Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Cowen Update (March 2020)
57 slides from Heron Therapeutics's conference presentation, Mar 2, 2020
Slide 1: Heron Therapeutics Cowen Update
Heron Therapeutics Cowen Update March 2, 2020
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: PRECLINICAL CLINICAL NDA APPROVED SUSTOL® (granisetron) US FDA Approved for CINV Prevention* extended-release injection CINV* CINVANTI® (aprepitant) US FDA
Slide 4: FDA Division Has Multiple Outstanding Opioid/Non-Opioid NDAs Pending
FDA Division Has Multiple Outstanding Opioid/Non-Opioid NDAs Pending* Aximris XR (oxycodone hydrochloride) extended-release tablets NDA Resubmission PDUFA - Aug2019; delayed for Jan2020 Advisory Committee; no new PDUFA Posimir (SABER-bupivacaine) NDA Resubmission post-2015 appeal denial - PDUFA: Dec
Slide 5: Clinical Studies in High-Value Procedures Have Demonstrated Better Pain Reduction Than Bupivacaine
Clinical Studies in High-Value Procedures Have Demonstrated Significantly Better Pain Reduction Than Bupivacaine % Local Significantly Annual Volume Anesthetic Reduced Pain (‘000s, US) Procedure Use vs BPV† Total Outpatient ASC Non- Inpatient Medicare Survey Procedures (C-code) (C-Code) Medicare** K
Slide 6: The Commercialization Plan for HTX-011
The Commercialization Plan for HTX-011 Advancing Pain Management 6 HTX-011 is an investigational new drug and not approved by the FDA Confidential
Slide 7: Established Platform With Experienced Teams in Place
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. EXISTING PLATFORM ADVANTAGES Key Account Payer Management Strong KOL relationships Successful hospital a
Slide 8: Heron Successfully Launched a Hospital Product and Achieved >40% Market Share
Heron has Successfully Launched a Hospital Product and Achieved >40% Market Share From Entrenched Competitor 118,767 120,000 CINVANTI Hospital Share/Units 65% 110,000 Hospital Share 60% 103,124 100,000 Hospital Units 55% 90,000 87,803 50% 43% 45% 80,000 39% 66,774 40% 70,000 32% 35% 60,000 51,471 30
Slide 9: CINVANTI Achieved Significant Penetration in 340B and Non-340B Hospital Market
CINVANTI Achieved Significant Penetration in Both the 340B and Non-340B Hospital Market 39% 33% 38% 31% Non-340B 28% 340B 47% 44% 20% 29% 23% 17% 6% 9% 0% 3% 1% 2018-Q1 2018-Q2 2018-Q3 2018-Q4 2019-Q1 2019-Q2 2019-Q3 2019-Q4 SOURCE: 867 1.8.20, IMS DDD 12.27.19 9 9
Slide 10: Hospital Launch Analysis: HTX-011 and CINVANTI Have Very Similar Profiles
Hospital Launch Analysis HTX-011 and CINVANTI Have Very Similar Profiles CINVANTI HTX-011 Market Category NK1 - CINV Local Anesthetics Annual Units 800,000 NK1 units in hospital 14M* Brand Leader EMEND IV EXPAREL - Unit Share 100% 7% 1.0M** units Generics at Launch No YES - Unit Share 0% 93% New P&T
Slide 11: The Market is Large and Waiting for an Effective Non-opioid Solution
The Market is Large and Waiting for an Effective Non-opioid Solution Potential Target Market ~30M Annual U.S. Surgical Procedures Requiring Postoperative Pain Management ~14M Initial Target Procedures ~7M Procedures ~9M Procedures Target Procedures (Initial Targets) Secondary Targets Tertiary Target
Slide 12: Branded Product Utilization Has Grown and is Approaching ~$1B
Branded Product Utilization Has Grown and is Approaching ~$1B Shift Away From Opioids Continues Avg. Cost Product Pack Units % Change WAC % Change per Patient Bupivacaine 20.8M 21% $44M 31% $5-7 Ropivacaine 1.6M 138% $24M 159% $39 Exparel 1.1M 20% $408M 16% $298 Ofirmev 10.8M 8% $422M 14% $86 On-Q*
Slide 13: Potential Market for an Effective 72-Hour Long-Acting Local Anesthetic is Huge
The Potential Market for an Effective Long-Acting Local Anesthetic Working 72-Hours is Huge If Exparel ordering accounts had continued to grow Exparel utilization - Exparel optimal WAC$ potential could have been 93% greater than FY19 A large number of accounts have discontinued use of Exparel over t
Slide 14: Clear Shift from Inpatient to Outpatient and ASC With Pass-Through Opportunity
Clear Shift from Inpatient (no reimbursement) to Outpatient and ASC With Opportunity for Pass-Through HTX-011 has Strategic Advantages Across All Settings of Care Ambulatory surgical centers Hospitals account for 90% (down from account for 9% 91%), with 5% decline in inpatient procedures 13.4 » 14 5
Slide 15: Initial Launch Focus – Fast Moving 340b Hospitals
Initial Launch Focus – Fast Moving 340b Hospitals Currently Using Branded Postop Pain Medication 340B + Branded Postop Pain Medication Use Inpatient Outpatient # Target Branded Pain Branded Pain # of Hospitals Formulary Timing # Procedures Procedures Meds Meds 65 0-3 220K $20M 204K $14M ($34M) 298 4
Slide 16: HTX-011 is Focused on the Largest Market Opportunity – Local Application
HTX-011 is Focused on the Largest Market Opportunity – Local Application Local Anesthetic Route of Delivery Local Anesthetic Volume Share Bupivacaine THE LARGEST 15% OPPORTUNITY Lidocaine All Local, 85% TO DRIVE 4% VALUE AND Exparel CREATE 53% 4% CHANGE NB, 15% Others 14% Ropivacaine NB 10% Bupivaca
Slide 17: HTX-011 Demonstrated Significant Pain Reduction in Nerve Block
HTX-011 Demonstrated Significant Pain Reduction in Nerve Block HTX-011 Instillation has Also Demonstrated Superiority to Bupivacaine NB and Similar Pain Reduction to HTX-011 Nerve Block Study 211: Compared to Placebo, Pain Reduction with HTX-011 Instillation Approximately Triple that of Bupivacaine
Slide 18: HTX-011 Demonstrated Significant Reduction in Opioid Use
HTX-011 Demonstrated Significant Reduction in Opioid Use with both Nerve Block and Instillation Study 211: Compared to Placebo, HTX-011 Instillation has Demonstrated Significantly Greater Opioid Reduction Compared to Bupivacaine NB Study 211: Phase 2b Breast Augmentation 3.2x Greater Mammoplasty Opi
Slide 19: Cross-Study Comparison of TKA Study 306 to Adductor Canal Nerve Block Study
Cross-Study Comparison of TKA Study 306 to Published Adductor Canal Nerve Block Study HTX-011 + MMA Produced Comparable or Better Pain Scores Than Nerve Block HTX-011 + MMA with APAP and Single-Shot Adductor Canal Block (SACB) & Celecoxib in Study 306 Continuous Adductor Canal Block (CACB) with MMA1
Slide 20: Physicians Indicated a Raw Preference Share of 56% for HTX-011
Physicians indicated a raw preference share of 56% for HTX-011 across the covered procedures Preference Share (%, Raw) Overall Wt. Average Preference Share Knee Arthroplasty 67% Hernia Repair - Open 67% Hernia Repair - Laparoscopic 67% Roux-en-Y Gastric Bypass 63% Hysterectomy - Laparoscopic Gastrec
Slide 21: HTX-011 Enjoyed a Physician Preference Share of 44%
HTX-011 Enjoyed a Physician Preference Share of 44% Adjusted Physician Preference Share Distribution • HTX-011 is likely to initially convert share from 14% Exparel, as well as the rest of the local anesthetics 25% -44% Other "caines" (bupivacaine & other “caines”) (e.g. lidocaine, ropivacaine, gene
Slide 22: Pharmacy Directors Surveyed Prefer HTX-011 to Exparel
Pharmacy Directors Surveyed Prefer HTX-011 to Exparel® Impact of HTX-011 Launch on Formulary Status of Exparel Most pharmacy directors indicate Exparel Formulary Status vs. Expected HTX-011 Status HTX-011 would displace Exparel on formulary • Over 50% of pharmacy directors report Exparel status that
Slide 23: High Procedure Volume in Target Markets Provides a Robust ROW Opportunity
High Procedure Volume in Target Markets Provides a Robust ROW Market Opportunity Remaining Secondary, Lower Total Procedures Requiring Volume & Procedures Total Surgical Procedures Initial Target Procedures Postop Pain Management Currently Not Using Local Country Anesthetics Germany 18.6M 6.8M 4.0M
Slide 24: 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 25: HTX-011 Development Program
HTX-011 Development Program Advancing Pain Management 25 HTX-011 is an investigational new drug and not approved by the FDA Confidential
Slide 26: Seven Active-Controlled Studies Showing Better Pain Reduction With HTX-011 Included in NDA
Seven Active-Controlled Studies Showing Significantly Better Pain Reduction With HTX-011 Than Bupivacaine Included in NDA Significant for Significant for Significant Tissue Pain Study Phase Surgical Model Pain Reduction Reduction in Type Reduction vs. vs. PBO Opioid Use BPV 202 2 Herniorrhaphy Soft
Slide 27: EPOCH 1: Bunionectomy Results
EPOCH 1: Bunionectomy Results (Study 301) EPOCH 1 Follow-on: Opioid Elimination Study in Bunionectomy
Slide 28: EPOCH 1 Follow-on: HTX-011 + OTC Kept Pain in the Mild Range Through 72 Hours
EPOCH 1 Follow-on: HTX-011 + OTC Acetaminophen and Ibuprofen Kept Pain in the MiId Range Through 72 Hours 10 9 8 Saline Placebo (N=100) Severe pain ≥ 7 7 6 Bupivacaine HCI 50 mg (N=155) Pain Intensity Score* 5 (Mean ± SE) HTX-011 60 mg (N=157) 4 Mild pain (0-4) 3 2 1 EPOCH 1 Follow-on: HTX-011 ≤ 60
Slide 29: HTX-011 Significantly Reduced Total Opioid Consumption
HTX-011 Significantly Reduced Total Opioid Consumption EPOCH 1 (Bunionectomy) EPOCH 1 Follow-on 50 p < 0.0001 40 p = 0.0022 Opioid 30 30.1 Consumption 25.1 (Mean MME1 ± SE) 20 0-72 Hours 18.8 10 1.6 0 Saline Bupivacaine HCI HTX-011 HTX-011 Placebo 50 mg 60 mg ≤ 60 mg + OTC N=100 N=155 N=157 N=31 1.
Slide 30: HTX-011 Significantly Increased Proportion of Opioid-Free Patients
HTX-011 Significantly Increased Proportion of Opioid-Free Patients EPOCH 1 (Bunionectomy) EPOCH 1 Follow-on 100% 80% 77.4% 100% remained opioid free % through Day 28 60% Opioid-free p < 0.0001 Through 72 Hours 40% p = 0.0001 28.7% 20% 2.0% 11.0% 0% Saline Bupivacaine HTX-011 HTX-011 Placebo HCI 50 m
Slide 31: EPOCH 2: Herniorrhaphy Results
EPOCH 2: Herniorrhaphy Results (Study 302) EPOCH 2 Follow-on: Opioid Elimination Study in Herniorrhaphy
Slide 32: EPOCH 2 Follow-on: HTX-011 + OTC Kept Pain in the Mild Range Through 72 Hours
EPOCH 2 Follow-on: HTX-011 + OTC Acetaminophen and Ibuprofen Kept Pain in the MiId Range Through 72 Hours 10 9 8 Severe pain (≥ 7) 7 Saline Placebo (N=82) Mean 6 Bupivacaine HCI 75 mg (N=172) Pain Intensity 5 Score (SE) 4 HTX-011 300 mg (N=164) 3 2 1 EPOCH 2 Follow-on: HTX-011 300 mg + OTC (N=33) Mi
Slide 33: HTX-011 Significantly Reduced Total Opioid Consumption
HTX-011 Significantly Reduced Total Opioid Consumption EPOCH 2 (Herniorrhaphy) EPOCH 2 Follow-on 50 40 p < 0.0001 30 Opioid p = 0.0240 Consumption 20 (Mean MME1 ± SE) 17.5 0-72 Hours 14.5 10 10.9 0.6 0 Saline Bupivacaine HCI HTX-011 HTX-011 Placebo 75 mg 300 mg 300 mg + OTC N=82 N=172 N=164 N=33 1.
Slide 34: HTX-011 Significantly Increased Proportion of Opioid-Free Patients
HTX-011 Significantly Increased Proportion of Opioid-Free Patients EPOCH 2 (Herniorrhaphy) EPOCH 2 Follow-on 100% 90.9% p < 0.0001 93% remained 80% opioid free p = 0.0486 through Day 28 % 60% Opioid-free 51.2% Through 40% 72 Hours 40.1% 20% 22.0% 0% Saline Bupivacaine HTX-011 HTX-011 Placebo HCI 75
Slide 35: 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 35
Slide 36: HOPE-1: Near Total Opioid-Free Recovery with HTX-011 + OTC
HOPE-1: Near Total Opioid-Free Recovery with HTX-011 + OTC Complete Opioid-Free Recovery 95% Received an Opioid Predischarge 5% Received an Opioid Prescription 9% (10 pills) Took an Opioid Post Discharge 3% (all patients had received predischarge opioid) Call Backs if Discharged Without 0% an Opioid
Slide 37: 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 Potential vsif Estimated Impact Opioid Usage HOPE-1 Extrapolated With~800,000 to t
Slide 38: Phase 2b Total Knee Arthroplasty (Study 209)
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 39: HTX-011 + Generic Analgesics Kept Pain Mild Through 72 Hours With 68% Less Opioid
Study 209 Follow-on: HTX-011 + Generic Analgesics* Kept Pain in the MiId Range Through 72 Hours With 68% Less Opioid Than Bupivacaine 10 Severe Pain 9 NRS Mean Pain Intensity Score 8 7 6 5 4 3 2 1 Mild Pain 0 0 1 4 8 12 24 36 48 60 72 Time Post Study Drug Administration Saline Placebo (N=53) Bupivac
Slide 40: Cross-Study Comparison of Day 1 in Study 306 and Exparel PILLAR Study
Cross-Study Comparison of Day 1 in Study 306 and Exparel PILLAR Study (Dysart 2019) PILLAR Study Cross-Study Comparison of 0 – 24 Hour Results in Study 306 TKA Using Pillar-Based MMA and the Same HTX-011 Analysis1 (N=51) Exparel + Bupivacaine1 Bupivacaine1 (N = 70) (N = 69) AUC0-24 VAS Pain 2 59.5 9
Slide 41: Cross-Study Comparison of 48 Hour Results From Study 306 and Exparel PILLAR
Cross-Study Comparison of 48 Hour Results From Study 306 (Preliminary Results) and Exparel Pillar Study (Mont 2017) PILLAR Study Study 306 Comparison of 48 Hr Results in TKA Using HTX-011 Pillar-Based MMA and the Same Analysis1 Exparel + Bupivacine1 Bupivacaine1 (N=51) (N = 70) (N = 69) Mean AUC12-4
Slide 42: 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
Slide 43: 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 loca
Slide 44: HTX-034 Development
HTX-034 Development Next Generation Product for Postoperative Pain
Slide 45: Inflammation From Surgery Modifies Pain Pathways and Can Produce Hyperalgesia
In Addition to Changes in pH, Inflammation From Surgery Modifies Pain Pathways and Can Produce Hyperalgesia Local tissue damage activates a variety of cells, which release inflammatory mediators1,2 Peripheral mediators of inflammation Macrophage Mast cell Tissue damage Platelets Immune cells Inflamm
Slide 46: HTX-034 Produces Complete Elimination of Pain in Pig Postoperative Pain Model
HTX-034 Produces Complete Elimination of Pain Through 7 Days in Pig Postoperative Pain Model Saline Placebo Liposomal Bupivacaine HTX-011 HTX-034 (Cohort 1) HTX-034 (Cohort 2) 70.0 This validated pig model of 60.0 postoperative pain has been Withdrawal Force (g) 50.0 predictive of clinical 40.0 obse
Slide 47: CINV Commercial Products
CINV Commercial Products
Slide 48: 2020 CINV Franchise Outlook
2020 CINV Franchise Outlook CINVANTI® • Cinvanti continues to have the best overall profile compared to the other available NK1 antagonists and is completely differentiated from generic fosaprepitant with the 2-min IV Push administration • Generic fosaprepitant entered the market in September 2019 a
Slide 49: Since CINVANTI Launch the NK1 Market Has Grown 36%
Prior To CINVANTI Entry NK1 Market Growth Was Flat, Since CINVANTI Launch The Market Has Grown 36% With Opportunity for Further Growth +17% AKYNZEO VIAL 1,787,896 +16% 58,245 CINVANTI 1,522,996 EMEND +1% 389 FOSAPREPITANT 1,292,297 1,310,314 264,247 723,872 1,258,360 879,530 126,249 2016 2017 2018 2
Slide 50: Heron's CINV Portfolio Achieved 2019 Net Sales of $146M
With CINVANTI Leading the Way, Heron’s CINV Portfolio Achieved 2019 Net Sales of $146M, an 88% Increase from 2018 • Launch of generic Emend IV in September resulted in a small decline in CINVANTI sales in 4Q Clinic-based practices are much faster to take advantage of the arbitrage • SUSTOL sales d
Slide 51: CINVANTI Hospital Share/Units Continued to Grow in 4Q2019
CINVANTI – Hospital Share/Units Continued to Grow in 4Q2019 +15% 118,767 120,000 65% 110,000 Hospital Share 60% 103,124 100,000 Hospital Units 55% 90,000 87,803 50% 43% 45% 80,000 39% 66,774 40% 70,000 32% 35% 60,000 51,471 30% 50,000 25% 21% 25% 40,000 20% 28,751 30,000 12% 15% 20,000 7,990 10% 528
Slide 52: CINVANTI Clinic Share/Units Declined in 4Q2019 Due to Emend IV Arbitrage
CINVANTI – Clinic Share/Units Declined in 4Q2019 Due to the Emend IV Arbitrage -19% 100,000 95,456 65% Clinic Share 89,281 60% 90,000 85,371 Clinic Units 55% 80,000 50% 77,334 72,106 53% 52% 50% 70,000 41% 45% 63,283 60,000 46% 40% 35% 50,000 37% 30% 40,000 25% 30,000 20% 21,137 21,882 15% 20,000 16
Slide 53: CINVANTI Maintains Market Leadership After Launch of EMEND IV Generics
CINVANTI Continues to Maintain Market Leadership Two Quarters After the Launch of Multiple EMEND IV Generics AKYNZEO VIAL DRY SD 235-0.25MG CINVANTI VIAL WT SD 130MG/18ML EMEND VIAL DRY SD 150MG FOSAPREPITANT D V DRY SD 150MG 70% 66% 64% 61% 60% 60% 56% 55% 53% 53% 50% 46% 43% 44% 42% 42% 42% 42% 41
Slide 54: Fosaprepitant Pricing Has Declined More Than Twice as Fast as Palonosetron
Fosaprepitant Pricing Has Declined More Than Twice as Fast as Palonosetron Did in First Two Quarters Base Acquisition Cost 1st QTR Post Gx Price 2nd QTR Post Gx Price Class Market Segment Aloxi Palonosetron Low Price High Price Low Price High Price $400 5HT3 Clinic -20% -7% -47% -20% ◄ % Change vs.
Slide 55: Aloxi Arbitrage is Over – SUSTOL Sales Should Rebound After ASP Reset
Aloxi Arbitrage is Over – Once the SUSTOL ASP Resets in 1Q2021 Sales Should Significantly Rebound $250.00 $213.25 $200.00 $161.71 $150.00 $141.00 $133 $120 NET Price (Unit Weighted) $110.61 $104 ALOXI ASP $95 $94 $100.00 $89 $81 $84.23 $76 $74.85 $66 $60 $60 $59 $58 $58.58 $50 $49 $50 $51 $50 $51 $4
Slide 56: Financial Summary
Financial Summary Heron expects that its cash, cash equivalents and short-term investments of $391.0 million at December 31, 2019 will be sufficient to fund its operations into 2022. Summary Statement of Operations and Net Cash Used in Operations Three Months Ended Twelve Months Ended (In thousands,
Slide 57: Key Catalysts in Pain Management & CINV Franchises
Key Catalysts in Pain Management & CINV Franchises CINVANTI ® and SUSTOL® for HTX-011 & HTX-034 for Postoperative Pain CINV Revised NDA submitted 26 Sep 2019 addressing CRL • 2020 net sales guidance for CINV PDUFA date extended to 26 June 2020 franchise: $70M - $80M EU MAA filing by Centralise