Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Investor Presentation (June 2018)
57 slides from Heron Therapeutics's investor presentation, Jun 5, 2018
Slide 1: Company Update
Company Update J U N E 5 th, 2 0 1 8
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- Approved by U.S. FDA for CINV Prevention release injection CINVANTI® (aprepitant) injectable Approved by U.S. FDA for CINV Prevention emulsion HTX-011 bupivacaine + • Fast Track designation grante
Slide 4: Postoperative Opioids: A Doorway to Addiction
Postoperative Opioids: A Doorway to Addiction As many as MORE THAN 40 MILLION patients undergoing surgical procedures are 2.6 MILLION PEOPLE Up to 440,000/yr prescribed opioids for pain management that take will become addicted to opioids. in the United States every year opioids to manage pain after
Slide 5: Large US Market Opportunity
Large US Market Opportunity Theoretical and Target Market ~28M Annual US Surgical Procedures Requiring Postoperative Pain Management That Were Considered Potentially Suited For HTX-011 ~15M procedures ~6M procedures ~7M procedures Initial Targets Secondary Targets Tertiary Targets Higher volume proc
Slide 6: 9.7 Million Out of 15 Million Initial Target Procedures in Outpatient Setting
9.7 Million Out of the 15 Million Initial Target Procedures (65%) Will Occur in Outpatient Setting Hospitals account for 76% Remaining outpatient facilities account for 24% [11.4 M procedures] [3.6 M procedures] 10% Ambulatory Surgical 14% Other (Physician 35% Inpatient 41% Hospital Outpatient Cente
Slide 7: Potential Reimbursement Opportunities with Approval: C-Code
Potential Reimbursement Opportunities with Approval C-Code Overview and Why It Is Important What is it? • Specific for procedures that occur in the Outpatient Setting • Good news: Rolling quarterly application deadlines with 90 days to receive approval • Once granted, C-Code covers the remainder of
Slide 8: Potential Reimbursement Opportunities with Approval: J-Code
Potential Reimbursement Opportunities with Approval J-Code Overview and Why It Is Important What is it? • CMS code that is assigned and takes into effect once application for J-Code is granted OR the C- Code expires • Unlike the C-Code, it does not provide for pass-through reimbursement What is the
Slide 9: Obtaining a C-Code Will Provide Broad Access for HTX-011
Obtaining a C-Code Will Provide Broad Access for HTX-011 Across 65% of Eligible Procedures 9.7 MILLION OUTPATIENT PROCEDURES (65% of Initial Market) Plan for HTX-011 EXPAREL C-Code has expired; now part of CMS Surgical C-Code providing ASP+6% pass-through Supply Package without separate pass-through
Slide 10: Very Positive Response to HTX-011's Target Product Profile
Very Positive Response by Physicians and Pharmacists to HTX-011’s Target Product Profile HTX-011 Target Product Profile: Strengths Reduction in Opioid Consumption 88% 11% Reduction in Pain Score 87% 13% Reduction in Opioid AEs* 80% 19% Analgesia Duration 79% 20% Mechanism of Action 73% 23% No Impact
Slide 11: Pharmacy Directors Preferred HTX-011 over Exparel
Pharmacy Directors Preferred HTX-011 over Exparel® Based on MOA, Reduction in Pain, and Reduction in Opioids Preference for HTX-011 vs. Exparel Based on Product Attributes Physician Responses Pharmacy Director Responses 32% 41% 23% 3% 1% Mechanism of Action 37% 29% 27% 7% 21% 43% 31% 6% 0% Duration
Slide 12: High Procedure Volume Provides Robust RoW Market Opportunity
High Procedure Volume in Target Markets Provides a Robust RoW Market Opportunity Remaining Secondary, Lower Total Procedures Requiring Total Surgical Procedures Initial Target Procedures Volume & Procedures Currently Postop Pain Management Not Using Local Anesthetics Country Germany 22,545,000 6,838
Slide 13: Why Haven't Extended Release Local Anesthetics Penetrated This Large Market
Why Haven’t Extended Release Local Anesthetics Penetrated This Large Market • Regardless of delivery technology, extended release bupivacaine products do not reduce pain sufficiently beyond 24 hours to beat bupivacaine HCl : – Exparel® (liposomal ER bupivacaine) 60-Hour Continuous Infusion of – Xara
Slide 14: Inflammation Can Reduce the Activity of Local Anesthetics
Inflammation Can Reduce the Activity of Local Anesthetics HTX-011 is Unique Because It Works to Block Both Pain and Local Inflammation • Surgical insult produces an BUPH+ BUPN + H+ immediate drop in pH Outside membrane • As inflammatory cytokines are Nerve Cell released and inflammation sets in, Mem
Slide 15: 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 ER Bupivacaine 2 Biochronomer ER Meloxicam HTX-011 (Biochronomer Bupivacaine + Meloxicam with 3-day release) Percentage of Maximal Force (60 gm) 100.0 90.0 80.0 In
Slide 16: Unique MOA of HTX-011 Produced Greater Pain Reduction in Phase 2
Unique MOA of HTX-011 Produced Significantly Greater Pain Reduction Than ER Versions of Bupivacaine or Meloxicam in Phase 2 p=0.0154 vs. HTX-002* p<0.0001 vs. HTX-009* p=0.0208 vs. HTX-002* p=0.0005 vs. HTX-009* p=0.0333 vs. HTX-002* p=0.0090 vs. HTX-009* p=0.2041 vs. HTX-002* p<0.0035 vs. HTX-009*
Slide 17: 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
Slide 18: 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 18
Slide 19: Study 301/EPOCH1: Phase 3 Bunionectomy Study Design
Study 301/EPOCH1: Phase 3 Bunionectomy Study Design HTX-011 60 mg Instillation Study 301 Randomization (3:3:2) N = 157 Endpoints Primary: Pain Intensity AUC0-72 vs. placebo Bupivacaine 50 mg Injection 1st Key Secondary: Pain Intensity AUC0-72 vs. N = 155 bupivacaine 2nd Key Secondary: Opioid use vs.
Slide 20: Study 301: Subject Demographics
Study 301: Subject Demographics HTX-011 60 mg Saline Placebo Bupivacaine HCl 50 mg Total (N=157) (N=100) (N=155) (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 21: Study 301: Results Hierarchy
Study 301: Results Hierarchy Primary and ALL Key Secondary Endpoints Significant Primary: AUC0-72 HTX-011 vs. Placebo p < 0.0001 1st Key Secondary: AUC0-72 HTX-011 vs. Bupivacaine p = 0.0002 2nd Key Secondary: Opioid Consumption HTX-011 vs. Placebo p < 0.0001 3rd Key Secondary: Opioid-Free HTX-011 v
Slide 22: Study 301: HTX-011 Reduces Pain After Bunionectomy
Study 301: HTX-011 Reduces Pain After Bunionectomy Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) Increasing Pain wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing data Source: Figure 14.2.7 22
Slide 23: Study 301: HTX-011 Significantly Reduces Total Opioid Use
Study 301: HTX-011 Significantly Reduces Total Opioid Use vs Bupivacaine and Placebo Opioid consumption is presented in mean milligrams of morphine equivalents Source: Figure 14.2.2 23
Slide 24: Study 301: Increases Proportion of Opioid-Free Subjects
Study 301: HTX-011 Significantly Increases Proportion of Opioid-Free Subjects vs Bupivacaine and Placebo Percent of Patients With Severe Pain at Any Time Through 72 hours HTX-011 53.5% 83.0% Saline Placebo p<0.0001 75.5% Bupivacaine p<0.0001 Source: Figure 14.2.3 24
Slide 25: Study 301 Safety
STUDY 301 SAFETY 25
Slide 26: Study 301: Treatment Emergent Adverse Events
Study 301: Incidence of Treatment Emergent Adverse Events Occurring in ≥ 5% in the HTX-011 Group HTX-011 60 mg Saline Placebo Bupivacaine HCl 50 mg Preferred Term (N=157) (N=101) (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 site oedema 17.2% 12.9%
Slide 27: Study 301: Lower Incidence of Opioid-Related Adverse Events
Study 301: Lower Incidence of Opioid-Related Adverse Events Observed with HTX-011 HTX-011 60 mg Saline Placebo Bupivacaine HCl 50 mg Preferred Term (N=157) (N=101) (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% Constipation 5.7% 6.9% 11
Slide 28: 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 28
Slide 29: Cross-Study Comparison of HTX-011 vs. Exparel in Bunionectomy
CROSS-STUDY COMPARISON OF HTX-011 VS. EXPAREL IN BUNIONECTOMY 29
Slide 30: Cross-Study Comparison of Phase 3 Bunionectomy Data
Cross-Study Comparison of Phase 3 Bunionectomy Data HTX-011 vs EXPAREL HTX-011 Phase 3 Exparel Phase 3 Increasing Mean Pain Intensity Source: HTX-011 Table 14.2.7. Source: Exparel FDA Statistical Review October 2011, Figure 3. Primary outcome measure: AUC of NRS pain intensity scores over full Prima
Slide 31: Cross-Study Comparison of Pain Reduction and Opioid-Free Patients
Cross-Study Comparison of Pain Reduction and Proportion of Patients Opioid-Free From Phase 3 Bunionectomy Studies with HTX-011 and EXPAREL HTX-011 HTX-011 Exparel Exparel 60 mg Placebo 120 mg Placebo Timepoint (N=157) (N=100) (N=97) (N=96) Pain Intensity AUC0-24 Mean (SD) 98.7 (59.5) 155.8 (48.5) 12
Slide 32: Study 302/EPOCH2: Phase 3 Herniorrhaphy Study Design
Study 302/EPOCH2: Phase 3 Herniorrhaphy Study Design HTX-011 300 mg Study 302 Instillation Randomization (2:2:1) Endpoints N = 164 Primary: Pain Intensity AUC0-72 vs. placebo Bupivacaine 75 mg 1st Key Secondary: Pain Intensity AUC0-72 vs. Injection bupivacaine N = 172 2nd Key Secondary: Opioid use v
Slide 33: Study 302: Subject Demographics
Study 302: Subject Demographics HTX-011 300 mg Saline Placebo Bupivacaine HCl 75 mg Total Number of subjects: (N=164) (N=82) (N=172) (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 34: Study 302: Results Hierarchy
Study 302: Results Hierarchy Primary and ALL Key Secondary Endpoints Significant Primary: AUC0-72 HTX-011 vs. Placebo p = 0.0004 1st Key Secondary: AUC0-72 HTX-011 vs. Bupivacaine p < 0.0001 2nd Key Secondary: Opioid Consumption HTX-011 vs. Placebo p = 0.0001 3rd Key Secondary: Opioid-Free HTX-011 v
Slide 35: Study 302: HTX-011 Reduces Pain After Herniorrhaphy
Study 302: HTX-011 Reduces Pain After Herniorrhaphy Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) Increasing Pain wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing data Source: Figure 14.2.7 35
Slide 36: Study 302: HTX-011 Significantly Reduces Total Opioid Use
Study 302: HTX-011 Significantly Reduces Total Opioid Use vs Bupivacaine and Placebo Opioid consumption is presented in mean milligrams of morphine equivalents Source: Figure 14.2.2 36
Slide 37: Study 302: Increases Proportion of Opioid-Free Subjects
Study 302: HTX-011 Significantly Increases Proportion of Opioid-Free Subjects vs Bupivacaine and Placebo Percent of Patients With Severe Pain at Any Time Through 72 hours HTX-011 48.8% 81.7% Saline Placebo p<0.0001 60.5% Bupivacaine p=0.0372 Source: Figure 14.2.3 37
Slide 38: Study 302 Safety
STUDY 302 SAFETY 38
Slide 39: Study 302: Treatment Emergent Adverse Events
Study 302: Incidence of Treatment Emergent Adverse Events Occurring in ≥ 5% in the HTX-011 Group HTX-011 300 mg Saline Placebo Bupivacaine HCl 75 mg Preferred Term (N=163) (N=82) (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 40: Study 302: Lower Incidence of Opioid-Related Adverse Events
Study 302: Lower Incidence of Opioid-Related Adverse Events Observed with HTX-011 HTX-011 300 mg Saline Placebo Bupivacaine HCl 75 mg Preferred Term (N=163) (N=82) (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.
Slide 41: 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 41
Slide 42: On-Going Phase 2b Studies
[EEIROWN THERAPEUTICS Developing Best-in-Class Medicine, Improving Lives.” On-Going Phase 2b Studies
Slide 43: Phase 2b Study 211: Nerve Block in Breast Augmentation
Phase 2b Study 211: Nerve Block in Breast Augmentation Study Design HTX-011 60 mg HTX-011 120 mg HTX-011 240 mg HTX-011 400 mg Nerve Block Nerve Block Nerve Block Nerve Block N = 12 N = 24 N = 24 N = 48 HTX-011 400 mg Instillation N = 48 Cohort 4 Cohort 1 Cohort 2 Cohort 3 Saline Placebo Saline Plac
Slide 44: 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 = 50 HTX-011 200 mg HTX-011 400 mg Instillation + Injection Instillation + Ropi Injection Cohort 2 N = 50 Cohort 1 N = 20 IRC Saline Placebo Saline Placebo Injection Injection N = 10 N = 50
Slide 45: 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 (positive Phase 2 & 3 data) – Herni
Slide 46: CINV Commercial Update
Heron Developing Best-in-Class Medicine, Improving Lives.” » CINV Commercial Update
Slide 47: CINV Has a High Clinical Burden
CINV Has a High Clinical Burden – Impacting Patients’ QOL and Cancer Treatment Patients identified CINV as the side effect of chemotherapy CINV commonly disrupts patients’ cancer they most wanted to avoid treatment More acceptable Worst 1.00 Constipation Sexual dysfunction Depression Mucositis Fatig
Slide 48: Preventing CINV Remains a Significant Clinical Challenge
Preventing CINV Remains a Significant Clinical Challenge • In a prospective observational EMR study of • In palonosetron Phase 3 HEC trial, ~50% of patients patients receiving single-day MEC or HEC in experienced breakthrough by day 2 and ~60% by day 3 leading community oncology practices – ~50% of
Slide 49: CINV Prophylaxis Typically Requires Two Complementary Mechanisms of Action
CINV Prophylaxis Typically Requires Two Complimentary Mechanisms of Action NK1 receptor antagonists NK1 receptor • Substance P is primary driver of delayed antagonist CINV, but related to ~15% of acute failures CINVANTI® • EMEND® IV (fosaprepitant), the US NK1 market leader, contains the synthetic s
Slide 50: The CINV Market Has Seen Dramatic Changes
The CINV Market Has Seen Dramatic Changes Creating Long-Term Opportunities for Heron Market Events Opportunities Q4 2017 Varubi IV launch SUSTOL o No Aloxi contract Q1 2018 CINVANTI launch o More rapid / shorter arbitrage Q1 2018 Reports of Varubi IV AEs, label update, o Permanent J code ass
Slide 51: Heron's CINV Portfolio Continues to Outperform
Heron’s CINV Portfolio Continues to Outperform All Recent CINV Branded Launches CINV Brand Launches Since 2008 New CINVANTI Accounts By Month Q1 CINVANTI Provider Demand Units Approximate administrations in 60 25,000 First 18 Months (launch aligned) 55 21,900 50 136,000 20,000 43 40 15,000 30 20 10,
Slide 52: Heron CINV Portfolio Achieved $11.6M Q1 2018 Net Sales
Heron CINV Portfolio achieved $11.6M Q1 2018 Net Sales $15.0 CINV Franchise Net Sales $13.0 $11.6 $11.0 $10.0 Net Sales ($M) $9.0 $8.5 $8.6 $5.2 $7.0 $5.0 $3.6 $3.0 $6.41 $1.3 $1.0 $(1.0) Q4 2016 Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 1If it were not for the fact that the Company adopted the requir
Slide 53: SUSTOL Will Decline Through Generic Arbitrage and Grow Thereafter
Market Insights Suggest SUSTOL® Will Decline Through the Generic Arbitrage and Grow Thereafter – Consistent with Aloxi® Analogue Recent Market Insights Unit Sales 700,000 • Practices that are converting to SUSTOL are likely to maintain use1 600,000 • ~67% of current “dabblers” likely to stop or redu
Slide 54: Heron's CINV Portfolio is Positioned to Lead the CINV Market
Heron’s CINV Portfolio is Positioned to Lead the CINV Market Well Into the Future 5-HT3 pathway NK1 pathway Heron CINV Akynzeo® IV SUSTOL® Palonosetron Portfolio CINVANTI® EMEND® IV (fosnetupitant + SUSTOL® & palonosetron) CINVANTI® Approved for acute and Provides standard of Yes Yes HEC MEC HEC MEC
Slide 55: 2018 CINV Franchise Outlook
2018 CINV Franchise Outlook CINV Franchise • Reaffirm 2018 guidance of $60M–$70M net sales for the CINV franchise • Despite the near-term challenge of generic palonosetron, recent market dynamics create long-term opportunities for Heron’s CINV franchise – Entry of 7 generic versions of palonosetron
Slide 56: Financial Summary
Financial Summary As of March 31, 2018, pro-forma cash, cash equivalents and short-term investments, adjusting for the April 2018 public offering, were $282.6 million. Summary Statement of Operations and Net Cash Used in Operations Three Months Ended (In thousands, except per share data) March 31, 2
Slide 57: Key Catalysts in Pain Management & CINV Franchises
Key Catalysts in Pain Management & CINV Franchises HTX-011 for Postoperative Pain CINVANTI ® and SUSTOL® for CINV 2018 net sales guidance for CINV Fast Track designation granted franchise: $60M - $70M Completed enrollment in Phase 3 pivotal trials Top-line Pivotal Phase 3 results 1H 2018 Topli
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