Slide 1: Company Overview
Exhibit 99.3 Company Overview OTCBB: APPA November 2013
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: $0.46 (11/8/2013) 1 Market Capitalization: $237 million 2 Cash: $23 million 2 Debt: $5 million 1 Based on 516 million fully diluted, as-converted common shares assuming the full conversion of convertible debt outstanding an
Slide 4: Senior Management
Senior Management Ardea Biosciences Barry D. Quart, PharmD Chief Executive Officer Agouron Pharmaceuticals Pfizer Bayer Healthcare President & Robert Rosen Sanofi-Synthèlabo Chief Commercial Officer Imclone Ardea Biosciences Stephen Davis Chief Operating Officer Neurogen GE Healthcare Senior Vice Pr
Slide 5: Highlights
Highlights Lead product candidate, SUSTOL™ (formerly known as 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 sin
Slide 6: Strategic Product Development
Strategic Product Development Framework Large, established markets with high unmet need Rapid development & approval pathway based on reformulations and 505(b)(2) strategy Premium pricing through innovation and product differentiation Clearly defined value proposition Opportunities to optimize ROI t
Slide 7: SUSTOL Clinical Summary
SUSTOL Clinical Summary Nov 2013 © 2013. 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 (results from 10 mg dose group presented) Patients stratified by type of chemotherapy
Slide 9: 5-Day Profile: APF530 Pharmacokinetics
5-Day Profile: APF530 Pharmacokinetics Granisetron is released rapidly following injection of APF530 and continues to be released over a 5-day period, providing long-acting coverage for CINV 20 15 All subjects (n= 18) mean ± SEM 10 Minimum therapeutic 5 concentration of granisetron* 0 0 24 48 72 96
Slide 10: Primary Efficacy Results: Complete Response
Primary Efficacy Results: Complete Response Patients Receiving Moderately Emetogenic Chemotherapy 100.0 90.0 80.0 75.0 76.9 70.0 57.2 58.5 60.0 50.0 Acute 40.0 30.0 APF530 10mg Delayed 20.0 10.0 0.0 -15 -10 -5 0 5 10 15 Acute Delayed Difference in Complete Response APF530-Aloxi (97.5% CI) Nov 2013 ©
Slide 11: Primary Efficacy Results: Complete Response
Primary Efficacy Results: Complete Response Patients Receiving Highly Emetogenic Chemotherapy 100 90 80.7 81.3 80 70 64.3 67.1 60 50 Acute 40 APF530 10mg 30 Delayed 20 10 0 -15 -10 -5 0 5 10 15 Acute Delayed Difference in Complete Response APF530-Aloxi (98.33% CI) Nov 2013 © 2013. A.P. Pharma, Inc.
Slide 12: Safety Summary
Safety Summary Reported in Cycle 1 1 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 72 15.4 62 13.4 Diarrhea 44 9.4 39 8.4 Abdominal pain 13 2.8 28 6.0 Nervous
Slide 13: FDA Requested ASCO 2011 Reanalysis Improves Difference Between SUSTOL and Aloxi
FDA Requested ASCO 2011 Reanalysis Improves Difference Between SUSTOL and Aloxi Protocol Specified HEC Population ASCO 2011 Guideline HEC Population 100 100 90 90 81 81 80 80 75 67 67 70 64 70 60 60 56 51 50 50 40 40 30 30 20 20 10 10 0 0 Acute Delayed Acute Delayed Nov 2013 © 2013. A.P. Pharma, Inc
Slide 14: Largest Differences Between Arms is Seen With Most Difficult Chemo Regimens
Largest Differences Between Arms is Seen With 1 Most Difficult Chemo Regimens CR Rates by 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
Slide 15: Summary of Clinical Results
Summary of Clinical Results Bio-erodible polymer technology releases granisetron to prevent CINV over at least 5 days Large, randomized, Phase 3 study conducted: APF530 10 mg showed non-inferiority to Aloxi For both acute- and delayed-onset CINV With both moderately and highly emetogenic chemotherap
Slide 16: SUSTOL Regulatory Status
SUSTOL Regulatory Status Nov 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 16
Slide 17: SUSTOL NDA Status
SUSTOL 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 multiple areas Resubmitted NDA in September 2012 Received Complete Response Letter March 2013 raising three main issues: CMC: correction of PAI issues
Slide 18: New Management Team Is Addressing the CRL
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 Transition is almost complete Secondary benefit of consolidating manufacturing and rele
Slide 19: SUSTOL Life-Cycle Management
SUSTOL Life-Cycle Management Plans to Obtain Post-Approval Indication for “Delayed HEC” Nov 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 19
Slide 20: Palonosetron lacks an indication in delayed HEC
Palonosetron lacks an indication in delayed HEC because it was unable to demonstrate superiority vs. ondansetron Goal for New HEC Study is a Differentiated Target Product Profile* Physician Feedback SUSTOL MEC – acute and delayed CINV “[The delayed HEC study] solidifies my impressionof Indication [A
Slide 21: Planned Phase 3 Delayed HEC Study Schematic
Planned Phase 3 “Delayed” HEC Study Schematic • Study design has been accepted by FDA for obtaining expanded indication • Study is powered to show superiority (10% difference) to three drug “standard of care” for HEC • Study planned to complete late 2014 Cycle 1 Ondansetron 0.15 mg/kg IV (up to 16 m
Slide 22: New SUSTOL Study in Delayed HEC Has a High Likelihood of Success
New SUSTOL Study in Delayed HEC Has a High Likelihood of Success Based on Previous Results Study powered for a 10% difference between arms 20% difference is expected with the addition of fosaprepitant, 100 Projected Standard of Care Phase 3 Study HEC Study Response 90 with addition of NK1 ^^ 80 67 S
Slide 23: SUSTOL Commercial Opportunity
SUSTOL Commercial Opportunity Nov 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 23
Slide 24: Continuing Unmet Need in CINV
Continuing Unmet Need in CINV NCI Statement On The Existing Need for long-acting antiemetic 1 therapies Unmet Need in CINV Delayed CINV (days 2-5) remains particularly challenging to manage “Despite the use of both first-generation Significant portion of patients fail to respond and second-generatio
Slide 25: Addressing Debilitating Effects of CINV
Addressing Debilitating Effects of CINV 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 AS
Slide 26: U.S. CINV Market Dynamics
U.S. CINV Market Dynamics Injectable Drugs for the Prevention of CINV Number of Package Units Sold by Quarter 800,000 700,000 600,000 500,000 400,000 300,000 200,000 100,000 0 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 (GRA
Slide 27: Physicians View SUSTOL As Highly Competitive vs. Palonosetron
Physicians View SUSTOL As Highly Competitive vs. Palonosetron Physicians responded favorably to HTH “Well designed, well done clinical trial, the kind of trial you study design vs. palonosetron – good want to see. I think that’s very favorable.” sample size, clinically meaningful – Oncologist, Mid-s
Slide 28: Significant portion of physicians view SUSTOL as differentiated
Despite lack of commercial presence, a significant portion of physicians view SUSTOL as differentiated Question: “Based on the design and results of these studies, how do you perceive SUSTOL vs. palonosetron?” “Well, this product in comparison to ““The [first] study is compared with Clinically palon
Slide 29: HEC regimens represent a significant market opportunity for SUSTOL
HEC regimens represent a significant market opportunity for SUSTOL Of all HEC administrations, ~20% are given HEC regimens account for ~20% (500K) without concomitant IV 5-HT3 – of palonosetron administrations inconsistent with clinical guidelines 1,600,000 1,463,558 1,200,000 1,400,000 1,000,000 1,
Slide 30: SUSTOL has the potential to be the next generation 5-HT3 receptor antagonist
SUSTOL has the potential to be the next generation 5-HT3 receptor antagonist (RA) 5-HT3 st nd rd 1 generation 2 generation 3 generation RAs ondansetron Products palonosetron SUSTOL granisetron Duration of Short acting Longer acting Long acting action ~ 8 hr half-life ~40 hr half-life PK profile 5-7
Slide 31: Palonosetron Clinical Use Is Highly Concentrated
Palonosetron Clinical Use Is Highly Concentrated 80% of all units (2.2M) comes from community clinics 2,200 80% of clinic units (1.7M) comes from 39% of accounts (904) 2,000 50% of clinic units (1.1M) comes from 15% of accounts (362) 1,800 1,600 1,400 1,200 1,000 800 600 400 200 0 32 87 161 252 362
Slide 32: Summary
Summary CINV market is a large, concentrated commercial opportunity 1 Over 2.7MM annual units of palonosetron 1 >80% of use is in the community practice setting – highly concentrated among large practices Physicians view a non-inferior SUSTOL profile as highly competitive 5-7 day PK profile Non-infe
Slide 33: New Product Initiative
New Product Initiative Nov 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 33
Slide 34: SUSTOL Product Lifecycle Considerations
SUSTOL Product Lifecycle Considerations SUSTOL 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 inject
Slide 35: Biochronomer Triple-Drug Combination for CINV in Dogs
Biochronomer Triple-Drug Combination for CINV in Dogs Single shot with all three of the drugs recommended for HEC Registration could be based primarily on bioequivalence 900 90 800 80 700 NK1 Antagonist 70 600 Granisetron 60 Dexamethasone 500 50 400 40 300 30 200 20 100 10 0 0 0 24 48 72 96 120 144
Slide 36: Biochronomer Bupivacaine/Ropivacaine: Post-Surgical Pain Control
Biochronomer™ Bupivacaine/Ropivacaine: Post-Surgical Pain Control Opportunity to use our polymer for post-surgical pain control utilizing the 505(b)(2) process Once we have an FDA approved polymer, manufacturing site and syringe filler, the next products using the polymer will be much easier and che
Slide 37: Greatest Benefit for EXPAREL Is First 12 Hours
Greatest Benefit for EXPAREL Is First 12 Hours Package insert states that there was minimal to no difference between Exparel and placebo treatments 24-72 hours post-dose* Adapted from EXPAREL Product Monograph *US Package Insert Nov 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 37
Slide 38: Mean Plasma Bupivacaine Concentrations After EXPAREL
Mean Plasma Bupivacaine Concentrations After EXPAREL From FDA Clinical Pharmacology Review Low concentrations of bupivacaine after 24 hr may explain why there was minimal to no difference between Exparel and placebo treatments 24-72 hours post-dose* Data from FDA Clinical Pharmacology Review; NDA 22
Slide 39: Biochronomer Bupivacaine Has Superior PK Profile in Dogs
Biochronomer™ Bupivacaine Has Superior PK Profile in Dogs *Projected from 7.5 mg/kg dose; EXPAREL data from Richard, et. al. 2012 Nov 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 39
Slide 40: Biochronomer Ropivacaine Has Superior PK Profile in Dogs
Biochronomer™ Ropivacaine Has Superior PK Profile in Dogs *Dose adjusted to match bupivacaine; EXPAREL data from Richard, et. al. 2012 Nov 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 40
Slide 41: Post-Operative Pain Management
Post-Operative Pain Management Commercial Considerations Nov 2013 © 2013. A.P. Pharma, Inc. All rights reserved. 41
Slide 42: Post-operative pain market represents an attractive opportunity
Post-operative pain market represents an attractive opportunity for product development • As of 2012, approximately 24.8 million procedures associated with post-operative pain were conducted in the US. Expected to grow to 32.3 million by 2022 • US post-operative pain market sales* are expected to gr
Slide 43: Innovation in a large, growing disease area with high unmet need
Innovation in a large, growing disease area with high unmet need will drive significant dollar market growth 2012 Post-Op Pain Market (US only) Procedures Requiring Post-Operative Pain Management 35 32.5 29.9 30.6 28.5 29.2 30 27.1 27.8 25.9 26.5 25.3 25 20 15 10 5 2012 Total: $3.1B 0 2012 2013 2014
Slide 44: Ropivacaine has advantages over bupivacaine
As a potential development candidate, ropivacaine has advantages over bupivacaine Bupivacaine Ropivacaine Notes 1 KOL Feedback2 • Both molecules have similar “Both of these products work well for efficacy, onset of action, and blocking pain…the issue is that they Efficacy analgesic potency are short
Slide 45: Summary – Pipeline offers significant opportunity
Summary – Pipeline offers significant opportunity for commercial value creation Chemotherapy-induced nausea Post-Operative Pain and vomiting Large, concentrated commercial opportunity Large, growing market Physicians view a non-inferior SUSTOL High unmet need profile as highly competitive with palon
Slide 46: Financial Summary
Financial Summary Summary Statement of Operations Nine Months Ended (In thousands, except per share data) September 30, 2013 Revenue $ – Operating expenses 40,626 Other income (expenses) (614) Net loss $ (41,240) Net loss per share1 $ (0.13) Condensed Balance Sheet Data September 30, 2013 (In thousa