EX-99.1 2 d565664dex991.htm EX-99.1

Company Overview OTCBB: APPA July 2013 Exhibit 99.1

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 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. 2 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

Company: A.P. Pharma, Inc. Ticker: OTCBB: APPA.OB Stock Price: $0.39 (7/5/2013) Market Capitalization: $119.2 million 1 Cash: $46 million 2 Debt: $4.8 million 2 Stock Summary 1 Based on 305.6 million common shares outstanding. Does not include outstanding warrants for 81.1 million shares with weighted average exercise price of $0.22/share, nor shares issuable upon conversion of notes convertible for up to 120.3 million shares based on a rate of 25,000 shares for every $1,000 of principal, nor currently exercisable employee stock options for up to 27.1 million shares with weighted average exercise price of $0.38/share. 2 As of March 31, 2013 3 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

Barry D. Quart, Pharm.D. Chief Executive Officer Ardea Biosciences Agouron Pharmaceuticals Pfizer Robert Rosen President & Chief Commercial Officer Bayer Healthcare Sanofi-Synthèlabo Imclone Steve Davis Chief Operating Officer Ardea Biosciences Neurogen Mark Gelder, M.D. Senior Vice President & Chief Medical Officer GE Healthcare Bayer Healthcare Wyeth Senior Management 4 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

A.P. Pharma Highlights July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 5 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 Patent coverage into 2024 APF530 shown to be non-inferior to market leader Aloxi ® 1,341-patient, randomized, controlled, Phase 3 study APF530 targets a large market opportunity, with approximately 7 million doses of chemotherapy annually in US alone* Recent competitive setbacks could enhance commercial uptake Could be second, long-acting, injectable product on market A.P. Pharma has the potential to leverage its Biochronomer™ drug delivery technology, its development capacity and commercial expertise into other opportunities *TDR August 2006 internal report

Clinical Summary 6 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

A Pivotal, Phase 3, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Palonosetron (Aloxi ® ) for CINV 1428 chemotherapy patients stratified by HEC or MEC First Randomization Primary Endpoint* Cycle 1 Cycles 2-4 Second Randomization All patients received dexamethasone as appropriate to their chemotherapy stratum. © 2013. A.P. Pharma, Inc. All rights reserved. 7 1,341 patients in primary efficacy population Placebo SC + Palonosetron 0.25 mg IV APF530 5 mg SC + Placebo IV APF530 10 mg SC + Placebo IV APF530 5 mg SC APF530 10 mg SC APF530 5 mg SC APF530 10 mg SC * 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. July 2013

APF530 Pharmacokinetics July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 8 Granisetron is released rapidly following injection of APF530 and continues to be released over at least 5-days, with therapeutic concentrations observed out to 6 days *Data from patent application 20120258164 for transdermal granisetron Time after Dosing (h) Minimum therapeutic concentration of granisetron*

Primary Efficacy Results: Complete Response Patients Receiving Moderately Emetogenic Chemotherapy Acute Delayed APF530 10mg Acute Delayed Difference in Complete Response APF530-Aloxi (97.5% CI) 9 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

Primary Efficacy Results: Complete Response Difference in Complete Response APF530-Aloxi (98.33% CI) Acute Delayed APF530 10mg Patients Receiving Highly Emetogenic Chemotherapy Acute Delayed 10 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

Safety Summary 1 Safety results with the 5 mg dose of APF530 studied in separate arm of the phase 3 study are not included 2 >90% of injection site reactions were reported as mild; one patient discontinued due to injection site reaction Reported in Cycle 1 11 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. APF530 10 mg Aloxi 0.25 mg N % N % Drug Related Serious Adverse Events 0 0 0 0 Discontinued Due to Adverse Event 1 0.2 0 0 Frequent Adverse Events Gastrointestinal Disorders Constipation Diarrhea Abdominal pain 72 44 13 15.4 9.4 2.8 62 39 28 13.4 8.4 6.0 Nervous System Headache 47 10.0 45 9.7 Injection Site Placebo (NaCl) Bruising Erythema (redness) Nodule (lump) Pain 93 51 50 33 19.9 10.9 10.7 7.1 41 14 3 5 8.9 3.0 0.6 1.1 2 1

Efficacy through Multiple Chemotherapy Cycles July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 12 1 Overall Complete Response defined as no emesis and no rescue medications during 0 to 120 hours following chemotherapy Moderately Emetogenic Chemotherapy Highly Emetogenic Chemotherapy Overall Complete Response Rates 1 for APF530 10 mg

Sustained Efficacy of APF530 in Cycles 1-4 *Sakai et al (Ann Oncol. 2008;19) Complete Response Rates for Delayed-Onset CINV in Patients Receiving Highly Emetogenic Chemotherapy 351 315 254 117 100% 90% 72% 33% 240 171 130 95 100% 71% 54% 40% N = % of Cycle 1 APF530 500 mg Palonosetron 0.75 mg* © 2013. A.P. Pharma, Inc. All rights reserved. CONFIDENTIAL 13 *Source: Majaro Tables, 14_2_1_91b and 14_2_1_14_1 July 2013

APF530’s Efficacy with Difficult Chemo Regimens 1 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% 1 Data from post-hoc analysis. Not statistically significant. Highlighted MEC regimen changed to HEC in 2011 ASCO Guidelines 14 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

Efficacy Maintained With Reanalysis of HEC Protocol Specified HEC Population Acute Delayed 15 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. Acute Delayed ASCO 2011 Guideline HEC Population

Summary of Clinical Results Bioerodible polymer technology releases granisetron to prevent CINV over at least 5 days Large, randomized, Phase 3 study conducted with APF530 showing non-inferiority to Aloxi with the 10 mg of APF530 For both acute- and delayed-onset CINV With both moderately and highly emetogenic chemotherapy APF530 was well-tolerated Incidence of adverse events comparable to Aloxi Injection site reactions where predominately mild Good response rates were observed in difficult chemotherapy regimens Efficacy was maintained with reanalysis using ASCO 2011 guidelines and through multiple cycles of chemotherapy TQT study showed APF530 has no effect on QT; differentiated from Zofran (most common dose restricted) and Anzemet (CINV claim removed) 16 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

Regulatory Status 17 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

APF530 NDA Status Submitted NDA in May 2009 under 505(b)(2) filing pathway Received Complete Response Letter in March 2010 FDA raised major issues in three main areas: Dosing system Chemistry, Manufacturing, and Controls (CMC) Clinical/statistical Resubmitted NDA in September 2012 Addressed issues raised in Complete Response Letter Received Complete Response Letter March 2013 raising three main issues: CMC: correction of PAI issues and revision of one in-vitro release method Requirement for Human Factors Validation Study with commercial product Re-analysis of the existing Phase 3 study using the ASCO 2011 guidelines for catagorization of MEC and HEC 18 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

New Management Team is Addressing the CRL Chemistry, Manufacturing, and Controls Sites with PAI issues are being eliminated from the supply chain, with work transferred to well established site with no PAI issues Secondary benefit of consolidating manufacturing and release efforts: substantial improvement in COGS New in-vitro release method has been developed and being validated Plan to produce three validation batches of finished product in advance of re-filing to supply Human Factors Study Human Factors Study Will be conducted as soon as commercial material available Re-analysis of Phase 3 using new ASCO 2011 Guidelines Re-analysis complete Complete dataset and programs ready to supply to FDA Re-submission is now planned for 1Q2014 19 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

Commercial Opportunity 20 © 2013. A.P. Pharma, Inc. All rights reserved. July 2013

Continuing Unmet Need in CINV Need for long-acting antiemetic therapies Delayed CINV (days 2-5) remains particularly challenging to manage Significant portion of patients fail to respond to Aloxi Need for antiemetic therapies with sustained efficacy CINV risk increases over multiple chemotherapy cycles 1 Available at: http://www.cancer.gov/cancertopics/pdq/supportivecare/nausea/HealthProfessional/page6#Section_183 “Despite the use of both first-generation and second-generation 5-HT 3 receptor antagonists, the control of acute CINV, and especially delayed nausea and vomiting, is suboptimal, and there is considerable opportunity for improvement with either the addition or substitution of new agents in current regimens.” NCI Statement On The Existing Unmet Need in CINV 21 © 2013. A.P. Pharma, Inc. All rights reserved. 1 July 2013

Addressing Debilitating Effects of CINV July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 22 More than 7 million cycles of chemotherapy administered each year* ~27% are highly emetogenic ~46% are moderately emetogenic Most chemotherapy patients will undergo 4-15 cycles of chemotherapy 5-HT3 antagonists are standard- of- care for CINV Recommended in ASCO, NCCN and ONS guidelines NK-1 antagonists are only indicated in combination with 5-HT3 antagonists An Injectable 5-HT3 antagonist is co-administered with more than 90% of MEC and HEC regimens If initial regimen is non-effective, drugs are added or changed to address CINV in subsequent cycles *TDR August 2006

5-HT3 Antagonists Have Made a Substantial Impact The use of high-dose metoclopramide Introduction of first-generation 5-HT3 antagonists (short-acting) Approval of second-generation 5-HT3 antagonist (long-acting) Approval of first NK-1 antagonist Adapted from Hawkins et al, Clinical Journal of Oncology Nursing 2009, Volume 13, Number 1 FDA withdrawal of Anzemet and 32 mg dose of ondansetron (Zofran) due to QT prolongation risk 5-HT3 receptor antagonists approved for CINV © 2013. A.P. Pharma, Inc. All rights reserved. 23 Chemotherapy Acute CINV Delayed CINV Highly Emetogenic granisetron (Kytril) ondansetron (Zofran) Aloxi None Moderately Emetogenic granisetron (Kytril) ondansetron (Zofran) Aloxi Aloxi July 2013

24 U.S. CINV Market Dynamics Source: WK 07/2013 July 2013 * US Oncology data added starting 1/2009. 0 100,000 200,000 300,000 400,000 500,000 600,000 700,000 800,000 Q2'06 Q4'06 Q2'07 Q4'07 Q2'08 Q4'08 Q2'09 Q4'09 Q2'10 Q4'10 Q2'11 Q4'11 Q2'12 Q4'12 ALOXI ANZEMET KYTRIL KYTRIL Generic (GRANISETRON) ZOFRAN ZOFRAN Generic (ONDANSETRON) EMEND Injectable Drugs for the Prevention of CINV Number of Package Units Sold by Quarter

Aloxi Market Performance Zofran went generic Pricing Average Selling Price = $175 Medicare Reimbursement = $186* Wholesale Acquisition Cost ~ $380 Orange Book Patent Exclusivity One patent expires April 2015 Three patents expire January 2024 25 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. *ASP plus 6% Aloxi Sales

~80% of Aloxi Is Used in Clinics Hospital Other Clinics 1 2.2 million units 2 0.5 million units 0 3 0.1 million units U.S. Aloxi Units by Class of Trade – 12 Months Ending June 30 2012 IMS Health and Source Healthcare Analytics (WKH) data and Eisai Co., Ltd. published sales figures 26 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. th

>90% of Aloxi Units Contracted Through GPOs July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 27 2.2 Million Clinic Units 8% 23% 48% 21% Misc Onmark ION USO IMS Health and Source Healthcare Analytics (WKH) data and Eisai Co., Ltd. published sales figures Clinic Units by GPO – 12 Months Ending June 30 th 2012

WKH Data Oct. 2012 – Clinic Analysis Aloxi Clinical Use Is Largely Concentrated Cumulative Number of Accounts 32 1% accts 87 4% accts 161 7% accts 252 11% accts 500 22% accts 674 29% accts 904 39% accts 1246 54% accts 2305 100% accts 362 15% accts 80% of units (1.7M) comes from 39% of accounts (904) 50% of units (1.1M) comes from 15% of accounts (362) 28 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 0 200 400 600 800 1,000 1,200 1,400 1,600 1,800 2,000 2,200

No New Injectable 5-HT3 Drug on Horizon 29 2012 *Company reports, Leerink Swann; **Clinical Trials.gov NCT01339260 FDC = Fixed Dose Combo; PDUFA date expected 12-15 months post P3 data 2013 2014 2015 EUR-1025 development program uncertain (once-a-day oral modified-release formulation of ondansetron) July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. Rolapitant P3 Oral Data Expected 2H 2013 Rolapitant Oral FDA Approval Expected Q4 2014 Rolapitant IV Study Data 1H 2014 Rolapitant IV FDA Approval Expected 2H 2015 FDC P3 Oral Data Expected Q1 2013 FDC Oral FDA Approval 1H 2014 Candidate Class Indication Sponsor Possible Launch APF530 5-HT3 Extended release Prevention of CINV in MEC/HEC A.P. Pharma 2H 2014 FDC** FDC combines netupitant (NK-1) with palonosetron (Aloxi) in a single oral tablet Prevention of CINV in MEC/HEC Eisai / Helsinn Oral 2H 2014 Rolapitant* Long-acting NK-1 Prevention of CINV in MEC/HEC only in combination with 5-HT3 Tesaro Oral 2H 2014 IV 2H 2015

APF530 Proposed Label July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 30 Proposed indication submitted in NDA INDICATIONS AND USAGE 1.1 Chemotherapy-Induced Nausea and Vomiting APF530 is indicated for: • Moderately emetogenic cancer chemotherapy (MEC)- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses • Highly emetogenic cancer chemotherapy (HEC)- prevention of acute nausea and vomiting associated with initial and repeat courses

CINV Market July 2013 31 © 2013. A.P. Pharma, Inc. All rights reserved. *Indications requested in previous submission Acute Onset (0-24 Hours) Delayed Onset (24-120 Hours) Moderately Emetogenic Highly Emetogenic Moderately Emetogenic Highly Emetogenic APF530* Aloxi Kytril Zofran

Summary July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 32 CINV market is a large commercial opportunity, with approximately 7 million doses of chemotherapy per year in US APF530 demonstrated non-inferiority to the market share leader Aloxi, with 2012 annual sales of $440M and ~50% unit market share APF530 product profile 5-day release PK profile Good response in difficult chemotherapy regimens Efficacy through multiple cycles of chemotherapy Clean QT results Current market dynamics are stale with minimal investment providing opportunities to become the market leader Competitive landscape creates opportunity with the removal of Anzemet and Zofran 32mg Greater than 80% of Aloxi sales are in the community setting and highly concentrated consistent with other supportive care products 1. TDR August 2006 internal report; 2. 2012 Eisai Annual Report; 3. Wolters Kluwer 1 2 3

A.P. Pharma Product Lifecycle Considerations 33 APF530 covered by multiple patents 2 patents covering combination of polymer, excipients and drug expire in 2021 3 patents covering APF530 expire in 2024 Polymer-based injectable products are difficult to copy independent of IP ANDA FDA requirements for injectable products Must have same inactive ingredients in the same concentration as the reference listed drug Polymers are complex mixtures of varying-length molecules, making characterization for “sameness” very challenging July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.

Financial Summary July 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 34 Expect cash sufficient to fund through resubmission of APF530 NDA Summary Statement of Operations (In thousands, except per share data) Three Months Ended March 31, 2013 Revenue $ – Operating expenses 12,752 Other income (expenses) (201) Net loss $ (12,953) Net loss per share 1 $ (0.04) Condensed Balance Sheet Data (In thousands) March 31, 2013 Cash and cash equivalents $ 45,722 Total assets $ 48,979 Total stockholders’ equity $ 41,383 1 Based on 305.1 million weighted average common shares outstanding for the period ended March 31, 2013.

Thank You A.P. Pharma, Inc. OTCBB: APPA July 2013 35 July 2013 © 2013. A.P. Pharma, Inc. All rights reserved.