Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (August 2017)
35 slides from Heron Therapeutics's corporate update, Aug 9, 2017
Slide 1: Company Update August 2017
Company Update August 2017 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™ (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: Postoperative Pain Program HTX-011
Postoperative Pain Program HTX-011: Proprietary Extended-Release Combination of Bupivacaine + Meloxicam
Slide 5: Market Is Large and Local Anesthetic Use Is Common, but Long-Acting Anesthetics Have Not Fulfilled the Promise
Market Is Large and Local Anesthetic Use Is Common, but Long-Acting Anesthetics Have Not Fulfilled the Promise ~100M surgeries are performed each year in the US with an estimated ~28M (in 2015) required postoperative pain management with non-OTC pain medications 74% Generic local anesthetics 23% No
Slide 6: Surgeons Expect to Use More Long-Acting Local Anesthetics as Better Options Become Available
Surgeons Expect to Use 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 anesthetics (e.g., HT
Slide 7: Reducing Pain at the Source Can Eliminate the Need for Opioids
Reducing Pain at the Source Can Eliminate the Need for Opioids and May Decrease the Development of Chronic Pain Acting on opiate receptors in the brain, opioids can reduce the sensation of pain, but do not block transmission of the pain signals. Occasionally, the affected nerves become hyper-stimula
Slide 8: HTX-011 Designed to Produce Marked Analgesia Through the First 72 Hours After Surgery
HTX-011 Designed to Produce Marked Analgesia Through the First 72 Hours After Surgery Pig Postoperative Pain Model1 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 9: HTX-011 Clinical Experience Shows Potential to Transform Postoperative Pain Control
HTX-011 Clinical Experience Shows It Has the Potential to Transform Postoperative Pain Control Phase 2 data has demonstrated: Statistically significant reductions in both pain and opioid use lasting up to 72 hours after surgery Utility in a broad selection of surgical procedures, including small pro
Slide 10: End-of-Phase 2 Meeting Agreements with FDA
End-of-Phase 2 Meeting Agreements with FDA Two Phase 3 adequate and well-controlled efficacy studies and a Phase 3 safety study of approximately 200 subjects in multiple surgical models are adequate to support an NDA for a broad indication for reduction in postoperative pain for 72 hours Primary and
Slide 11: Phase 3 Program has been initiated
pHase 3 Program has been initiated
Slide 12: 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 13: 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 14: HTX-011 Study 208: Phase 2 Bunionectomy Updated Results
HTX-011 Study 208: Phase 2 Bunionectomy Updated Results With the Phase 3 Dose Analyzed by the FDA Requested Methodology (wWOCF) (5 Clinical Sites Enrolled Subjects)
Slide 15: HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine After Bunionectomy
HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Bunionectomy Increasing Pain
Slide 16: HTX-011 Produces 24-Fold Greater Reduction in Pain Compared to Bupivacaine in Bunionectomy
HTX-011 60 mg Produces 24-Fold Greater Reduction in Pain Compared to Bupivacaine 50 mg Through 72 Hours in Bunionectomy *p-values are from ANOVA using AUC0-72 of Pain Intensity with wWOCF for HTX-011 vs. bupivacaine Greater Pain Reduction vs. Placebo p=0.0020* p=0.0020* p=0.0166*
Slide 17: HTX-011 Greater Pain Reduction Than Extended-Release Bupivacaine or Meloxicam
HTX-011 Has Demonstrated Significantly Greater Pain Reduction Than Extended-Release Versions of Bupivacaine or Meloxicam Using the Same Formulation p=0.0154 vs. HTX-002* p<0.0001 vs. HTX-009* ER Meloxicam Not Different Than Placebo Study 208 *p-value from ANOVA, LSMD of area under the curve for HTX-
Slide 18: HTX-011 Study 202: Phase 2 Hernia Repair Updated Results
HTX-011 Study 202: Phase 2 Hernia Repair Updated Results With the Phase 3 Dose Analyzed by the FDA Requested Methodology (wWOCF) (3 Clinical Sites Enrolled Subjects)
Slide 19: HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine After Herniorrhaphy
HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Herniorrhaphy Increasing Pain
Slide 20: HTX-011 Produces 4-Fold Greater Reduction in Pain Compared to Bupivacaine in Hernia Repair
HTX-011 300 mg Produces 4-Fold Greater Reduction in Pain Compared to Bupivacaine 75 mg Through 72 Hours in Hernia Repair *p-values are from ANOVA using AUC0-72 of Pain Intensity with wWOCF for HTX-011 vs. bupivacaine Greater Pain Reduction vs. Placebo p=0.0052* p=0.0128* p=0.0427*
Slide 21: HTX-011 Study 203: Phase 2 Abdominoplasty Updated Results
HTX-011 Study 203: Phase 2 Abdominoplasty Updated Results Using wWOCF (8 Clinical Sites Enrolled Subjects)
Slide 22: HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine After Abdominoplasty
HTX-011 Reduces Pain Significantly Better Than Placebo or Bupivacaine (Standard-of-Care) After Abdominoplasty Increasing Pain
Slide 23: HTX-011 Produces 5-Fold Greater Reduction in Pain Compared to Bupivacaine in Abdominoplasty
HTX-011 400 mg Produces 5-Fold Greater Reduction in Pain Compared to Bupivacaine 100 mg Through 72 Hours in Abdominoplasty *p-values are from ANOVA using AUC0-72 of Pain Intensity with wWOCF for HTX-011 vs. bupivacaine Greater Pain Reduction vs. Placebo p=0.0985* p=0.0460* p=0.0399*
Slide 24: 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 25: CINV
THERAPEUTICS CINV
Slide 26: CINV Prophylaxis Requires Two Complementary Mechanisms of Action
CINV Prophylaxis Requires Two Complementary Mechanisms of Action CINVANTI™ (HTX-019) (aprepitant for injection) is an investigational proprietary, surfactant-free intravenous formulation of the NK1 receptor antagonist aprepitant EMEND® IV is currently the only intravenous NK1 receptor antagonist on
Slide 27: CINV Franchise Commercial Update
CINV Franchise Commercial Update
Slide 28: SUSTOL Launch Performance Aligns Closely With Market Research Insights
SUSTOL Launch Performance Aligns Closely With “Buying Process” Insights From Market Research Note: In what timeframe do you expect Sustol to become the practice’s branded 5-HT3 of choice? Source: Putnam SUSTOL Tracking Surveys (November 2016) Q4 2016: 56% of MDs said they would evaluate SUSTOL as th
Slide 29: SUSTOL Has Delivered Triple-Digit Unit Growth Quarter-Over-Quarter
Purchasing Accounts by Quarter Since Launch, SUSTOL Has Delivered Triple-Digit Unit Growth Quarter-Over-Quarter 215% unit growth 156% unit growth 74 accounts (167 affiliated sites) 88 accounts (252 affiliated sites) 105 accounts (291 affiliated sites) SUSTOL Units by Quarter 86% (76 of 88) of accoun
Slide 30: Account Growth and Penetration Enabled SUSTOL to Outperform Recent CINV Launches
Account Growth and Penetration Has Enabled SUSTOL to Outperform Recent CINV Launches Branded 5-HT3 Unit Share In Key Accounts (~460K Eligible Annual Units) CINV Launches Since 2008 Source: IMS DDD; Heron actuals (distributor 867 reports) Sources: IMS DDD; Heron actuals (distributor 867 reports); due
Slide 31: Market Insights Suggest SUSTOL May Decline Modestly Through the Arbitrage and Grow Thereafter
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 during arbitrage
Slide 32: CINVANTI Gives Heron a 2-Product CINV Franchise
CINVANTI Gives Heron a 2-Product CINV Franchise With Little Incremental Investment Significant market opportunity Emend ® IV accounts for 80% (~1.2M units) of NK-1 market Potential for significant growth as NK-1s are underutilized particularly in MEC CINVANTI will offer established efficacy without
Slide 33: 2017 CINV Franchise Outlook
2017 CINV Franchise Outlook Building on the strong momentum built by Heron, we expect steady but measured growth in SUSTOL® trial and adoption We are raising our guidance to $25M - $30M in SUSTOL net sales in 2017 CINVANTI™ (HTX-019) program advancing PDUFA date November 12, 2017 Anticipate launch Q
Slide 34: Financial Summary
Financial Summary Cash, cash equivalents and short-term investments of $109.3 million plus accounts receivable of $18.6 million at June 30, 2017, along with collections from SUSTOL sales after June 30, 2017 provides enough funding to complete the HTX-011 pivotal Phase 3 efficacy studies in the first
Slide 35: Key Catalysts in Pain & CINV Franchises
Key Catalysts in Pain & CINV Franchises HTX-011 for Postoperative Pain CINVANTI™ (HTX-019) for CINV SUSTOL® for CINV Top-line results abdominoplasty NDA submission 2017 net sales guidance increased: $25M - $30M Phase 2 program in nerve block initiated NDA PDUFA Date Nov. 12, 2017 TKA study initiated