Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — JP Morgan Conference January 2018
52 slides from Heron Therapeutics's conference presentation, Jan 8, 2018
Slide 1: Company Update JP Morgan Conference January 2018
Company Update JP Morgan Conference January 2018 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: Status of Product Portfolio
Preclinical Clinical NDA Approved SUSTOL® (granisetron) extended-release injection CINVANTI™ (aprepitant) injectable emulsion HTX-011 bupivacaine + meloxicam ER Local Administration HTX-011 bupivacaine + meloxicam ER Nerve Block Approved by U.S. Food and Drug Administration Status of Product Portfol
Slide 4: CINV Commercial Products
THERAPEUTICS - CINV Commercial Products
Slide 5: The Management of CINV Remains a Significant Clinical Challenge
The Management of CINV Remains a Significant Clinical Challenge Despite treatment with previously available therapies, many patients experience breakthrough CINV particularly in the delayed phase (days 2-5) CINV has a high clinical burden – impacting patients’ QOL and cancer treatment Prior to SUSTO
Slide 6: Large Percentage of Patients Experience Breakthrough CINV
Despite Previously Available Therapies, a Large Percentage of Patients Experience Breakthrough CINV % of MEC/HEC patients with breakthrough CINV despite prophylaxis Community practice observational study Source: Gilmore JW et al. J Oncol. 2014;10:68-74. Data from a prospective observational study en
Slide 7: CINV Has a High Clinical Burden
CINV Has a High Clinical Burden – Impacting Patients’ QOL and Cancer Treatment Sun CC et al. Support Care Cancer. 2005;13:219-227. Van Laar ES et al. Support Care Cancer. 2015;23:151-7 1.00 0.80 0.60 0.40 0.20 0.0 Alopecia Depression Sexual dysfunction Constipation Fatigue Peripheral neuropathy Febr
Slide 8: CINV Prophylaxis Requires Two Complementary Mechanisms of Action
CINV Prophylaxis Typically Requires Two Complimentary Mechanisms of Action NK1 receptor antagonists Substance P is primary driver of delayed CINV, but related to ~15% of acute failures EMEND® IV (fosaprepitant), which has 90% share of the US NK1 market, contains the synthetic surfactant polysorbate
Slide 9: Only Company with Two Single-Agent Products for Acute and Delayed CINV
Cisplatin Cyclophosphamide/carboplatin Acute phase Delayed phase Intensity of Emesis 0 1 2 3 4 5 Days Heron Therapeutics Is the Only Company with Two Single-Agent Products Approved for Prevention of Acute and Delayed CINV NK1 5-HT3
Slide 10: SUSTOL Outperformed All Recent CINV New Brand Launches
SUSTOL® Outperformed ALL Recent CINV New Brand Launches CINV New Brand Launches Since 2008 Sources: IMS DDD; Heron actuals (distributor 867 reports) are for 4Q2016 through 3Q2017; due to data availability, Sancuso data includes actuals for launch months 3-12 and estimates for months 1-2. Administrat
Slide 11: SUSTOL Net Revenue Up 16% to $10 Million in Q4
SUSTOL® Net Revenue Up 16% to $10 Million in Q4 Over 100,000 Units of SUSTOL Sold to Practices in 2017 Full Year 2017 Net Revenue Was Approximately $31M SUSTOL Quarterly Unit Performance (Provider Demand) Source: Heron 867 data Net Sales $1.3M $3.6M $8.5M $8.6M $10M 16%↑
Slide 12: SUSTOL May Decline Modestly Through the Arbitrage and Grow Thereafter
Unit Sales Market Insights Suggest SUSTOL® May Decline Modestly Through the Arbitrage and Grow Thereafter – Consistent with Aloxi® Analogue Recent Market Insights Practices that are converting to SUSTOL are likely to maintain use1 ~67% of current “dabblers” likely to stop or reduce use of SUSTOL dur
Slide 13: Study of Hydration Rates With SUSTOL vs ALOXI
Study Conducted to Evaluate Hydration Rates With SUSTOL® vs ALOXI® Based on Prior Observation of Fewer Unscheduled Visits Due to CINV by HEC Patients Receiving SUSTOL Vacirca, et. Al., ASCO Palliative Care Symposium, San Diego, CA; October 27-28, 2017 Abstract 108. Patients receiving HEC and a 3-dru
Slide 14: HEC Patients on SUSTOL Had Lower Hydration Requirements
HEC Patients Treated With SUSTOL Experienced Significantly Lower Requirements For Hydration Compared to ALOXI HEC: Highly emetogenic chemotherapy; max: Maximum; min: Minimum; SD: Standard deviation. Treatment Number of chemotherapy cycles Hydration rate P-value for difference in hydration vs Aloxi M
Slide 15: CINVANTI Now Launched
CINVANTI™ Now Launched CINVANTI™ is the first and only polysorbate 80-free IV NK1 receptor antagonist approved for the prevention of both acute and delayed CINV CINVANTI™ is indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting
Slide 16: NK1s are Underutilized Despite NCCN Recommendation
Despite an NCCN Category 1 Recommendation, NK1’s are Underutilized Percent of Patients Receiving NK1 Therapy HEC 5-HT3 dexamethasone NK1 olanzapine 5-HT3 dexamethasone NK1 olanzapine MEC NCCN Antiemetic Guidelines IPSOS “US Tandem Oncology Monitor Anti-Emetics Report” is based on chart audit data of
Slide 17: Aprepitant Has Provided Trusted Efficacy for Nearly 15 Years
Aprepitant Has Provided Trusted Efficacy for CINV Prevention for Nearly 15 Years FDA approved 2003 NCCN Category 1 recommendation Yes Phase 3/4 clinical trials* 22 Patients studied in clinical trials* 7100+ ~1.4 million administrations per year*^ ~90% of which is IV fosaprepitant Aprepitant is the o
Slide 18: CINVANTI Is the First and Only Polysorbate 80-Free IV NK1
CINVANTI™ Is the First and Only Polysorbate 80-Free IV NK1 Approved for the Prevention of Both Acute and Delayed CINV CINVANTI™ IV EMEND® IV Varubi® IV aprepitant emulsion fosaprepitant rolapitant Indicated for prevention of both acute and delayed CINV Yes Yes No Can be administered regardless of ch
Slide 19: CINVANTI Was Well Tolerated as Infusion or IV Push
CINVANTI ® Was Well Tolerated Given as an Infusion or as an IV Push CINVANTI Was Well Tolerated When Given by Both 30-minute Infusion and 2-minute IV Push2 CINVANTI Produced Fewer TEAEs Within 30 Minutes of Infusion Than EMEND IV1 1. Data on file. 2. FDA-approved dosing administration included in th
Slide 20: Heron Adds a Second Best-In-Class Therapy in Branded CINV Market
With CINVANTI™, Heron Adds a Second Best-In-Class Therapy to Compete in a Branded CINV Market with ~3.6M Annual Units Source: IMS TTM Q3’17 Leading Branded CINV Products (Annual Units)
Slide 21: 2018 CINV Franchise Outlook
2018 CINV Franchise Outlook SUSTOL®: We continue to expect core SUSTOL business to hold firm and with possibility of modest decline during arbitrage and growth thereafter Even with the potential for generic palonosetron, 4th quarter unit sales grew 22% Approximately $31M in net product sales in 2017
Slide 22: Postoperative Pain Program HTX-011
Postoperative Pain Program HTX-011: Proprietary Extended-Release Combination of Bupivacaine + Meloxicam
Slide 23: Postoperative Opioids: A Doorway to Addiction
Postoperative Opioids: A Doorway to Addiction $ As many as 6.5% of patients that take opioids to manage pain after surgery may become persistent opioid users. That equals about 2.6 MILLION PEOPLE. MORE THAN 50 MILLION surgical procedures happen in the United States. 80% of patients undergoing a surg
Slide 24: Market Is Large but Current Extended Release Anesthetics Have Not Fulfilled the Promise
Market Is Large and Local Anesthetic Use Is Common, but Current Extended Release Anesthetics Have Not Fulfilled the Promise of Long-Acting Pain Relief ~28M surgeries in 2015 required postoperative pain management with non-OTC pain medications and had sufficient pain to warrant an extended-release lo
Slide 25: Surgeons Expect to Use Less Opioids and More Long-Acting Local Anesthetics
Surgeons Expect to Use Less Opioids and More Long-Acting Local Anesthetics as Better Options Become Available Source: DRG Physician Survey (2016) 72% of surgeons expect to use fewer opioids 62% of surgeons expect to use more local anesthetics 73% of surgeons expect to use more long-acting local anes
Slide 26: Large US Market Opportunity
Large US Market Opportunity Theoretical and Target Market Initial Targets Higher volume procedures across 4 major specialties ~6.5M Orthopedic procedures ~4.3M General Surgery procedures ~3.3 M OB/GYN procedures ~1.1M Plastic Surgery procedures Secondary Targets Higher volume procedures in non-core
Slide 27: High Procedure Volume Provides a Robust ROW Market Opportunity
High Procedure Volume in Target Markets Provides a Robust ROW Market Opportunity Country Total Surgical Procedures Total Procedures Requiring Postop Pain Management Initial Target Procedures Remaining Secondary, Lower Volume & Procedures Currently Not Using Local Anesthetics Germany 22,545,000 6,838
Slide 28: Why Extended Release Local Anesthetics Haven't 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) Xaracoll™ (bupivacaine collagen matrix) P
Slide 29: Inflammation Plays a Key Role in Pain Management
Inflammation Plays a Key Role in Pain Management (Current local anesthetics do not address this) Surgical insult produces an immediate drop in pH As inflammatory cytokines are released and inflammation sets in, the acidic environment is maintained for many days The acidic environment shifts the bala
Slide 30: HTX-011 Designed to Produce Analgesia Through 72 Hours After Surgery
HTX-011 Designed to Produce Marked Analgesia Through the First 72 Hours After Surgery1 1 Postoperative pain model in pigs from Castle et al, 2013 EPJ 2 Human dose of liposomal bupivacaine with 40% smaller incision (n=4 pigs in each arm) Increasing Analgesia 2
Slide 31: Activity of HTX-011 Cannot Be Replicated by Systemic Meloxicam
Activity of HTX-011 Cannot Be Replicated By Systemic Administration of Meloxicam Along With ER Bupivacaine *Supratherapeutic dose of meloxicam administered SQ Post-operative pain model in pigs from Castle et al, 2013 EPJ Pig Post-Operative Pain Model (n=4 pigs in each arm) Increasing Analgesia
Slide 32: Unique Mechanism of Action Demonstrated in Pig Post-Op Pain Model
The Unique Mechanism of Action of HTX-011 Has Been Demonstrated in the Pig Post-Op Pain Model The normalization of pH starting at 8 hours with HTX-011 allows almost 10x more bupivacaine (BPV) to enter the nerve to block the pain signal % of un-ionized BPV available to enter nerve 7.94% 0.79%
Slide 33: Unique MOA Produces Greater Pain Reduction Than ER Bupivacaine or Meloxicam
Unique MOA of HTX-011 Produces Significantly Greater Pain Reduction Than ER Versions of Bupivacaine or Meloxicam 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-value from ANOVA, LSMD of area under the curve for H
Slide 34: HTX-011 Shows an Excellent PK-PD Relationship
Unique MOA of HTX-011 Results in an Excellent PK-PD Relationship Not Seen With Other ER Bupivacaine Formulations Source: Data on File, Heron Therapeutics, Inc. *LOCF method used to account for missing data, with wWOCF adjustment for use of rescue medications Mean Pain Intensity vs Time PK-PD Relatio
Slide 35: Exparel Does Not Demonstrate a PK-PD Relationship
Exparel® Does Not Demonstrate a PK-PD Relationship Source: EXPAREL FDA Clinical Pharmacology and Biopharmaceutics Review; Golf, et al. Adv Ther (2011) 28(9):776-788. No PK-PD Relationship Mean Pain Intensity vs Time AUC0-24 hr Exparel vs P: p = 0.0005 AUC0-48 hr Exparel vs P: p = 0.1316 AUC0-72 hr E
Slide 36: HTX-011 Phase Results
HTX-011 Phase 2 Results
Slide 37: Study 202: HTX-011 Reduces Pain After Herniorrhaphy
Study 202: HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Herniorrhaphy Increasing Pain wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing data
Slide 38: Study 208: HTX-011 Reduces Pain After Bunionectomy
Study 208: HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Bunionectomy Increasing Pain wWOCF, windowed-worst observation carried-forward for use of opioid rescue medication and LOCF for missing data
Slide 39: Cross-Study Comparison of Extended-Release Bupivacaine in Bunionectomy Model
In a Cross-Study Comparison of a Standardized Bunionectomy Model Two Forms of Extended-Release Bupivacaine Produced Remarkably Similar Results Sources: Data on File, Heron Therapeutics, Inc., and *Onel E, Daniels S, Golf M, Patou G. A phase 3, randomized, placebo-controlled trial of Exparel ®, an ex
Slide 40: HTX-011 Reduces Total Opioid Use in Phase 2
HTX-011 Reduces Total Opioid Use vs Bupivacaine and Placebo in Phase 2 Source: Data on File, Heron Therapeutics, Inc. Study 208 - Bunionectomy Study Study 202 - Herniorrhaphy Study
Slide 41: HTX-011 Increases Proportion of Opioid-Free Subjects in Phase 2
HTX-011 Increases Proportion of Opioid-Free Subjects vs Bupivacaine and Placebo in Phase 2 Source: Data on File, Heron Therapeutics, Inc. . Study 202 - Herniorrhaphy Study Study 208 - Bunionectomy Study
Slide 42: Enrollment Completed in Both Phase 3 Pivotal Trials
Enrollment completed in Both pHase 3 pivotal trials
Slide 43: Study 301: Phase 3 Bunionectomy Study Design
Study 301: Phase 3 Bunionectomy Study Design Randomization (3:3:2) HTX-011 60 mg Instillation N = 150 Saline Placebo Instillation N = 100 Bupivacaine 50 mg Injection N = 150 Study 301 Endpoints Primary: Pain Intensity AUC0-72 vs. placebo 1st Key Secondary: Pain Intensity AUC0-72 vs. bupivacaine 2nd
Slide 44: Study 302: Phase 3 Herniorrhaphy Study Design
Study 302: Phase 3 Herniorrhaphy Study Design HTX-011 300 mg Instillation N = 160 Saline Placebo Instillation N = 80 Bupivacaine 75 mg Injection N = 160 Randomization (2:2:1) Study 302 Endpoints Primary: Pain Intensity AUC0-72 vs. placebo 1st Key Secondary: Pain Intensity AUC0-72 vs. bupivacaine 2nd
Slide 45: On-Going Phase 2b Studies
THERAPEUTICS On-Going Phase 2b Studies
Slide 46: Phase 2b Study 211: Nerve Block in Breast Augmentation Study Design
HTX-011 60 mg Nerve Block N = 12 Saline Placebo Nerve Block N = 6 Phase 2b Study 211: Nerve Block in Breast Augmentation Study Design Cohort 1 Cohort 2 Interim Review Committee (IRC) Cohort 2 dose decision HTX-011 120 mg Nerve Block N = 24 Saline Placebo Nerve Block N = 12 Bupivacaine 50 mg Nerve Bl
Slide 47: Phase 2b Total Knee Arthroplasty Study Design
Phase 2b Total Knee Arthroplasty Study Design HTX-011 400 mg Instillation N = 50 HTX-011 400 mg Instillation + Ropi Injection N = 50 Saline Placebo Injection N = 50 Bupivacaine 125 mg Injection N = 50 Cohort 1 HTX-011 200 mg Instillation N = 20 HTX-011 200 mg Instillation + Injection N = 20 Saline P
Slide 48: Summary: HTX-011 Is Poised to Fulfill the Promise of a Long-Acting Local Anesthetic
Summary: HTX-011 Is Poised to Fulfill the Promise of a Long-Acting Extended-Release Local Anesthetic Large, growing market opportunity ü Differentiated, synergistic mechanism addresses inflammation – a key inhibitor of both generic and long-acting local anesthetics ü Demonstrated superiority vs. gen
Slide 49: Positive Response by Physicians and Pharmacists to HTX-011 Target Product Profile
Overwhelmingly Positive Response by Physicians and Pharmacists to HTX-011’s Target Product Profile HTX-011 Target Product Profile: Strengths n = 376 total (101 anesthesiologists, 51 general surgeons, 122 orthopedic surgeons, 50 plastic surgeons, 52 pharmacy directors) *Opioid AE’s are assumed to be
Slide 50: Pharmacy Directors Strongly Preferred HTX-011 over Exparel
Pharmacy Directors Strongly Preferred HTX-011 over Exparel® Based on MOA, Reduction in Pain, and Reduction in Opioids n = 52 pharmacy directors n = 324 total (101 anesthesiologists, 51 general surgeons, 122 orthopedic surgeons, 50 plastic surgeons) Mechanism of Action Duration of Analgesia Reduction
Slide 51: Financial Summary
Financial Summary Condensed Balance Sheet Data (In thousands) September 30, 2017 Cash, cash equivalents and short-term investments $ 74,016 Accounts receivable, net $ 28,851 Total assets $ 118,196 Promissory note payable $ 25,000 Total stockholders’ equity $ 40,053 In December 2017, we issued 9.7 mi
Slide 52: Key Catalysts in Pain Management & CINV Franchises
Key Catalysts in Pain Management & CINV Franchises HTX-011 for Postoperative Pain CINVANTI™ and SUSTOL® for CINV Fast Track designation granted 2018 net sales guidance for CINV franchise: $60M - $70M Completed enrollment in Phase 3 pivotal trials Top-line Pivotal Phase 3 results 1H 2018 NDA filing 2
Heron Therapeutics — JP Morgan Conference January 2018 on 6ix