Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (December 2014)
40 slides from Heron Therapeutics's corporate update, Dec 10, 2014
Slide 1: Company Update
Exhibit 99.1 Company Update December 2014
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
Status of Development Programs Preclinical Phase 1 Phase 2 Phase 3 NDA SUSTOL (APF530) CINV: Acute and Delayed after MEC, and Acute HEC SUSTOL (APF530) Delayed HEC Will be evaluated in soft HTX-011 Pain Program tissue, nerve block, and orthopedic indications Intravenous HTX-019 NK1 for CINV HTX-003
Slide 4: CINV Franchise
CINV FRANCHISE
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 moderatel
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 20 15 All subjects (n= 18) mean ± SEM 10 5 Minimum therapeutic concentration of granisetron* 0 0 24 48 72 96 120 144 1
Slide 7: SUSTOL Pivotal Phase 3 Study Overview
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 che
Slide 8: Primary Efficacy Results: Complete Response
Primary Efficacy Results: Complete Response Patients Receiving Moderately Emetogenic Chemotherapy 100.0 90.0 80.0 75.0 76.9 70.0 57.2 58.5 60.0 50.0 Acute 40.0 30.0 APF530 10mg Delayed 20.0 10.0 0.0 -15 -10 -5 0 5 10 15 Acute Delayed Difference in Complete Response APF530-Aloxi (97.5% CI) 8
Slide 9: Primary Efficacy Results: Complete Response
Primary Efficacy Results: Complete Response Patients Receiving Highly Emetogenic Chemotherapy 100 90 80.7 81.3 80 70 64.3 67.1 60 50 Acute 40 30 APF530 10mg Delayed 20 10 0 -15 -10 -5 0 5 10 15 Acute Delayed Difference in Complete Response APF530-Aloxi (98.33% CI) 9
Slide 10: Safety Summary
Safety Summary 1 Cycle 1 Safety Results APF530 10 mg Aloxi 0.25 mg N % N % Drug Related Serious Adverse Events 0 0 0 0 Discontinued Due to Adverse Event 1 0.2 0 0 Frequent Adverse Events Gastrointestinal Disorders Constipation 72 15.4 62 13.4 Diarrhea 44 9.4 39 8.4 Abdominal pain 13 2.8 28 6.0 Nervo
Slide 11: FDA-Requested ASCO 2011 Reanalysis Improves Difference Between SUSTOL and Aloxi in HEC Patients
FDA-Requested ASCO 2011 Reanalysis Improves Difference Between SUSTOL and Aloxi in HEC Patients Protocol Specified HEC Population ASCO 2011 Guideline HEC Population 100 100 90 90 81 81 80 80 75 67 67 70 64 70 60 60 56 51 50 50 40 40 30 30 20 20 10 10 0 0 Acute Delayed Acute Delayed 11
Slide 12: Largest Differences Between Arms is Seen With Most Difficult Chemo Regimens
Largest Differences Between Arms is Seen With Most Difficult Chemo Regimens1 CR Rates by Treatment Chemotherapeutic Regimen APF530 10 mg Aloxi 0.25 mg Cyclophosphamide/Doxorubicin 70.7% 65.7% Acute Moderately All other regimens 84.4% 85.0% Emetogenic Cyclophosphamide/Doxorubicin 47.4% 46.3% Delayed
Slide 13: Response Rates With Chemotherapy Classified as HEC by Both Hesketh and 2011 ASCO
Response Rates With Chemotherapy Classified as HEC by Both Hesketh and 2011 ASCO* SUSTOL reflects 9-11% greater response rate in the most emetogenic chemotherapy 90% 80% 78% 69% 70% 66% 60% 55% 50% Aloxi 40% SUSTOL 30% 20% 10% 0% Acute Delayed *Cisplatin, carmustine, dacarbazine, dactinomycin, mechl
Slide 14: A Delayed-HEC Indication Would Provide Clear Differentiation in an Important Segment of the CINV Market
A Delayed-HEC Indication Would Provide Clear Differentiation in an Important Segment of the CINV Market Distribution of Aloxi Sales* HEC regimens account for ~20% (500K) of palonosetron administrations This is the same segment of HEC the CINV market where NK 1 Minimal receptor antagonists are extens
Slide 15: Phase 3 "MAGIC" Study
Phase 3 “MAGIC” Study Superiority design assuming a CR rate of 65% in the control (ondansetron) arm, a binary endpoint (CR or no CR), a 2-sided alpha = 0.05 to test 65% vs 75%; for 90% power you need 880 evaluable patients Cycle 1 Ondansetron 0.15 mg/kg IV (up to 16 mg IV) d 1 + fosaprepitant 150 mg
Slide 16: New SUSTOL Study Strategically Designed Based on Previous Results
New SUSTOL Study Strategically Designed Based on Previous Results Study powered for a 10% difference between arms 20% difference is expected with the addition of fosaprepitant, 100 Projected Standard of Care Phase 3 Study HEC Study Response 90 with addition 80 87% of NK1 ^^ 70 Study powered 60 to sh
Slide 17: HEC Study Update
HEC Study Update • >150 site locations have drug • Expect to complete enrollment in 1Q2015, with an NDA resubmission shortly thereafter • FDA has previously indicated that a positive outcome from this study would be sufficient to obtain “delayed-HEC” indication 17
Slide 18: 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 1 st generation 2 nd generation 3 rd 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
Slide 19: SUSTOL Regulatory Status
SUSTOL REGULATORY STATUS
Slide 20: SUSTOL NDA Status
SUSTOL NDA Status • Submitted NDA in May 2009 under 505(b)(2) filing pathway • Received Complete Response Letter in March 2010 • FDA raised major issues in multiple areas Resubmitted NDA in September 2012 – Received Complete Response Letter March 2013 raising three main issues: • CMC: correction of
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: CINV Franchise Commercial Opportunity
CINV FRANCHISE COMMERCIAL OPPORTUNITY
Slide 23: Commercial Opportunity Summary
Commercial Opportunity Summary • Heron has the opportunity to establish a long-term, dominant position in a CINV market targeting 3.6M units of IV 5HT-3 and NK-1 annually Market • The NK-1 market grew 10% YOY in 2013 with significant opportunity for increased penetration into MEC regimens • New bran
Slide 24: Heron has the opportunity to establish a long-term, dominant position in a CINV market
Heron has the opportunity to establish a long-term, dominant position in a CINV market that has over 3.6M penetrable units Injectable Drugs for the Prevention of CINV Number of Package Units Sold by Quarter 800,000 700,000 Aloxi 600,000 500,000 400,000 300,000 200,000 Emend 100,000 0 Q2'06 Q4'06 Q2'
Slide 25: New branded, injectable agents will be well-positioned to gain significant share
New branded, injectable agents will be well- positioned to gain significant share as current market leaders (Aloxi, EMEND) lose patent protection AKYNZEO palonosetron fosaprepitant (oral) patent expiry patent expiry 2014 2015 2016 2017 2018 2019 Rolapitant?? Rolapitant?? (oral) (IV) Possible Candida
Slide 26: SUSTOL would be the first and only injectable 5HT3 indicated for acute and delayed CINV
SUSTOL would be the first and only injectable 5HT3 indicated for acute and delayed CINV in both MEC and HEC favored by more than 50% of oncologists Attribute Favor IV Aloxi (1-2) No Preference (3) Favor SUSTOL (4-5) Avg. (N=66) Effective for prevention of delayed CINV in assoc. with HEC 6% 33% 61% 3
Slide 27: HEC Regimens Represent a Significant Market Opportunity for SUSTOL and HTX-019
HEC Regimens Represent a Significant Market Opportunity for SUSTOL and HTX-019 Of all HEC administrations, ~20% are given HEC regimens account for ~20% (500K) without concomitant IV 5-HT3 – inconsistent of palonosetron administrations with clinical guidelines 1,600,000 1,463,558 1,200,000 1,400,000
Slide 28: Post-Operative Pain Program
POST-OPERATIVE PAIN PROGRAM
Slide 29: Goals for Pain Program
Goals for Pain Program • Develop products that provide a clear advantage compared to available therapies • Take advantage of the FDA’s current focus on reducing the use of opiates • Main goals of therapy for our post-operative pain program – Significantly reduce: • pain intensity for 3-4 days post-o
Slide 30: Biochronomer Bupivacaine/Meloxicam Significantly Superior to EXPAREL at 24-72 Hours
Biochronomer Bupivacaine/Meloxicam Significantly Superior to EXPAREL at 24-72 Hours Pig Post-Operative Pain Model Saline Control (1) Biochronomer Bupivacaine (1) Biochronomer Ropivacaine (1) Biochronomer Bupivacaine + Meloxicam (2) Exparel (2) 100.0 90.0 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 0
Slide 31: Next Steps for Post-Operative Pain Program
Next Steps for Post-Operative Pain Program • Phase 1 enabling toxicology completed – no issues • Complete Phase 1 SAD in 1Q15 • Quickly initiate Phase 1b/2 studies 1H15 based on Phase 1 SAD • Completing toxicology for nerve-block and orthopedic indications to allow expansion of program 31
Slide 32: Post-Operative Pain Program Commercial Opportunity
POST-OPERATIVE PAIN PROGRAM COMMERCIAL OPPORTUNITY
Slide 33: U.S. Post-Operative Pain Market
U.S. Post-Operative Pain Market • Treatment options have remained stable over the past decade and new therapies are expected to be dominated by reformulations of existing molecules • The total number of procedures is anticipated to increase 3% per year driven by aging population • Unmet needs includ
Slide 34: > 72 hour 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% 9% 12% 24 Hours 48
Slide 35: Across Procedures, 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 36: HTX-003 Long-Acting Buprenorphine for Chronic Pain and Addiction
HTX-003 LONG-ACTING BUPRENORPHINE FOR CHRONIC PAIN AND ADDICTION
Slide 37: 30-Day Buprenorphine
30-Day Buprenorphine Comparison to Competitive Products in Development* *RB Pharma is from US2013/0210853; Camurus data from US2013/0190341 37
Slide 38: Repeat Dose Model
Repeat Dose Model* Excellent PK profile for once monthly dosing Cmax achieves steady state by second dose Therapeutic range *Prediction based on 15 mg dosed monthly 38
Slide 39: 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 2020 • 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
Slide 40: Financial Summary
Financial Summary Summary Statement of Operations Nine Months Ended (In thousands, except per share data) September 30, 2014 Revenue $ – Operating expenses 55,066 Other income (expenses) (677) Net loss $ (55,743) 1 Net loss per share $ (2.17) Condensed Balance Sheet Data September 30, 2014 (In thous
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