Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — AP Pharma — Investor Presentation (July 2012)
41 slides from Heron Therapeutics's investor presentation, Jul 25, 2012
Slide 1: Company Overview
Exhibit 99.2 Company Overview OTCBB: APPA July 2012
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
Slide 3: Stock Summary
Stock Summary Company: A.P. Pharma, Inc. Ticker: OTCBB: APPA.OB Stock Price: $0.66 (7/24/12) Market Capitalization: $309.1 million 1 Pro Forma Cash: $67.1 million 2 Debt: $4.6 million 2 1 Based on 497.1 million fully diluted, as-converted common shares assuming the full conversion of convertible deb
Slide 4: Management
Management John B. Whelan President, CEO & CFO Raven Biotechnologies Eos Biotechnology Hewlett Packard/Agilent Michael A. Adam, Senior Vice President & Spectrum Pharmaceuticals Ph.D. Chief Operating Officer Pfizer/Agouron Bristol-Myers Squibb Thomas Ottoboni, Vice President, Talima Therapeutics Ph.D
Slide 5: A.P. Pharma Highlights
A.P. Pharma Highlights Lead product candidate, 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 with single injection APF5
Slide 6: Important APF530 Milestones
Important APF530 Milestones Milestone Timing Status Successful End-of-Review Meetings with 1Q 2011 FDA Successful Completion of Thorough QT 1Q 2012 Study Successful Completion of Metabolism 1Q 2012 Study Successful Completion of Formative 1Q 2012 Human Factors Study Complete Human Factors Validation
Slide 7: Clinical Summary
Clinical Summary July 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 7
Slide 8: 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 Patients stratified by type of chemotherapy regimen (moderately or highly emetogenic)
Slide 9: Primary Efficacy Results: Complete Response
Primary Efficacy Results: Complete Response Patients Receiving Moderately Emetogenic Chemotherapy Acute APF530 5mg Delayed Acute APF530 10mg Delayed -15 -10 -5 0 5 10 15 Acute Delayed Difference in Complete Response APF530-Aloxi (97.5% CI) July 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 9
Slide 10: Primary Efficacy Results: Complete Response
Primary Efficacy Results: Complete Response Patients Receiving Highly Emetogenic Chemotherapy Acute APF530 5mg Delayed Acute APF530 10mg Delayed -15 -10 -5 0 5 10 15 Acute Delayed Difference in Complete Response APF530-Aloxi (98.33% CI) July 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 10
Slide 11: Safety Summary
Safety Summary Reported in Cycle 1 APF530 5 mg APF530 10 mg Aloxi 0.25 mg N % N % N % Drug Related Serious Adverse Events 1 1 0.2 0 0 0 0 Discontinued Due to Adverse Event 1 0.2 1 0.2 0 0 Frequent Adverse Events Gastrointestinal disorders Constipation 62 13.4 72 15.4 62 13.4 Diarrhea 49 10.6 44 9.4
Slide 12: APF530's Efficacy with Difficult Chemo Regimens
APF530’s Efficacy with Difficult Chemo Regimens 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 All other regimens 72.9% 70.0% Cisplatin
Slide 13: APF530's Sustained Efficacy in Cycles 2-4
APF530’s Sustained Efficacy in Cycles 2-4 Complete Response Rates for Delayed-onset CINV in Patients Receiving Highly Emetogenic Chemotherapy APF530 10mg Aloxi 0.75mg* N= 240 169 129 94 351 315 254 117 % of Cycle 1 100% 70% 54% 39% 100% 90% 72% 33% * Sakai et al (Annals of Oncology, Vol. 19 Sept. 20
Slide 14: Summary of APF530 Phase 3 Results
Summary of APF530 Phase 3 Results One of the largest, randomized, controlled clinical studies conducted in the CINV setting Non-inferiority to Aloxi was demonstrated For both acute- and delayed-onset CINV With both moderately and highly emetogenic chemotherapy APF530 was safe and well-tolerated Inci
Slide 15: Regulatory Status
Regulatory Status July 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 15
Slide 16: APF530 NDA Status
APF530 NDA Status Submitted NDA in May 2009 under 505(b)(2) filing pathway Received Complete Response Letter in March 2010 FDA raised issues in three main areas: Dosing system Two-syringe system Chemistry, Manufacturing, and Controls (CMC) Sterilization Characterization Clinical/statistical Specific
Slide 17: Progress of NDA Resubmission
Progress of NDA Resubmission Dosing System Change to single-syringe system – completed Enhanced dosing instructions – completed Overall, simpler and more convenient Formative, non-clinical human factors study – completed Human factors validation study – pending Chemistry, Manufacturing, and Controls
Slide 18: Improved Dosing System
Improved Dosing System Original Two-syringe System New Single-syringe System July 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 18
Slide 19: Thorough QT Study Background
Thorough QT Study Background The QT interval represents the amount of time the heart’s electrical system takes to repolarize after each beat Prolongation of the QT/QTc interval is associated with increased susceptibility to fatal cardiac tachyarrhythmias Thorough QT studies are intended to determine
Slide 20: Zofran Use in CINV Restricted
Zofran Use in CINV Restricted Most widely used generic 5-HT3 now restricted FDA issued a Drug Safety Communication June 29, 2012 “The use of a single 32 mg intravenous dose of ondansetron should be avoided. New information indicates that QT prolongation occurs in a dose-dependent manner, and specifi
Slide 21: Anzemet in CINV Previously Removed
Anzemet in CINV Previously Removed FDA issued a Drug Safety Communication Dec. 17, 2010 “Anzemet causes a dose-dependent prolongation in the QT, PR, and QRS intervals on an electrocardiogram (ECG) …” “Anzemet injection should no longer be used to prevent nausea and vomiting associated with initial a
Slide 22: APF530 Thorough QT Study Design
APF530 Thorough QT Study Design Double-blind, single-site Four-way crossover 56 healthy male and female subjects Study Arms SC APF530 1 g (granisetron 20 mg) – 2x therapeutic dose IV Granisetron 50 µg/kg over 3 minutes – 5x therapeutic dose Oral Moxifloxacin 400 mg (Avelox®) – positive control Place
Slide 23: APF530 Thorough QT Study Results
APF530 Thorough QT Study Results Primary Endpoint Achieved in Both Granisetron Dose Groups Both APF530 and IV granisetron dose groups did not approach or exceed the upperbound of 10 ms at any time point The primary end point was met irrespective of heart-rate correction methodology – QTcF, QTcI, QTc
Slide 24: Granisetron Thorough QT PK/PD Results
Granisetron Thorough QT PK/PD Results ddQTcF vs. Granisetron Plasma Concentration Slope = -0.019 Plasma Concentration (ng/ml) July 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 24
Slide 25: Metabolism/Fate of Polymer Study
Metabolism/Fate of Polymer Study FDA requested study at end-of-review meeting in 1Q 2011 Purpose of study is to demonstrate fate of polymer in human subjects Confirm polymer breaks down into same hydrolytic end-products as seen in animals Confirm lack of other detectable polymer-related metabolites
Slide 26: Principle Activities Remaining for NDA Filing
Principle Activities Remaining for NDA Filing Human Factors Formative study successfully completed FDA agreement on validation study protocol Validation study scheduled for Q3 2012 Registration Lots Three of three required lots successfully filled Analytical testing for lot release underway Complete
Slide 27: Human Factors Study
Human Factors Study Assess the Instructions-for-Use and usability of APF530 in simulated oncology setting Follows June 2011 FDA guidance: “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” Initial risk assessment followed by iterative process of formative studies Va
Slide 28: Commercial Opportunity
Commercial Opportunity July 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 28
Slide 29: U.S. Market Opportunity for APF530
U.S. Market Opportunity for APF530 More than 7 million cycles of chemotherapy administered each year ~27% are highly emetogenic ~46% are moderately emetogenic Significant unmet medical need for additional therapies to address delayed-onset CINV 5-HT3 antagonists are standard-of-care for CINV Recomme
Slide 30: Complete Response Rates for 5-HT3 Antagonists
Complete Response Rates for 5-HT3 Antagonists 1st generation 5-HT3 Average Overall Complete Response1 Rates2 Moderately Emetogenic Chemotherapy ~ 42% Highly Emetogenic Chemotherapy ~ 39% Aloxi Average Overall Complete Response Rates2 Moderately Emetogenic Chemotherapy ~ 57% Highly Emetogenic Chemoth
Slide 31: Antiemetic Treatment Patterns
Antiemetic Treatment Patterns Most chemotherapy patients will undergo 4 to 15 cycles of chemotherapy Doctors prefer to administer antiemetics on-site for moderately and highly emetogenic chemotherapy Patient compliance is a significant concern Average cost per CINV event ranges from $4,000 to $5,300
Slide 32: CINV Market Dynamics
CINV Market Dynamics ~35% drop and rebound in 6-month period ~85% drop following tQT FDA Safety Letter Source: Wolters Kluwer Usage in CINV estimated based on vial size July 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 32
Slide 33: Aloxi Market Performance
Aloxi Market Performance Aloxi Sales Pricing Average Selling Price = $175 Zofran went Medicare Reimbursement = $186 generic Wholesale Acquisition Cost ~ $380 Orange Book Patent Exclusivity One patent expires April 2015 Three patents expire January 2024 July 2012 © 2012. A.P. Pharma, Inc. All rights
Slide 34: CINV Market Dynamics: Conclusions
CINV Market Dynamics: Conclusions Aloxi has gained market share over last 3 years despite availability of generics for acute-onset CINV From 48% in 2008 to 56% in 4Q 2011 Kytril was widely used prior to Zofran® going generic High physician acceptance of granisetron Possible shift away from generic Z
Slide 35: APF530's Potential Competitive Positioning
APF530’s Potential Competitive Positioning Provides 5 days of prevention against chemotherapy-induced nausea and vomiting with a single injection Second, long-acting, injectable product on market Lack of complete effectiveness of available antiemetics indicates need for additional products to preven
Slide 36: Oncology Supportive Care Market Addressable by Small Organization
Oncology Supportive Care Market Addressable by Small Organization Less than 3,000 oncology practices in the US 50% of market represented by several hundred practices Handful of group purchasing organizations (GPOs) facilitate purchases for majority of market 3rd party infrastructure in place to supp
Slide 37: APF530 Commercialization Plan
APF530 Commercialization Plan A.P. Pharma owns worldwide rights to APF530 No milestone or royalty obligations owed to any third parties Building core sales and marketing team ahead of launch with plan to expand on approval Hire core sales and marketing leadership in 2H 2012 (~10 people) Hire field t
Slide 38: A.P. Pharma Product Lifecycle Considerations
A.P. Pharma Product Lifecycle Considerations APF530 covered by multiple patents 2 patents covering combination of polymer, excipients and drug expire in 2021 3 patents just allowed covering APF530 – expire in 2025 Polymer-based injectable products are difficult to copy independent of IP ANDA FDA req
Slide 39: Financial Summary
Financial Summary Expect cash sufficient to fund commercial launch of APF530 Summary Statement of Operations Year Ended Quarter Ended (In thousands, except per share data) December 31, 2011 March 31, 2012 Revenue $ 646 $ – Operating expenses 11,708 4,769 Other income (expenses) (752) (152) Net loss
Slide 40: A.P. Pharma Highlights
A.P. Pharma Highlights Lead product candidate, 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 with single injection APF53
Slide 41: Thank You
Thank You A.P. Pharma, Inc. OTCBB: APPA July 2012 July 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 41