Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Investor Presentation (May 2017)
54 slides from Heron Therapeutics's investor presentation, May 2017
Slide 1: Company Update May 2017
Heron : Developing Best-in-Class Medicine. Improving Lives.” Company Update May 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™ (HTX- 019) aprepitant for IV NK1 for CINV Prevention PDUFA Date of November 12, 2017 injection HTX-011 bupivacaine + D
Slide 4: CINV Programs: SUSTOL, CINVANTI
CINV PROGRAMS: SUSTOL® CINVANTI™ (aprepitant for injection)
Slide 5: SUSTOL Performance
SUSTOL® Performance Launch Update Market Research Insights Q1 2017 (Conducted eight weeks post-launch performance: and updated in March 2017) ~10,300 units • Practices go through a “buying process” sold, $495 WAC, to evaluate adoption of new drugs which Date of first ~$3.6M net sales commercial sale
Slide 6: 46 Percent of MDs Evaluating SUSTOL as Potential Branded Agent of Choice
46 Percent of MDs Evaluating SUSTOL® as Potential Branded Agent of Choice (~6-9 Month Timeline) Degree of MD Experience With SUSTOL Practice’s Experience With SUSTOL Trial Timing for SUSTOL To Be Brand of Choice 100% 100% Efficacy 8% 38% 31% 6% 1-3 months 17% I and other MDs in my practice have used
Slide 7: Most RNs with SUSTOL Experience are Satisfied, Have Administered Successfully
Most RNs with SUSTOL® Experience are Satisfied, Have Administered Successfully RN Overall Experience Administering SUSTOL RN View of SUSTOL vs. other oncology SC products 100% 100% SUSTOL is similar to other 14% 14% subcutaneous injections in oncology 80% 80% 60% Very satisfied (6-7) 57% 60% Satisfi
Slide 8: CINV Prophylaxis Requires Two Complimentary Mechanisms of Action
CINV Prophylaxis Requires Two Complimentary 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 9: 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 10: 2017 CINV Franchise Outlook
2017 CINV Franchise Outlook Heron expects steady but measured growth in SUSTOL® trial and adoption • Continue to anticipate $15M - $25M in SUSTOL net sales in 2017 CINVANTI™ (HTX-019) program advancing • PDUFA date November 12, 2017, launch Q1 2018 • If approved, Heron would be the first company to
Slide 11: Post-Operative Pain Program
Post-Operative Pain Program HTX-011: Proprietary Extended-Release Combination of Bupivacaine + Meloxicam
Slide 12: Market Is Large 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 Post- Local Anesthetic Usage Across Key Limiters of Current Long- Operative Pain Relief, 2015-20201 Key Surgeries, 20151* Acting Anesthetics Penetration 35 32 3% • Perc
Slide 13: HTX-011 Has the Potential to Transform Post-Operative Pain Management
HTX-011 Has the Potential to Transform Post- Operative Pain Management “I would love a product that is superior to Exparel® in that it Generic Long-Acting actually provided 72 hours of pain relief; this would Product Attribute Local Local HTX-011 reduce rates of nausea, vomiting, and constipation an
Slide 14: Acute Pain After Surgery Is an Important Component of Chronic Opioid Abuse
ACUTE PAIN AFTER SURGERY IS AN IMPORTANT COMPONENT OF CHRONIC OPIOID ABUSE 14
Slide 15: 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 16: 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 17: Reducing Pain Signals at the Site of the Incision
Reducing Pain Signals at the Site of the Incision May Decrease the Development of Chronic Pain Activing on opiate receptors in the brain, opioids can reduce the sensation of pain, but do not block transmission of the pain signals. Occasionally, the HTX-011 directly blocks transmission of the pain si
Slide 18: Biochronomer Bupivacaine Produced Significant Reductions in Pain in Preclinical Models
Biochronomer® Bupivacaine Produced Significant Reductions in Pain in Preclinical Models1 Pig Post-Operative Pain Model Saline Control Biochronomer Bupivacaine Bupivacaine Liposome Injectable Suspension (2) Percentage of Maximal Force (60 gm) Tolerated 100.0 90.0 80.0 70.0 Higher bar = greater analge
Slide 19: 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 20: Bupivacaine & Meloxicam Combination Produced Complete Analgesia
Unique Combination of Bupivacaine & Meloxicam Produced Complete Analgesia1 Pig Post-Operative Pain Model Saline Control Biochronomer Bupivacaine Bupivacaine Liposome Injectable Suspension (2) Biochronomer Bupivacaine + Meloxicam 6 Day Release Percentage of Maximal Force (60 gm) Tolerated 100.0 90.0
Slide 21: >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 22: HTX-011 Produced Marked Analgesia Through 72 Hours
HTX-011’s Unique Combination of Bupivacaine & Meloxicam Produced Marked Analgesia Through 72 Hours1 Pig Post-Operative Pain Model Saline Control Biochronomer Bupivacaine HTX-011 Bupivacaine Liposome Injectable Suspension (2) Biochronomer Meloxicam Percentage of Maximal Force (60 gm) Tolerated 100.0
Slide 23: HTX-011 Activity 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 + Injectable Meloxicam* 100.0 90.0 80.0 Percent of Maximum Force 70.0 Higher bar = 60.0 G
Slide 24: HTX-011 Clinical Experience Shows Potential to Transform Post-Operative Pain Control
HTX-011 Clinical Experience Shows It Has the Potential to Transform Post-Operative Pain Control • Phase 2 data has demonstrated: – Unprecedented statistically significant reductions in both pain and opioid use lasting up to 96 hours after surgery – Utility in both small procedures (bunion), medium s
Slide 25: HTX-011 Study 203: Phase 2 Abdominoplasty
HTX-011 STUDY 203: Phase 2 Abdominoplasty 25
Slide 26: Study 203: Abdominoplasty Study Design & Demographics
Study 203: Abdominoplasty Study Design & Demographics Saline HTX-011 Characteristic Parameter Placebo 400mg HTX-011 200mg Inj HTX-011 400 mg Age (Years) n 21 20 significantly reduced Mean 43.0 41.4 HTX-011 400mg Inj Minimum 29 27 pain (SPI0-24 p=0.012); no Maximum 58 60 HTX-011 600mg Inj additional
Slide 27: HTX-011: Instillation Faster, Easier and Potentially Safer
HTX-011: Instillation Faster, Easier and Potentially Safer Compared to injection, instillation into the incision site is: • Easier to administer and less invasive, avoiding up to 50 or more injections into the skin with large operations • Safer, reducing the risk of venous puncture 27
Slide 28: Study 203: Mean Pain Intensity Scores
Study 203: Mean Pain Intensity Scores* HTX-011 Is Significantly Better Than Placebo Through 96 Hours After Abdominoplasty HTX-011 400mg Instillation (n=20) Saline Placebo (n=21) 9 SPI24-48 SPI48-72 SPI72-96 • Results confirm 8 p=0.007 p=0.038 p=0.016 that HTX-011 7 can be SPI0-72 would likely succes
Slide 29: Study 203: HTX-011 Significantly Reduces Opioid Use
Study 203: HTX-011 Significantly Reduces Opioid Use HTX-011 Mean Opioid Rescue Placebo (P) 400 mg HTX-011 Over Time (n=21) (n=20) produced significant 16.1mg 0 – 24 hours 25.9mg reductions in p=0.014 opioid rescue medication 27.2mg through 96 0 – 48 hours 40.8mg p=0.021 hours after abdominoplasty 32
Slide 30: Study 203: Treatment-Emergent Related Adverse Reactions
Study 203: Treatment-Emergent Related Adverse Reactions for All Cohorts* Saline Placebo HTX-011 Preferred Term (n=84) (n=68) Any Adverse Event 25.0% 25.0% Nausea 7.1% 7.4% Vomiting 1.2% 2.9% Headache 3.6% 7.4% Dizziness 3.6% 0 Hypoesthesia 1.2% 2.9% Wound dehiscence 2.4% 1.5% Pruritus 8.3% 2.9% Hypo
Slide 31: HTX-011 Study 208: Phase 2 Bunionectomy
HTX-011 STUDY 208: Phase 2 Bunionectomy 31
Slide 32: Study 208: Bunionectomy Study Design & Demographics
Study 208: Bunionectomy Study Design & Demographics HTX-011 200mg Characteristic Parameter Saline Bupivacaine HTX-011 HTX-011 HTX-011 200mg 120mg 60mg Age (Years) n 86 15 30 56 35 HTX-011 120mg Mean 49.9 52.7 52 49.6 54.2 Minimum 21 36 20 24 24 HTX-011 60mg Maximum 76 84 71 75 76 Bupivacaine 50mg Ge
Slide 33: Study 208: Mean Pain Intensity Scores vs Placebo
Study 208: Mean Pain Intensity Scores* HTX-011 Is Significantly Better Than Placebo For All Doses Tested 8 SPI24-48 200mg v B: p=0.0025 7 120mg v B: p=0.0169 6 60mg v B: p=0.170 Mean Pain Intensity 5 SPI0-72 4 would likely be the 3 Phase 3 SPI0-48 SPI0-72 SPI0-96 endpoint 2 200mg v P: p<0.0001 200mg
Slide 34: Study 208: Mean Pain Intensity Scores vs Bupivacaine
Study 208: Mean Pain Intensity Scores* HTX-011 Is Significantly Better Than Bupivacaine For All Doses Tested SPI24-48 8 200mg v P: p=0.0029 7 120mg v P: p=0.0201 60mg of 60mg v P: p=0.127 bupivacaine 6 combined with Mean Pain Intensity 5 meloxicam in HTX-011 is 4 significantly 3 better than SPI0-48
Slide 35: HTX-011 Produces 26-Fold Greater Reduction in Pain vs Bupivacaine
HTX-011 60 mg Produces 26-Fold Greater Reduction in Pain Compared to Bupivacaine 50 mg Through 72 Hours Bupivacaine 50 mg (n=25) HTX-011 60 mg (n=52) Greater Pain Reduction vs Placebo 120 26-fold Greater Reduction in Pain 100 AUC LSMD(−) vs Placebo 80 60 40 20 p=0.002 p=0.002 p=0.017 0 0 - 24 hr 0 -
Slide 36: Study 208: HTX-011 Significantly Reduces Opioid Use
Study 208: HTX-011 Significantly Reduces Opioid Use Mean Opioid Bupivacaine HTX-011 HTX-011 Placebo (P) Doses down to Rescue Over (n=86) Solution (B) 120 mg 60 mg Time (n=15) (n=56) (n=35) 60mg HTX-011 produced 8.0mg 8.2mg significant 0 – 24 hours 16.5mg 16.3mg p<0.0001 v P p<0.0001 v P reductions i
Slide 37: Study 208: Treatment-Emergent Related Adverse Reactions
Study 208: Treatment-Emergent Related Adverse Reactions for All Cohorts* Saline Placebo Bupivacaine HTX-011 Preferred Term (n=86) (n=15) (n=121) Any Adverse Event 20.9% 20.0% 27.3% Nausea 9.3% 13.3% 14.0% Vomiting 11.6% 6.7% 3.3% Erythema 1.2% 0 5.0% Headache 1.2% 0 5.8% Swelling 0 0 2.5% *Adverse e
Slide 38: HTX-011 Study 202: Phase 2 Hernia Repair
HTX-011 STUDY 202: Phase 2 Hernia Repair Data Presented at 2016 Pain Week 38
Slide 39: Study 202: Herniorrhaphy Study Design
HTX-011 Study 202: Herniorrhaphy Study Design Injection HTX-011 200mg Instillation Part B Injection HTX-011 400mg Instillation Saline Injection 39
Slide 40: Instillation and Injection Reduced Pain Equally Well
Instillation and Injection Reduced Pain Equally Well 140 121.6 120 100 86.2 85.2 Mean SPI0-24 80 60 40 20 0 HTX-011B 400mg Injection (N=14) HTX-011B 400mg Instillation (N=16) Saline Placebo (N=31) 40
Slide 41: Study 202: Mean Pain Intensity Scores
Study 202: Mean Pain Intensity Scores HTX-011 400mg Significantly Better than Placebo Through 48 hours 8 SPI24-48 7 p=0.138 6 Mean Pain Intensity 5 4 3 2 1 SPI0-24 SPI0-48 SPI0-72 p=0.0035 p=0.025 p=0.082 0 0 6 12 18 24 30 36 42 48 54 60 66 72 HTX-011 200mg HTX-011 400mg Saline Placebo *LOCF method
Slide 42: Study 202: Opioid Use Substantially Reduced
Study 202: Opioid Use Substantially Reduced Consistent with the significant reductions in pain observed with HTX-011, opiate use was also reduced: • Percent of patients who required no opioid rescue medication for the 96 hour study period substantially increased (24.1% versus 6.5%) • Mean total opio
Slide 43: Summary of Treatment-Emergent Adverse Events in Study 202
Summary of Treatment-Emergent Adverse Events (TEAEs) in Study 202* Preferred Term HTX-011B 200 mg (N=31) HTX-011B 400 mg (N=30) Saline Placebo (N=31) Any TEAE 12 (38.7%) 10 (33.3%) 16 (51.6%) >1 TEAE in any treatment arm Nausea 2 (6.5%) 5 (16.7%) 4 (12.9%) Headache 3 (9.7%) 3 (10.0%) 0 Constipation
Slide 44: Synergy Between Bupivacaine and Meloxicam Confirmed in Two Pain Clinical Models
SYNERGY BETWEEN BUPIVACAINE AND MELOXICAM HAS BEEN CONFIRMED IN TWO PAIN CLINICAL MODELS HTX-011 SIGNIFICANTLY BETTER THAN EITHER COMPONENT ALONE 44
Slide 45: HTX-011 Greater Pain Reduction Than Either Bupivacaine or Meloxicam Alone
HTX-011 Has Demonstrated Significantly Greater Pain Reduction Than Either Bupivacaine or Meloxicam Alone Comparison of AUC0-72 HTX-002 (Bupivacaine) HTX-009 (Meloxicam) HTX-002 + HTX-009 HTX-011 (Bupivacaine + Meloxicam) 140 ~7-fold Synergy 120 AUC LSMD(-) vs Placebo 100 ~9-fold Synergy 80 60 40 p=0
Slide 46: No Extended Release Bupivacaine Has Demonstrated a PK-PD Relationship
No Extended Release Bupivacaine Has Demonstrated a PK– PD Relationship EXPAREL® HTX-002 (ER Bupivacaine) (ER Bupivacaine) • No PK-PD Relationship • No PK-PD Relationship 3 140 ∆ Pain Score Plasma Conc 120 2.5 Plasma Bupivacaine (ng/mL) 100 (Saline minus Exparel) 2 ∆ Pain Score (Saline – HTX-002) 80
Slide 47: Bupivacaine & Meloxicam Demonstrates Clear PK-PD Relationship
Unique Combination of Bupivacaine & Meloxicam Demonstrates Clear PK–PD Relationship • For the first time an extended release local anesthetic has shown a clinical PK – PD relationship Study 208 Similar PK – PD relationship observed with HTX-011 in Study 202 Hernia Repair 47
Slide 48: Phase 2 Studies in TKA and Nerve Block Have Started
PHASE 2 STUDIES IN TKA AND NERVE BLOCK HAVE STARTED 48
Slide 49: Study 209: Total Knee Arthroplasty Study Design
Study 209: Total Knee Arthroplasty Study Design (n=120) HTX-011 200 mg HTX-011 400 mg Instillation ± Injection Instillation ± Injection Cohort 1 Cohort 2 Saline Placebo Saline Placebo Injection Injection Bupivacaine 150 mg Bupivacaine 150 mg Injection Injection 49
Slide 50: Study 211: Pectoral Pocket Nerve Block Study Design
Study 211: Pectoral Pocket Nerve Block in Breast Augmentation Study Design (n=72) HTX-011 60 mg HTX-011 60 to 120 mg Nerve Block Nerve Block Cohort 1 Cohort 2 Saline Placebo Saline Placebo Nerve Block Nerve Block Bupivacaine 50 mg Bupivacaine 50 mg Nerve Block Nerve Block 50
Slide 51: HTX-011 Shows Durable Response in Sciatic Nerve Block Model in Pigs
HTX-011 Shows Durable Response in Sciatic Nerve Block Model in Pigs Saline Bupivacaine 25 mg Exparel 106 mg HTX-011 100 mg 300 250 200 Force in Grams 150 100 50 0 0.5H 1H 2H 4H 6H 8H 9H 10H 24H 28H 48H HOURS 51
Slide 52: Summary: HTX-011 Is Poised to Fulfill the Promise of Long-Acting Local Anesthetics
Summary: HTX-011 Is Poised to Fulfill the Promise of Long-Acting Local Anesthetics in Post-Op Pain Large, growing market opportunity Differentiated, synergistic mechanism addresses inflammation – a key inhibitor of both generic and long-acting local anesthetics Demonstrated superiority vs. gener
Slide 53: Key Catalysts in Pain & CINV Franchises
Key Catalysts in Pain & CINV Franchises HTX-011 for Post-Operative CINVANTI™ (HTX-019) for CINV SUSTOL® for CINV Pain Early Q1 Top-line 2017 net sales guidance: Q1 (Jan.) – NDA submission abdominoplasty data $15M - $25M Early Q1 Phase 2 program in Q4 – PDUFA goal date of 11/12/17 nerve block i
Slide 54: Financial Update (May 10, 2017)
Financial Update (May 10, 2017) • Current cash, cash equivalents and short-term investments are sufficient for at least one year. Summary Statement of Operations Three Months Ended (In thousands, except per share data) March 31, 2017 Net product sales $ 3,632 Operating expenses1 52,931 Other expense
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