Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Investor Presentation (March 2016)
49 slides from Heron Therapeutics's investor presentation, Mar 7, 2016
Slide 1: Company Update
* TEERRON ~ THERAPEUTICS Developing Best-in-Class Medicine. Improving Lives” Company Update March 7, 2016 THERAPEUTICS
Slide 2: Legal Disclaimer
Legal Disclaimer This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with the development, regulatory approval, manufacture, la
Slide 3: Status of Product Portfolio
Status of Product Portfolio Preclinical Phase 1 Phase 2 Phase 3 NDA Approved SUSTOL® Acute and Delayed Nausea and Vomiting Associated HEC and MEC BE Study completed – Developing with 505(b)(2) Pathway – Phase 2 HTX-019 IV NK1 for CINV Prevention & 3 should not be required; NDA Submission Expected 2H
Slide 4: CINV Franchise
CINV FRANCHISE THERAPEUTICS
Slide 5: SUSTOL
SUSTOL® • SUSTOL® (granisetron) Injection, extended release, is a long-acting, injectable product for the prevention of chemotherapy-induced nausea and vomiting (CINV) – 1,341-patient, randomized, controlled, Phase 3 study demonstrated activity in acute and delayed CINV after moderately emetogenic c
Slide 6: CMS Regulations to Achieve a Unique J-Code
CMS Regulations to Achieve a Unique J-Code Scenario Notification Permanent J-Code FDA approval in Q1 ‘16 Q4 ‘16 January 1, 2017 FDA approval post Q1 Q4 ‘17 January 1, 2018 ‘16 • Activities to address potential impact of miscellaneous j-code: – Appropriate dating through the Specialty Distributors –
Slide 7: Recent Launches of Drugs Reimbursed Using the ASP + 6% System
Recent Launches of Drugs Reimbursed Using the ASP + 6% System 7
Slide 8: Recent Launches of Drugs Reimbursed Using the ASP + 6% System
Recent Launches of Drugs Reimbursed Using the ASP + 6% System 8
Slide 9: SUSTOL Has the Potential to be the Next Generation 5-HT3 Receptor Antagonist
SUSTOL Has the Potential to be the Next Generation 5-HT3 Receptor Antagonist 5-HT3 1st generation 2nd generation 3rd generation RAs ondansetron Products palonosetron SUSTOL granisetron Duration of Short acting Longer acting Long acting action ~ 8 hr half-life ~40 hr half-life PK profile 5-7 days Pre
Slide 10: HTX-019 Potential Tolerability Benefit
HTX-019 Potential Tolerability Benefit • Fosaprepitant is currently the only injectable NK1 RA approved in the U.S. • Fosaprepitant contains polysorbate 80, which may cause: – Hypersensitivity reactions, including flushing, itching or shortness of breath, and has the potential to cause severe anaphy
Slide 11: HTX-019 is Bioequivalent to EMEND IV for Both Aprepitant and Total Aprepitant Equivalents
HTX-019 is Bioequivalent to EMEND IV® for Both Aprepitant and Total Aprepitant Equivalents 11
Slide 12: HTX-019 vs EMEND IV Human BE Study: Clear Safety Advantage
HTX-019 vs EMEND IV Human BE Study: HTX-019 Shows Clear Safety Advantage • 100 subjects received HTX-019 and EMEND IV in standard cross-over design SAFETY HTX-019 EMEND IV All AEs 28% 56% AEs considered at least possibly 20% 52% related Moderate AEs 0 6% Hypersensitivity Reactions 0 3% Premature Dis
Slide 13: CINV Franchise Commercial Opportunity
CINV FRANCHISE COMMERCIAL OPPORTUNITY 13
Slide 14: The Management of CINV Remains a Significant Clinical Challenge
The Management of CINV Remains a Significant Clinical Challenge > In the U.S., over 1 million people receive CINV therapy each year > On average, they each receive 5-6 cycles of CINV therapy Unmet Need 2.4 Despite treatment with existing therapies, many Million patients experience breakthrough CIN
Slide 15: Despite Available Therapies, Many Patients Experience Breakthrough CINV
Despite Available Therapies, a Large Percentage of Patients Experience Breakthrough CINV % of MEC/HEC patients with breakthrough % of MEC/HEC patients with breakthrough CINV despite prophylaxis CINV despite prophylaxis Community practice observational study Physician perception 70% Percent of patien
Slide 16: 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 CINV commonly disrupts patients’ chemotherapy they most wanted to avoid cancer treatment More acceptable Worst 1.00 Constipation Median visual analog scale (VAS) score CINV F
Slide 17: 87% of Oncologists Believe New Agents are Needed to Address Unmet Needs in CINV
87% of Oncologists Believe New Agents are Needed to Address Unmet Needs in CINV Prevention Unmet Needs In Prevention of CINV CINV agent that effectively prevents both acute and delayed CINV 55% CINV agent that effectively prevents delayed CINV in patients receiving HEC 45% CINV agent with a long-act
Slide 18: Across Phase 3 Studies, SUSTOL Was Effective in Preventing Acute and Delayed CINV
Across 2 Phase 3 Studies, SUSTOL Was Effective in Preventing Acute and Delayed CINV in MEC and HEC STUDY C2006 MAGIC STUDY SUSTOL was non-inferior to IV palonosetron in preventing SUSTOL is the first and only acute and delayed CINV in MEC and acute CINV in HEC 5-HT3 to demonstrate superiority vs. an
Slide 19: MAGIC is the First Pivotal HEC Trial to Incorporate a 3-Drug Regimen in Both Arms
MAGIC is the First Pivotal HEC Trial to Incorporate a Guideline-Recommended 3-Drug Regimen in Both Arms • In MAGIC, the efficacy advantage of SUSTOL vs. the standard-of-care 5-HT3 was similar to the benefit shown in recent trials of adding an NK-1 • SUSTOL is the first 5-HT3 to demonstrate superiori
Slide 20: More Than 80% of Oncologists Found the MAGIC Trial Clinically Meaningful
More Than 80% of Oncologists Found the MAGIC Trial Design and Results to be Clinically Meaningful Clinically relevant design: The Mean score trial’s 3-drug vs. 3-drug design is 81% more clinically relevant than those 4.0 with a 3-drug vs. 2-drug design 1 = Strongly disagree 0% 20% 40% 60% 80% 100% 2
Slide 21: SUSTOL was Rated Higher than Aloxi on Most Clinical Attributes
SUSTOL was Rated Higher than Aloxi® on Most Clinical Attributes Including Those That Influence Product Choice the Most SUSTOL vs. Aloxi Product Attribute Ratings Attribute influence on SUSTOL Aloxi product choice Higher 4.4 Ability to prevent delayed CINV 4.4 Ability to prevent CINV in HEC 4.3 Safet
Slide 22: The Branded 5-HT3 Market (Aloxi) Consists of 2.6 Million Units
The Branded 5-HT3 Market (Aloxi) Consists of 2.6 Million Units Injectable Drugs for the Prevention of CINV Number of Package Units Sold by Quarter 800,000 700,000 Aloxi 600,000 500,000 400,000 300,000 EMEND 200,000 100,000 0 Q2'06 Q4'06 Q2'07 Q4'07 Q2'08 Q4'08 Q2'09 Q4'09 Q2'10 Q4'10 Q2'11 Q4'11 Q2'
Slide 23: Significant Awareness of SUSTOL Exists Among Oncologists Surveyed
Despite No Promotion to Date, Significant Awareness of SUSTOL Exists Among Oncologists Surveyed Awareness of CINV products (4) Very familiar with product (3) Know some basic product information (2) Know little more than the product name (1) I am not aware of this product Mean Score (1-4) EMEND (apre
Slide 24: Heron's Commercial Plans will Address Traditional Launch Barriers
Heron’s Commercial Plans will Address Traditional Launch Barriers for Providers, Patients, and Payers Objectives The Heron Approach • Differentiated ER technology and broadest clinical data set Establish SUSTOL • Robust in-office and peer-to-peer education via multiple channels as preferred agent •
Slide 25: SUSTOL Pricing Strategy Will Consider CINV Product Benchmarks
SUSTOL Pricing Strategy Will Consider CINV Product Benchmarks Product WAC AKZYNEO (NEPA) $499.80 (300-0.5mg capsule) ORAL EMEND (aprepitant) $539.60 (TriPack – 1x 120mg and 2x 80mg) VARUBI (rolapitant) $533.00 (2x 90mg tablet) ALOXI (palonosetron) $434.00 IV (0.25mg/5mL vial) EMEND IV (fosaprepitant
Slide 26: Post-Operative Pain Program
POST-OPERATIVE PAIN PROGRAM 26
Slide 27: Biochronomer Bupivacaine Superior to EXPAREL at 24-72 Hours
Biochronomer® Bupivacaine Superior to EXPAREL® at 24-72 Hours Pig Post-Operative Pain Model Saline Control (1) Biochronomer Bupivacaine (1) Exparel (2) 100.0 Percentage of Maximal Force (60 gm) Tolerated by 90.0 80.0 70.0 60.0 Animal 50.0 40.0 30.0 20.0 10.0 0.0 0 1 3 5 24 48 72 96 120 HOURS 1. Stud
Slide 28: Local Anesthetics Exist in a Balance Between Water-Soluble and Lipid-Soluble Forms
Local Anesthetics Exist in a Balance Between Water-Soluble and Lipid-Soluble Forms Acidic Environment Shifts the Balance to Ionized Form Unable to Penetrate Nerve Cell Membrane BUPH+ BUPN + H+ Nerve Cell Membrane BUPH+ BUPN + H+ • The acidic environment associated with inflammation shifts the balanc
Slide 29: HTX-011 Significantly Superior to EXPAREL at 24-72 Hours
HTX-011 Significantly Superior to EXPAREL at 24-72 Hours Pig Post-Operative Pain Model Saline Control (1) Biochronomer Bupivacaine (1) HTX-011 (2) Exparel (2) 100.0 Percentage of Maximal Force (60 gm) Tolerated by 90.0 80.0 70.0 60.0 Animal 50.0 40.0 30.0 20.0 10.0 0.0 0 1 3 5 24 48 72 96 120 HOURS
Slide 30: Phase 2 Study of HTX-011 in 64 Bunionectomy Patients
A Randomized, Placebo- Controlled, Double-Blind, Phase 2 Study of HTX-011 in the Management of Post-Operative Pain in 64 Patients Undergoing Bunionectomy 30
Slide 31: Phase 2a Bunionectomy Study Design
Phase 2a Bunionectomy Study Design Screening Treatment (96-hour evaluation) Primary Endpoint Part A - HTX-011 • SPI 0-24 hrs 200 mg bupivacaine (n=20) Secondary Endpoints • SPI 0-48 & 24-48 hrs Placebo - All subjects pooled • SPI 0-72 & 48-72 hrs Subjects for endpoint analysis • SPI 0-96 & 72-96 hrs
Slide 32: Historical Context: Exparel Pivotal Bunionectomy Study
Historical Context: Exparel Pivotal Bunionectomy Study Source: FDA Clinical Review of NDA 022-496, page 48 32
Slide 33: Pain Intensity Difference at 200 mg
Pain Intensity Difference at 200 mg 7.00 HTX-011 200 mg 6.00 Placebo Mean Pain Intensity Score* 5.00 4.00 3.00 2.00 SPID0-24 -25%, p=0.022 1.00 0.00 0 10 20 30 40 50 60 70 Hours *Standard LOCF method used to account for use of rescue medications from Golf et al, Adv 33 Ther, 28(9):776-788, 2011
Slide 34: Pain Intensity Difference at 400 mg
Pain Intensity Difference at 400 mg 7.00 SPID24-48 HTX-011 400 mg 6.00 -38%, p=0.0176 Placebo Mean Pain Intensity Score* 5.00 4.00 3.00 2.00 1.00 SPID0-24 SPID0-48 SPID0-72 -69%, p<0.0001 -52%, p<0.0001 -40%, p=0.0064 0.00 0 10 20 30 Hours 40 50 60 70 *Standard LOCF method used to account for use of
Slide 35: Historical Context: Percent of Patients Pain Free, Cross-Study Comparison to Exparel
Historical Context: Percent of Patients Pain Free, Cross-Study Comparison to Exparel 100 Percent of Patients Pain Free (PI ≤ 1) 90 HTX-011 400 mg 80 Placebo 70 60 50 40 30 20 10 0 0 12 24 36 48 60 72 Hours Source: Golf et al, Adv Ther, 28(9):776-788, 2011 35
Slide 36: Mean Time to First Use of Opiate Rescue Medication
Mean Time to First Use of Opiate Rescue Medication • 488% longer time to first use of rescue medications with 400 mg dose compared to placebo HTX-011 HTX-011 Placebo 200 mg 400 mg 20.8 hours 48.2 hours 8.2 hours p=0.15 p<0.0001 Cross-study comparison: Mean time with Exparel was 7.2 hours versus 4.3
Slide 37: Percent of Patients Who Received No Opiate Rescue Medication
Historical Context: Percent of Patients Who Received No Opiate Rescue Medication, Cross-Study Comparison to Exparel 100 HTX-011 400 mg Percent of Patients Who Received No 90 80 Placebo Opiate Rescue Medication 70 60 50 40 30 20 10 0 0 12 24 36 48 60 72 Hours Source: Golf et al, Adv Ther, 28(9):776-7
Slide 38: Pain Intensity NOT Adjusted for Opiate Use
Pain Intensity NOT Adjusted for Opiate Use: HTX-011 Significantly Better Than Unlimited Opiates* 7 HTX-011 400 mg 6 Placebo Mean Pain Intensity Scores 5 4 3 2 1 SPID0-24 SPID0-48 SPID0-72 0 p<0.0001 p=0.0001 p=0.0051 0 10 20 30 Hours 40 50 60 70 *Patients were permitted to take 5 mg oxycodone every
Slide 39: Preliminary Safety
Preliminary Safety • HTX-011 was generally well tolerated • The most common adverse events were: headache, nausea, vomiting, constipation, erythema, cellulitis, dizziness, and hypoxia, none of which were considered drug-related 39
Slide 40: HTX-011b: Second Formulation with Distinct Properties
HTX-011b: Second Formulation with Distinct Properties • HTX-011b is our second formulation with greater volume (potentially up to 20 ml) • Phase 1 study in healthy volunteers showed: – Therapeutic drug levels achieved faster – Higher drug levels achieved • First cohort of Phase 2 study in 5 patients
Slide 41: HTX-011b is a Higher Volume Formulation
HTX-011b is a Higher Volume Formulation (Potentially up to 20 ml) 600 Mean Bupivacaine Plasma Concentrations* HTX-011 200 mg 500 HTX-011 400 mg HTX-011b 200 mg 400 (ng/mL) 300 200 100 0 0 20 40 60 80 100 120 140 160 Hours *From Phase 1 Study in healthy volunteers 41
Slide 42: Pain Intensity: HTX-011b 200 mg vs. HTX-011 400 mg
Pain Intensity: HTX-011b 200 mg vs. HTX-011 400 mg 7 HTX-011b 200 mg (n=5) 6 Mean Pain Intensity Scores* HTX-011 400 mg (n=22) 5 4 3 2 1 0 0 12 24 36 48 60 72 Hours *Not adjusted for use of rescue medications 42
Slide 43: HTX-011 Phase 2 Hernia Repair Study – Expanded Target Enrollment
HTX-011 Phase 2 Hernia Repair Study – Expanded Target Enrollment Screening Treatment (96 hour evaluation) Primary Endpoint A) 200 mg of HTX-011-19 by injection into the SPI 0-24 hrs surgical wound (n=15 subjects) B) 400 mg of HTX-011-19 by injection into the Secondary Endpoints surgical wound (n=1
Slide 44: Design of Phase 2 Study of HTX-011b in Abdominoplasty
Design of Phase 2 Study (Study 203) of HTX-011b in Abdominoplasty Screening Treatment (96 hour evaluation) Primary Endpoint SPI 0-24 hrs Part A (n=45) 1) 200 mg of HTX-011b (n=10 subjects) Secondary Endpoints SPI 0-48 & 24-48 hrs 2) 400 mg of HTX-011b (n=10 subjects) SPI 0-72 & 48-72 hrs Subje
Slide 45: HTX-011 Clinical Development Program
HTX-011 Clinical Development Program 2H15 1H16 2H16 Study 202 – Hernia Repair After initial study, add HTX-011b and HTX-002* Study 203 – Abdominoplasty with HTX- 011b Study 207 – Pilot bunion with HTX-011b, HTX-002*, bupivacaine solution Pilot studies are designed to confirm our sample size projecti
Slide 46: Long-Acting Injectable Products Contain Many Times the Single Dose
Long-Acting Injectable Products Contain Many Times the Single Dose: HTX-011 is at the Low End of the Range Maximum Maximum Maximum LAI Dose vs. Short-Acting Approved Long-Acting Injectable Approved LAI Maximum Short-Acting Injectable Drug Indication Daily Dose (LAI) Drug Dose Daily Dose Ratio Sandos
Slide 47: Duration of Action Seen as Ideal by Physicians
> 72 hour Duration of Action Seen as “Ideal” by Physicians, With 48 hours Minimally Acceptable Ideal Duration of Efficacy for Long- Minimally Acceptable Duration of Acting Local Anesthetic Efficacy for Long-Acting Local Anesthetic >5 days 2% 5 days 4% ≤ 24 hours 72 hours 4 days 11% 12% 9% ≤ 24 48 ho
Slide 48: Many MDs Expect the Use of Long-Acting Local Anesthetics to Increase
Across Procedures, Many MDs Expect the Use of Long-Acting Local Anesthetics to Increase Use of Long-Acting Local Anesthetics in the Future, by Procedure Arthroplasty knee (inpatient) 3% 49% 48% Hernia (inpatient) 7% 47% 46% Hip replacement, total and partial 3% 49% 48% Hernia (outpatient) 5% 41% 54%
Slide 49: Financial Summary
Financial Summary Summary Statement of Operations Year Ended (In thousands, except per share data) December 31, 2015 Revenue $ – Operating expenses 96,925 Other income (expenses) (666) Net loss $ (97,591) Net loss per share1 $ (2.95) Condensed Balance Sheet Data December 31, 2015 (In thousands) Cash
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