Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (January 2017)
35 slides from Heron Therapeutics's corporate update, Jan 4, 2017
Slide 1: Company Update January 2017
Company Update JANUARY 2017 Exhibit 99.3
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™ (HTX-019) aprepitant for injection HTX-011 bupivacaine + meloxicam ER Local Administration HTX-011 bupivacaine + meloxicam ER Nerve Block IV NK1 for CINV Prevention Status of Product Portfolio Now Approved b
Slide 4: CINV Programs: SUSTOL, CINVANTI
CINV PROGRAMS: SUSTOL® CINVANTI™ (aprepitant for injection)
Slide 5: SUSTOL Performance Launch Update
SUSTOL® Performance Launch Update Date of first commercial sale: October 11, 2016 Q4 performance: ~3,200 units sold, $495 WAC, ~$1.1M net sales 75 practices have begun trial and evaluation of SUSTOL representing ~20% of the 1.4M targeted Aloxi units Positive payer coverage: all 12 Medicare MACs cove
Slide 6: Percent of MDs Evaluating SUSTOL as Potential Branded Agent of Choice
46 Percent of MDs Evaluating SUSTOL® as Potential Branded Agent of Choice (~6-9 Month Timeline) Efficacy Safety Preparation and administration Payer coverage Impact to practice operations Payer reimbursement rate / time 8% 8% 8% 8% 8% 15% Degree of MD Experience With SUSTOL Practice’s Experience Wit
Slide 7: 2017 CINV Franchise Outlook
2017 CINV Franchise Outlook Heron expects steady but measured growth in SUSTOL® trial and adoption Anticipate $15M - $25M in SUSTOL net sales in 2017 CINVANTI™ (HTX-019) program advancing File NDA in January 2017 Anticipate approval Q4 2017, launch Q1 2018 If approved, Heron would be the first compa
Slide 8: Post-Operative Pain Program HTX-011
Post-Operative Pain Program HTX-011: Proprietary Extended-Release Combination of Bupivacaine + Meloxicam
Slide 9: Market Is Large and Local Anesthetic Use Is Common
Market Is Large and Local Anesthetic Use Is Common, but Long-Acting Anesthetics Have Not Fulfilled the Promise Procedure growth driven by aging population and more active seniors 74% Generic local anesthetics 23% No local anesthetics 3% long-acting anesthetics Local Anesthetic Usage Across Key Surge
Slide 10: HTX-011 Has the Potential to Transform Post-Operative Pain Management
HTX-011 Has the Potential to Transform Post-Operative Pain Management Product Attribute Generic Local Anesthetics Long-Acting Local Anesthetics HTX-011 Extended-release formulation No Yes Yes Synergistic MOA potentiates local anesthetic efficacy by reducing inflammation No No Yes Consistent 72 hour
Slide 11: Biochronomer Bupivacaine Reductions in Pain in Preclinical Models
Biochronomer® Bupivacaine Produced Significant Reductions in Pain in Preclinical Models1 Pig Post-Operative Pain Model Post-operative pain model in pigs from Castle et al, 2013 EPJ Human dose of bupivacaine liposome with 40% smaller incision (n=4 pigs) Higher bar = greater analgesia
Slide 12: Inflammation Plays a Key Role in Pain Management
Inflammation Plays a Key Role in Pain Management (Current local anesthetics do not address this) Inflammation produces an acidic environment Shifts the balance to ionized form, which is unable to penetrate nerve cell membrane 1. Ueno, et al. J of Inflammation Research 1:41-48 2008. 2. Local anesthet
Slide 13: HTX-011 Combination Produced Marked Analgesia Through 72 Hours
HTX-011’s Unique Combination of Bupivacaine & Meloxicam Produced Marked Analgesia Through 72 Hours1 Pig Post-Operative Pain Model Post-operative pain model in pigs from Castle et al, 2013 EPJ Human dose of bupivacaine liposome with 40% smaller incision (n=4 pigs in each arm) Higher bar = Greater ana
Slide 14: 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 *Same dose of meloxicam as in HTX-011 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) Higher bar = Greater ana
Slide 15: HTX-011 Clinical Experience Potential to Transform Post-Operative Pain Control
HTX-011 Clinical Experience Shows It Has the Potential to Transform Post-Operative Pain Control Previously released HTX-011 clinical data has demonstrated: Unprecedented statistically significant reductions in both pain and opioid use lasting up to 96 hours after surgery Utility in both small proced
Slide 16: HTX-011 Study 203: Phase 2 Abdominoplasty
HTX-011 Study 203: Phase 2 Abdominoplasty
Slide 17: Study 203: Abdominoplasty Study Design & Demographics
Study 203: Abdominoplasty Study Design & Demographics HTX-011 200mg Inj Saline Placebo Injection HTX-011 400mg Inj HTX-011 600mg Inj HTX-011 400mg Instillation* Saline Placebo Instillation* HTX-011 400 mg significantly reduced pain (SPI0-24 p=0.012); no additional benefit seen with 600mg Characteris
Slide 18: HTX-011: Instillation Faster, Easier and Potentially Safer
Compared to injection, instillation into the incision site is: Easier to administer and less invasive, avoiding up to 50 or more injections into the skin with large operations Safer, reducing the risk of venous puncture HTX-011: Instillation Faster, Easier and Potentially Safer
Slide 19: Study 203: Mean Pain Intensity Scores
Study 203: Mean Pain Intensity Scores* HTX-011 Is Significantly Better Than Placebo Through 96 Hours After Abdominoplasty Results confirm that HTX-011 can be successfully used in even the largest incisions 53 patients an arm should be sufficient to achieve p<0.05 for SPI0-24 SPI0-24 p=0.086 SPI0-96
Slide 20: Study 203: HTX-011 Significantly Reduces Opioid Use
Study 203: HTX-011 Significantly Reduces Opioid Use Mean Opioid Rescue Over Time Placebo (P) (n=21) HTX-011 400 mg (n=20) 0 – 24 hours 25.9mg 16.1mg p=0.014 0 – 48 hours 40.8mg 27.2mg p=0.021 0 – 72 hours 51.3mg 32.7mg p=0.011 0 – 96 hours 52.9mg 33.2mg p=0.011 HTX-011 produced significant reduction
Slide 21: Study 203: Treatment-Emergent Related Adverse Reactions
Study 203: Treatment-Emergent Related Adverse Reactions for All Cohorts* Preferred Term Saline Placebo (n=84) HTX-011 (n=68) Any Adverse Event 25.0% 25.0% Nausea 7.1% 7.4% Vomiting 1.2% 2.9% Headache 3.6% 7.4% Dizziness 3.6% 0 Hypoesthesia 1.2% 2.9% Wound dehiscence 2.4% 1.5% Pruritus 8.3% 2.9% Hypo
Slide 22: HTX-011 Study 208: Phase 2 Bunionectomy
HTX-011 Study 208: Phase 2 Bunionectomy
Slide 23: Study 208: Bunionectomy Study Design & Demographics
Study 208: Bunionectomy Study Design & Demographics HTX-011 200mg Bupivacaine 50mg Saline Placebo HTX-011 120mg HTX-011 60mg HTX-002 120mg HTX-009 120mg HTX-011 30mg on-going Characteristic Parameter Saline Bupivacaine HTX-011 200mg HTX-011 120mg HTX-011 60mg Age (Years) n 86 15 30 56 35 Mean 49.9 5
Slide 24: Study 208: HTX-011 Significantly Better Than Placebo For All Doses
Study 208: Mean Pain Intensity Scores* HTX-011 Is Significantly Better Than Placebo For All Doses Tested SPI0-24 200mg v P: p<0.0001 120mg v P: p<0.0001 60mg v P: p<0.0001 SPI0-48 200mg v P: p<0.0001 120mg v P: p<0.0001 60mg v P: p=0.0063 SPI0-72 200mg v P: p<0.0001 120mg v P: p=0.0009 60mg v P: p=0
Slide 25: Study 208: HTX-011 Significantly Better Than Bupivacaine For All Doses
Study 208: Mean Pain Intensity Scores* HTX-011 Is Significantly Better Than Bupivacaine For All Doses Tested SPI0-24 200mg v B: p<0.0001 120mg v B: p=0.0002 60mg v B: p=0.0031 SPI0-48 200mg v B: p<0.0001 120mg v B: p=0.0009 60mg v B: p=0.0206 SPI0-72 200mg v B: p=0.0001 120mg v B: p=0.0103 60mg v B:
Slide 26: Study 208: HTX-011 Significantly Reduces Opioid Use
Study 208: HTX-011 Significantly Reduces Opioid Use Mean Opioid Rescue Over Time Placebo (P) (n=86) Bupivacaine Solution (B) (n=15) HTX-011 120 mg (n=56) HTX-011 60 mg (n=35) 0 – 24 hours 16.5mg 16.3mg 8.0mg p<0.0001 v P p=0.0008 v B 8.2mg p<0.0001 v P p=0.002 v B 0 – 48 hours 26.6mg 28.6mg 17.8mg p
Slide 27: Study 208: Treatment-Emergent Related Adverse Reactions
Study 208: Treatment-Emergent Related Adverse Reactions for All Cohorts* Preferred Term Saline Placebo (n=86) Bupivacaine (n=15) HTX-011 (n=121) Any Adverse Event 20.9% 20.0% 27.3% Nausea 9.3% 13.3% 14.0% Vomiting 11.6% 6.7% 3.3% Erythema 1.2% 0 5.0% Headache 1.2% 0 5.8% Swelling 0 0 2.5% *Adverse e
Slide 28: HTX-011 Better Than Individual Components Providing Evidence of Synergy
HTX-011 Is Significantly Better Than Individual Components Providing Evidence of Synergy SPI0-24 120mg v 002: p<0.0001 120mg v 009: p<0.0001 SPI0-48 120mg v 002: p=0.0001 120mg v 009: p=0.0042 SPI0-72 120mg v 002: p=0.0007 120mg v 009: p=0.084 SPI0-96 120mg v 002: p=0.0011 120mg v 009: p=0.238 *LOCF
Slide 29: Confirmation of the Meloxicam Hypothesis
Confirmation of the MeloxicaM hypothesis
Slide 30: No Extended Release Bupivacaine Has Demonstrated a PK-PD Relationship
No Extended Release Bupivacaine Has Demonstrated a PK–PD Relationship EXPAREL® (ER Bupivacaine) No PK-PD Relationship HTX-002 (ER Bupivacaine) No PK-PD Relationship PK – PD data from Exparel® Bunionectomy Study; Golf, et. al.
Slide 31: Bupivacaine & Meloxicam Combination Demonstrates Clear PK-PD Relationship
Unique Combination of Bupivacaine & Meloxicam Demonstrates Clear PK–PD Relationship For the first time an extended release local anesthetic has shown a clinical PK – PD relationship Study 208 Similar PK – PD relationship observed with HTX-011 in Study 202 Hernia Repair
Slide 32: Heron Established Synergy of Bupivacaine & Meloxicam
Heron Established Synergy of Bupivacaine & Meloxicam Statistically significant superiority of HTX-011 directly compared to bupivacaine alone or meloxicam alone in the Biochronomer polymer in Study 208 Statistically significantly superiority of similar doses of HTX-011 versus bupivacaine solution in
Slide 33: Post-Operative Pain Program Summary
Post-Operative Pain Program Summary
Slide 34: Summary: HTX-011 Is Poised to Fulfill the Promise of Long-Acting Local Anesthetics
Summary: HTX-011 Is Poised to Fulfill the Promise of Long-Acting Local Anesthetics in Post-Op Pain 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. gener
Slide 35: Key Catalysts in Pain & CINV Franchises
Key Catalysts in Pain & CINV Franchises HTX-011 for Post-Operative Pain CINVANTI™ (HTX-019) for CINV SUSTOL® for CINV Early Q1 Top-line abdominoplasty data Q1 (Jan.) – NDA submission 2017 net sales guidance: $15M - $25M Early Q1 Phase 2 program in nerve block initiated Q4 – NDA Approval End-of-Phase