Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (May 2015)
52 slides from Heron Therapeutics's corporate update, May 13, 2015
Slide 1: Company Update May 2015
Company Update May 2015 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 Development Programs
Intravenous NK 1 for CINV CINV: Acute- and Delayed-Onset after MEC, and Acute-Onset after HEC CINV: Delayed-Onset after HEC Bupivacaine + meloxicam for post-operative pain Status of Development Programs Preclinical Phase 1 Phase 2 Phase 3 NDA SUSTOL (APF530) SUSTOL (APF530) HTX-019 HTX-011 Will be e
Slide 4: ries
¥ ries THERAPEUTICS.
Slide 5: CINV Highlights
CINV Highlights • 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-onset CINV after moderate
Slide 6: 5-Day Profile: APF530 Pharmacokinetics
5-Day Profile: APF530 Pharmacokinetics Granisetron is released rapidly following injection of APF530 and continues to be released for 5-days, providing long-acting coverage for CINV *Data from patent application 20120258164 for transdermal granisetron Time after Dosing (h) All subjects (n= 18) mean
Slide 7: SUSTOL Pivotal Phase 3 Study
SUSTOL Pivotal Phase 3 Study Overview • Randomized, controlled, multi-center study • 1,341 patients in primary efficacy population • Two doses of APF530 (5 mg and 10 mg granisetron) compared to the approved dose of Aloxi ® (results from 10 mg dose group presented) • Patients stratified by type of ch
Slide 8: Primary Efficacy Results: Complete Response (MEC)
Primary Efficacy Results: Complete Response Patients Receiving Moderately Emetogenic Chemotherapy - + Acute Delayed APF530 10mg Acute Delayed Difference in Complete Response APF530-Aloxi (97.5% CI) -15 -10 -5
Slide 9: Primary Efficacy Results: Complete Response (HEC)
Primary Efficacy Results: Complete Response Patients Receiving Highly Emetogenic Chemotherapy Difference in Complete Response APF530-Aloxi (98.33% CI) -15 -10 -5 Acute Delayed APF530 10mg Acute Delayed - +
Slide 10: Safety Summary
APF530 10 mg 1 Aloxi 0.25 mg N % N % Safety Summary • Safety results with the 5 mg dose of APF530 studied in separate arm of the phase 3 study are not included • >90% of injection site reactions were reported as mild; one patient discontinued due to injection site reaction Cycle 1 Safety Results Dru
Slide 11: FDA-Requested ASCO Reanalysis Improves Difference in HEC Patients
FDA- Requested ASCO Reanalysis Improves Difference Between SUSTOL and Aloxi in HEC Patients Protocol Specified HEC Population ASCO 2011 Guideline HEC Population Acute Delayed Acute Delayed
Slide 12: CR Rates by Treatment and Chemotherapeutic Regimen
CR Rates by Treatment Chemotherapeutic Regimen APF530 10 mg Aloxi 0.25 mg Moderately Emetogenic Acute Cyclophosphamide/Doxorubicin 70.7% 65.7% All other regimens 84.4% 85.0% Delayed Cyclophosphamide/Doxorubicin 47.4% 46.3% All other regimens 72.9% 70.0% Highly Emetogenic Acute Cisplatin regimens 81.
Slide 13: Response Rates With Chemotherapy Classified as HEC
Response Rates With Chemotherapy Classified as HEC by Both Hesketh and 2011 ASCO* *Cisplatin, carmustine, dacarbazine, dactinomycin, mechlorethamine, streptozotocin SUSTOL reflects 9-11% greater response rate in the most emetogenic chemotherapy
Slide 14: Delayed-HEC Indication Would Provide Clear Differentiation
HEC A Delayed-HEC Indication Would Provide Clear Differentiation in an Important Segment of the CINV Market IntrinsiQ data from July 2012 – June 2013 HEC regimens account for ~20% (500K) of palonosetron administrations This is the same segment of the CINV market where NK receptor antagonists are ext
Slide 15: Phase 3 MAGIC Study
> 900 patients received HEC* randomized 1:1 APF530 500 mg SC d 1 + fosaprepitant 150 mg IV d 1 + DEX + placebo IV d 1 Phase 3 “MAGIC” Study Ondansetron 0.15 mg/kg IV (up to 16 mg IV) d 1 + fosaprepitant 150 mg IV d 1 + DEX + placebo SC d1 Cycle 1 1. All subjects will receive dexamethasone 12 mg IV o
Slide 16: New SUSTOL Study Strategically Designed
67% 65% 45% 75% New SUSTOL Study Strategically Designed Based on Previous Results ^^Average Complete Response rate improvement adding NK-1 RA to 5-HT RA and Dexamethasone is ~15 - 20% in the delayed HEC *Poll-Bigelli; Cancer, 97:12, 3090, 2003 **Projection of what would happen with a 20% increased r
Slide 17: HEC Study Update
HEC Study Update • Enrollment closed end of March 2015, with over 900 patients enrolled • NDA resubmission at mid-year 2015 • FDA has previously indicated that a positive outcome from this study would be sufficient to obtain “delayed-HEC” indication
Slide 18: SUSTOL Potential to be Next Generation 5-HT3 Receptor Antagonist
5-HT 3 RAs 1 st generation 2 nd generation 3 rd generation Products Duration of action Indications SUSTOL Has the Potential to be the Next Generation 5-HT Receptor Antagonist ondansetron granisetron palonosetron SUSTOL Short acting ~ 8 hr half-life Longer acting ~40 hr half-life Long acting PK profi
Slide 19: SUSTOL Regulatory Status
SUSTOL REGULATORY STATUS
Slide 20: SUSTOL NDA Status
SUSTOL NDA Status NDA resubmitted in September 2012 • CMC: correction of PAI issues and revision of one in-vitro release method • Requirement for Human Factors Validation Study with commercial product • Re-analysis of the existing Phase 3 study using the ASCO 2011 guidelines for categorization of ME
Slide 21: How We Are Addressing the CRL
How We Are Addressing the CRL • Chemistry, Manufacturing, and Controls – Sites with PAI issues have been eliminated from the supply chain, with work transferred to a well-established site with no PAI issues • Transition is complete, with secondary benefit of improvement in the COGS – New in-vitro re
Slide 22: HTX-019: Aprepitant IV
HTX-019: Aprepitant IV • HTX-019 is a proprietary IV formulation of aprepitant, an NK receptor antagonist. NK receptor antagonists are recommended to be used in combination with 5-HT receptor antagonists for prevention of CINV • Primary Composition of Matter patent protection of aprepitant expired A
Slide 23: CINV Franchise Commercial Opportunity
CINV FRANCHISE COMMERCIAL OPPORTUNITY
Slide 24: Commercial Opportunity Summary
Market Competitive Landscape Go-To-Market Strategies Commercial Opportunity Summary • Heron has the opportunity to establish a long-term, dominant position in a CINV market targeting 3.6M units of IV 5-HT and NK annually • The NK market grew 10% YOY in with significant opportunity for increased pene
Slide 25: Opportunity in a CINV Market with Over 3.6M Penetrable Units
Heron has the opportunity to establish a long-term, dominant position in a CINV market that has over 3.6M penetrable units Q2'13 Q4'13 Injectable Drugs for the Prevention of CINV Number of Package Units Sold by Quarter ALOXI ANZEMET KYTRIL KYTRIL Generic (GRANISETRON) ZOFRAN ZOFRAN Generic (ONDANSET
Slide 26: New Branded Injectable Agents Positioned as Leaders Lose Patents
Candidate Class Indication Sponsor Possible Launch AKYNZEO ® Generic palonosetron Rolapitant Generic fosaprepitant 2014 2015 2016 2017 2018 2019 New branded, injectable agents will be well- positioned to gain significant share as current market leaders (Aloxi, EMEND) lose patent protection Oral FDC
Slide 27: Physician Preference for SUSTOL vs IV Aloxi
Favor IV Aloxi (1-2) No Preference (3) Favor SUSTOL (4-5) SUSTOL would be the first and only injectable 5-HT indicated for acute and delayed CINV in both MEC and HEC favored by more than 50% of oncologists Attribute Avg. (N=66) Effective for prevention of delayed CINV in assoc. with HEC 3.65 Is long
Slide 28: HEC Regimens Represent a Significant Market Opportunity
317,915 188,988 497,256 HEC Regimens Represent a Significant Market Opportunity for SUSTOL and HTX-019 Source: IntrinsiQ data from July – June HEC Regimens Account For ~20% (500K) of Palonosetron Administrations Of All HEC Administrations, ~20% Are Given Without Concomitant IV 5-HT – Inconsistent Wi
Slide 29: Post-Operative Pain Program
POST-OPERATIVE PAIN PROGRAM
Slide 30: Heron Post-Operative Pain Program
Heron Post-Operative Pain Program Target Product Profile for Best-in-Class Product: An injectable pain therapeutic that utilizes proprietary Biochronomer ® polymer-based drug delivery platform technology Designed to deliver both bupivacaine (anesthetic) and meloxicam (anti-inflammatory) evenly over
Slide 31: HTX-011 Significantly Superior to EXPAREL at 24-72 Hours
HTX-011 Significantly Superior to EXPAREL at 24-72 Hours 1. Study #1; All studies used the post-operative pain model in pigs from Castle et al, 2013 EPJ Pig Post-Operative Pain Model (n=4 pigs, except at 120 hrs for Study #2: preliminary results from 2 animals) 2. Study #2 compared <½ expected human
Slide 32: HTX-011 Shows Durable Response in Sciatic Nerve Block Model in Pigs
HTX-011 Shows Durable Response in Sciatic Nerve Block Model in Pigs
Slide 33: Local Anesthetics Exist in a Balance Between Water- and Lipid-Soluble Forms
Local Anesthetics Exist in a Balance Between Water-Soluble and Lipid-Soluble Forms • Local anesthetics have pKa values > 7.4, so at normal physiologic pH of 7.4, the majority of molecules exist as the water-soluble quaternary salt not able to penetrate nerve cell membrane Water-Soluble Ionized Form
Slide 34: Local Anesthetics Exist in a Balance Between Water- 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
Slide 35: HTX-011 Phase 1 Single-Ascending-Dose Study
HTX-011 Phase 1 Single-Ascending-Dose Study Cohort 1 100 mg HTX-011 (5 active:1 placebo) Min 7-day Observation Safety PK evaluation Min 7-day Observation Safety PK evaluation Randomized, Single-Blind, Placebo-Controlled 3 Single Rising Dose Cohorts 144 hr pharmacokinetic & pharmacodynamic assessment
Slide 36: Plasma Concentrations of Bupivacaine Observed with HTX-011
Plasma Concentrations of Bupivacaine Observed with HTX-011 Hours HTX - 011 100 mg HTX - 011 200 mg HTX-011 400 mg
Slide 37: HTX-011 Provides Longer Duration of Bupivacaine Release
HTX-011 Provides Longer Duration of Bupivacaine Release without a Large Initial Peak * Exparel data extracted from FDA Clin Pharm review
Slide 38: Mechanical Detection Threshold Using von Frey Fibers
Mechanical Detection Threshold Using von Frey Fibers *Combined placebo data from all cohorts
Slide 39: Pharmacodynamic Effects of HTX-011 Correlate with Pharmacokinetic Profile
*Combined placebo data from all cohorts Pharmacodynamic Effects of HTX-011 Correlate with Pharmacokinetic Profile
Slide 40: Safety
Safety • No serious adverse events or premature discontinuations • No clinically relevant ECG changes • No clinically relevant laboratory changes • Only adverse events considered possibly related to drug were associated with the subcutaneous administration of the product: mild redness and bruising a
Slide 41: Summary
Summary • Initial Phase 1 experience validates target product profile for HTX-011 • Desired pharmacokinetic profile for both bupivacaine and meloxicam achieved • Strong pharmacodynamic activity that correlated with pharmacokinetic profile observed – Rapid on-set of action without a large, potentiall
Slide 42: Next Steps for Post-Operative Pain Program
Next Steps for Post-Operative Pain Program • SAD evaluation to complete in 1Q15 • Quickly initiate Phase 2 studies 2Q15 – Bunionectomy study scheduled to start late 2Q • Completing toxicology for nerve-block and orthopedic indications to allow expansion of program
Slide 43: Phase 3 Trial of Exparel in Bunionectomy
Phase 3 Trial of Exparel® in Bunionectomy Michael Golf, et. al. Adv Ther (2011) 28(9):776-788.
Slide 44: Post-Operative Pain Program Commercial Opportunity
POST-OPERATIVE PAIN PROGRAM COMMERCIAL OPPORTUNITY
Slide 45: U.S. Post-Operative Pain Market
2012 Post-Op Pain Market (US only) 2021 Post-Op Pain Market (US only) Strong opioid analgesics; 53% Simple analgesics; 11% Strong opioid analgesics; 51% Simple analgesics; 13% U.S. Post-Operative Pain Market Source: Decision Resources, Post-Operative Pain Pharmacor, May 2006; Decision Resources, Acu
Slide 46: 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 Efficacy for Long-Acting Local Anesthetic Source: Decision Resources Post-Operative Pain Physician Research Initiative (N=30 qualitative intervi
Slide 47: Many MDs Expect Increased Use of Long-Acting Local Anesthetics
53% 60% 45% 62% 58% 58% 66% 44% 60% 60% 50% 41% 49% 47% 49% 37% 33% 49% 29% 36% 37% 28% 53% 34% 35% 43% 54% 48% 46% 48% 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 in
Slide 48: HTX-003 Long-Acting Buprenorphine for Chronic Pain and Addiction
HTX-003 LONG-ACTING BUPRENORPHINE FOR CHRONIC PAIN AND ADDICTION
Slide 49: 30-Day Buprenorphine
30-Day Buprenorphine Comparison to Competitive Products in Development* *RB Pharma is from US2013/0210853; Camurus data from US2013/0190341
Slide 50: Repeat Dose Model
Repeat Dose Model* Therapeutic range *Prediction based on 15 mg dosed monthly Excellent PK profile for once monthly dosing Cmax achieves steady state by second dose
Slide 51: Partnering Opportunity for Long-Acting Buprenorphine Products
Partnering Opportunity for Long- Acting Buprenorphine Products • Projected sales of products for opioid addiction to reach $3B by • Recent deals for buprenorphine products show significant interest in the space: • Titan license of Probuphine to Braeburn (12/17/2012) • 6 month sub-dermal implant for
Slide 52: Financial Summary
Summary Statement of Operations (In thousands, except per share data) Three Months Ended March 31, 2015 Condensed Balance Sheet Data (In thousands) March 31, 2015 Financial Summary Revenue $ – Operating expenses 20,360 Other income (expenses) (210) Net loss $ (20,570) Net loss per share $ (0.70) Cas