Slide 1: Company Overview
Exhibit 99.1 Company Overview OTCBB: APPA March 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: $0.33 (3/23/12) 1 Market Capitalization: $111.2 million 2 Cash: $18.0 million 2 Debt: $1.57 million 1 Based on 394.5 million fully diluted, as-converted common shares assuming the full conversion of convertible debt outstan
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 Bristol-Myers Squibb Thomas Ottoboni, Vice President, Talima Therapeutics Ph.D. Pharma
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 anatgonist - granisetron (Kytril ®) 5-day delivery profile Reduces both acute- and delayed-onset CINV with single injection APF
Slide 6: Important APF530 Milestones
Important APF530 Milestones Milestone Timing Status Successful end-of-review meetings 1Q 2011 with FDA $24M New Funding 2Q 2011 Successful Completion of Thorough 1Q 2012 QT Study Successful Completion of 1Q 2012 Metabolism Study Human Factors Validation Study 2Q 2012* Complete CMC Activities 2Q 2012
Slide 7: Clinical Summary
Clinical Summary © 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: APF530 Phase 3 Study Design
APF530 Phase 3 Study Design Patient Stratification (n = 1,341) Moderately Emetogenic Highly Emetogenic (n = 634) (n = 707) Cycle 1 APF530 APF530 APF530 APF530 Aloxi Aloxi (5mg) (10mg) (5mg) (10mg) Cycles APF530 APF530 APF530 APF530 2 to 4 (5mg) (10mg) (5mg) (10mg) March 2012 © 2012. A.P. Pharma, Inc
Slide 10: 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) March 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 10
Slide 11: Primary Efficacy Results: Complete Response
Primary Efficacy Results: Complete Response Patients Receiving Highly Emetogenic Chemotherapy 100 90 80.7 81.3 77.7 80 Acute 66.4 68.3 70 64.6 60 APF530 5mg 50 Delayed 40 30 20 Acute 10 APF530 10mg 0 Delayed -15 -10 -5 0 5 10 15 Acute Delayed Difference in Complete Response APF530-Aloxi (98.33% CI)
Slide 12: Safety Summary
Safety Summary Reported in Cycle 1 APF530 5 mg APF530 10 mg Aloxi 0.25 mg N % N % N % 1 Drug Related Serious Adverse Events 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 13: 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 14: 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* 100 87.2 90 79.1 80 76.3 68.3 70 65.0 62.2 58.7 60 54.3 50 40 30 20 10 0 Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 1 Cycle 2 Cycle 3 Cyc
Slide 15: 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 16: Regulatory Status
Regulatory Status © 2012. A.P. Pharma, Inc. All rights reserved. 16
Slide 17: APF530 NDA Status
APF530 NDA Status Submitted NDA in May 2009 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 studies Presentation of data H
Slide 18: 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 Validation protocol under review by FDA Chemistry, Manufacturing, and Controls
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: Cardiac Safety Concerns in 5-HT3 Antagonist Class
Cardiac Safety Concerns in 5-HT3 Antagonist Class “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 and repeat courses of emetogenic cancer c
Slide 21: 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 50µg/kg over 3 minutes – 5x therapeutic dose Oral Moxifloxacin 400 mg (Avelox®) – positive control Placeb
Slide 22: 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 23: Granisetron Thorough QT PK/PD Results
Granisetron Thorough QT PK/PD Results ddQTcF vs. Granisetron Plasma Concentration Slope = -0.019 Plasma Concentration (ng/ml) March 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 23
Slide 24: Metabolism Study
Metabolism Study Protocol reviewed by FDA prior to starting study Single blind, single site 14 healthy male and female subjects Gather and analyze plasma and urine samples for metabolic products Results corroborated in humans the metabolism data previously observed in preclinical animal studies Stud
Slide 25: Commercial Opportunity
Commercial Opportunity © 2012. A.P. Pharma, Inc. All rights reserved. 25
Slide 26: 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 27: 1st Generation 5-HT3 Antagonist Study Results
st 1 Generation 5-HT3 Antagonist Study Results Average Overall Complete Response* rates Moderately Emetogenic Chemotherapy ~ 42% Highly Emetogenic Chemotherapy ~ 39% Overall Complete Response rates by study: Moderately Emetogenic Chemotherapy - Ondansetron Gralla Eisenberg 50% 34% Highly Emetogenic
Slide 28: Aloxi Study Results
Aloxi Study Results Average Overall Complete Response rates Moderately Emetogenic Chemotherapy ~ 57% Highly Emetogenic Chemotherapy ~ 51% Overall Complete Response rates by study: Moderately Emetogenic Chemotherapy Eisenberg Gralla Grunberg Hajdenberg APPA Ph 3 46% 69% 59% 59% 52% Highly Emetogenic
Slide 29: 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 30: CINV Market Dynamics
CINV Market Dynamics Injectable Drugs for the Prevention of CINV Number of Package Units Sold by Quarter * US Oncology data added starting Q1'09. Source: Wolters Kluwer Usage in CINV estimated based on vial size March 2012 © 2011. A.P. Pharma, Inc. All rights reserved. 30
Slide 31: Aloxi Market Performance
Aloxi Market Performance Aloxi Sales 450 Pricing Average Selling Price = $175 400 Zofran went Medicare Reimbursement = $186 350 generic Wholesale Acquisition Cost ~ $300 - $330 300 250 Orange Book Patent Exclusivity 200 One patent expires April 2015 150 Three patents expire January 2024 100 50 0 200
Slide 32: 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 2Q 2011 Kytril was widely used prior to Zofran® going generic High physician acceptance of granisetron Aloxi dipped 30% when Zofran went
Slide 33: 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 preve
Slide 34: APF530 Commercialization Strategy
APF530 Commercialization Strategy A.P. Pharma owns worldwide rights to APF530 APF530 can be commercialized with a compact commercial infrastructure targeting oncologists Company evaluating partnering opportunities March 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 34
Slide 35: Financial Summary
Financial Summary Completed $24MM PIPE in July 2011 Current resources expected to fund Company into 2013 Summary Statement of Operations Year Ended (In thousands, except per share data) December 31, 2011 Revenue $ 646 Operating expenses 11,708 1 Other income (expenses) (752) Net loss $ (11,814) 2 Ne
Slide 36: 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 APF
Slide 37: Thank You
Thank You A.P. Pharma, Inc. OTCBB: APPA March 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 37