Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (October 2019)
46 slides from Heron Therapeutics's corporate update, Oct 2, 2019
Slide 1: Corporate Update October 2, 2019
Corporate Update October 2, 2019 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: Heron Pipeline
Heron Pipeline We are currently developing and commercializing pharmaceutical products for patients suffering from cancer or postoperative pain: SUSTOL® (granisetron) extended-release injection Fast Track and Breakthrough Therapy designations granted NDA received Priority Review; CRL received 30 Apr
Slide 4: HTX-011 Has Shown Favorable Results on Postoperative Pain in Several High-Value Procedures
HTX-011 Has Shown Favorable Results on Postoperative Pain in Several High-Value Procedures Procedure Annual Volume (‘000s, US, 2015) Overall % Local Anesthetic Use Total Procedures Inpatient Outpatient (C-code) ASC (C-Code) Medicare Non-Medicare** Survey Ortho Surgery Knee arthroplasty 1,043 977 41
Slide 5: Phase 2b Total Knee Arthroplasty (Study 209) and Follow-on (Study 306)
Phase 2b Total Knee Arthroplasty (TKA) (Study 209) Study 209 Follow-on: HTX-011 + MMA in TKA* (Study 306) *The multimodal analgesic (MMA) regimen used in this study was identical to the PILLAR Study of liposomal bupivacaine
Slide 6: Study TKA: Results Hierarchy
Study 209 TKA: Results Hierarchy AUC0-48 HTX-011 400 mg vs. Placebo AUC0-72 HTX-011 400 mg+ Ropivacaine vs. Placebo AUC0-48 HTX-011 400 mg + Ropivacaine vs. Placebo p < 0.0001 AUC0-72 HTX-011 400 mg vs. Placebo p = 0.0002 p < 0.0001 p = 0.0004 HTX-011 via instillation achieved primary and key second
Slide 7: Study TKA: HTX-011 Significantly Superior to Placebo and Bupivacaine Through 72 Hours
Study 209 TKA: HTX-011 Significantly Superior to Both Placebo and Bupivacaine Through 72 Hours Without Adjusting for Opioid Use Notes: Pain intensity collected using Numeric Rating Scale (NRS) LOCF for missing data and no adjustment for use of opioid rescue medication HTX-011 is an investigational n
Slide 8: Study Follow-on: HTX-011 + Generic Analgesics Kept Pain in Mild Range
Study 209 Follow-on: HTX-011 + Generic Analgesics* Kept Pain in the MiId Range Through 72 Hours With 68% Less Opioid Than Bupivacaine HTX-011 is an investigational new drug and not approved by the FDA LOCF for missing pain data 1 4 8 * Multimodal analgesic (MMA) regimen for postoperative pain in Stu
Slide 9: Cross-Study Comparison of Day 1 Results and Exparel PILLAR Study
Cross-Study Comparison of Day 1 in Study 306 and Exparel PILLAR Study (Dysart 2019) Cross-Study Comparison of 0 – 24 Hour Results in TKA Using Pillar-Based MMA and the Same Analysis1 Study 306 HTX-011 (N=51) PILLAR Study Exparel + Bupivacaine1 (N = 70) Bupivacaine1 (N = 69) AUC0-24 VAS Pain 2 59.5 9
Slide 10: Cross-Study Comparison of 48 Hour Results and Exparel PILLAR Study
Cross-Study Comparison of 48 Hour Results From Study 306 (Preliminary Results) and Exparel Pillar Study (Mont 2017) Comparison of 48 Hr Results in TKA Using Pillar-Based MMA and the Same Analysis1 Study 306 HTX-011 (N=51) PILLAR Study Exparel + Bupivacine1 (N = 70) Bupivacaine1 (N = 69) Mean AUC12-4
Slide 11: Potential Reduction of Discharge Opioids Based on Study 306
Potential Reduction of Discharge Opioids Based on Study 306 Currently, following TKA an average of 90 opioid pills are prescribed per patient at the time of discharge, with an additional 4 refills over the next year1 Potential Impact on Discharge Opioids of Study 306 Extrapolated to the 1,043,000 TK
Slide 12: EPOCH 1: Bunionectomy Results (Study 301)
EPOCH 1: Bunionectomy Results (Study 301) EPOCH 1 Follow-on: Opioid Elimination Study in Bunionectomy
Slide 13: EPOCH Bunionectomy: All Key Endpoints Favor HTX-011
EPOCH 1 Bunionectomy: All Key Endpoints Favor HTX-011 Hierarchical hypothesis testing (P ≤ .05) NRS: numeric rating scale AUC: area under the curve; placebo: saline placebo p < 0.0001 p = 0.0002 p < 0.0001 p = 0.0001 p = 0.0022 Primary NRS Pain Intensity (AUC0-72) vs placebo 1st Key Secondary NRS Pa
Slide 14: EPOCH Bunionectomy: HTX-011 Significantly Reduced Pain Through 72 Hours
EPOCH 1 Bunionectomy: HTX-011 Significantly Reduced Pain Through 72-hours as Compared to Bupivacaine and Placebo * Using Numeric Rating Scale (NRS) with window worst observation carried forward (wWOCF) Time (hour) Pain Intensity Score* (Mean ± SE) AUC0-24 HTX-011 vs P: p < 0.0001 HTX-011 vs B: p < 0
Slide 15: EPOCH Follow-on: HTX-011 + OTC Kept Pain in the Mild Range
Epoch 1 Follow-on: HTX-011 + OTC Acetaminophen and Ibuprofen Kept Pain in the MiId Range Through 72 Hours HTX-011 60 mg (N=157) Saline Placebo (N=100) Bupivacaine HCI 50 mg (N=155) Severe pain ≥ 7 Mild pain (0-4) Time (hour) EPOCH 1 Follow-on: HTX-011 ≤ 60 mg + OTC (N=31) OTC = Over the counter anal
Slide 16: HTX-011 Significantly Reduced Total Opioid Consumption Through 72 Hours
HTX-011 Significantly Reduced Total Opioid Consumption Through 72-hours as Compared to Bupivacaine and Placebo 1. Based on morphine milligram equivalents p = 0.0022 p < 0.0001 Opioid Consumption (Mean MME1 ± SE) 0-72 Hours N=31 EPOCH 1 Follow-on N=100 N=155 N=157 OTC = Over the counter analgesic reg
Slide 17: HTX-011 Significantly Increased Proportion of Opioid-Free Patients
HTX-011 Significantly Increased Proportion of Opioid-Free Patients Through 72-hours as Compared to Bupivacaine and Placebo p = 0.0001 p < 0.0001 % Opioid-free Through 72 Hours EPOCH 1 Follow-on N=31 EPOCH 1 (Bunionectomy) N=100 N=155 N=157 OTC = Over the counter analgesic regimen of ibuprofen 600 mg
Slide 18: EPOCH 2: Herniorrhaphy Results (Study 302)
EPOCH 2: Herniorrhaphy Results (Study 302) EPOCH 2 Follow-on: Opioid Elimination Study in Herniorrhaphy
Slide 19: EPOCH Herniorrhaphy: All Key Endpoints Favor HTX-011
EPOCH 2 Herniorrhaphy: All Key Endpoints Favor HTX-011 Hierarchical hypothesis testing (P ≤ .05) AUC: area under the curve; placebo: saline placebo p = 0.0004 p < 0.0001 p = 0.0001 p = 0.0486 p = 0.0240 Primary NRS Pain Intensity (AUC0-72) vs placebo 1st Key Secondary NRS Pain Intensity (AUC0-72) vs
Slide 20: EPOCH Herniorrhaphy: HTX-011 Significantly Reduced Pain Through 72 Hours
EPOCH 2 Herniorrhaphy: HTX-011 Significantly Reduced Pain Through 72-hours as Compared to Bupivacaine and Placebo Time (hour) Mean Pain Intensity Score (SE) AUC0-24 HTX-011 vs P: p < 0.0001 HTX-011 vs B: p < 0.0001 AUC24-72 HTX-011 vs P: p = 0.0264 HTX-011 vs B: p = 0.0007 AUC0-72 HTX-011 vs P: p =
Slide 21: EPOCH Follow-on: HTX-011 + OTC Kept Pain in the Mild Range
Epoch 2 Follow-on: HTX-011 + OTC Acetaminophen and Ibuprofen Kept Pain in the MiId Range Through 72 Hours Time (hour) Mean Pain Intensity Score (SE) HTX-011 300 mg (N=164) Saline Placebo (N=82) Bupivacaine HCI 75 mg (N=172) Source: Figure 14.2.7 HTX-011 is an investigational new drug and not approve
Slide 22: HTX-011 Significantly Reduced Total Opioid Consumption Through 72 Hours
HTX-011 Significantly Reduced Total Opioid Consumption Through 72-hours as Compared to Bupivacaine and Placebo 1. Based on morphine milligram equivalents N=82 N=172 N=164 p = 0.0240 p < 0.0001 EPOCH 2 (Herniorrhaphy) N=33 EPOCH 2 Follow-on OTC = Over the counter analgesic regimen of ibuprofen 600 mg
Slide 23: HTX-011 Significantly Increased Proportion of Opioid-Free Patients
HTX-011 Significantly Increased Proportion of Opioid-Free Patients Through 72-hours as Compared to Bupivacaine and Placebo p = 0.0486 p < 0.0001 EPOCH 2 Follow-on EPOCH 2 (Herniorrhaphy) % Opioid-free Through 72 Hours N=82 N=172 N=164 N=33 40.1% OTC = Over the counter analgesic regimen of ibuprofen
Slide 24: HOPE-1: Real World Evidence of Opioid-Free Recovery Post Inguinal Herniorrhaphy
HOPE-1: Real World Evidence of Opioid-Free Recovery Post Inguinal Herniorrhaphy with HTX-011 + OTC Analgesics
Slide 25: HOPE-1: Opioid-Free Recovery in 95% of Inguinal Herniorrhaphy Patients
HOPE-1: Opioid-Free Recovery in 95% of Inguinal Herniorrhaphy Patients with HTX-011 + OTC Analgesics 5% N=93 in initial pilot program 93% HTX-011 is an investigational new drug and not approved by the FDA [BAR CHART]
Slide 26: Potential Reduction of Discharge Opioids Based on HOPE-1
Potential Reduction of Discharge Opioids Based on HOPE-1 Currently, following inguinal hernia repair an average of 30 opioid pills are prescribed per patient of which an average of 9 pills are consumed1 HOPE-1 Study vs Estimated Opioid Usage With Current Practice Assumptions (n=93) Pills Prescribed
Slide 27: Safety Summary
Safety Summary HTX-011 was generally well tolerated across all Phase 2 and Phase 3 studies with no clinically meaningful differences from placebo and bupivacaine in: Overall adverse events The incidence of serious adverse events Premature discontinuations due to adverse events Potential local anesth
Slide 28: The Commercialization of HTX-011 Advancing Pain Management
The Commercialization of HTX-011 Advancing Pain Management HTX-011 is an investigational new drug and not approved by the FDA
Slide 29: Established Platform With Experienced Teams in Place
EXISTING PLATFORM ADVANTAGES Established Platform With Experienced Teams in Place We are prepared for the launch of HTX-011. Our critical teams are already in place, with extensive experience in successful hospital launches. Strong KOL relationships Successful hospital and pain management launch exp
Slide 30: CINVANTI Market Share is Climbing Steadily Across All Segments
TOTAL CLINIC HOSPITAL CINVANTI Market Share is Climbing Steadily Across All Segments NK1 Units (K) 345 384 395 409 426 439 NK1 Units (K) 137 155 157 160 173 167 NK1 Units (K) 208 229 237 248 253 273 EMEND/AKYNZEO CINVANTI EMEND/AKYNZEO CINVANTI EMEND/AKYNZEO CINVANTI Data Source(s): 867 through 7/6/
Slide 31: Key CINVANTI Learnings to Support HTX-011 Launch
Key CINVANTI Learnings to Support HTX-011 Launch HTX-011 MOA, First and Only DALA Broad Access Pricing 3-year pass through (C-Code) Top 200 IDNs, 965 Hospitals and 340B Selected GPOs / IDNs Ambulatory Surgical Centers Exparel, On-Q Leverage ASCs and Outpatient for access and confidence Reduce / Elim
Slide 32: The Market is Large and Waiting for an Effective Non-opioid Solution
The Market is Large and Waiting for an Effective Non-opioid Solution Theoretical and Target Market ~29M Annual US Surgical Procedures Requiring Postoperative Pain Management Initial Targets Higher volume procedures across 4 major specialties ~5.9M Orthopedic ~4.2M General Surgery ~2.6M OB/GYN ~0.8M
Slide 33: HTX-011 is Focused on the Largest Market Opportunity
HTX-011 is Focused on the Largest Market Opportunity THE LARGEST OPPORTUNITY TO DRIVE VALUE AND CREATE CHANGE NB: Nerve Block N = 22M Procedures DRG Foundational Insights Research Dec. 2016 HTX-011 is an investigational new drug and not approved by the FDA [PIE CHART]
Slide 34: Physicians Indicated a Raw Preference Share of 56% for HTX-011 Attributes
Physicians Indicated a Raw Preference Share of 56% for a Drug with HTX-011’s Potential Attributes Across the Covered Procedures Overall Wt. Average Preference Share Preference Share (%, Raw) 56% Raw preference share for a drug with HTX-011’s potential attributes from physicians: 56% The top procedur
Slide 35: Adjusted Physician Preference Share Distribution
Adjusted Physician Preference Share Distribution -44% -44% -45% Future Therapy (Applying HTX-011 preference share) Current Therapy (Actual) (e.g. lidocaine, ropivacaine, generic combo, etc.) Current therapy based on Claims data from 2017 for Exparel, other agents are based on 2018 Physician Survey D
Slide 36: HTX-011 has Potential Strategic Advantages Across Each Setting of Care
HTX-011 has Potential Strategic Advantages Across Each Setting of Care Clearly differentiated strategy supported by building advocacy with pharmacy, surgeons, and anesthesiologists 52% Hospital Inpatient (7M procedures) Part of DRG payment Multiple SKUs - lower average cost ~50% connected 340B hospi
Slide 37: 340B Hospital Summary and Drug Reimbursement for Postoperative Pain
~2258 hospitals (excluding children’s & psych) 8.4M outpatient surgeries/year 4.4M inpatient surgeries/year Manufacturers required to provide 23.1% discount off ASP/WAC Discount does not impact ASP or best price calculations Products used in the OR that are considered part of the surgical package ar
Slide 38: Heron is Well Positioned to Execute a Blockbuster Launch for HTX-011
Heron is Well Positioned to Execute a Blockbuster Launch for HTX-011 Proven track record with hospital launch success Existing robust platform and structure to support launch Significant unmet need and market opportunity Highly focused launch strategy to accelerate sales Unprecedented value proposit
Slide 39: CINV Commercial Products
CINV Commercial Products
Slide 40: CINV Portfolio Continues to Grow With Over $177M Since Inception
CINV Portfolio Continues to Grow With Over $177M Since Inception CINV portfolio net sales by quarter [BAR CHART]
Slide 41: CINVANTI is Both Taking Share From Emend and Growing the NK1 Market
CINVANTI is Both Taking Share From Emend and Growing the NK1 Market NK1 market has grown since introduction of CINVANTI [LINE CHART]
Slide 42: Strategy to Preserve CINVANTI Through Generic Arbitrage
Strategy to Preserve CINVANTI Through Generic Arbitrage Leverage favorable 340B pass through status, ASP+ 6% through 2020 IV push sNDA approved further differentiating CINVANTI from Emend and generics Long-term contracting CINVANTI has become an established brand across both clinics and hospital cap
Slide 43: Branded ALOXI/Palonosetron Arbitrage Lasted Longer Than Projected, Accelerating Sustol ASP Decline
Branded ALOXI/Palonosetron Arbitrage Lasted Much Longer Than Projected, Resulting in an Accelerated Decline in Sustol ASP Even with multiple generics on the market, the price of palonosetron did not drop as quickly as in past arbitrage periods Slow decline in prices resulted in a very long arbitrage
Slide 44: 2019 CINV Franchise Outlook
2019 CINV Franchise Outlook SUSTOL®: To recover from the protracted palonosetron arbitrage, Heron has implemented an innovative strategy to refresh the ASP This will result in greatly reduced sales for approximately 5 quarters, followed by a significant rebound in units and revenue CINVANTI® Cinvant
Slide 45: Financial Summary
Financial Summary Heron expects to end 2019 with more than $190 million in cash, cash equivalents and short-term investments. Summary Statement of Operations and Net Cash Used in Operations (In thousands, except per share data) Three Months Ended June 30, 2019 Six Months Ended June 30, 2019 Net prod
Slide 46: Key Catalysts in Pain Management & CINV Franchises
Key Catalysts in Pain Management & CINV Franchises HTX-011 & HTX-034 for Postoperative Pain CINVANTI ® and SUSTOL® for CINV CRL received 30 April 2019 identified issues relating to CMC and non-clinical No issues related to clinical efficacy or safety were noted NDA resubmitted 26 September 2019 addr