Corporate Presentation Corporate Overview & Business Strategy. January 2018

Transcription

1 Corporate Presentation Corporate Overview & Business Strategy January 2018

2 Disclaimer 2 This presentation includes certain statements that constitute forward-looking statements within the meaning of applicable securities laws. Forwardlooking statements include, but are not limited to, statements regarding ongoing royalty stream on sales of Vimovo ; patent protection with respect to our products; our 2017 guidance and preliminary 2018 outlook, including our expectations with respect to net revenues and Adjusted EBITDA; our expectation with respect to sufficient cash for 2018 and beyond; the commercial launch and positioning of, and opportunities with respect to, Zontivity in the U.S.; the commercialization of Yosprala ; Toprol-XL franchise performance, including expected improvements; the performance of our business in the U.S. and Canada; pro forma financial information; expected improvements to deliver profitability (on an Adjusted EBITDA basis) and extend cash runway, including SG&A expense reductions and expectations to be better positioned for refinancing debt; our strategies, plans, objectives, goals, prospects, future performance or results of current and anticipated products, and other statements that are not historical facts, and such statements are typically identified by use of terms such as may, will, would, should, could, expect, plan, intend, anticipate, believe, estimate, predict, likely, potential, continue or the negative or similar words, variations of these words or other comparable words or phrases, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements included herein represent management s current judgment and expectations, and are based on current estimates and assumptions made by management in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that it believes are appropriate and reasonable under the circumstances, but there can be no assurance that such estimates and assumptions will prove to be correct and, as a result, the forward-looking statements based on those estimates and assumptions could prove to be incorrect. Accordingly, actual results, level of activity, performance or achievements or future events or developments could differ materially from those expressed or implied in the forward-looking statements. Material factors, risks or assumptions that were applied or taken into account in providing financial guidance for the year ending December 31, 2017 and the preliminary 2018 financial outlook, include, but are not limited to, the material factors and assumptions outlined in this presentation and under the caption Cautionary Note Regarding Forward-Looking Statements in our press release dated November 9, 2017 announcing results for the third quarter ended September 30, Readers are cautioned that our actual future operating results and economic performance, including with respect to our net revenues and Adjusted EBITDA for the years ending December 31, 2017 and December 31, 2018, are subject to a number of risks and uncertainties, including, among other things, those described below, and could differ materially from what is currently expected as set out in this presentation. In addition, our operations, 2017 financial guidance and preliminary 2018 financial outlook involve risks and uncertainties, many of which are outside of our control, and any one or any combination of these risks and uncertainties could also affect whether the forward-looking statements ultimately prove to be correct and could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, without limitation, the risks and uncertainties outlined under the caption Cautionary Note Regarding Forward-Looking Statements in our press release dated November 9, 2017 announcing results for the third quarter ended September 30, 2017 and those risks detailed from time-to-time under the caption Risk Factors and elsewhere in our Securities and Exchange Commission ( SEC ) filings and reports and Canadian securities law filings, including in our Annual Report on Form 10-K for the year ended December 31, 2016 and our Quarterly Report on Form 10-Q for the third quarter ended September 30, 2017, which are available on EDGAR at on SEDAR at and on our website at and those described from time to time in our future reports filed with the SEC and applicable securities regulatory authorities in Canada. You should not place undue importance on forward-looking statements and should not rely upon this information as of any other date. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. This presentation was provided on or about January 8, 2018 as part of an oral presentation and is qualified thereby.

3 Aralez: Business Overview Who We Are Global specialty pharmaceutical company formed in February 2016 focused primarily in cardiovascular disease and other specialty areas Canadian domiciled with operations in the U.S., Canada and Ireland U.S. Cardiovascular Portfolio Zontivity acquired from Merck in September 2016; full-scale re-launch in June 2017 Toprol-XL and its Authorized Generic (AG) acquired from AstraZeneca in October 2016; Long-term supply agreement with AZ Yosprala launched in October 2016 Fibricor promotion began in April 2016 Ongoing Vimovo royalty stream on product sales Canadian Growth Drivers Profitable segment of the Aralez business on an adjusted EBITDA basis Key product contributors include Cambia, Soriatane and Blexten 3

4 Zontivity: Overview and Product Positioning Zontivity Overview Acquired from Merck in September 2016 Composition of matter patent to 2024 with potential extension through 2027 Full re-launch in June 2017 with 75 reps Recently reached new all-time highs in both NRx and TRx Product Positioning Zontivity is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD) 4 Important safety information available at

5 Zontivity: PAD and MI Target Populations PAD only plus PAD & M I 3,5,6,7 7.4 M MI Prevalence w/o PAD (> 20 years) M Market Opportunity (Labeled Population) 14.2 M Smoking (66%) and/or Diabetic (24%) Patients 1,8 Smoking (24% for 20-60yrs, 23% for 60+yrs) and/or Diabetic (43% for 20-60yrs, 71% for 60+) 1,8 Persistent Risk (Focal Population) 9 M 4.8 M 4.2 M Zontivity is being positioned for PAD patients and/or post-mi patients with a focus on persistent risk patients 5 1 Pande et al., Secondary Prevention and Mortality in Peripheral Artery Disease National Health and Nutrition Examination Study, 1999 to 2004, Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics 2016 update. 3 Bonaca et al., Ticagrelor for prevention of ischemic events after myocardial infarction in patients with peripheral artery disease, Wallentin et al, Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes, Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis, US Department of Health and Human Services, Facts about Peripheral Artery Disease, USPSTF: (PAD) and CVD in Adults: Risk Assessment with ABI, Heart Disease and Stroke Statistics 2016 Update Important safety information available at

6 Zontivity: Solid Managed Care Position COVERED LIVES (MILLIONS) ~70M ~170M Commercial Coverage ~90% of Commercial Lives* covered ~80% of Rx claims being approved weekly Covered by the 4 largest PBMs in the U.S. Covered by the majority of downstream clients without a Prior Authorization (PA) Less than 15% of commercial lives with a PA Majority of existing PA s are merely to label Medicare Part D and Medicaid ~65% of Medicare Part D lives covered and on over 70% of state Medicaid formularies Added to the two largest Medicare Part D formularies since July 1st Mix of Tier 2 and Tier 3 coverage with copay mitigation programs in place (April 1, 2017) 6 *Excludes Medicaid and other government programs

7 Zontivity: Weekly Prescription Performance 600 TRx NRx Aralez Launch 500 Total Prescriptions (TRx) New Prescriptions (NRx) 0 0 Nearly 3-fold increase in Rx volume in 6 months post-launch Of the prescriptions generated 63% are from Cards, 25% PCPs, and 7% Vascular Surgeons Currently have 1.6% market share of new to brand patients among target HCPs 7 Source: Symphony Health

8 Zontivity: Research Activity Investigator Initiated Research Studies: XLPAD-TRACE Placebo-controlled study examining Zontivity vs. placebo in PAD patients with intermittent claudication Endpoints include improvement in peak walking time, claudication onset time and safety VORA-PRACTIC Open-label study examining Zontivity use with prasugrel (Effient) and ticagrelor (Brilinta) Endpoints include platelet aggregation and safety OPTIMUS 5 Open-label study examining Zontivity use in PAD patients with and without diabetes Endpoints include platelet aggregation and safety We are currently evaluating life cycle management opportunities which could explore peripheral endpoints including acute limb ischemia (ALI), peripheral revascularization and amputation prevention in PAD patients and diabetics Publications have presented post-hoc safety and efficacy data which may support such a clinical research program Intense investigator interest due to the lack of good alternatives in this patient population 8

9 Toprol-XL Franchise: Prescription Performance Toprol-XL Franchise Performance NRx TRx Prescription Growth 2017 Over ,000 16% 15% Weekly Prescriptions 250, , , ,000 50,000 Percent Growth 1 st 9M % 12% 10% 8% 6% 4% 2% 11% 0 0% YTD'17 NRx vs YTD'16 TRx 9 Source: Symphony Health. Does not include volume generated from the VA. Important Safety Information Available at Toprol-XL.com

10 Toprol-XL Franchise: Positive 2018 Outlook Toprol-XL Franchise Net Sales Toprol-XL Franchise Revenues Consist of: Total Net Revenues ** Due to our Transition Services Agreement (TSA) with AstraZeneca, we will only record Total Net Revenues in 2017 Cost of Product Revenues and Transition Fees Total Net Product Sales Commencing Jan. 2018, our TSA expired, and we now record Toprol-XL Franchise Revenues as Net Product Sales (and not Net Revenues), which in 2017 would have been ~$80M annualized, the same way we record Yosprala, Zontivity and Fibricor 2017 Annualized* ~$49M ~$31M ~$80M 10 Toprol-XL Franchise: Positive Outlook in 2018 In 2018, Revenues will be recorded as Total Net Product Sales Lannett replaced Endo/Par as our Toprol-XL Authorized Generic distributor Expected improvements in 2018 Total Net Product Sales over 2017 due to improved volume and margins resulting from, among other things, renegotiated distribution and other fees with our various partners *Annualized based on 1 st 9M For the 1 st 9M 2017 Total Net Revenues were $37M and Total Net Product Sales were $60M. **Included in Other Revenue.

11 Yosprala: Commercial Performance Retail Prescription Equivalent (RPE) 10,000 8,000 6,000 4,000 2,000 0 Yosprala Prescriptions +31% +91% +87% Q4'16 Q1'17 Q2'17 Q3'17 Launched in October 2016; Patented to late 2032 with possible term extension to 2033 Commercial Strategy Minimal marketing spend and move to P2 detail position that fits well behind Zontivity Commercial Performance Continued quarterly increase in RPE s Pills per Rx have increased with a shift to 90 day supply Payor rejections and patient abandonment decreased significantly 11 Source: Symphony Health, RPE = Retail Prescription Equivalent Important safety information available at

12 Aralez: Strong Performance of Canadian Business Amounts in US $M 12 $8 $7 $6 $5 $4 $3 $2 $1 $0 Canadian Portfolio Net Revenue $5.7M $6.9M 1Q Q Q 2017 Growth Drivers $7.1M Other Products 61% 39% Strong revenue performance Canadian business continues to be a profitable segment of our business on an Adjusted EBITDA basis Portfolio growth drivers include Cambia, Soriatane, and Blexten Represent 39% of Canadian business Successful Blexten launch The business, driven particularly by the growth drivers, remains resilient despite significant generic erosion of some other brands such as Fiorinal and Bezalip SR during 2017 Focus on maintaining efficient, productive and profitable business

13 3Q 2017 and 1 st 9M 2017 Revenue Growth Amounts in US $M 3Q 2017 Net Revenue $30 $25 $24.3M $20 +$10.7M $13.5 $15 $13.6M $0.2 $10 $8.1 $7.1 $5 $5.3 $3.7 $0 3Q Q 2017 Royalties/License Fees Canadian Products US Core Business Amounts in US $M 1 st 9M 2017 Net Revenue (Option 2) $90 $80 $77.9 $70 $42.9 $60 +$43.6M $50 $40 $34.3M $30 $1.3 $18.0 $19.7 $20 $10 $15.0 $15.3 $0 9M M 2017 Royalties/License Fees Canadian Products US Core Business 13 Note 1: US Core Business includes net revenues from Zontivity and Toprol-XL (and its AG) during their transition periods, and net product sales from Fibricor, Yosprala and Zontivity (after the transition period). Note 2: 1 st 9M 2017 Royalties / License Fees includes Vimovo royalties; $4.0M in license fees in Q Note 3: 1 st 9M 2016 Net Product Revenues includes sales of Canadian products and Fibricor for the period February 5, 2016 (date of the Tribute acquisition) through September 30, 2016.

14 Year over Year Growth and Preliminary 2018 Outlook Net Revenue Growth Adjusted EBITDA Growth $175 $60 $150 $140-$160 $40 $35-$55 Amounts in US $M $125 $100 $75 $50 $54 $95-$105* Amounts in US $M $20 $0 -$20 ($5)-$0 $25 -$40 $ Actual 2017 Guidance (Midpoint) 2018 Outlook (Midpoint) -$60 ($51) 2016 Actual 2017 Guidance (Midpoint) 2018 Outlook (Midpoint) 14 * 2017 Net Revenues for the Toprol-XL franchise are recorded net of related costs. For better comparability, the 2017 guidance for Net Revenues would have been ~$125M-$135M, on a pro forma basis, using the 2018 accounting treatment. Beginning in 2018, the Company will record Net Revenues and Cost of Revenues separately, consistent with its other products (see slide 9).

15 Aralez: Becoming a Profitable and Growth Company Solid revenue performance in both US and Canada 1 st 9M 2017 Expect to pivot into a profitable 1 and growth company in E Revenues expected to be in a range of $140M to $160M, an increase of $50M over 2017 guidance midpoint E Adjusted EBITDA expected to be in a range of $35M to $55M, an increase of ~$48M over the 2017 guidance midpoint Improvements to deliver profitability 1 and extend cash runway Significantly improving overall costs and cash management Leaner, nimble and more efficient performance-oriented operating model Plans to streamline SG&A expenses in 2018 compared to the FY 2017 estimate Broad efforts aimed to produce significant Adjusted EBITDA in 2018 and beyond Company expected to be better positioned for potential refinancing of the debt We are currently projecting to have sufficient cash through 2018 and beyond Goal is to create long-term shareholder value through driving growth with commercial excellence, significantly improved costs, operational enhancements and a pathway to improve capital structure 15 1 On an Adjusted EBITDA basis, a non-gaap measure. 2 See slide 11 for more information relating to the change in accounting treatment for the Toprol-XL franchise. 3 The $32 million estimated annual SG&A reduction reflects the reductions announced in April 2017 as well as incremental expense reductions.

16 Corporate Presentation Corporate Overview & Business Strategy January 2018

17 17 Appendix

18 TRA 2 P-TIMI 50: Study Overview Overall Population N=26,449 (randomized) a 13,225 ZONTIVITY (vorapaxar) 13,224 placebo Post-MI (spontaneous MI 2 weeks to 12 months prior to enrollment) (n=17,779) or Ischemic Stroke (n=4,883) or Patients were followed for up to 4 years (median 2.5 years) Documented PAD (n=3,787) The primary and key secondary endpoint composites of thrombotic CV events were met in the overall population Patients with prior stroke or TIA were removed from efficacy and bleeding analyses due to an increase in ICH Label Population Post-MI (n=16,897) or PAD (n=3,273) without history of stroke or TIA (n=20,170) (randomized) b 10,080 ZONTIVITY, 10,090 placebo 18 a Actually treated: 13,186 on ZONTIVITY, 13,166 on placebo; b Actually treated: 10,059 on ZONTIVITY, 10,049 on placebo. TRA 2 P-TIMI 50 = Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events Thrombolysis in Myocardial Infarction 50; MI = myocardial infarction; PAD = peripheral arterial disease; CV = cardiovascular; TIA = transient ischemic attack; ICH = intracranial hemorrhage. 1. Morrow DA et al. N Engl J Med. 2012;366:

19 Zontivity Reduced Thrombotic CV Events in Post-MI or PAD Patients Without a History of Stroke or TIA Primary Composite Efficacy Endpoint (CV Death, MI, Stroke, UCR) a Incidence, % ZONTIVITY (896/10,080) Placebo (1,073/10,090) Placebo 11.8% ZONTIVITY 10.1% 17% RRR 1.7% ARR 0 HR 95% CI P Value ZONTIVITY vs Placebo < Months from Randomization NNT 1,b = 59 patients Patients who had experienced a prior MI were eligible for the trial if at least 2 weeks post-mi at enrollment 2 19 a Intent-to-treat (randomization to last visit) 3-year Kaplan-Meier rate; b NNT = 1/ARR 1 CV = cardiovascular; MI = myocardial infarction; PAD = peripheral arterial disease; TIA = transient ischemic attack; UCR = urgent coronary revascularization; RRR = relative risk reduction; ARR = absolute risk reduction; HR = hazard ratio; CI = confidence interval; NNT = number needed to treat. 1. Barratt A et al. CMAJ. 2004;171: ; 2. Morrow DA et al. Am Heart J. 2009;158: e3.

20 Components of the Primary Composite Efficacy Endpoint in Post- MI or PAD Patients Without a History of Stroke or TIA Primary Composite Endpoint Results for Zontivity (vorapaxar) added to aspirin and/or clopidogrel CV death, MI, stroke, or UCR 17% RRR 1.7% ARR HR % CI ( ) CV Death 14% RRR 0.4% ARR HR % CI ( ) MI 18% RRR 1.0% ARR HR % CI ( ) First Stroke 33% RRR 0.4% ARR HR % CI ( ) UCR 12% RRR 0.2% ARR HR % CI ( ) Patients who had experienced a prior MI were eligible for the trial if at least 2 weeks post-mi at enrollment a Intent-to-treat (randomization to last visit) 3-year Kaplan-Meier rate. MI = myocardial infarction; PAD = peripheral arterial disease; TIA = transient ischemic attack; CV = cardiovascular; UCR = urgent coronary revascularization; RRR = relative risk reduction; ARR = absolute risk reduction; HR = hazard ratio; CI = confidence interval. 1. Morrow DA et al. Am Heart J. 2009;158: e3.

21 Zontivity Reduced Thrombotic CV Events in Post-MI or PAD Patients Without a History of Stroke or TIA Key Secondary Composite Efficacy Endpoint (CV Death, MI, Stroke) 1,a Incidence, % ZONTIVITY (688/10,080) Placebo (851/10,090) Placebo 9.5% ZONTIVITY 7.9% HR 95% CI P Value ZONTIVITY vs Placebo < Months from Randomization 20% RRR 1.6% 20% RRR ARR 1.6% ARR NNT 2,b = 63 patients Patients who had experienced a prior MI were eligible for the trial if at least 2 weeks post-mi at enrollment 3 21 a Intent-to-treat (randomization to last visit) 3-year Kaplan-Meier rate; b NNT = 1/ARR. 2 CV = cardiovascular; MI = myocardial infarction; PAD = peripheral arterial disease; TIA = transient ischemic attack; RRR = relative risk reduction; ARR = absolute risk reduction; HR = hazard ratio; CI = confidence interval; NNT = number needed to treat. Adapted with permission from Magnani G et al Magnani G et al. J Am Heart Assoc. 2015;4:e doi: /JAHA ; 2. Barratt A et al. CMAJ. 2004;171: ; 3. Morrow DA et al. Am Heart J. 2009;158: e3.

22 Zontivity Reduced a Composite Endpoint including UH-VCIN in Post-MI or PAD Patients Without a History of Stroke or TIA Key Secondary Composite Efficacy Endpoint - CV Death, MI, Stroke, UCR, or UH-VCIN at 3 Yrs RRR HR (95% CI) 17% 0.83 ( ) ARR 2.0% a NNT = 1/ARR. 2 Incidence, % Placebo n=10,090 UH-VCIN included: acute limb ischemia, myocardial ischemia or TIA. Excluded MI events counted as part of separate MI component. CV = cardiovascular; MI = myocardial infarction; UCR = urgent coronary revascularization; UH-VCIN = urgent hospitalization for vascular cause of 22 ischemic nature; PAD = peripheral arterial disease; TIA = transient ischemic attack; RRR = relative risk reduction; HR = hazard ratio; CI = confidence interval; ARR = absolute risk reduction. Data available on request from Aralez Medical Information 11.9 ZONTIVITY n=10,080 NNT a = 50 patients

23 Zontivity in Subgroup of Patients With PAD Incidence, % Composite of CV Death, MI, Stroke, or UCR at 3 years 1 RRR HR (95% CI) % 0.83 ( ) 13% 0.87 ( ) ARR 1.7% 1.7% All 10.1 n=20,170 Placebo ZONTIVITY 12.8 n=3, PAD Patients Subgroup analyses must be interpreted cautiously, as differences may reflect the play of chance among a large number of subgroups examined for their influence on outcomes. The trial was not designed to evaluate the relative benefits and risks of ZONTIVITY in individual patient subgroups. The rate of GUSTO moderate or severe a bleeding with ZONTIVITY was also consistent between the overall post-mi or PAD group (HR 1.55: 95% CI [ ]) and the PAD group (HR 1.60: 95% CI [ ]) 1 23 a GUSTO severe bleeding: fatal, intracranial, or bleeding with hemodynamic compromise requiring intervention; GUSTO moderate bleeding: bleeding requiring transfusion of whole blood or packed red blood cells without hemodynamic compromise. CV = cardiovascular; PAD = peripheral arterial disease; TIA= transient ischemic attack; MI = myocardial infarction; UCR = urgent coronary revascularization; RRR = relative risk reduction; ARR = absolute risk reduction; GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries; HR = hazard ratio; CI = confidence interval. 1. Data available on request from Aralez Medical Information

24 Consistent CV Risk Reduction Was Seen in the Subgroup of Patients With Diabetes Incidence, % Composite of CV Death, MI, Stroke, or UCR at 3 years 1 RRR HR (95% CI) % 0.83 ( ) Placebo All 10.1 n=20,170 ZONTIVITY % 0.79 ( ) ARR (NNT a ) 1.7% (59) 2.9% (34) 15.3 History of Diabetes n=4,762 Compared with all post-mi or PAD patients without a history of stroke or TIA, consistent benefit was seen in the subgroup of patients with diabetes when ZONTIVITY was added to aspirin and/or clopidogrel. Subgroup analyses must be interpreted cautiously, as differences may reflect the play of chance among a large number of subgroups examined for their influence on outcomes. The trial was not designed to evaluate the relative benefits and risks of ZONTIVITY in individual patient subgroups a NNT = 1/ARR CV = cardiovascular; MI = myocardial infarction; UCR = urgent coronary revascularization; RRR = relative risk reduction; HR = hazard ratio; CI = confidence interval; ARR = absolute risk reduction; NNT = number needed to treat. 1. Data available on request from Aralez Medical Information

25 Zontivity: Bleeding Adverse Events Safety population 13,186 patients 2,187 patients treated for more than 3 years. Adverse events in the ZONTIVITY-treated (n=10,059) and placebo-treated (n=10,049) post- MI or PAD patients with no history of stroke or TIA Definitions: GUSTO severe bleeding was defined as fatal, intracranial, or bleeding with hemodynamic compromise requiring intervention GUSTO moderate bleeding was defined as bleeding requiring transfusion without hemodynamic compromise 25 GUSTO: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries.

26 Zontivity Non CABG-Related Bleeding Rates Over 3 Yrs 3-year Kaplan-Meier Estimate, % Bleeding was evaluated in more than 20,000 Post-MI or PAD patients without a history of stroke or TIA Non CABG-Related Bleeds in As-Treated Patient Population (first dose to last dose + 30 Days) GUSTO Moderate or Severe HR, % CI, Placebo plus aspirin and/or clopidogrel (n=10,049) ZONTIVITY plus aspirin and/or clopidogrel (n=10,059) CABG = coronary artery bypass graft; MI = myocardial infarction; PAD = peripheral arterial disease; TIA = transient ischemic attack; GUSTO = 26Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries; ICH = intracranial hemorrhage; HR = hazard ratio for ZONTIVITY group vs placebo group; CI = confidence interval GUSTO Severe ICH Fatal HR, % CI, HR, % CI, HR, % CI, Any GUSTO bleeding (severe/moderate/mild) over 3 years occurred in 19.8% of patients taking placebo (1,769/10,049) (HR, 1.52; 95% CI, ) and in 27.7% of patients taking ZONTIVITY (2,518/10,059) Clinically significant bleeding over 3 years occurred in 10.9% (950/10,049) of patients taking placebo (HR, 1.47; 95% CI, ) and in 15.5% (1,349/10,059) of patients taking ZONTIVITY

27 Zontivity: Indication and Administration Zontivity is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). Zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. There is no experience with use of Zontivity alone as the only administered antiplatelet agent. Zontivity has been studied only as an addition to aspirin and/or clopidogrel. 27

28 Zontivity: Boxed Warning WARNING: BLEEDING RISK Do not use Zontivity in patients with a history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH); or active pathological bleeding Antiplatelet agents, including Zontivity, increase the risk of bleeding, including ICH and fatal bleeding. 28