EX-99.1 2 d323470dex991.htm CORPORATE PRESENTATION

Company Overview OTCBB: APPA March 2012 Exhibit 99.1

Legal Disclaimer March 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 2 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 of new products, satisfactory completion of clinical studies, establishment of new corporate alliances, progress in research and development programs and other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. Actual results may differ materially from the results expected in our forward looking statements. We caution investors that forward-looking statements reflect our analysis only on their stated date. We do not intend to update them except as required by law.

Company: A.P. Pharma, Inc. Ticker: OTCBB: APPA.OB Stock Price: $0.33 (3/23/12) Market Capitalization: $111.2 million 1 Cash: $18.0 million 2 Debt: $1.57 million 2 Stock Summary 3 1 Based on 394.5 million fully diluted, as-converted common shares assuming the full conversion of convertible debt outstanding or subject to purchase rights and 80 million warrants using treasury stock method; not including options 2 As of December 31, 2011 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

John B. Whelan President, CEO & CFO Raven Biotechnologies Eos Biotechnology Hewlett Packard/Agilent Michael A. Adam, Ph.D. Senior Vice President & Chief Operating Officer Spectrum Pharmaceuticals Pfizer Bristol-Myers Squibb Thomas Ottoboni, Ph.D. Vice President, Pharmaceutical Development Talima Therapeutics Point Biomedical InSite Vision Kristin Ficks* Head of Commercial Operations Gemini Healthcare Celgene Eisai/MGI Pharma Management 4 *Ms. Ficks is an employee of Gemini Healthcare, LLC, and a consultant to A.P. Pharma © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

A.P. Pharma Highlights 5 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 APF530 shown to be non-inferior to market leader Aloxi ® 1,341-patient, randomized, controlled, Phase 3 study Presented at ASCO 2009 Company is addressing issues raised in Complete Response Letter End-of-review meetings held in 1Q 2011 Resubmission planned for mid-2012 APF530 targets a $900 million market opportunity in US alone Could be second, long-acting, injectable product on market A.P. Pharma has the potential to leverage its Biochronomer™ drug delivery technology into other opportunities © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

Important APF530 Milestones March 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 6 Milestone Timing Status Successful end-of-review meetings with FDA 1Q 2011 $24M New Funding 2Q 2011 Successful Completion of Thorough QT Study 1Q 2012 Successful Completion of Metabolism Study 1Q 2012 Human Factors Validation Study 2Q 2012* Complete CMC Activities 2Q 2012* Resubmit NDA Mid-2012* Expected NDA Approval Decision ~Year-end 2012* * Indicates expected milestone timing

Clinical Summary 7 © 2012. A.P. Pharma, Inc. All rights reserved.

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) Primary end point compared complete response between groups in both the acute (day 1) and delayed (days 2-5) phase Complete response defined as no emesis and no rescue medications A ±15% margin was used to establish non-inferiority 8 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

APF530 Phase 3 Study Design APF530 (10mg) APF530 (5mg) APF530 (5mg) Aloxi APF530 (10mg) APF530 (5mg) Aloxi APF530 (10mg) APF530 (5mg) APF530 (10mg) Cycle 1 Cycles 2 to 4 Patient Stratification (n = 1,341) Moderately Emetogenic (n = 634) Highly Emetogenic (n = 707) 9 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

Primary Efficacy Results: Complete Response Patients Receiving Moderately Emetogenic Chemotherapy 10 Acute Delayed APF530 5mg APF530 10mg Acute Delayed Acute Delayed Difference in Complete Response APF530-Aloxi (97.5% CI) -15 -10 -5 0 5 10 15 March 2012 © 2012. A.P. Pharma, Inc. All rights reserved.

Primary Efficacy Results: Complete Response Difference in Complete Response APF530-Aloxi (98.33% CI) -15 -10 -5 0 5 10 15 Acute Acute Delayed Delayed APF530 5mg APF530 10mg Patients Receiving Highly Emetogenic Chemotherapy 11 Acute Delayed March 2012 © 2012. A.P. Pharma, Inc. All rights reserved. 80.7 77.7 81.3 66.4 64.6 68.3 0 10 20 30 40 50 60 70 80 90 100

Safety Summary 1 Pulmonary embolism in morbidly obese patient on day 16 2 >90% of injection site reactions were reported as mild; one patient discontinued due to Reported in Cycle 1 12 March 2012 © 2012. A.P. Pharma, Inc. All rights reserved. N % N % N % Drug Related Serious Adverse Events 1 0.2 0 0 0 Discontinued Due to Adverse Event 1 0.2 1 0.2 0 0 Frequent Adverse Events Gastrointestinal disorders Constipation Diarrhea Abdominal pain 62 49 21 13.4 10.6 4.5 72 44 13 15.4 9.4 2.8 62 39 28 13.4 8.4 6.0 Nervous System Headache 31 6.7 47 10.0 45 9.7 Injection Site 2 Placebo (NaCl) Bruising Erythema (redness) Nodule (lump) Pain 78 33 22 16 16.8 7.1 4.7 3.4 93 51 50 33 10.9 10.7 7.1 14 3 5 8.9 3.0 0.6 1.1 0 19.9 41 APF530 5 mg APF530 10 mg Aloxi 0.25 mg injection site reaction 1

APF530’s Efficacy with Difficult Chemo Regimens 13 Treatment Chemotherapeutic Regimen APF530 10 mg Aloxi 0.25 mg Moderately Emetogenic Acute Cyclophosphamide/Doxorubicin 70.7% 65.7% All other regimens 84.4% 85.0% Delayed Cyclophosphamide/Doxorubicin 47.4% 46.3% All other regimens 72.9% 70.0% Highly Emetogenic Acute Cisplatin regimens 81.1% 75.5% Carboplatin/Paclitaxel 85.4% 89.8% All other regimens 75.4% 67.6% Delayed Cisplatin regimens 66.0% 60.4% Carboplatin/Paclitaxel 70.8% 71.4% All other regimens 65.2% 57.4% March 2012 © 2012. A.P. Pharma, Inc. All rights reserved.

APF530’s Sustained Efficacy in Cycles 2-4 14 * Sakai et al (Annals of Oncology, Vol. 19 Sept. 2008) Complete Response Rates for Delayed-onset CINV in Patients Receiving Highly Emetogenic Chemotherapy 351 315 254 117 100% 90% 72% 33% 240 169 129 94 100% 70% 54% 39% N = % of Cycle 1 APF530 10mg Aloxi 0.75mg* © 2012. A.P. Pharma, Inc. All rights reserved. March 2012 68.3 76.3 79.1 87.2 58.7 54.3 62.2 65.0 0 10 20 30 40 50 60 70 80 90 100 Cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 1 Cycle 2 Cycle 3 Cycle 4

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 Incidence of adverse events comparable to Aloxi High response rates were observed in difficult chemotherapy regimens A high level of efficacy was maintained through multiple cycles of chemotherapy 15 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

Regulatory Status 16 © 2012. A.P. Pharma, Inc. All rights reserved.

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 Held end-of-review meetings with FDA in 1Q 2011 No additional clinical efficacy studies requested Implementing plan to resubmit NDA in mid-2012 17 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

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 Change from bulk to terminal irradiation – feasibility completed Additional specifications and assays for raw materials, polymer and drug product – in progress Manufacturing runs incorporating these changes – in progress Clinical/Statistical Thorough QT study – completed Metabolism study – completed Phase 3 clinical data presentation revision – in progress 18 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

Thorough QT Study Background 19 Prolongation of the QT/QTc interval is associated with increased susceptibility to fatal cardiac tachyarrhythmias Thorough QT studies are intended to determine whether a drug has a threshold pharmacologic effect on cardiac repolarization Thorough QT studies are now routinely required by the FDA prior to drug approval The QT interval represents the amount of time the heart’s electrical system takes to repolarize after each beat © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

Cardiac Safety Concerns in 5-HT3 Antagonist Class 20 “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 chemotherapy.” - FDA Drug Safety Communication, Dec. 17, 2010 “Ondansetron (Zofran) may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.” - FDA Drug Safety Communication, Sept. 15, 2011 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

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 Placebo 0.9% Normal Saline 0.84 mL Primary endpoint: the upper bound of the one-sided 95% confidence interval for placebo-adjusted, baseline- subtracted QTcF being less than 10 milliseconds at all time points 21 March 2012 © 2012. A.P. Pharma, Inc. All rights reserved.

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, QTcB PK/PD relationship was flat – also showing no QTc signal Valid Study Moxifloxacin positive control group showed expected change – assay sensitivity reached 22 March 2012 © 2012. A.P. Pharma, Inc. All rights reserved.

Granisetron Thorough QT PK/PD Results 23 March 2012 © 2012. A.P. Pharma, Inc. All rights reserved. Plasma Concentration (ng/ml) ddQTcF vs. Granisetron Plasma Concentration Slope = -0.19

Metabolism Study 24 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 Study results will be included in NDA resubmission March 2012 © 2012. A.P. Pharma, Inc. All rights reserved.

Commercial Opportunity 25 © 2012. A.P. Pharma, Inc. All rights reserved.

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 Recommended in treatment guidelines – NCCN, ASCO, ONS An injectable 5-HT3 antagonist is co-administered with more than 90% of moderately and highly emetogenic regimens APF530 targets a $900 million market opportunity in the US alone In 2010, there were 5.14 million vials of injectable 5-HT3 antagonists administered for CINV The average selling price for market leader Aloxi is $175 Sources: Company-sponsored survey and analysis and Wolters Kluwer 26 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

1 st Generation 5-HT3 Antagonist Study Results 27 Moderately Emetogenic Chemotherapy - Ondansetron Gralla Eisenberg 50% 34% Highly Emetogenic Chemotherapy Ondansetron Granisetron Aapro Emend Label Studies Emend Label Saito 25% 43% 52% 43% 33% 40% Average Overall Complete Response* rates Moderately Emetogenic Chemotherapy ~ 42% Highly Emetogenic Chemotherapy ~ 39% Overall Complete Response rates by study: *Overall Complete Response defined as no emesis and no rescue medications during 0 to 120 hours following chemotherapy © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

Aloxi Study Results 28 Moderately Emetogenic Chemotherapy Eisenberg Gralla Grunberg Hajdenberg APPA Ph 3 46% 69% 59% 59% 52% Highly Emetogenic Chemotherapy Aapro APPA Ph 3 41% 62% Average Overall Complete Response rates Moderately Emetogenic Chemotherapy ~ 57% Highly Emetogenic Chemotherapy ~ 51% Overall Complete Response rates by study: © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

Antiemetic Treatment Patterns 29 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 Issues controlling CINV typically appear during the first few cycles If the initial prevention regimen is not effective, drugs are added and/or changed to address CINV in subsequent cycles No long-acting injectable alternative to Aloxi is available to prevent delayed-onset CINV © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

© 2011. A.P. Pharma, Inc. All rights reserved. 30 March 2012 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

Aloxi Market Performance 31 Pricing Average Selling Price = $175 Medicare Reimbursement = $186 Wholesale Acquisition Cost ~ $300 - $330 Orange Book Patent Exclusivity One patent expires April 2015 Three patents expire January 2024 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012 Zofran went generic Aloxi Sales 2004 2005 2006 2007 2008 2009 2010 0 50 100 150 200 250 300 350 400 450

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 generic but then regained 100% of its lost share two quarters later NK1 antagonists typically are only used as an adjunct to 5- HT3 antatgonists Injectable Emend ® units sold less than 10% of injectable units sold for CINV prevention 32 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

APF530’s Potential Competitive Positioning 33 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 prevent CINV Most patients undergo 4 to 15 cycles of chemotherapy Product Effective for Delayed- onset CINV Cardiac Safety Aloxi Yes Clean tQT results Anzamet No QT effect – contraindicated for CINV Zofran/ondansetron No Warning added to label Kytril/granisetron No - AFP530 Yes Clean tQT results March 2012 © 2012. A.P. Pharma, Inc. All rights reserved.

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 34 © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

Financial Summary 35 Completed $24MM PIPE in July 2011 Current resources expected to fund Company into 2013 Summary Statement of Operations (In thousands, except per share data) Year Ended December 31, 2011 Revenue $ 646 Operating expenses 11,708 Other income (expenses) 1 (752) Net loss $ (11,814) Net loss per share 2 $ (0.10) Condensed Balance Sheet Data (In thousands) December 31, 2011 December 31, 2010 Cash and cash equivalents $ 17,974 $ 2,109 Working capital $ 14,547 $ 941 Total assets $ 19,445 $ 2,911 Total stockholders’ equity $ 15,752 $ 1,316 1 Includes discontinued operations 2 Based on 120.3 million weighted average common shares outstanding © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

A.P. Pharma Highlights 36 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 APF530 shown to be non-inferior to market leader Aloxi ® 1,341-patient, randomized, controlled, Phase 3 study Presented at ASCO 2009 Company is addressing issues raised in Complete Response Letter End-of-review meetings held in 1Q 2011 Resubmission planned for mid-2012 APF530 targets a $900 million market opportunity in US alone Could be second, long-acting, injectable product on market A.P. Pharma has the potential to leverage its Biochronomer™ drug delivery technology into other opportunities © 2012. A.P. Pharma, Inc. All rights reserved. March 2012

Thank You A.P. Pharma, Inc. OTCBB: APPA March 2012 37 © 2012. A.P. Pharma, Inc. All rights reserved.