 BIO CEO & Investor Conference February 2013 Exhibit 99.1 |
 Forward-Looking Statements 2 The following presentation includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on current market data and research (including third party and POZEN sponsored market studies and reports), management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to license our PA product candidates on terms and timing acceptable to us, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies, or the failure to obtain such approval of our product candidates, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence AstraZeneca for the sales and marketing of VIMOVO™; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended September 30, 2012. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements. |
 PA32540, PA8140, PA10040 and other PA product candidates are investigational new drugs. No claims, either expressed or implied, are made with respect to the safety or efficacy of the PA product candidates for the indications under investigation. ’s PA Franchise: Improving the Risk/Benefit Balance of Aspirin 3 POZEN |
 Targeting NDA for PA32540 and PA8140 by April 2013 Positive top-line PA32540 Phase 3 results Seeking US and ROW commercial partner(s) to commercialize PA32540 / PA8140 / PA10040 • Ideal partner brings strong commercial capabilities and financial resources, as well as embraces the POZEN commercialization philosophy Extensive market research in US, EU and Latin America validates commercial opportunity 2013 Focus – PA regulatory filings, partnerships and controlled spending VIMOVO® sales are growing Key Message Take-Aways for Today 4 |
 POZEN intends to maximize bottom line contribution from the PA franchise Limit ancillary expenditures Evaluation of current pipeline opportunities ongoing Only move additional programs into Phase 3 when partnered Management will remain focused on return to shareholders • 17% of shares owned by “insiders” Longer Term Strategy Focused on Building Shareholder Value 5 |
 PA32540 Two Pivotal Phase 3 Studies 6 Two Phase 3 pivotal trials under SPA • Total of 1,049 patients • Treatment with either PA32540 or EC ASA 325 mg once daily Primary endpoint met • Cumulative observed incidence of gastric ulcers over six months Key secondary endpoints met • Cumulative incidence of gastric and duodenal ulcers • Discontinuation due to pre-specified UGI adverse events • Heartburn resolution Completed long-term safety study • (N=379) with no unexpected findings, and AEs consistent with the population and known profiles of ASA and omeprazole : Positive Top-Line Results from |
 Significant Reduction of Gastric Ulcers, Gastro-duodenal Ulcers and Discontinuations with PA32540 at 6 Months 7 Pooled PA32540-301 and PA32540-302 ITT Population; PA32540 (n=524), EC ASA (n=525) P < 0.001 P < 0.001 P < 0.001 3.2 3.4 1.5 8.6 11.6 8.2 0 2 4 6 8 10 12 14 16 Gastric Ulcers (Primary Endpoint) Gastro-duodenal Ulcers Discontinuations: UGI AEs PA32540 EC ASA 325mg 82% 63% 71% |
 Bioavailability 8 Study PA32540-115 • The FDA has indicated that Study 115, together with additional information that will be submitted in the NDA, should constitute sufficient data to support the establishment of a bridge to Ecotrin ® (325 mg) Study PA8140-102 • Demonstrated that PA8140 had comparable bioavailability relative to EC aspirin (81 mg) • The study demonstrated that PA8140 is bioequivalent to EC aspirin (81 mg) using criteria for highly variable drugs. |
 PA Commercial Opportunity 9 |
 Large Patient base (U.S. alone) • 24MM secondary prevention patients 1 • 60 - 80%+ use daily aspirin already 2 ACC & ACG 2008 * Clinical Consensus recommend PPIs for ASA-induced GI injury: • 20% on low-dose aspirin are at risk for UGI AEs, e.g., gastric or duodenal ulcers 3 • 12% discontinue / reduce aspirin intake due to UGI side effects 3 • Aspirin discontinuation leads to 3x increased risk of potentially fatal CV event 4 • Some physicians (40% - 60%) recommend use of a gastro-protective agent to some (35% - 51%) patients 2 • Adherence to multiple medications is poor and results in worse clinical outcomes 5 PA CV: Addresses a High Unmet Medical Need 10 1. American Heart Association, 2010 2. POZEN Market Research 2010, Data On File 3. Cayla G et al., 2010 4. Biondi-Zoccai G, 2006 5. Yusuf S, et al., 2011 *Updated Nov 2010 for ‘high risk’ |
 11 Payer Market Research Findings: PA32540 Strong Payer Acceptance at $1.00/day Payers’ initial reservations not unexpected • “Both products are OTC or generic” • Many requested efficacy data vs. the separate components Affordable pricing changed Payer view to positive • Pricing is the key component to interest • Tier 2 placement most likely (~$30/month) • Patient out-of-pocket co-pay makes it cost-neutral to plan (~$30/mo.) • The “component” issue avoided with this reasonable price • Tracking ASA as an Rx is seen as a benefit • Pharmaco-economic model could be helpful for integrated Plans • “Keep it simple” Primary Source: POZEN Qualitative & Quantitative Market Research with Payers, 2008-2012, Data On File |
 Positive reaction to affordability (~$1/day) Would prescribe PA32540 or PA8140 for about 30% - 40% of secondary prevention patients 80+% of physicians would prescribe PA instead of separate components Compliance and control over therapy are among the top reasons Key “at risk” patients are identifiable (GI history; on GPA) Market Research Findings: PA32540 Strong Physician Interest to RX at $1.00/day 12 Primary Source: POZEN Qualitative & Quantitative Market Research with PCPs, CARDs, NEUROs, IMs, 2008-2012, Data On File Physician |
 Patient Market Research Findings: PA32540 Significant Patient Interest at ~$1.00/Day 13 36% willing to pay $30/month Cost per Month 1 drugstore.com 2 2011 Commercial and 2012 projected Medicare Co-pays. 52% ‘extremely’ or ‘very’ interested 60% would ask their doctor about it 36% Willing to Pay at $30/month • 46% on ASA+PPI Cost/Month Today for: 2012 OTC PPI : $15.60 - $27.90 Tier 1 Co-pay range : $ 3.79 - $10.00 Tier 2 Co-pay range : $29.00 - $40.60 Tier 3 Co-pay range : $49.00 - $91.67 0% 25% 50% 75% 100% $10 $15 $20 $25 $30 $35 $40 $50 $60 Patient Willingness to Pay ($ / Month) 1 2 2 2 Primary source: POZEN Qualitative & Quantitative Market Research with MI/Angina & Stroke/TIA Patients, 2011, Data On File Additional pricing sources: Sources: Kaiser/HRET Survey of Employer-Sponsored Health Benefits, 2001–2011; http://www.avalerehealth.net/wm/show.php?c=1&id=893 |
 Affordable pricing (~$1.00/day) for a potentially life saving medication • Pricing at or near the sum of generic components remains profitable • Value of the product to be supported by a pharmaco-economic model Large target patient population Targeted physician audience • Aspirin and PPIs are well known • Specialists drive majority of ASA initiation PA benefits from a significant data package • Immediate-release omeprazole has unique pK and pD characteristics, not substitutable • Efficacy / Tolerability profile supported by full Phase 3 program PA’s Potential Commercial Advantages 14 |
 Modeling the US Market Opportunity for PA32540/PA8140 15 1 American Heart Association, 2010 • There are 24MM CV secondary prevention patients in the US 1 • 95%+ of them take aspirin 2 • Doctors would prescribe PA32540/PA8140 for 30-40% of secondary prevention patients 2 • 36% of patients would be willing to pay at $1.00/day 2 2 Sources: POZEN Qualitative & Quantitative Market Research with PCPs, CARDs, NEUROs, IMs, 2008-2012, Data On File; POZEN Qualitative & Quantitative Market Research with MI/Angina & Stroke/TIA Patients, 2009-2012, Data On File $0 $300 $600 $900 $1,200 $1,500 $1,800 5% 10% 15% 20% % Share of Secondary Prevention Patients |
 >$400 MM US Market Opportunity 16 Differentiation Selected U.S. Market Research Results Targeted Indication (1) AHA, 2011 Coordinated delivery of aspirin and omeprazole Affordable and convenient vs. taking two separate products Global expansion opportunity Additional patent applications filed could extend to protection to 2022 - 2030 Secondary prevention of CVD in patients at risk for aspirin-induced gastric ulcers Physicians would prescribe PA for 30% - 40% of patients Patient willingness to pay – 36% at $1.00/day price High payer acceptance for Tier 2 Estimated >$400MM US market opportunity at 5% share of secondary prevention patients : PA32540 / PA8140 |
 PA Products are Protected by a Robust Patent Position 17 ‘A pharmaceutical composition in unit dosage form comprising an enteric-coated NSAID and a non-enteric- coated acid inhibitor formulated for coordinated release’ Two US Patents issued (expire 2/28/2023) • 6,926,907 issued 8/9/2005: Rights ex-aspirin licensed to AZ 2006 • 8,206,741 issued 6/26/2012: Claims are limited to aspirin and acid inhibitors, POZEN retains full rights Foreign Patents • Issued: Australia, Canada, Eurasia, Europe, Japan, Mexico • Pending: Europe, Israel, Norway Additional patent applications filed could extend protection to 2032 |
 Aspirin Use in Cancer 18 |
 Benefits • Strong anti-tumor effect demonstrated in various animal models • Compelling evidence for a life prolonging effect of ASA in various cancers from epidemiologic studies • Positive effect of ASA from recent prospective studies in colon cancer • Inexpensive, widely available now Risks • Risk profile primarily related to antiplatelet activity and GI toxicity • Perhaps the most well known safety profile of all drugs with over 100 years of clinical experience • Available in most countries OTC Consider the Benefit/Risk Profile of ASA in Cancer 19 |
 20 Cancer and ASA: What Is Being Studied |
 Cancer and ASA: What Is Being Said 21 Benefits: Based on solid evidence, daily aspirin for at least 5 years reduces CRC incidence and mortality. This is based on two reports of extended follow-up of two RCTs and meta-analysis of observational studies. A third report that adds extended follow-up of an additional two RCTs (with a meta-analysis of all four RCTs) adds certainty to this conclusion. Magnitude of Effect: The estimated average excess risk of upper gastrointestinal complications is 10 to 30 per 1,000 people for a period of 10 years, on the higher end for men and on the lower end for women. Risk increases with age. National Cancer Institute at the National Institutes of Health After 23 years of follow-up, incidence of CRC in the placebo group was 3.8% and in the ASA group 2.5%. In the report, the 20-year risk of death due to CRC in trials that allocated ASA for at least 5 years was reduced by about 40% (HR = 0.60; 95% CI, 0.45–0.81), absolute risk reduction was from about 3.1% to 1.9%. The primary effect was on mortality from proximal colon cancer. • • • http://www.cancer.gov/cancertopics/pdq/prevention/colorectal/HealthProfessional/page1/AllPages#Reference2.17 |
 Cancer and ASA: What Is Being Said 22 The American Cancer Society does not currently recommend taking aspirin as a colon cancer prevention measure, Jacobs emphasizes. "Aspirin, even at low doses, substantially increases the risk of serious, occasionally fatal, gastrointestinal bleeding," he says. "Current evidence suggests that very low doses of aspirin, such as 81 mg, may increase risk of gastrointestinal bleeding as much, or nearly as much, as higher doses, such as 500 mg. Decisions about whether an individual should start taking aspirin should continue to be made by balancing the benefits of aspirin use in preventing cardiovascular disease against the risks of gastrointestinal bleeding, taking into account each individual’s medical history and risk factors.“ Eric Jacobs, PhD, Strategic Director of Epidemiology at the American Cancer Society “Low-Dose Aspirin May Lower Colon Cancer Risk” October 2010 |
 Cancer and ASA: What Is Being Written 23 |
 Ongoing Clinical Studies with a Focus on Determining Aspirin’s Effect on Cancer Outcomes* Protocol Title Study Period Sponsor Estimated Enrollment Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers 2007-2019 National Cancer Centre, Singapore University of Oxford 2,660 The Effect Of Aspirin On Survival in Lung Cancer 2010-2020 Liverpool Heart and Chest Hospital NHS Foundation Trust 2,500 Aspirin in Reducing Events in the Elderly (including cancer events) 2009-2016 Minneapolis Medical Research Foundation; National Health and Medical Research Council, Australia; Bayer; Monash University; Berman Center 19,000 The International Polycap Study 3 (TIPS-3). Polycap vs. Aspirin in cancer outcome. 2012-2018 Population Health Research Institute; Cadila Pharmaceuticals; Wellcome Trust; Canadian Institutes of Health Research (CIHR); Heart and Stroke Foundation of Ontario 5,500 A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease (includes assessment of cancer events) 2007-2015 Bayer 12,589 *ClinicalTrials.gov 2013 24 |
 Financial Overview 25 |
 VIMOVO Sales Growth in Q4 and 2012 $ (millions) Q4 Growth vs. Q3 2012 Growth vs. 2011 US VIMOVO Sales* $6m 79% $25m 19% ROW VIMOVO Sales* $12m 24% $40m 208% Global Sales* $18m 38% $65m 91% 26 * As reported by AstraZeneca on 1/31/2013 |
 Key Financial Facts 27 Financial Overview Net Cash at 6/30/12 $95.3 Million Net Cash at 9/30/12 $92.3 Million Shares Outstanding 30 Million Market Cap – 2/8/13 $171 Million Self funding since IPO in 2000 2012 Results to be Reported 3/6/2013 |
 Targeting NDA for PA32540 and PA8140 by April 2013 Positive top-line PA32540 Phase 3 results Seeking US and ROW commercial partner(s) to commercialize PA32540 / PA8140 / PA10040 • Ideal partner brings strong commercial capabilities and financial resources, as well as embraces the POZEN commercialization philosophy Extensive market research in US, EU and Latin America validates commercial opportunity 2013 Focus – PA regulatory filings, partnerships and controlled spending VIMOVO® sales are growing Key Message Take-Aways for Today 28 |
 BIO CEO & Investor Conference February 2013 |
 Conducted with Key Stakeholders* 30 * PA8140 and PA10020 also included in select Market Research Sources: POZEN Qualitative Market Research with Medical Directors & Pharmacy Directors, 2009-2012, Data On File POZEN Qualitative & Quantitative Market Research with PCPs, CARDs, NEUROs, IMs, 2008-2012, Data On File POZEN Qualitative & Quantitative Market Research with MI/Angina & Stroke/TIA Patients, 2012, Data On File : Substantial Market Research PA32540 Managed Care Advisory Panel Payer Situation Assessment CV Secondary Prevention MCO Assessment MCO Roundtable Value Proposition Research Consultants Advisory Panel Plan/Benefit Co-Pay Analysis & Exploratory European P&R Assessment • Payers (N=148) • • • • • • • • Patient Incidence Study Patient Exploratory Patient ATU & Willingness to Pay Patient Exploratory Research (w/Product Profile) Brand Logo Test PA10040 Concept Test Patient Segmentation Study • • • • • • Qual. Product Profile Testing & Forecast Qual. Positioning, Attribute Testing & Forecast Update Hospital-Based Physician Exploratory Quant. Product Profile & Forecasting Study w/Choice Modeling Brand Promise Development Iterative Positioning Development Positioning Concept Test Affordability Positioning Qual. Hosp. Formulary Dynamics Brand Name Development & Testing Brand Logo Test Phase 3 Product Profile Qual. w/ HCPs ASA Treatment Practices Exploratory PA10040 Concept Test Physician Segmentation Study Market Potential of PA10020/PA30020 in Europe LATAM Market Assessment & Forecast for PA32540 Quantitative Evaluation of PA10040/32540 in Europe & Canada Patients (N=2,600+) Health Care Providers (N=4,000+) • • • • • • • • • • • • • • • • • • |