Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — AP Pharma — Investor Presentation (July 2013)
35 slides from Heron Therapeutics's investor presentation, Jul 9, 2013
Slide 1: Company Overview
Company Overview OTCBB: APPA Exhibit 99.1
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
Company: A.P. Pharma, Inc. Ticker: OTCBB: APPA.OB Stock Price: $0.39 (7/5/2013) Market Capitalization: $119.2 million Cash: $46 million Debt: $4.8 million Stock Summary Based on 305.6 million common shares outstanding. Does not include outstanding warrants for 81.1 million shares with weighted avera
Slide 4: Senior Management
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 & Chie
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 antagonist - granisetron (Kytril ® ) 5-day delivery profile Reduces both acute- and delayed-onset CINV with single injection Pa
Slide 6: Clinical Summary
Clinical Summary
Slide 7: Pivotal Phase 3 Trial of APF530 vs Palonosetron for CINV
1428 chemotherapy patients stratified by HEC or MEC 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 A Pivotal, Phase 3, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared
Slide 8: APF530 Pharmacokinetics
APF530 Pharmacokinetics 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 therapeu
Slide 9: Primary Efficacy Results: Complete Response (MEC)
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)
Slide 10: Primary Efficacy Results: Complete Response (HEC)
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
Slide 11: Safety Summary
APF530 10 mg Aloxi 0.25 mg N % N % 1 Safety Summary Safety results with the 5 mg dose of APF530 studied in separate arm of the phase 3 study are not included >90% of injection site reactions were reported as mild; one patient discontinued due to injection site reaction Reported in Cycle 1 Drug Relat
Slide 12: Efficacy through Multiple Chemotherapy Cycles
Efficacy through Multiple Chemotherapy Cycles 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 for APF530 10 mg
Slide 13: Sustained Efficacy of APF530 in Cycles 1-4
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 100% 90% 72% 33% 100% 71% 54% 40% N = % of Cycle 1 APF530 500 mg Palonosetron 0.75 mg* 2013. A.P. Pharma, Inc. All rights
Slide 14: APF530's Efficacy with Difficult Chemo Regimens
Treatment Chemotherapeutic Regimen APF530 10 mg Aloxi 0.25 mg APF530’s Efficacy with Difficult Chemo Regimens 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 Eme
Slide 15: Efficacy Maintained With Reanalysis of HEC
Efficacy Maintained With Reanalysis of HEC Protocol Specified HEC Population Acute Delayed Acute Delayed ASCO 2011 Guideline HEC Population
Slide 16: Summary of Clinical Results
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
Slide 17: Regulatory Status
Regulatory Status
Slide 18: APF530 NDA Status
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 r
Slide 19: 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 Secondary benefit of consolidating manufacturing and release efforts: substantial impro
Slide 20: Commercial Opportunity
Commercial Opportunity July
Slide 21: Continuing Unmet Need in CINV
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 cyc
Slide 22: 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 23: 5-HT3 Antagonists Have Made a Substantial Impact
Chemotherapy Acute CINV Delayed CINV Highly Emetogenic Moderately Emetogenic 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
Slide 24: U.S. CINV Market Dynamics
U.S. CINV Market Dynamics Source: WK 07/2013 * US Oncology data added starting 1/2009. 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 G
Slide 25: Aloxi Market Performance and Pricing
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 *ASP plus 6% Aloxi Sales
Slide 26: ~80% of Aloxi Is Used in Clinics
~80% of Aloxi Is Used in Clinics Hospital Other Clinics 2.2 million units 0.5 million units 0.1 million units U.S. Aloxi Units by Class of Trade – Months Ending June IMS Health and Source Healthcare Analytics (WKH) data and Eisai Co., Ltd. published sales figures th
Slide 27: >90% of Aloxi Units Contracted Through GPOs
8% 23% 48% 21% >90% of Aloxi Units Contracted Through GPOs 2.2 Million Clinic Units Misc Onmark ION USO IMS Health and Source Healthcare Analytics (WKH) data and Eisai Co., Ltd. published sales figures Clinic Units by GPO – Months Ending June th
Slide 28: Aloxi Clinical Use Is Largely Concentrated
WKH Data Oct. – Clinic Analysis Aloxi Clinical Use Is Largely Concentrated Cumulative Number of Accounts 1% accts 4% accts 7% accts 11% accts 22% accts 29% accts 39% accts 54% accts 100% accts 15% accts 80% of units (1.7M) comes from 39% of accounts (904) 50% of units (1.1M) comes from 15% of accoun
Slide 29: No New Injectable 5-HT3 Drug on Horizon
2012 2013 2014 2015 Candidate Class Indication Sponsor Possible Launch No New Injectable 5-HT3 Drug on Horizon *Company reports, Leerink Swann; **Clinical Trials.gov NCT01339260 FDC = Fixed Dose Combo; PDUFA date expected 12-15 months post P3 data EUR-1025 development program uncertain (once-a-day o
Slide 30: APF530 Proposed Label
APF530 Proposed Label 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 • H
Slide 31: CINV Market
CINV Market *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
Slide 32: Summary
Summary 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 Go
Slide 33: Product Lifecycle Considerations
A.P. Pharma Product Lifecycle Considerations APF530 covered by multiple patents 2 patents covering combination of polymer, excipients and drug expire in 3 patents covering APF530 expire in 2024 Polymer-based injectable products are difficult to copy independent of IP ANDA FDA requirements for inject
Slide 34: Financial Summary
Summary Statement of Operations (In thousands, except per share data) Three Months Ended March 31, 2013 Condensed Balance Sheet Data (In thousands) March 31, 2013 Financial Summary Expect cash sufficient to fund through resubmission of APF530 NDA Revenue $ – Operating expenses 12,752 Other income (e
Slide 35: Thank You
Thank You A.P. Pharma, Inc. OTCBB: APPA