Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (January 2021)
65 slides from Heron Therapeutics's corporate update, Jan 11, 2021
Slide 1: Heron Therapeutics Update
Heron Therapeutics Update January 11, 2021 Exhibit 99.2 1
Slide 2: 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 involve substantial risks a
Slide 3: Corporate Updates
CINV PONV Pain Management Corporate Updates Strong Financial Positioning Preliminary Q4 2020 net product sales for CINV franchise of ~$20.3 Million Preliminary full-year 2020 net product sales for CINV franchise of ~$88.3 Million Versus Guidance of $85 Million Full-year 2021 net product sales guidan
Slide 4: Heron Pipeline
Heron Pipeline Marketing Applications Under Review in the U.S. and Canada, and Approved in EU HTX-011 (bupivacaine/meloxicam) PAIN MANAGEMENT *CINV: Chemotherapy-induced nausea and vomiting. SUSTOL® (granisetron) extended-release injection is indicated in combination with other antiemetics in adults
Slide 5: NDA Resubmitted Based on Guidance at Type A Meeting
Pharmacokinetic data generated for 3 excipients in toxicology animals and patients receiving HTX-011 400 mg in TKA and C-section studies Cmax of excipients at doses administered in reproductive toxicology studies are >50- to >200-fold higher than observed in patients receiving highest dose of HTX-01
Slide 6: DMSO: Animal Pharmacokinetics vs Human Plasma Levels in TKA Study
DMSO: Animal Pharmacokinetics (PK) vs Human Plasma Levels in TKA Study Animal PK NOAEL Dose Level Human PK (HTX-011 400 mg) Note: Mean Plasma Concentration Time Profiles of DMSO in Pregnant Rats and Rabbits (1,000 mg/kg/day DMSO via Oral Administration) and in Humans (HTX-011 400 mg/12 mg via Instal
Slide 7: Maleic Acid: Animal Pharmacokinetics vs Human Plasma Levels in TKA Study
Maleic Acid: Animal Pharmacokinetics vs Human Plasma Levels in TKA Study Note: Mean Plasma Concentration Time Profiles of Maleic Acid in Pregnant (20 mg/kg/day Maleic Acid via Oral Administration) and in Humans (HTX-011 400 mg/12 mg via Installation into the Surgical Site) Maleic Acid Cmax in toxico
Slide 8: Triacetin: Animal Pharmacokinetics vs Human Plasma Levels in TKA Study
Triacetin: Animal Pharmacokinetics vs Human Plasma Levels in TKA Study Note: Mean Plasma Concentration Time Profiles of Triacetin in Rats (1,000 mg/kg Triacetin via Oral Administration) and in Humans (HTX-011 400 mg/12 mg via Installation into the Surgical Site) Rat PK NOAEL Dose Level Human PK (HTX
Slide 9: HTX-011 Commercialization
HTX-011 Commercialization Advancing Pain Management HTX-011 is an investigational new drug and not approved by the FDA
Slide 10: Existing Platform Advantages
Existing Platform Advantages We are prepared for the potential launch of HTX-011. Critical teams are already in place, with extensive experience in successful hospital launches. Established Platform With Experienced Teams in Place Strong KOL relationships Successful hospital and pain management laun
Slide 11: A Proven Track Record of Hospital Launch Success
A Proven Track Record of Hospital Launch Success Achieved >40% Market Share From Entrenched Competitor 40.000 110.000 100.000 60.000 90.000 70.000 80.000 50.000 30.000 20.000 0 10.000 120.000 2019-Q1 2019-Q4 2019-Q2 66,983 2019-Q3 2018-Q2 2018-Q1 2018-Q3 2018-Q4 8,832 119,922 28,178 52,906 88,228 10
Slide 12: HTX-011 Is Well Positioned on Core Drivers
Heron is positioned for a successful launch HTX-011 Is Well Positioned on Core Drivers to Create Fast Access and Uptake High Awareness with key formulary decision makers Outperforms both branded and generic competition on every important core attribute for a LA Reduction in Severe Pain Elimination o
Slide 13: Importance of Core Attributes in Selecting a LA
Importance of Core Attributes in Selecting a LA Top 2 Boxes HTX-011 Is Well Positioned on Core Drivers to Create Fast Access and Uptake Mean Product Rating on Core Attributes 1-5 Scale HTX-011 Exparel Bupivacaine On-Q 3 5 Source: Company-sponsored ATU Study July 2020 – Survey of 386 surgeons, anesth
Slide 14: Published Peer-Reviewed Manuscripts
Published Peer-Reviewed Manuscripts EPOCH 1 (301), Regional Anesthesia & Pain Medicine EPOCH 2 (302), Hernia Hernia Follow-on (215), Surgery EPOC TKA (209), Journal of Arthroplasty Mechanism of Action, Regional Anesthesia & Pain Medicine Truven HEOR (Opioid Naïve Users), Journal of Managed Care & Sp
Slide 15: In 2019 Branded Use Grew to Over $1B
In 2019 Branded Use Grew to Over $1B, however, 2020 has been Impacted by COVID 19 On-Q sales are estimated at ~$150M (down mid-single digits) / Avanos Earnings Call 11/05/19 $63M $143M $403M $472M $1,693M $612M 2019 $ 1 Billion in Branded Drug Utilization +14% On-Q Local Anesthetics Exparel Ofirmev
Slide 16: HTX-011 Competitive Position Across Settings of Care
HTX-011 Competitive Position Across Settings of Care Hospital Inpatient 47% (6.6M procedures) Bundled in DRG 56% (3.7M) of inpatient procedures are done in 340B hospitals Hospital Outpatient 43% (6.0M procedures) 16% (1.0M) have Medicare reimbursement (3-year pass-through) 57% (3.4M) eligible for 34
Slide 17: New CMS OPPS Rules
New CMS OPPS* Rules CMS will eliminate the Inpatient Procedure Only (IPO) list over 3 years starting in CY 2021 In CY 2021 266 musculoskeletal-related procedures will be removed from (IPO) CMS will continue to package non-opioid pain management products in the hospital outpatient setting but product
Slide 18: Impact of Previous CMS Rule Change on TKA
Impact of Previous CMS Rule Change on TKA Outpatient Moved from 4% of TKA Procedures to 46% in Less Than 3 Years 98% 2% 84% 16% 74% 26% January 1, 2018 CMS removes TKA from IPO list 54% 46% Source: LexisNexis Procedure data full year 2017, 2018, 2019, 2020 data January – 12/27/20 2017 2019 2018 2020
Slide 19: Physicians and Pharmacists Believe HTX-011 Will Grow the Local Anesthetics Market
Physicians and Pharmacists Surveyed Believe HTX-011 Will Grow the Local Anesthetics Market Product Z Alone Product Z in Combo Pre-HTX-011 With HTX-011 With the option of using Product Z available, respondents preferred using a local anesthetic 7% more of the time across their procedures Across all 4
Slide 20: Highly Focused Launch Approach: Targeting the Top Specialties
Highly Focused Launch Approach: Targeting the Top 2 Specialties – Orthopedics and General Surgeons Initial Targets Highest-volume procedures in 2 major specialties ~6.0M Orthopedic procedures ~4.5M General surgery procedures ~2.6M OB/GYN procedures ~900K Plastic surgery procedures ~14M Target Proced
Slide 21: General Surgeons: HTX-011 Expected to Take Share
General Surgeons: HTX-011 Expected to Take Share from Other Treatment Options, With the Most Significant Being from Generic LAs Anticipated Local Anesthetic Use - Soft Tissue Procedures Source: Company-sponsored ATU Study July 2020 – Survey of 386 surgeons, anesthesiologists, pharmacists, NP/Pas of
Slide 22: Orthopedic Surgeons: HTX-011 Expected to Take Share
Anticipated Local Anesthetic Use - Orthopedic Procedures Source: Company-sponsored ATU Study July 2020 – Survey of 386 surgeons, anesthesiologists, pharmacists, NP/Pas of potential use of an approved product with the attributes for which we are developing HTX-011 HTX-011 is an investigational new dr
Slide 23: HTX-011 Expected to Take Share from Exparel and Generic LAs
Across All Customers Surveyed, HTX-011 is Expected to Take Share from Both Exparel and Generic LAs HTX-011 Generic LA Exparel On-Q Personal Mix While generic LA usage appears to decline by 40 percentage points, 40% of HTX-011 preference includes use in combination with another local anesthetic – the
Slide 24: Highly Focused Launch Approach: Primary Hospital Targets
Highly Focused Launch Approach: 3 Primary Hospital Targets Using $570M in Branded Pain Drugs Target 1 340B + Branded Target 2 Non-340B + Branded Target 3 Large-Procedure Volume 340B % Target Procedures Branded Utilization Hospitals Hospital Targets ASCs Targets Source: Symphony Drug Market – 2017-20
Slide 25: Profiled and Prioritized Fastest Moving Launch Accounts
Total Hospital & ASC Branded Annual WAC* $875M Targeted Hospital & ASC Branded WAC* $591M $353M Green/Yellow Branded Annual WAC* Profiled and Prioritized Fastest Moving Launch Accounts Source: Symphony Drug Market – 2017-2019 / LexisNexis Procedure Data August 2019 YTD * Excludes ON-Q 340B % Target
Slide 26: HTX-011 Ease of Use and Implementation
Needle-free application Eliminates the need for up to 120 injections (as in total knee arthroplasty)1 and the time needed for aspiration and application Avoids risks of inadvertent venous punctures and eliminates accidental needle sticks with local anesthetics2 No specialized training or certificati
Slide 27: Market Opportunity for Zynrelef in Europe
Market Opportunity for Zynrelef in Europe is ~15.8M Procedures of Which ~80% are Priority Procedures Notes: (1) In-scope procedures are those covered by current SmPC; (2) EU11 markets include Netherlands, Belgium, Luxembourg, Denmark, Sweden, Finland, Norway, Switzerland, Austria, Portugal, Ireland;
Slide 28: Key Value Messages in EU5
Resource Savings and Better Pain Management are Key Value Messages in EU5, as is Opioid Reduction, Particularly in the UK EU5 Potential alleviation of staff and bed constraints is a key value driver for Zynrelef Extended duration is a key strength to ~80% of HCPs and payers across the EU5. Demonstra
Slide 29: Opportunity in Europe to Reduce Hospital Length of Stay
There is an Opportunity in Europe to Demonstrate Significant Reductions in Hospital Length of Stay across Multiple Procedures Example: Hernia Repair (HOPE Data) Notes: 1) Open inguinal hernia repair patients were treated with ZYNRELEF and a scheduled non-opioid oral over-the-counter (OTC) analgesic
Slide 30: HTX-011 Clinical Development
HTX-011 Clinical Development Postoperative Pain
Slide 31: EPOCH (Bunionectomy) and Follow-on Study
EPOCH 1 (Bunionectomy) and Follow-on Study Not actual health care provider.
Slide 32: EPOCH Follow-on: 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 Time (hour) Using Numeric Rating Scale (NRS) with window worst observation carried forward (wWOCF) OTC = Over the counter analgesic regimen of ibuprofen 600 mg q6h alternating 3 hours later with
Slide 33: HTX-011 Reduced Severe Pain and Increased Opioid-Free Patients
HTX-011 Significantly Reduced the Proportion of Patients Experiencing Severe Pain and Increased Proportion of Opioid-Free Patients 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 ibuprofe
Slide 34: EPOCH (Herniorrhaphy) and Follow-on Study
EPOCH 2 (Herniorrhaphy) and Follow-on Study Not actual health care provider.
Slide 35: EPOCH Follow-on: 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 Time (hour) Mean Pain Intensity Score (SE) EPOCH 2: Bupivacaine HCI 75 mg (N=172) EPOCH 2: published online Hernia. doi: 10.1007/s10029-019-02023-6. EPOCH 2-Follow-on: Surgery. doi: 10.1016/j.su
Slide 36: HTX-011 Reduced Severe Pain and Increased Opioid-Free Patients
HTX-011 Significantly Reduced the Proportion of Patients Experiencing Severe Pain and Increased Proportion of Opioid-Free Patients 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 ib
Slide 37: HOPE-1: Real World Evidence of Opioid-Free Recovery
HOPE-1: Real World Evidence of Opioid-Free Recovery Post Inguinal Herniorrhaphy with HTX-011 + OTC Analgesics 37
Slide 38: HOPE-1: Near Total Opioid-Free Recovery
HOPE-1: Near Total Opioid-Free Recovery with HTX-011 + OTC 5% N=93 in initial pilot program Presented at the American Society of Health-System Pharmacists (ASHP) Midyear 2019 Congress, December 8-12, 2019, Las Vegas, NV. 93% HTX-011 is an investigational new drug and not approved by the FDA
Slide 39: Study Total Knee Arthroplasty (TKA)
Study 306 Total Knee Arthroplasty (TKA) Not actual health care provider.
Slide 40: TKA: Pain in the Mild Range With Low Opioid Consumption
Study 306 TKA: HTX-011 + Generic Non-Opioid Analgesics* Kept Pain in the MiId Range Through 72 Hours With Low Opioid Consumption and Up to 26% Opioid-Free HTX-011 is an investigational new drug and not approved by the FDA LOCF for missing pain data Cohort 1 patients received oral acetaminophen 1000
Slide 41: Cross-Study Comparison of 0-24 Hour Results in TKA
Cross-Study Comparison of Day 1 in Study 306 and Exparel PILLAR Study (Dysart 2019) Disclaimer This is a cross-study comparison of Study 306 to the PILLAR Study of Exparel plus bupivacaine; these comparisons do not imply a clinical benefit of HTX-011 over Exparel HTX-011 is an investigational new dr
Slide 42: Cross-Study Comparison of 48 Hour Results in TKA
Cross-Study Comparison of 48 Hour Results From Study 306 and Exparel Pillar Study (Mont 2017) HTX-011 is an investigational new drug and not approved by the FDA Disclaimer This is a cross-study comparison of Study 306 to the PILLAR Study of Exparel plus bupivacaine; these comparisons do not imply a
Slide 43: HTX-011 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 anesthetic systemic t
Slide 44: HTX-034 Development
HTX-034 Development Next Generation Product for Postoperative Pain
Slide 45: Inflammation From Surgery Modifies Pain Pathways
Local tissue damage activates a variety of cells, which release inflammatory mediators1,2 HTX-034, an investigational non-opioid, is a fixed-dose combination, extended-release solution of the local anesthetic bupivacaine, the nonsteroidal anti-inflammatory drug meloxicam and aprepitant, an additiona
Slide 46: Aprepitant Reduces Postoperative Pain Medications
Aprepitant Has Been Shown to Significantly Reduce Postoperative Pain Medications and Lower Pain After Laparoscopic Gynecological Procedures* p<0.05 *Published results from Kakuta N, et al. J Med Invest 58:246-251;2011 (n=64) p>0.05
Slide 47: HTX-034 Eliminates Pain in Pig Postoperative Pain Model
HTX-034 Produces Complete Elimination of Pain Through 7 Days in Pig Postoperative Pain Model HTX-011 & HTX-034 are investigational new drugs and not approved by the FDA Data from multiple animal experiments using a validated postoperative pain model in pigs from Castle et al, 2013 EPJ
Slide 48: HTX-034 21.7 mg Produced Greater Pain Reduction and Lower Opioid Use
These cross-study comparisons confirm that addition of aprepitant in HTX-034 enhanced the activity of bupivacaine in the formulation 45.5% of patients receiving HTX-034 21.7 mg opioid-free through Day 15 without scheduled MMA Phase 2 will begin 1Q2021 HTX-034 21.7 mg Produced Greater Pain Reduction
Slide 49: HTX-034 Phase 1b Safety Summary
HTX-034 was well tolerated with no: Clinically meaningful differences in adverse events Serious adverse events Premature discontinuations due to adverse events Local anesthetic systemic toxicity (LAST) Wound healing related adverse events HTX-034 Phase 1b Safety Summary
Slide 50: HTX-019 for Postoperative Nausea and Vomiting (PONV)
HTX-019 for Postoperative Nausea and Vomiting (PONV) HTX-019 is an investigational new drug for PONV and not approved by the FDA
Slide 51: PONV Is a Large Market
PONV is a large market ~20x the size of CINV HTX-019 has significant potential advantages over oral aprepitant and fosaprepitant IND active, BE to oral aprepitant demonstrated and 505(b)(2) NDA for PONV prevention planned for Q4 2021 Several hundred million dollar a year potential market opportunity
Slide 52: Aprepitant Efficacy Compared to Ondansetron
Aprepitant Efficacy – Large Differential in Vomiting Episodes Compared to Ondansetron* Aprepitant delayed the time to first vomiting episode compared with ondansetron. *Published results from Gan TJ, et al. Ambul Anesth. 2007; 1082-89. Figure 5. Kaplan-Meier curves for the time to first vomiting dur
Slide 53: 2020 Cochrane Meta-Analysis on Aprepitant for PONV
2020 Cochrane Meta-Analysis Concluded That Aprepitant is the Most Effective Drug for PONV* Approximately 100 fewer patients vomiting per 1000 *Weibel S, Rücker G, Eberhart LHJ, Pace NL, Hartl HM, Jordan OL, et al. Cochrane Database of Systematic Reviews. 2020
Slide 54: PONV Market Is >20X the Size of the CINV Market
PONV Market is >20X the size of the CINV Market PONV ~53M Patients vs. ~2.5M CINV Patients Patient Population & Market Size Approximately 65M diagnostic and surgical procedures are at risk of resulting in PONV in the US More than half of these patients are at moderate to high risk of PONV ~5M 2nd Li
Slide 55: Target ~14M Surgical Procedures Where PONV Is High Clinical Concern
Target ~ 14M Surgical Procedures Where PONV is High Clinical Concern Key Surgical Types where Postoperative Emesis could be Clinically Concerning Abdominal (GI and OB) As vomiting directly involves the gastrointestinal tract, emesis can directly injure surgical sites that involve this organ system C
Slide 56: Oral Aprepitant Volume Is Growing Rapidly
Oral Aprepitant volume is growing rapidly at premium price despite no promotion Q2’20 WAC ~ $88/capsule Acquisition cost: $43 - $64 per capsule1 ~ 1,100 current ordering accounts2 Oral Aprepitant is Already Rapidly Growing with No Promotion, Product Limitations and High Acquisition Cost HTX-019 adva
Slide 57: HTX-019 for PONV Is Ideal Strategic Fit for Heron
Large market ~ 14M target surgical procedures with significant unmet need for more convenient formulations of NK-1 class drugs Potential Significant Advantages of HTX-019 30-second IV Push injection with immediate onset of action Aprepitant is the most effective therapeutic agent for emesis 505(b)(2
Slide 58: CINV Commercial Products
CINV Commercial Products HeRow THERAPEUTICS’
Slide 59: 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 and let to reduced sales of CINVA
Slide 60: CINV Franchise Sales Will Return to Growth in 2021
Launch of generic Emend IV in September 2019 resulted in declining CINVANTI sales Clinic-based practices are much faster to take advantage of the arbitrage, but are expected to return to CINVANTI post-arbitrage in early 2021 SUSTOL sales continue to be low due to the Refresh Program and should rebou
Slide 61: CINVANTI Hospital Share/Units
CINVANTI – Hospital Share/Units Were Down in 1Q20 Through 3Q20 Due to the Emend IV Generic Arbitrage, but Began to Rebound in 4Q 60K 110K 40K 120K 50K 0K 70K 10K 20K 30K 80K 90K 130K 100K 2020-Q4 2018-Q1 4% 2019-Q1 2018-Q2 95K 2018-Q3 2018-Q4 2019-Q2 2019-Q3 2019-Q4 2020-Q1 2020-Q3 91K 0K 2020-Q2 9K
Slide 62: CINVANTI Clinic Share/Units
CINVANTI – Clinic Share/Units Declined in 1Q20 Through 3Q20 Due to the Emend IV Generic Arbitrage, but Began to Rebound in 4Q 30K 15K 0K 25K 5K 10K 85K 20K 35K 40K 45K 50K 75K 90K 60K 55K 80K 65K 70K 95K 100K 2019-Q3 2019-Q2 42K Pack Units 22K 2018-Q3 2018-Q1 2018-Q4 2019-Q1 2019-Q4 2020-Q1 71K 2020
Slide 63: The NK1 Market Has Grown 43% Since Launch of CINVANTI
The NK1 Market Has Grown 43% Since the Launch of CINVANTI 0.4M 2017 0.3M 0.0M 0.7M 2019 1.3M 2018 0.9M 0.1M 0.1M 1.8M 1.3M 1.5M 2020 1.9M 0.9M 0.6M 0.1M +43% EMEND CINVANTI AKYNZEO VIAL FOSAPREPITANT Source: IMS DDD Q4’20 though 12.25.20 with final week projected
Slide 64: Financial Summary
Financial Summary Common shares outstanding as of September 30, 2020 totaled 90.9 million. 1 Includes $11.1 million and $34.2 million of non-cash, stock-based compensation expense for the three and nine months ended September 30, 2020, respectively. 2 Based on 90.8 million and 90.7 million weighted-
Slide 65: Key Catalysts in Pain Management & CINV Franchises
Key Catalysts in Pain Management & CINV Franchises HTX-011, HTX-034 and HTX-019 are investigational new drugs and not approved by the FDA HTX-011 & HTX-034 for Postoperative Pain CINVANTI ® and SUSTOL® for CINV HTX-019 for PONV • CRL received 26 June 2020 • NDA resubmitted; PDUFA goal date of 05/12/