Neovasc Inc. Corporate Strategy
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Neovasc Inc.
Corporate Strategy
1
Forward Looking Statements This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words "expect", "anticipate", "estimate", "may", "will", "should", "intend," "believe", and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the nature of the target population for the Reducer and Tiara, the nature of the safety and efficacy and safety data of the Reducer and Tiara, Neovasc Inc.’s (the “Company”) value creation strategies, the Company’s plans respecting the use of cash and expenses, the Company’s targeting of CE Mark Decision under EU Medical Device Regulation for the Tiara TA, the intimation of a U.S. IDE Study, the Company’s plans to pause Tiara TF related activity, the Company’s targeting of new proposed ICD-10 diagnosis codes and new APC code, the expected outcomes of international reimbursement review decisions and the timing thereof, the Company’s plans to expand direct sales force and the timing thereof, the promising nature of Tiara TA results, the design and details of the COSIRA II trial and the timing thereof, the nature and size of the mitral regurgitation market, the expected timing of EU regulatory decision on Tiara TA, the expected approval of the Reducer in Brazil and Latin America and the timing thereof, the expected timing of the Reducer COSMIA data readout, the expectation of FDA approval for the Reducer and the timing thereof, the assumption of commercial partnership with respect to the Tiara TA, revenue projections for the Tiara and the Reducer and the projections of market potential, risks, timelines and costs of the Reducer, Tiara TA and Tiara TF programs. Many factors and assumptions could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company's ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company's operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company's expected schedule; risks relating to the Company's need for significant additional future capital and the Company's ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company's common shares (the "Common Shares") may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company's significant indebtedness, and its effect on the Company's financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company's resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company's ability to establish, maintain and defend intellectual property rights in the Company's products; risks relating to results from clinical trials of the Company's products, which may be unfavorable or perceived as unfavorable; the Company's history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company's products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company's ability to achieve or maintain expected levels of market acceptance for the Company's products, as well as the Company's ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company's ability to convince public payors and hospitals to include the Company's products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company's products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company's products; risks relating to health and safety concerns associated with the Company's products and industry; risks relating to the Company's manufacturing operations, including the regulation of the Company's manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company's products; risks relating to the manufacturing capacity of third-party manufacturers for the Company's products, including risks of supply interruptions impacting the Company's ability to manufacture its own products; risks relating to the Company's dependence on limited products for substantially all of the Company's current revenues; risks relating to the Company's exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a "passive foreign investment company"; risks relating to breaches of anti-bribery laws by the Company's employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company's dependence upon key personnel to achieve its business objectives; risks relating to the Company's ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company's management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company's ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company's officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company's constating documents which could discourage a third-party from making a takeover bid beneficial to the Company's shareholders. These risk factors and others relating to the Company are discussed in greater detail in the "Risk Factors" section of the Company's Annual Information Form and in the ff Discussion and Analysis for the three months ended March 31, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law. 2
Neovasc Core Products
Neovasc Reducer™ device for minimally Tiara™ mitral valve replacement for
invasive treatment of refractory angina minimally invasive treatment of mitral valve
disease
• NEJM COSIRA Sham-controlled RCT1 • Over 5 Million patients in both the U.S. and
• Initiating COSIRA-II Trial E.U. suffer from mitral regurgitation3,4
• FDA Breakthrough Medical Device Designation • Tiara TA – Targeting CE Mark Decision under
EU Medical Device Regulation
• Included in ESC Guidelines2
1N Engl J Med 2015; 372:519-527
2 European Heart Journal 2020; 41:407-477
3 Neovasc Market Model, Data on File
3 4 Asgar et al. Secondary Mitral Regurgitation in Heart Failure. JACC 2015;65:1231-48
Tiara is an Investigational Device not currently approved in any geography Reducer is not available for sale in the United States
Focused Execution To Increase Shareholder Value
Reducer Market Development
• Working to Grow Revenue in Existing and New Geographies
• Pushing to Expand Reimbursement
• Initiating U.S. IDE Study: COSIRA-II
Tiara TA Mitral Valve Program
• Targeting CE Mark Decision for Tiara TA under Medical Device Regulation
• Pausing Tiara TF Related Activity
Improved Cash Flow
• Focusing on Optimal Use of Cash Following $72M Capital Raise
• Reducing Expenses
4 .
Tiara is an Investigational Device not currently approved in any geography Reducer is not available for sale in the United States
Refractory Angina: An Underserved Market
• Chronic, refractory angina (RA) pectoris affects millions of patients worldwide and represents a
potential multi-billion-dollar opportunity1
• Over 2 Million angiograms per year in both the U.S. and E.U.1
• Over 500,000 patients per year in each market present with Angina with Non-Obstructive Coronary Artery
Disease (ANOCA)1,2
• Over 1.2 Million PCI/CABG procedures per year in the U.S. and E.U.1
• Over 250,000 patients, already revascularized (PCI or CABG) continue to experience angina, even with
contemporary stents or bypass surgery1,3
• Refractory angina is an expensive, often debilitating condition and both patients and
physicians are looking for new alternatives
1. Neovasc Market Model, Data on File
2. Patel, M. N Engl J Med 2010; 362:886-895
3. Abdallah, M. Syntax Trial, J Am Coll Cardiol 2017;69:2039-50
5
Reducer is not available for sale in the United States
Clinical Study Showed Reducer Improves Symptoms in
Refractory Angina Patients
CCS: 4 Classes of Angina: I Angina only with strenuous exertion, II With moderate exertion, III With mild exertion, IV With any activity or at rest
N Engl J Med 2015; 372:519-527
6
Reducer is not available for sale in the United States
REDUCER-I: Real World Clinical Trial Results
Primary Endpoint: Reduction in CCS Grade
≥1 Grade ≥2 Grade
100 81.0%
79.3% 76.9%
90
74.1% 70.6%
80 70.2%
70 38.1%
Patients (%)
60 38.5%
50 33.8%
40 27.2% 28.4%
24.2%
30
20
10
0
6 Mo 12 Mo 24 Mo 36 Mo 48 Mo 60 Mo
N=198 N=158 N=116 N=68 N=39 N=21
Includes data through analysis lock on 13 August 2020 and is 79% monitored; on file at Neovasc
7
Reducer is not available for sale in the United States
REDUCER-I Reduction in Emergency Visits
Number of Documented Emergency Department Visits Due to Angina in the Past 12 Months
1 Based on Subjects with Baseline and 12 Month Visits; excluding one subject with 15 ED visits at baseline,
patients act as their own control in matched analysis
2
Data are presented as % (n/N)
3
Data are presented as mean ± SD (N) [min, max]
4 Based on a Wilcoxon Signed Rank test
Includes data through analysis lock on 13 August 2020 and is 79% monitored; on file at Neovasc
8
Reducer is not available for sale in the United States
Exercise Tolerance Test in COSIRA
N Engl J Med 2015; 372:519-527 Appendix
9
Reducer is not available for sale in the United States
COSIRA-II Trial
COronary SInus Reducer for Refractory Angina II
Design: Sham-Controlled, Randomized, Controlled, Double-Blind Trial
Patient Population:
• Patients with CCS Class III & IV Angina despite guideline directed maximal medical therapy
• Evidence of reversible ischemia on non-invasive testing
• Ineligible for conventional revascularization procedures (PCI or CABG)
Sample Size = ~380
Number of Centers = ~30
Primary Endpoint = Change in Exercise Tolerance Testing Time via Modified Bruce Protocol
Principal Investigators: Gregg Stone, M.D., Tim Henry, M.D.
10
Reducer is not available for sale in the United StatesCOSIRA-II Executive Steering Committee
Gregg W. Stone, MD Tim Henry, MD Marc Jolicoeur, MD Allen Jeremias, MD
Director of Academic Affairs Medical Director, The Carl MD Associate Professor of Associate Director, Cardiac
for the Mount Sinai Heart and Edyth Lindner Center Medicine Universite de Catheterization Laboratory
Health System for Research and Education Montréal Director, Interventional
Professor of Medicine The Carl and Edyth Lindner Interventional Cardiologist Cardiology Research
(Cardiology) Family Distinguished Chair CHUM St. Francis Hospital
Professor of Population in Clinical Research Montreal, Canada The Heart Center
Health Sciences and Policy Director of Programmatic Roslyn, NY
The Zena and Michael A. and Network Development
Wiener Cardiovascular Christ Hospital
Institute Cincinnati, OH
Icahn School of Medicine at
Mount Sinai
New York, NY
11
Reducer is not available for sale in the United StatesCOSIRA-II Trial Additional Information
• Primary Safety Endpoint: composite of death, myocardial infarction (MI), pericardial effusion
requiring surgical or percutaneous intervention, device embolization, or BARC 3 or 5 bleeding within
12 months post-procedure
• Key Secondary Endpoints
• Improvement by ≥1 CCS angina grade at 6 months
• Improvement by ≥2 CCS angina grades at 6 months
• Change in Angina Stability domain score from the Seattle Angina Questionnaire (SAQ) at 6 months
• Two imaging sub-studies
• Positron Emission Tomography (PET) Ischemia: to assess transmural perfusion, subendocardial
defects and improvement in absolute flow
• University of Texas Health Science Center at Houston
• Computed Tomography Angiography (CTA): to assess Reducer position/migration, patency,
neointima, lumen diameter, and fracture
• MedStar Health Research Institute, Inc
• Additional core labs for: Angiography and Exercise Tolerance
12
Reducer is not available for sale in the United StatesReducer U.S. Reimbursement
• Issued New ICD-10 Procedure Code Effective October 2021
• X2V73Q7 Restriction of Coronary Sinus with Reduction Device,
Percutaneous Approach, New Technology Group 7
• Issued New MS-DRG Codes – Effective October 2021
• MS-DRG 228, Other Cardiothoracic Procedures with
MCC, 2022 Proposed Average Payment Rate $35,260
• MS-DRG 229, Other Cardiothoracic Procedures without MCC,
2022 Proposed Average Payment Rate $22,760
• CMS Proposed New Tech Add-On Payment by CMS, May 2021
• $9,750 Add-on (65% of $15,000 Expected ASP) pending FDA
Approval
• Neovasc withdrew application while pursuing FDA Approval
• Targeting New Proposed ICD-10 Diagnosis Codes
• Refractory Angina Codes Targeted for October 2022
• Targeting New APC Code
13
Reducer is not available for sale in the United StatesInternational Reimbursement Targets
Germany
NUB Status 1 for 2021
Targeting ZE Full National Coverage – Decision expected 2H 2021
United Kingdom
NICE Interventional Procedures Advisory Committee (IPAC) review ongoing
Included on High-Cost Tariff Excluded Devices (HCTED) list beginning 2H 2021
France
HAS Review underway for National Coverage – Decision expected 2H 2021
Netherlands
ZIN Review underway for National Coverage – Decision expected 1H 2022
14
Reducer is not available for sale in the United StatesPlanning for Direct Sales Force Expansion
Today 2021 2022 2023 2024
Germany
France 2
Expansions planned assuming
U.K. 1 positive reimbursement
developments in targeted markets
France 2
Germany 1
Belgium 1
Netherlands 1
Germany 3
15
Reducer is not available for sale in the United StatesMicrovascular Disease May Be an Emerging Target for
Reducer
• Coronary Microvascular Disease
may represent an emerging
frontier for Reducer
• Case reports suggest potential
for positive outcomes with
Reducer
• Numerous investigational
studies underway
• University of Mainz
• Mayo Clinic
Image from Taqueti et al, Coronary Microvascular Disease Pathogenic Mechanisms and Therapeutic Options: JACC State-of-the-Art Review, Volume
72, Issue 21, 27 November 2018, Pages 2625-2641
16
Reducer is not available for sale in the United StatesTiara: Mitral Regurgitation is an Underserved Market
• Over 5 Million patients in both the U.S. and E.U. suffer from mitral
regurgitation1,2
• Anticipate $2B+ market by 20231
• Prognosis is poor for patients with undertreated mitral regurgitation
• Vast majority of patients with MR do not get adequate treatment due to
complexity of disease and device solutions
• There is no single approach that can treat all patients
• TA initial results promising
1 Neovasc Market Model, Data on File
2 Asgar et al. Secondary Mitral Regurgitation in Heart Failure. JACC 2015;65:1231-48
17 Tiara is an Investigational Device not currently approved in any geographyPoor Prognosis for Patients with Functional MR
5 yr survival for
secondary (functional)
mitral regurgitation
is 46%
Dziadzko V et al. Outcomes and undertreatment of mitral regurgitation: a community cohort study. Lancet 2018;391:960-9 Observed-Survival in patients with MR
18 Tiara is an Investigational Device not currently approved in any geographyTraditional Mitral Valve Replacement Surgery has High Morbidity and Mortality Low-, Moderate- and High-risk categorized patients Chancellor WZ, Hunter Mehaffey J, Clark SA, et al. Outcomes of surgical mitral valve replacement: A benchmark to assess transcatheter technologies. J Card Surg. 2020;1–5. 19 Tiara is an Investigational Device not currently approved in any geography
Tiara TA Procedural Outcomes
Absence
Successful Successful of Emergency
Absence of
Access, Delivery, Deployment Surgery/
Study Procedural
and Retrieval and Correct Reintervention
Mortality
of Delivery System Positioning of Valve Related to Device or
Access Procedure
Overall
100% (83/83) 99% (82/83) 93% (77/83) 93% (77/83)
(N=83)
TIARA-I
100% (27/27) 100% (27/27) 93% (25/27) 89% (24/27)
(N=27)
TIARA-II
100% (34/34) 97% (33/34) 91% (31/34) 94% (32/34)
(N=34)
Compassionate Use
100% (22/22) 100% (22/22) 96% (21/22) 96% (21/22)
(N=22)
Data cut-off 12 Nov 2020
20
Tiara is an Investigational Device not currently approved in any geographyTiara TA Mitral Valve Insufficiency Over Time
100% 3.8% 4.7%
1.9% 13.9% 10.7%
90% 5.8% 9.3% 16.7%
80%
70%
% of Implanted Patients
60%
86.9%
50% 100.0%
88.5% 86.0% 86.1% 89.3%
40% 83.3%
30%
20%
10%
13.1%
0%
Baseline N=61 Day 10/ 30 Day 90 Day 180 Day 1 Year 2 Year
Discharge N=52 N=43 N=36 N=28 N=24 N=9
None/Trace Mild Moderate Moderate/Severe Severe Not Evaluated
Data cut-off 12 Nov 2020
21
Tiara is an Investigational Device not currently approved in any geographyNYHA Improvement for TIARA-I and TIARA-II
100% 3.2% 3.8% 2.4% 7.4%
12.9% 15.4%
90%
28.2%
80%
47.6%
70%
% of Implanted Patients
60% 69.2% 66.7%
82.0% 64.5% 61.5%
50%
53.8%
40%
30% 38.1%
20%
23.1% 25.9%
10% 17.9% 22.6% 23.1%
14.8% 11.9%
0% 3.8%
Baseline N=61 Day 10/ 30 Days 90 Days 180 Days 1 Year 2 Years
Discharge N=42 N=39 N=31 N=27 N=13
N=26
Class I Class II Class III Class IV
Data cut-off 12 Nov 2020
22
Tiara is an Investigational Device not currently approved in any geographyTiara TA Status
• Targeting CE Mark Decision under the European Medical Device Regulation
(EU MDR)
• Discussing MDR Transition with Notified Body
• Additional Finite Element Analysis (FEA) work underway to characterize
device performance over time
• Additional fatigue testing required to validate device durability
• Clinical results to date suggest strong device performance in vivo
• Targeting 2H 2022 for EU regulatory decision
23
Tiara is an Investigational Device not currently approved in any geographyValue Creation Milestone Objectives
2021 2022 2023 2024 2025
Reducer U.K. Reducer Germany NUB 1 Reducer COSIRA II Reducer COSIRA II
Reimbursement and ZE Full Reducer FDA Approval
Enrollment Completion Data Readout
Reimbursement Decision Decision
Reducer
Reducer France Reducer France
Reimbursement Decision Direct Sales Force
Reducer COSIMA 1st Reducer Brazil / Reducer COSIMA Data
Patient Enrollment Latin America Readout
Approval Decision
Reducer COSIRA II 1st
Patient Enrollment
Tiara
Tiara TA CE Mark
Decision
24
Tiara is an Investigational Device not currently approved in any geography Reducer is not available for sale in the United StatesNeovasc Investment Highlights
Two Unique Products for Large, Underserved Patient Populations
• Reducer – refractory angina
• Tiara – mitral valve replacement
Three-Pronged Value Creation Strategy in Place
• Expanding adoption and reimbursement of Reducer in Europe
• Initiating U.S. IDE study for Reducer in US and Canada
• Targeting CE Mark decision for Tiara TA under Medical Device Regulation
Multi-year Cash Runway and Falling Cash Outflows
• Focusing on optimal use of cash following $72M capital raise
• Rationalizing expenses
25
Tiara is an Investigational Device not currently approved in any geography Reducer is not available for sale in the United StatesThank You 26
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