Slide 1: Company Overview
Exhibit 99.1 Company Overview OTCQB: APPA.PK September 2011
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: OTCQB: APPA.PK Stock Price: $0.25 (9/16/11) 1 Market Capitalization: $98.1 million 2 Cash: $23.6 million 3 Debt: $1.5 million 1 Based on 392.5 million as-converted common shares assuming the full conversion of convertible debt outstanding or subject t
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 John Barr, Ph.D. Senior Vice President, Cortech Research and Deve
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 5HT3 anatgonist - granisetron (Kytril®) 5-day delivery profile Reduces both acute- and delayed-onset CINV with single injection APF53
Slide 6: Product Pipeline
Product Pipeline Product Potential Target Candidate Indication Drug Duration Preclinical Phase 1 Phase 2 Phase 3 NDA Chemotherapy- induced nausea Granisetron 5 days APF530 and vomiting Post-surgical pain relief Mepivacaine 3 days APF112 (opiate-sparing) Sustained pain Buprenorphine 7 days APF580 rel
Slide 7: APF530 Milestones 2011 - 2012
APF530 Milestones 2011 - 2012 Complete thorough QT and Complete validation activities metabolism study Complete human factors study FDA approval decision 1Q 2012 2Q 2012 2H 2012 Complete CMC activities Resubmit APF530 NDA September 2011 © 2011. A.P. Pharma, Inc. All rights reserved. 7
Slide 8: Clinical Summary
Clinical Summary September 2011 © 2011. A.P. Pharma, Inc. All rights reserved. 8
Slide 9: 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 10: 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 Aloxi APF530 APF530 APF530 APF530 Aloxi (5mg) (10mg) (5mg) (10mg) Cycles APF530 APF530 APF530 APF530 2 to 4 (5mg) (10mg) (5mg) (10mg) September 2011 © 2011. A.P. Pharma,
Slide 11: Primary Efficacy Results: Complete Response
Primary Efficacy Results: Complete Response Patients Receiving Moderately Emetogenic Chemotherapy 75 74.8 76.9 Acute 57.7 59.0 51.4 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) September 2011 © 2011. A.P. Phar
Slide 12: Primary Efficacy Results: Complete Response
Primary Efficacy Results: Complete Response Patients Receiving Highly Emetogenic Chemotherapy 80.7 81.3 77.7 68.3 Acute 66.4 64.6 APF530 5mg Delayed Acute APF530 10mg Delayed Acute Delayed Difference in Complete Response APF530-Aloxi (98.33% CI) September 2011 © 2011. A.P. Pharma, Inc. All rights re
Slide 13: Safety Summary
Safety Summary Reported in Cycle 1 APF530 5 mg APF530 10 mg Aloxi 0.25 mg N % N % N % 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 Nausea 56 12.1 60 12.8 41 8.9 Diarrhea
Slide 14: 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 15: 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 16: Summary of APF530 Phase 3 Results
Summary of APF530 Phase 3 Results 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 Incidence of adverse events comparable to Aloxi High response rates were observed in difficult
Slide 17: Regulatory Status and Strategy
Regulatory Status and Strategy September 2011 © 2011. A.P. Pharma, Inc. All rights reserved. 17
Slide 18: 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 19: Outcome of FDA Meetings
Outcome of FDA Meetings Dosing System Changed to single-syringe system Single glass syringe for storage and administration Smaller needle: switch from 1” x 16 gauge to 5/8” x 18 gauge thin-wall Enhanced dosing instructions Overall, simpler and more convenient Non-clinical human factors study planned
Slide 20: Commercial Opportunity
Commercial Opportunity September 2011 © 2011. A.P. Pharma, Inc. All rights reserved. 20
Slide 21: 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 5HT3 antagonists are standard-of-care for CINV Recommen
Slide 22: 1st Generation 5HT3 Antagonists Study Results
1st Generation 5HT3 Antagonists 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 C
Slide 23: 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 24: 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 25: CINV Injectable Number of Units Sold
CINV Injectable Number 0Q 100,000 200,000 300,000 400,000 500,000 600,000 700,000 800,000 *ALOXI Source: Usage September 25 a.p.pharma 2’06 US Oncology Market in Q3’06 Wolters ANZEMET of CINV Drugs 2011 Package Q4’06 Dynamics estimated data Kluwer © for2011. Units the KYTRIL added Q1’07 Prevention A
Slide 26: Aloxi Market Performance
Aloxi Market Performance Pricing Average Selling Price = $179 Zofran went Medicare Reimbursement = $189 generic Wholesale Acquisition Cost ~ $300 - $330 Orange Book Patent Exclusivity One patent expires April 2015 Three patents expire January 2024 September 2011 © 2011. A.P. Pharma, Inc. All rights
Slide 27: 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 28: Competitive Landscape
Competitive Landscape APF530 would be one of two injectable products approved for preventing delayed-onset CINV 5HT3 antagonists are standard-of-care 1st generation products have limited effectiveness in preventing delayed- onset CINV Patients continue to experience CINV despite currently available
Slide 29: 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 to evaluate partnering opportunities before and after FDA approval September 2011 © 2011. A.P. Pharma, Inc. All rights res
Slide 30: Financial Summary
Financial Summary Completed $24MM PIPE in July 2011 Current resources expected to fund company into 2013 Summary Statement of Operations Six Months Ended (In thousands, except per share data) June 30, 2011 Revenue $ 646 Operating expenses 3,501 1 Other income (expenses) (496) Net loss $ (3,351) 2 Ne
Slide 31: 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 5HT3 antagonist - granisetron (Kytril®) 5-day delivery profile Reduces both acute- and delayed-onset CINV with single injection APF53
Slide 32: Thank You
Thank You A.P. Pharma, Inc. OTCQB: APPA.PK September 2011 © 2011. A.P. Pharma, Inc. All rights reserved. 32