HTX-011 60 mg HTX-011 120 mg HTX-011 240 mg Nerve Block Nerve Block Nerve Block N = 12 N = 24 N = 24 Cohort 3 Cohort 1 Cohort 2 Saline Placebo Saline Placebo Saline Placebo Nerve Block Nerve Block Nerve Block N=6 N = 12 N = 12 IRC IRC dose decis
Slide 47: Summary: HTX-011 Is Poised to Fulfill the Promise of 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
Slide 48: CINV
THERAPEUTICS Developing Best-in-Class Medicine. Improving Lives.” : CINV
Slide 49: 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
Slide 50: CINV Franchise Commercial Update
CINV FRANCHISE COMMERCIAL UPDATE 50
Slide 51: SUSTOL Launch Performance Aligns With 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
Slide 52: SUSTOL 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
Slide 53: SUSTOL Outperforms 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
Slide 54: SUSTOL May Decline Modestly Through 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
Slide 55: CINVANTI Gives Heron a 2-Product CINV Franchise
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
Slide 56: CINVANTI (HTX-019) for CINV
CINVANTI™ (HTX-019) for CINV PDUFA Date of November 12, 2017 BE Study #104 Safety • CINVANTI™ is a proprietary, Results surfactant-free intravenous (IV) HTX-019 EMEND IV formulation of the NK1 receptor SAFETY Events Patients Events Patients antagonist aprepitant – Bioequivalency study comparing Tota
Slide 57: 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 • Our current guidance is $25M - $30M in SUSTOL net sales in 2017 CINVANTI™ (HTX-019) program advancing • PDUFA date November 12, 2017 • Anticipate launch Q1
Slide 58: 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
Slide 59: 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