Heron Therapeutics, Inc. · NASDAQ:HRTX

Heron Therapeutics — Corporate Update (January 2014)

31 slides from Heron Therapeutics's corporate update, Jan 13, 2014

  1. Slide 1: Company Update

    Exhibit 99.1 Company Update January 13, 2014 © 2013. Heron Therapeutics, Inc. All rights reserved. Confidential.

  2. 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 timely development, approval, launch and acceptance o

  3. Slide 3: Senior Management

    Senior Management Ardea Biosciences Barry D. Quart, PharmD Chief Executive Officer Agouron Pharmaceuticals Pfizer Bayer Healthcare President & Sanofi-Synthèlabo Robert Rosen Chief Commercial Officer Imclone Ardea Biosciences Stephen Davis Chief Operating Officer Neurogen GE Healthcare Senior Vice Pr

  4. Slide 4: Highlights

    Highlights • Lead product candidate, SUSTOL™ (formerly known as APF530), is long-acting, injectable product for chemotherapy-induced nausea and vomiting (CINV) – Incorporates widely used 5-HT3 antagonist - granisetron (Kytril ®) – 5-day delivery profile – Reduces both acute- and delayed-onset CINV w

  5. Slide 5: SUSTOL Clinical Summary

    SUSTOL CLINICAL SUMMARY © 2013. Heron Therapeutics, Inc. All rights reserved. Confidential.

  6. 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 over a 5-day period, 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

  7. Slide 7: APF530 Pivotal Phase 3 Study Overview

    APF530 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 chem

  8. 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 © 2013.

  9. Slide 9: Primary Efficacy Results: Complete Response

    Primary Efficacy Results: Complete Response Patients Receiving Highly Emetogenic Chemotherapy 100 - + 90 80.7 81.3 80 64.3 67.1 70 60 50 Acute 40 APF530 10mg 30 Delayed 20 10 0 -15 -10 -5 0 5 10 15 Acute Delayed Difference in Complete Response APF530-Aloxi (98.33% CI) 9 © 2013. Heron Therapeutics, I

  10. 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

  11. Slide 11: FDA Requested ASCO 2011 Reanalysis Improves Difference Between SUSTOL and Aloxi

    FDA Requested ASCO 2011 Reanalysis Improves Difference Between SUSTOL and Aloxi 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 © 2013. Heron Therapeutics, In

  12. Slide 12: Largest Differences Between Arms is Seen With Most Difficult Chemo Regimens

    Largest Differences Between Arms is Seen 1 With Most Difficult Chemo Regimens 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

  13. Slide 13: Summary of Clinical Results

    Summary of Clinical Results • Bio-erodible polymer technology releases granisetron to prevent CINV over at least 5 days • Large, randomized, Phase 3 study conducted: APF530 10 mg showed non-inferiority to Aloxi – For both acute- and delayed-onset CINV – With both moderately and highly emetogenic che

  14. Slide 14: SUSTOL Regulatory Status

    SUSTOL REGULATORY STATUS © 2013. Heron Therapeutics, Inc. All rights reserved. Confidential.

  15. Slide 15: 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

  16. Slide 16: New Management Team Is Addressing the CRL

    New Management Team Is Addressing the CRL • Chemistry, Manufacturing, and Controls – Sites with PAI issues are being eliminated from the supply chain, with work transferred to well established site with no PAI issues • Transition is complete, with secondary benefit of improvement in the COGS – New i

  17. Slide 17: SUSTOL Life-Cycle Management: Plans to Obtain Post-Approval Indication for Delayed HEC

    SUSTOL LIFE-CYCLE MANAGEMENT PLANS TO OBTAIN POST-APPROVAL INDICATION FOR “DELAYED HEC” © 2013. Heron Therapeutics, Inc. All rights reserved. Confidential.

  18. Slide 18: Planned Phase 3 Delayed HEC Study Schematic

    Planned Phase 3 “Delayed” HEC Study Schematic • Study design has been accepted by FDA for obtaining expanded indication • Study is powered to show superiority (10% difference) to three drug “standard of care” for HEC • Study planned to complete late 2014 Cycle 1 Ondansetron 0.15 mg/kg IV (up to 16 m

  19. Slide 19: New SUSTOL Study Has a High Likelihood of Success Based on Previous Results

    New SUSTOL Study Has a High Likelihood of Success 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 of NK1 ^^ 67 Study 70 65 powe

  20. Slide 20: 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 st nd rd 1 generation 2 generation 3 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

  21. Slide 21: SUSTOL Commercial Opportunity

    SUSTOL COMMERCIAL OPPORTUNITY © 2013. Heron Therapeutics, Inc. All rights reserved. Confidential.

  22. Slide 22: U.S. CINV Market Dynamics

    U.S. CINV Market Dynamics Injectable Drugs for the Prevention of CINV Number of Package Units Sold by Quarter 800,000 700,000 600,000 500,000 400,000 300,000 200,000 100,000 0 Q2'06 Q4'06 Q2'07 Q4'07 Q2'08 Q4'08 Q2'09 Q4'09 Q2'10 Q4'10 Q2'11 Q4'11 Q2'12 Q4'12 ALOXI ANZEMET KYTRIL KYTRIL Generic (GRA

  23. Slide 23: HEC Regimens Represent a Significant Market Opportunity for SUSTOL

    HEC Regimens Represent a Significant Market Opportunity for SUSTOL Of all HEC administrations, ~20% are given HEC regimens account for ~20% (500K) without concomitant IV 5-HT3 – of palonosetron administrations inconsistent with clinical guidelines 1,600,000 1,200,000 1,463,558 1,400,000 1,000,000 1,

  24. Slide 24: New Product Initiative

    NEW PRODUCT INITIATIVE © 2013. Heron Therapeutics, Inc. All rights reserved. Confidential.

  25. Slide 25: Biochronomer Bupivacaine Has Superior PK Profile in Dogs

    Biochronomer™ Bupivacaine Has Superior PK Profile in Dogs 1000 900 800 Biochronomer Bupivacaine 15 mg/kg* 700 Bupivacaine Solution 9 mg/kg 600 500 Exparel 9 mg/kg 400 300 200 100 0 0 24 48 72 96 120 144 168 Hours *Projected from 7.5 mg/kg dose; EXPAREL data from Richard, et. al. 2012 © 2013. Heron T

  26. Slide 26: Biochronomer Ropivacaine Has Superior PK Profile in Dogs

    Biochronomer™ Ropivacaine Has Superior PK Profile in Dogs 450.0 400.0 350.0 Biochronomer Ropivacaine* 300.0 Exparel 9mg/kg 250.0 200.0 150.0 100.0 50.0 0.0 0 20 40 60 Hours 80 100 120 140 *Dose adjusted to match bupivacaine; EXPAREL data from Richard, et. al. 2012 26 © 2013. Heron Therapeutics, Inc.

  27. Slide 27: Evaluation of the Local Analgesic Effects of Two BIOCHRONOMER Formulations in the Pig Model

    Evaluation of the Local Analgesic Effects of Two BIOCHRONOMER Formulations in the Pig Model for Post-Operative Pain Both BIOCHRONOMER formulations provided sustained analgesic effects of 3-5 days compared to control BIOCHRONOMER products produced equal or greater analgesic effects for 24 hours than

  28. Slide 28: Ropivacaine Has Advantages Over Bupivacaine

    Ropivacaine Has Advantages Over Bupivacaine Bupivacaine Ropivacaine Notes 1 KOL Feedback 2 • Both molecules have similar “Both of these products work well for efficacy, onset of action, and blocking pain…the issue is that they Efficacy analgesic potency are short acting.” – Orthopedic Surgeon • Lowe

  29. Slide 29: Next Steps for Post-Operative Pain Program

    Next Steps for Post-Operative Pain Program • Finalize formulation optimization (dog PK provides a good indicator of analgesic duration) • Conduct additional pain models • Conduct Short-term toxicology • Initiate Phase 1 in 1H2014 • Assuming positive results from Phase 1, initiate Phase 2 program in

  30. Slide 30: Summary – Pipeline offers significant opportunity for commercial value creation

    Summary – Pipeline offers significant opportunity for commercial value creation Chemotherapy-induced nausea Post-Operative Pain and vomiting • Large, concentrated commercial • Large, growing market opportunity • High unmet need • Physicians view a non-inferior SUSTOL profile as highly competitive wi

  31. Slide 31: Financial Summary

    Financial Summary $60M raised November 2013 Summary Statement of Operations Nine Months Ended (In thousands, except per share data) September 30, 2013 Revenue $ – Operating expenses 40,626 Other income (expenses) (614) Net loss $ (41,240) Net loss per share1 $ (0.13) Condensed Balance Sheet Data Sep

Heron Therapeutics — Corporate Update (January 2014) on 6ix