Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (January 2016)
47 slides from Heron Therapeutics's corporate update, Jan 11, 2016
Slide 1: Company Update January 11, 2016
Company Update January 11, 2016 Exhibit 99.1
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
Preclinical Phase 1 Phase 2 Phase 3 NDA Approved SUSTOL® HTX-019 SUSTOL LCM HTX-011 Status of Product Portfolio Acute and Delayed Nausea and Vomiting Associated HEC and MEC IV NK1 for CINV Prevention Long-Acting Bupivacaine + Meloxicam for Post-Op Pain BE Study Underway – Developing with 505(b)(2) P
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 chemo
Slide 6: 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 RAs 1st generation 2nd generation 3rd generation Products ondansetron granisetron palonosetron SUSTOL Duration of action Short acting ~ 8 hr half-life Longer acting ~40 hr half-life Long acting PK profile 5-7 days Ind
Slide 7: HTX-019
HTX-019 HTX-019 is a proprietary intravenous (IV) formulation of aprepitant, an NK1 receptor antagonist and is distinguished from EMEND IV®, the only IV NK1 receptor antagonist presently approved in the U.S., in that it does not contain polysorbate 80, which may cause infusion site reactions, hypers
Slide 8: HTX-019 Demonstrated Bioequivalence to Fosaprepitant
HTX-019 Demonstrated Bioequivalence to Fosaprepitant
Slide 9: 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 anaphylaxis
Slide 10: 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 related 20% 52% Moderate AEs 0 6% Hypersensitivity Reactions 0 3% Premature Disco
Slide 11: CINV Franchise Commercial Opportunity
CINV Franchise Commercial Opportunity
Slide 12: The Management of CINV Remains a Significant Clinical Challenge
The Management of CINV Remains a Significant Clinical Challenge Despite treatment with existing 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 Historically, there have b
Slide 13: Large Percentage of Patients Experience Breakthrough CINV
Despite 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 enrolling che
Slide 14: 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 15: 87% of Oncologists Believe New Agents are Needed
87% of Oncologists Believe New Agents are Needed to Address Unmet Needs in CINV Prevention % of respondents CINV agent that effectively prevents both acute and delayed CINV CINV agent that effectively prevents delayed CINV in patients receiving HEC CINV agent with a long-acting formulation CINV agen
Slide 16: SUSTOL Study C2006 and MAGIC Study Results
Because the study was designed to show non-inferiority, P=NS indicates that the endpoint of non-inferiority was reached, and that SUSTOL was as effective as IV palonosetron Raftopoulos H et al. Support Care Cancer. 2014 Epub; Sep 2:1-10; Fig 2; p6 col2, ¶5. Although not statistically significant, th
Slide 17: MAGIC is the First Pivotal HEC Trial with 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 HEC Studies Study Arm Comparator Arm Delayed CR Absolute Difference Relative Difference SUSTOL* (SC)1 3 drug 3 drug 8.0% 14.2% NEPA* (PO)2 3 drug 2 drug 7.4% 10.6% NEPA (PO)2 3 drug 2 drug 10.3% 1
Slide 18: More Than 80% of Oncologists Found MAGIC Clinically Meaningful
More Than 80% of Oncologists Found the MAGIC Trial Design and Results to be Clinically Meaningful Clinically relevant design: The trial’s 3-drug vs. 3-drug design is more clinically relevant than those with a 3-drug vs. 2-drug design Clinically meaningful results: the 8.1% absolute CR difference (P=
Slide 19: SUSTOL 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 4.4 Ability to prevent delayed CINV 4.4 Ability to prevent CINV in HEC 4.3 Safety 4.3 Ability to prevent CINV in MEC 4.3 Efficacy in reducing breakthrough CINV and rescue medication
Slide 20: The Branded 5-HT3 Market Consists of 2.6 Million Units
The Branded 5-HT3 Market (Aloxi) Consists of 2.6 Million Units Aloxi EMEND Source: Symphony Health Solutions data, 2015
Slide 21: Significant Awareness of SUSTOL Exists Among Oncologists
4.0 3.9 3.4 3.0 2.9 % of respondents Mean Score (1-4) Despite No Promotion to Date, Significant Awareness of SUSTOL Exists Among Oncologists Surveyed Awareness of CINV products Source: Instar Market Research, Dec 2015, N=75 oncologists
Slide 22: 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 Providers Establish SUSTOL as preferred agent Differentiated ER technology and broadest clinical data set Robust in-office and peer-to-peer education via multiple chann
Slide 23: U.S. Commercial Organization Has Been Built and is Poised for Launch
U.S. Commercial Organization Has Been Built and is Poised for Launch Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Commercial leadership in place Field leadership established MSL team established Sales and nurse educator teams established Payer account team established FCS Ongoing interactions with key on
Slide 24: SUSTOL Pricing Strategy Will Consider CINV Product Benchmarks
Product WAC AKZYNEO (NEPA) (300-0.5mg capsule) $499.80 EMEND (aprepitant) (TriPack – 1x 120mg and 2x 80mg) $539.60 VARUBI (rolapitant) (2x 90mg tablet) $533.00 ALOXI (palonosetron) (0.25mg/5mL vial) $434.00 EMEND IV (fosaprepitant) (150mg vial) $268.52 ORAL IV Source: BluePrint Market Research, Dec
Slide 25: Post-Operative Pain Program
Post-Operative Pain Program
Slide 26: Biochronomer Bupivacaine Superior to EXPAREL at 24-72 Hours
Biochronomer® Bupivacaine Superior to EXPAREL® at 24-72 Hours Study #1; All studies used the post-operative pain model in pigs from Castle et al, 2013 EPJ Study #2 used the human dose of EXPAREL with 40% smaller incision Pig Post-Operative Pain Model (n=4 pigs)
Slide 27: 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 The acidic environment associated with inflammation shifts the balance further to the left, resulting in far less drug penetrating the nerve membrane and reduced anesthetic effects. With a pKa of 8.1, bupivacaine is v
Slide 28: HTX-011 Significantly Superior to EXPAREL at 24-72 Hours
HTX-011 Significantly Superior to EXPAREL at 24-72 Hours Study #1; All studies used the post-operative pain model in pigs from Castle et al, 2013 EPJ Study #2 compared <½ expected human dose of Biochronomer bupivacaine/meloxicam formulation to the human dose of EXPAREL (40% smaller incision used wit
Slide 29: Phase 2 Study of HTX-011 in Post-Operative Pain After Bunionectomy
A Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study of HTX-011 in the Management of Post-Operative Pain in 64 Patients Undergoing Bunionectomy
Slide 30: Phase 2a Bunionectomy Study Design
Phase 2a Bunionectomy Study Design Placebo - All subjects pooled for endpoint analysis Part A (n=10), Part B (n=10) Part B - HTX-011 400 mg bupivacaine (n=20) Part A - HTX-011 200 mg bupivacaine (n=20) Primary Endpoint SPI 0-24 hrs Secondary Endpoints SPI 0-48 & 24-48 hrs SPI 0-72 & 48-72 hrs SPI 0-
Slide 31: Historical Context: Exparel Pivotal Bunionectomy Study
Historical Context: Exparel Pivotal Bunionectomy Study Source: FDA Clinical Review of NDA 022-496, page 48
Slide 32: Pain Intensity Difference at 200 mg
Pain Intensity Difference at 200 mg *Standard LOCF method used to account for use of rescue medications from Golf et al, Adv Ther, 28(9):776-788, 2011 SPID0-24 -25%, p=0.022
Slide 33: Pain Intensity Difference at 400 mg
Pain Intensity Difference at 400 mg *Standard LOCF method used to account for use of rescue medications from Golf et al, Adv Ther, 28(9):776-788, 2011 SPID0-24 -69%, p<0.0001 SPID0-48 -52%, p<0.0001 SPID0-72 -40%, p=0.0064 SPID24-48 -38%, p=0.0176
Slide 34: Percent of Patients Pain Free, Cross-Study Comparison to Exparel
Historical Context: Percent of Patients Pain Free, Cross-Study Comparison to Exparel Source: Golf et al, Adv Ther, 28(9):776-788, 2011
Slide 35: Mean Time to First Use of Opiate Rescue Medication
Mean Time to First Use of Opiate Rescue Medication Placebo HTX-011 200 mg HTX-011 400 mg 8.2 hours 20.8 hours p=0.15 48.2 hours p<0.0001 Cross-study comparison: Mean time with Exparel was 7.2 hours versus 4.3 hours on placebo Source: Golf et al, Adv Ther, 28(9):776-788, 2011 488% longer time to firs
Slide 36: Percent of Patients Receiving No Opiate Rescue, Cross-Study Comparison to Exparel
Historical Context: Percent of Patients Who Received No Opiate Rescue Medication, Cross-Study Comparison to Exparel Source: Golf et al, Adv Ther, 28(9):776-788, 2011
Slide 37: Pain Intensity Not Adjusted for Opiate Use
Pain Intensity NOT Adjusted for Opiate Use: HTX-011 Significantly Better Than Unlimited Opiates* SPID0-72 p=0.0051 SPID0-48 p=0.0001 SPID0-24 p<0.0001 *Patients were permitted to take 5 mg oxycodone every 2 hours as needed for pain; data not adjusted for opiate use
Slide 38: 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
Slide 39: 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 undergoin
Slide 40: HTX-011b is a Higher Volume Formulation
HTX-011b is a Higher Volume Formulation (Potentially up to 20 ml) Hours Mean Bupivacaine Plasma Concentrations* (ng/mL) *From Phase 1 Study in healthy volunteers
Slide 41: Pain Intensity: HTX-011b vs. HTX-011
Pain Intensity: HTX-011b 200 mg vs. HTX-011 400 mg *Not adjusted for use of rescue medications
Slide 42: HTX-011 Clinical Development Program
HTX-011 Clinical Development Program Study 203 – Abdominoplasty with HTX-011b Study 207 – Pilot bunion with HTX-011b, HTX-002*, bupivacaine solution Study 202 – Hernia Repair 2H15 1H16 2H16 Study 206 – Pilot hernia with HTX-011b, HTX-002* Phase 2/3 with HTX-011b, HTX-002, bupivacaine EoP2 Pilot stud
Slide 43: 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
Slide 44: 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-Acting Local Anesthetic Minimally Acceptable Duration of Efficacy for Long-Acting Local Anesthetic Source: Decision Resources Post-Operative Pain Physician Research Init
Slide 45: Many MDs Expect 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 Percentage of physicians indicating how frequently they expect to use long-acting local anesthetics in the future “Minimizing opioid use by using l
Slide 46: Financial Summary
Financial Summary Summary Statement of Operations (In thousands, except per share data) Nine Months Ended September 30, 2015 Revenue $ – Operating expenses 65,865 Other income (expenses) (484) Net loss $ (66,349) Net loss per share1 $ (2.07) Condensed Balance Sheet Data (In thousands) September 30,
Slide 47: Condensed Balance Sheet Data – December 31, 2015
Condensed Balance Sheet Data – December 31, 2015 Condensed Balance Sheet Data (In thousands, Unaudited) As of December 31, 2015 Cash and cash equivalents $ 131,000 Current cash resources expected to fund operations through 2016, including potential SUSTOL commercial launch