Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (June 2014)
40 slides from Heron Therapeutics's corporate update, Jun 2, 2014
Slide 1: Company Update June 2014
Exhibit 99.2 Company June Exhibit 2014 99.2 Update
Slide 2: Disclaimer
Legalpresentation This associated programs 2statements. Disclaimer and with Weother caution timely contains risks development, investors and “forward uncertainties that-looking approval, forward identified statements” -looking launchinand statements theas acceptance Company’s defined reflect byoffil
Slide 3: Lead Product Highlights: SUSTOL
Lead Highlights SUSTOL 3_Leveraging Shown On-going No Long-acting *TDR5-HT3 product August to targets our be 1000 agent candidate, local non-inferior Biochronomer 2006 apatient is large anesthetic-NSAID approved internal market SUSTOLTM, study to market report drug for inopportunity, patients delaye
Slide 4: SUSTOL Clinical Summary
SUSTOL CLINICAL SUMMARY
Slide 5: 5-Day Granisetron Plasma Concentration Profile
5-Day Granisetron 0(ng/mL) Time 5*Data Minimum 24 48 after from Profile: 72 20Dosing 96 patent nis Plasma granisetro 120 released APF530 144 application (h) therapeutic 168 rapidly Pharmacokinetics 15 of All 20120258164 following concentration subjectsinjection (n=for of 18) transdermal granisetron*
Slide 6: SUSTOL Randomized Pivotal Phase 3 Study Overview
SUSTOL Randomized, 1,341 Two Patients 6_Primary Complete ±15% doses patients margin stratified end Pivotal ofresponse point APF530 controlled, inused primary Phase by compared type to defined (5establish 3multi-center mg efficacy Study of chemotherapy complete and as no Overview non-inferiority 10 p
Slide 7: Primary Efficacy Results: Moderately Emetogenic Chemotherapy
Primary Patients 100.0 (%) 575.0 R 70.0 50.0 60.0 Response APF530 Complete 20.0 Delayed 30.0 00. Aloxi 7Acute 7.2mg 90.0 Acute 76.9 58.5 APF530 -´ Delayed mg +´ Receiving Efficacy 10mg ates 40.0 10.0 mgmg 80.0 Aloxi Difference Results: . Moderately 2510 APF530 . Complete 2510 in Complete -15 Emetoge
Slide 8: Primary Efficacy Results: Highly Emetogenic Chemotherapy
Primary Patients 100 (%) 90 Rates 80 60 Response 30 0Complete Aloxi 8Acute mg 50 20 80.7 -´mg 70 APF530 Delayed +´Receiving Efficacy 64.3 81.3 mgmg 40 10 67.1 Aloxi Difference 25 Results: Highly .10 APF530 . 2510 Complete in Emetogenic Complete -15 0 0 -10Response -5Chemotherapy Response 0 5 10 15AP
Slide 9: Safety Summary
Safety Cycle Constipation Diarrhea Abdominal Bruising Erythema Pain “1 9“2 Safety >90% 331Summary 7.1 Safety 93 44 of results (redness) pain 5injection 19.9 9.4 72 1.1 Results 39 15.4 .with 41 . Nervous 8.4 51 8.9 62 site the APF530 10.9 13.4 reactions 5 mg 14 System 3.0 dose 10 Nodule mg1 were Head
Slide 10: FDA-Requested Protocol Reanalysis Improves SUSTOL Results in HEC
FDA-Requested Protocol 100 90 (%) 80 ates 70 R 60 56 50 51 Response 30 20 Complete 0.25 Aloxi Acute 10 .0R10 90 80 64 60 50 30 20 mg 0 81 100 67 0APF530 75 70 25 Delayed 81 mg ates Specified 10 40 10 (%) mg 67 25 Response Complete Aloxi mgmgmg Acute . ASCO 10HEC . APF530 2510 Delayed 40 10 2011 Popu
Slide 11: Largest CR Differences by Chemotherapeutic Regimen
Largest CR Chemotherapeutic Cyclophosphamide/Doxorubicin All Carboplatin/Paclitaxel 1Data Highlighted 11 other Rates from Differences regimens bypost-hoc HEC Treatment regimens Regimen 72.9% Between analysis. 70.8% 70.0% were APF530 Arms 71.4% Not70.7% considered Cisplatin statistically isAll 10 See
Slide 12: SUSTOL Response Rates With Chemotherapy Classified as HEC
Response SUSTOL 78% 90% 70% 40% *Cisplatin, Delayed Acute 12 Aloxi 80% is 66% Rates 69% 60% SUSTOL carmustine, 9-11% 55% With Better 50% 30% Chemotherapy dacarbazine, Than 20% Aloxi 10% dactinomycin, 0% Classified in the Most as Emetogenic HEC mechlorethamine, by Both Chemotherapy Hesketh streptozot
Slide 13: Delayed-HEC Indication Would Provide Clear Differentiation
AIntrinsiQ Distribution 1HEC MEC 13Delayed-HEC regimens Minimal data ofLEC Aloxi account from Indication Sales* July for2012 ~20% Would - June (500K) Provide 2013 ofClear palonosetron Differentiation administrations in an Important Segment of the CINV Market
Slide 14: Phase 3 Superiority Study Design
Phase Superiority evaluable Ondansetron 1000 1:1 + 1. 2. *HEC 14 placebo fosaprepitant All APF530 patients subjects 3agents “MAGIC” patients SC design 500 0.15 as scheduled d1 will 150 defined mgmg/kg Cycle assuming receive be Study mg SC allowed IV dto in 1IV 1ddexamethasone receive the (up 1a CR +
Slide 15: New Phase 3 Study Has High Likelihood of Success
New 20% 100 Standard (%) 90 80 Rate Study 60 powered 50 Response 45% 30 10 Ondansetron + a^^Average 15 20% Fosaprepitant* 87% to 65% 0Complete with Projected 70 difference 65% SUSTOL show powered increased ofaddition vs of40 67% NK1 75% Complete 10% Care + 20Study Dex* 75% for is^^ difference: respo
Slide 16: Study Enrollment Expected Faster Than Projected
Study 117 Enrollment Expect FDA 16 site has Start-up tolocations previously complete is progressing Faster have this agreed Than drug study well Projected that anda positive be able to outcome file fullfrom report this in study 4Q2014would resubmission be sufficient to obtain “delayed -HEC” indicati
Slide 17: Clinical Trial Active Study Summary
Clinical 117 Active 17 Study Awaiting Trial Locations SiteSIV Activation Have Awaiting Drug Summary IRB/CTA
Slide 18: 5-HT3 RA Products and SUSTOL Potential
SUSTOL RAs 5-HT3 Products Duration Prevention MEC *Obtaining 18 1st - acute& generation palonosetron of Has of delayed Short CINV the delayed Potential acting 2nd HEC in SUSTOL CINV generation Longer will to be MEC acting granisetron the based 3rd -Next acute generation Long on Generation completion
Slide 19: SUSTOL Regulatory Status
SUSTOL REGULATORY STATUS
Slide 20: SUSTOL FDA Submission Status
SUSTOL Submitted FDA Resubmitted Received CMC: Requirement Re-analysis 20 raised correction Complete NDA NDA major ofNDA for the Status in Human ofissues existing in May Response PAI September 2009 issues Factors in Phase multiple under Letter and Validation 2012 3 study revision 505(b)(2) areas in
Slide 21: How We Are Addressing CRL Issues
“_How 21 Transition Chemistry, Human Re-analysis Re-submission Sites New Multiple Successfully Complete Wein-vitro with Are Factors validation dataset PAI isManufacturing, Addressing of complete complete, completed release Phase issues isValidation planned and batches method 3have programs using wit
Slide 22: Obtaining Delayed-HEC Approval Sooner
Obtaining Submitting 2014 Q1 Delayed Original NDA Approval Revised Achieves Best Sooner 22 Q2Labeling 2015 sNDA Q3 NDA Plan -HEC Plan the for Optimal Q4 2016 the for Acute Approval Delayed Q1 Study NDA Delayed Q2 Labeling and with Q3 -HEC HEC. for Delayed HEC Q4 aAll positive MEC Sooner Study Q14 Qu
Slide 23: SUSTOL Commercial Opportunity
SUSTOL COMMERCIAL OPPORTUNITY
Slide 24: US Injectable CINV Prevention Market Dynamics
U.2’06 Injectable 800,000 700,000 0Q *ALOXI 24US S. Oncology CINV Q4’06 ANZEMET Number 600,000 Drugs Market Q2’07 data for 500,000 of Dynamics Package the KYTRIL added Q4’07 Prevention 400,000 starting Q2’08 Units KYTRIL 300,000 Q4’08 Sold 1/2009. of CINV Generic byQ2’09 Quarter 200,000 Data (GRANIS
Slide 25: HEC Represents a Significant Annual Market Opportunity
Of-IntrinsiQ of 1,463,558 1,600,000 (annual) 1,400,000 1,200,000 IV 188,988 451,490 497,256 600,000 Aloxi -400,000 1HEC 25 palonosetron 5HT3 allMEC Regimens 200,000 HEC palonosetron 1,000,000 1,000,000 1,200,000 Untreated data LEC administrations, 497,256 administrations Represent from Minimal 800,0
Slide 26: Post-Operative Pain Program
POST-OPERATIVE PAIN PROGRAM
Slide 27: Heron Therapeutics
¥ ~* * FAEEFRROON x THERAPEUTICS Advancing Medicine. Improving Health.
Slide 28: Goals of Post-Operative Pain Program
Goals Develop Take Main pain _Target 28Significantly Easy intensity advantage goals for for toproducts use Pain product offor for therapy Program reduce: ofa3-4 that the large days FDA’s for provide variety our post-operatively current post-operative a of clear procedures focus advantage on opiate p
Slide 29: Biochronomer Bupivacaine/Meloxicam Preclinical Results
1. Significantly Pig SalineControl(1) Biochronomer Exparel Tolerated 90.0 30.0 40.0 Anima Percentage 010.0 2.1Study 3Post 20.0 5 HOURS EXPAREL) 29 (n=4 (2) -Operative #1; 80.0 #2 of 100.0 All Superior Maximal (60gm) compared pigs, exceptPain at<to 72 /96 70.0 force used expected 1Model Bupivacaine/M
Slide 30: Bupivacaine-Meloxicam Combination Formulation
InThe A Bupivacaine –Meloxicam Combination 30Local New combination order very Formulation tolerability to achieve low was was product product dose selected selected near ofof ofproduced meloxicam Bupivacaine using meloxicam complete asfor theour the NSAID significantly combination Biochronomer contr
Slide 31: Post-Operative Pain Program Commercial Opportunity
POST-OPERATIVE PAIN PROGRAM COMMERCIAL OPPORTUNITY
Slide 32: Post-Operative Pain Represents an Attractive Market Opportunity
The Post-Operative Pain High Costs Reimbursement Local Current Treatment MDs Paradigm Physicians –Unmet Source: Initiative 32Reliable, Further Post-Operative iscost commonly cite of anesthetic aNeeds Decision opioid major 2014 pain reduction EXPAREL of acting identified extended reduction (N=30 driv
Slide 33: U.S. Post-Operative Pain Treatment Market
U.S. Treatment The Unmet Antiepileptic Traditional 1% 11% 2012 Source: 33 Decision Local total Post-Operative 13% Total: Post-Op needs Decision number 1% Dual-Acting options Drugs $3.1B Resources, Traditional include 9% PainResources, of anesthetics; NSAIDs; 2021 have Market procedures Pain longer-a
Slide 34: A Wide Variety of High-Volume Surgical Procedures
A Wide Timeframe Volume Top Cholecystectomy Arthroplasty hip procedures dislocation Source: 34 and Surgical femur Variety Decision of % on procedure ofknee Post-Op Using (inpatient) musculoskeletal ofResources (inpatient) (outpatient) High-Volume Pain Orthopedic Orthopedic %Post-Operative General Us
Slide 35: Ideal Duration of Action for Long-Acting Local Anesthetic
³72 Ideal £>5 48 Source: Initiative 3524hours days hour Duration Decision 2% Duration hours 72 2014 hours 5 days of (N=30 27%Resources Efficacy of 45% 4% 44% Action qualitative £46% 24for hours Seen Post-Operative Long-Minimally interviews; as 72“Ideal” hours 4Pain by N=184 days Acceptable Physician
Slide 36: Reliable 3-Day Duration of Action Would Be Important
Local “With “A Procedures Hip Orthopedic Knee Shoulder Foot Hand Spinal Soft Laparoscopic Nephrectomy Prostatectomy Hysterectomy Appendectomy Hernia Source: 36 local replacement Tissue /replacement surgeries Anesthetic ankle EXPAREL, procedures KOL anesthetic surgeries mentioned surgeries interviews
Slide 37: Use of Long-Acting Local Anesthetics Across Procedures
Across Use shoulder, Cholecystectomy 7% muscles Repair Treatment, procedure 6% hip Other 9% Arthroplasty 0% Percentage Less –“Minimizing Source: 37General and 50% 60% 58% 62% 20% of frequently therapeutic fracture non-OR Long-Acting of Procedures, femur Decision and 43% 34% 37% 36% 29% 40% or toe su
Slide 38: Next Steps: Post-Operative Pain Program
Next Steps Combination Starting Initiate Assuming Continue 38 Phase Phase development positive forformulation 11Post-Operative with enabling results combination of Biochronomer toxicology has from been Pain Phase product selected Program 1, initiate ropivacaine in second Phase half formulation 2 pro
Slide 39: Heron Therapeutics Summary
Heron Chemotherapy-induced _A HEC pain Post-operative Large, –Significant MDs EXPAREL Innovative 39Only Extended Data Favorable Reduced differentiated management regimens view expect Therapeutics concentrated growing showing 5-HT3 ahospital pain opioid product represents unmet release safety use non
Slide 40: Financial Summary
Financial Summary Revenue Condensed March 1Cashandcash 40Based31, on $Summary Statement 2014 –23.7 Balance Operating equivalents (In million thousands) Sheet of Operations expenses weighted $Data 57,47517,322 average Total Threeassets Other Months common $income 62,793 Ended shares (expenses) Total