Industry Review Recommendation: Buy Micro Industry: Cardiovascular Medical Devices Analyst: Bobby Ma Date: April 12, 2020 NBA 4120 Executive Summary This report focuses on medical device companies focusing on treating Cardiovascular diseases. They design and manufacture devices for sale to healthcare providers to treat patients. Their operations are primarily in the United States, but they are also beginning to expand their footprint internationally. The industry includes Angio Dynamics. Merit Medical Systems, and Cardiovascular Systems. Ticker Name ANGO Angio Dynamics Merit Medical MMSI Systems Cardiovascular CSII Systems Mkt cap Revenue 394.7 270.6 EPS P/S Rank NM 1.5x High 1907.7 994.9 122.3x 1.9x High 1409.9 264.4 NM 5.3x Moderate Note: Data as of April 12, 2020 Historical Returns of Company Stock vs S&P 500 188.00% 88.00% -12.00% -112.00% Merit Medical Systems, Inc. (NasdaqGS:MMSI) - Share Pricing Cardiovascular Systems, Inc. (NasdaqGS:CSII) - Share Pricing AngioDynamics, Inc. (NasdaqGS:ANGO) - Share Pricing S&P 500 (^SPX) - Index Value Source: Capital IQ 1 Investment Thesis (Buy) • • • • • • • The small cap Cardiovascular Medical Devices Industry is trading at a discount relative to the Russell 2000, and it will outperform the market because positive factors outweigh the negatives in its future outlook The industry has grown significantly as a result of receiving approval for innovative products that advance the way various Cardiovascular Diseases are treated Cardiovascular diseases are one of the most common types in the United States and globally, and companies in the industry are well-poised to continue offer new treatments The US FDA has expanded programs to develop “breakthrough technologies” in which the industry certainly fits the criteria of and has seen success in However, the shift to value-based care and industry consolidation will put some downward pressure on pricing and margins Internationally, brighter prospects in Asia will be counter-balanced by stringent EU Medical Device Regulations The industry is well-equipped to recover to pre-COVID-19 growth and operating levels after the pandemic subsides due to the nature Cardiovascular Diseases being mandatory (not elective) for long-term health and normalizing of supply chains Industry Overview Industry Definition The Cardiovascular Medical Devices industry designs and manufactures medical devices for the purpose of treating various heart and vascular diseases. Companies spend on R&D and go through an approval process before being authorized to sell their products. Primary customers are health care providers that use their products for their operations to treat patients. Sector Breakdown The small cap US Cardiovascular Medical Devices revenue (ANGO, CSII, MMSI) has experienced rapid growth, culminating in 1.53 billion in 2019. Industry Revenue 2,000.0 20.0% 1,500.0 15.0% 1,000.0 10.0% 500.0 5.0% 0.0 0.0% 2010 2011 2012 2013 2014 Total Revenue 2015 2016 2017 2018 2019 % Revenue Growth 2 The Cardiovascular Medical Devices industry fits within the broader Medical Devices Sector. As of April 9, 2020 the companies in the sector have a Market Cap of 1.14T. Industry revenue was 425.5 billion in 2018, with North America making up 169.3 billion. The Cardiovascular segment had revenue of 40.7 billion in 2018. US Medical Devices Segmentation Other 20.7% Cardiovascular 25.9% Diabetes 4.6% Neurumodulation and Spinal 12.4% Patient Irradiation 20.9% Recovery and Non-invasive 15.5% Source: IBISWorld There are several major categories of Cardiovascular Disease: 1) Coronary Heart Disease: Disease of the blood vessels supplying the heart muscle 2) Peripheral Artery Disease: Disease of the arteries supplying the arms and legs 3) Stroke: Disruption of blood supply to the brain resulting in either blockage or rupture of blood vessels 4) Aortic Aneurysm and Dissection: Dilation and rupture of the aorta, the main artery of the body 5) Deep Venous Thrombosis (DVT) and Pulmonary Embolism: Blood clots in the leg veins, which can be dislodged and relocate to heart and lungs 6) Rheumatic Heart Disease: Damage to heart muscle and valves caused by fever from streptococcal bacteria 7) Congenital Heart Disease: Malformations of heart structures existing at birth caused by genetic factors or adverse exposure during carriage US Medical Devices Distribution International Exports 28.6% Hospitals 36.6% Specialists and Third-Party Alternative Distributors HC Providers 25.8% 9.0% Source: IBISWorld • Products across the medical devices industry are sold to a number of distribution channels 3 • • • Hospitals and Specialists & Alternative Healthcare Providers represent a more direct channel where a salesforce from the company markets the products Third-party distributors help with domestic distribution as well as the bulk of the products exported internationally as they are familiar with the market The small-cap cardiovascular devices industry largely follows the same structure, but exports are far lower as companies first focus on the domestic market Key Players Top 10 Medical Device Companies (2014) 30 25% 20% 15% 10% 5% 0% -5% -10% 25 20 15 10 5 0 Johnson & Medtronic Siemens Johnson Roche Covidien Abbot Labs General Electric Revenue (bn) Stryker Philips Boston Scientific Growth Rate Source: iHealthcare • • Small and large companies each bring unique advantages towards product innovation o Small companies are more focused on innovative products in key area / niche o Large companies have resources / a platform o Leads to dynamic where companies like Boston Scientific / Abbot Laboratories as well as small cap players thrive o ANGO, CSII, and MMSI have targeted focus, but compete against the broad platform, brand name, and resource base of large camp medical device companies Industry suppliers also have power in cost of inputs. Typically have a lot of options of firms and industries to sell to, so the industry does not have negotiating leverage and thus are dependent on commodity prices of various inputs, i.e. metals / alloys US Regulations Inpatient Prospect System rule • • • The Center for Medicare and Medicaid Services (CMS) finalized the Inpatient Prospect System (IPPS) rule expanding on the Expedited Access Pathway (EAP) program begun in 2015 EAP provided provisions for specially designated “breakthrough technologies” that treated serious, life-threatening, or irreversibly damaging conditions o One approved technology in program is in Cardiovascular space so represents opportunity for industry to take advantage to accelerate development timeline Before, access to new technology add-on payments required demonstration of “substantial clinical approvement” 4 • Now, device manufacturers can demonstrate meeting cost criteria (i.e. existing payments are not enough to cover cost of care) thus expediting access to reimbursements for new technologies Expansion of Value-Based Care • • • • To curb healthcare costs and improve patient outcomes, federal and state governments, as well as industry members, are phasing out fee-for-service models in favor of value-based care o Fee-for-service charge payers per unit service performed, i.e. each procedure or visit and all costs / products used during the medical engagement o Value-based care bases payments off health outcomes and improvements from each treatment Fee-for-service encouraged volume of procedures, which created incentives that benefited cardiovascular medical device companies as it led to a larger volume of purchases Value-based care will force the industry to control costs and integrate themselves further into the health care system to assess the patient outcomes from using their products Over the past two decades, Cardiovascular care costs have doubled to US 556 billion, while outcome improvement has stagnated making industry particularly vulnerable Value-Based Arrangement Among HCTTF Members 41% 47% 52% 30% 2015 2016 2017 2018 Source: Healthcare Transformation Task Force • Adoption for value-based care has been growing, as public pressure forces shifts among the payment scheme. In addition to task force members, Aetna estimates that 50% of all healthcare payments were value-based in 2016 and growing European Union Medical Device Regulations (EU MDR) • • Coming May 26, 2020, the EU MDR will replace the current Medical Device Directive o Regulation are binding and carry legal force, so consequences much steeper for noncompliant firms Emphasis shift to product life cycle as opposed to strictly pre-market approval o Assigns each device a unique device identification (UDI) code o Clear obligations to monitor quality, safety, and performance of devices o Necessitates investments into technology to ensure fast and accurate reporting of data on each device with an UDI o Non-compliance results in products being withdrawn from sale 5 • MDR applies to all products sold within EU, so United States Cardiovascular Industry are required to comply with new regulations o Effect 1: May prevent firms in the industry from further European expansion due to extra steps necessary to be incompliance with regulation, hurting revenue growth prospects o Effect 2: Firms that do enter the market must incur extra SG&A costs in order to register each device to an UDI as well as maintain monitoring performance and provider relationships regarding users of their products Asian Regulations • • The main countries companies in the US Cardiovascular Medical Devices industry have presence in (albeit at a fledgling stage) are China, India, and Japan Historically, environments have been a minefield of uncertainty and bureaucracy leading to an unstable situation towards breaking into a new market Recently, new initiatives will streamline the process for better access by US companies • China • In 2014, the National Medical Products Administration (NMPA), the regulatory body responsible for medical devices, introduced a class system based on risk to human body, in line with EU and United States regulation structure • In 2018, NMPA, approved an amendment to allow manufacturers to submit foreign clinical study data in place of China study data • New initiative allows R&D efficiency because same studies done in the United States can be used in another country, making the costs to international expansion less of a burden for firms in the US Cardiovascular Medical Devices industry India • No regulations existed prior to 2005, meaning the India government has been characterized by uncertainty and local bureaucracy • In 2017, the Central Drugs Standard Control Organization (CDSCO), published new Medical Device Rules that came into effect in 2018 • Introduced risk-based class system, inspection rules, and unique identifiers • Core feature for US industry is the government does not require clinical investigation for devices approved in the United States • Expedites international growth and improves R&D efficiency. Once the upfront costs of US approval realize its benefits, the same device can be marketed in India as well Japan • Most developed and stable of the Asian countries • Has risk-classification, registration system, and approval requirements • US industry manufacturers must obtain Foreign Manufacturer Registration • Cardiovascular Systems has a head start, with a core product already approved and several in the process allowing early access to the Japanese market (approx. 12bn) 6 Healthcare Industry Consolidation • • • Increased consolidation among Healthcare Corporations squeeze and crowd out the US Small Cap Cardiovascular Medical Devices Industry Consolidation among other Medical Device Companies o Acquisition of products by bigger firms incorporate innovative products in larger portfolio and platform, allows for synergies in terms of marketing to providers o Core success factor is leveraging product benefits and using litigation to protect from copycats to outcompete other firms in terms of quality o Top-notch innovation will still win out in the end, but the decrease in market share from failure of technological advancement will prove more catastrophic Consolidation among Healthcare Providers o Industry revenue primarily comes from selling medical devices to Healthcare Providers for use of treatments o Increased M&A activity means heighted monopsony power from larger and fewer buyers, limiting out revenue growth and putting downward pressure on prices Global Healthcare M&A 500 4000 450 3500 400 3000 350 300 2500 250 2000 200 1500 150 1000 100 500 50 0 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Deal Value Deal Count Source: Bain Capital 2019 Healthcare Report COVID-19 Effects • • Medical devices industry as a whole will be negatively affected in terms of both sales and costs o Decreased demand from patients as lockdowns and prevention measures force people to stay home o Decreased demand from healthcare providers due to hospital shifting priorities to the pandemic (i.e. caring for patients with Coronavirus) o Increased costs of goods sold and less inventory manufactured due to factory and supply chain disruptions Cardiovascular Medical devices will not experience lowered demand from patients staying home because diseases in the industry are not elective, but life-threatening / altering 7 • • Industry, however, will see decreased sales (~10%) YoY in 2020 due to hospital prioritization of pandemic response, but will resume pre-COVID-19 trajectory in 2021 Gross Profit Margin of industry to also decrease ~15% due to factory shutdowns and increased costs to acquire raw materials Valuation Key Profitability and Valuation Measures Industry Revenue 2,000.0 20.0% 1,500.0 15.0% 1,000.0 10.0% 500.0 5.0% 0.0 0.0% 2010 2011 2012 2013 2014 Total Revenue 2015 2016 2017 2018 2019 % Revenue Growth Industry Gross Profit 1,000.0 20.0% 800.0 15.0% 600.0 10.0% 400.0 5.0% 200.0 0.0 0.0% 2010 2011 2012 2013 2014 Total Gross Profit 2015 2016 2017 2018 2019 % GP Growth Companies in the Cardiovascular Medical Devices have either not reached profitability or have barely reached profitability. This is because of high R&D and marketing costs associated with getting new, innovative products out to market. As a result, Revenue Growth and Gross Profit Margin were most descriptive of the industry. Revenue Growth is important because the purpose of investing in products through incurring high R&D and marketing is to scale and mass produce the product. The Gross Profit Margin is a measure of how profitable each unit of the medical device is as that represents the greatest share of variable costs after upfront R&D and marketing are assumed. Price / Sales is the valuation metric of choice, because Cardiovascular Medical Device companies do not have a lot of dept on their balance sheet, so the market capitalization makes up almost all of the 8 Enterprise Value. Because these companies are burning cash, they have negative operating income and net income for most years of operation. Sales was chosen over book value because companies in this industry have begun selling their products to generate revenue, so P / S is a more accurate measure over P / B as to how effective the Industry’s products are on the market. As more products pass clinical trials and can be marketed to hospitals and their patients, revenue and gross profit will continue to increase, but operating income will start to become more positive as the industry matures. Thus, in the future, EV / EBIT may be a more effective metric to value companies in the industry. Sales Growth and Gross Profit Margin were both chosen as valuation drivers of the industry. As the valuation of metric of choice was P / S, sales growth is important to determine how much investors are willing to pay for each dollar of sales as its ability to grow increases the attractiveness of the industry. Meanwhile, gross profit margin is important because if companies in the industry can profit more on each dollar of sales, then that also makes investors willing to pay more for sales. Time Series Valuation (P / S over time) 5.00x 4.50x 4.00x 3.50x 3.00x 2.50x 2.00x 1.50x 1.00x 0.50x 0.00x 4.16x 2.66x 1.28x Russell 2000 Index (^RUT) - Market Cap/Total Revenues Index: CSII, ANGO, MMSI - Market Cap/Total Revenues Source: Capital IQ 9 P / S vs Sales Growth (Dec 31 of CY) 4.0x 20.0% 3.0x 15.0% 2.0x 10.0% 1.0x 5.0% .0x 0.0% 2010 2011 2012 2013 2014 Industry P/S 2015 2016 2017 2018 2019 % Revenue Growth P / S vs Gross Margin (Dec 31 of CY) 4.0x 55.0% 54.0% 53.0% 52.0% 51.0% 50.0% 49.0% 48.0% 3.0x 2.0x 1.0x .0x 2010 2011 2012 2013 2014 2015 Industry P/S 2016 2017 2018 2019 % Gross Margin Revenue growth explains the Industry P / S multiple better as on the aggregate, Industry Gross Margin is stable. But different regulatory and macroeconomic conditions affect sales growth over time which causes the market to value the industry’s revenues differently. Cross-Sectional Comparison P / S vs % Revenue Growth 6.0x 5.0x y = 17.99x + 1.4964 R² = 0.3453 4.0x ANGO 2.1x 3.0x P / S vs % Gross Margin 6.0x CSII 5.6x CSII 5.6x y = 10.083x - 2.8459 R² = 0.869 5.0x 4.0x 3.0x MMSI 2.0x 2.0x MMSI 2.0x 2.0x 1.0x ANGO 2.1x 1.0x .0x .0x 0.0% 5.0% 10.0% 15.0% 20.0% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% Note: P/S multiples as of Dec 31, 2019 10 In the cross-sectional analysis, Gross Margin explains variation in P/S multiple the best. Each company’s product mix has different economics, so if a product costs less to make but can be sold at a higher price, then if its products pass clinical trials, then they will be more profitable. Final Recommendation and Ranking Due to the economic impact of the COVID-19 pandemic, the price target was calculated by projecting out 2021 Revenue and Gross Profit (Appendix C). An industry average discount rate of 8.39% was used to discount price targets to 2020 (Appendix D). I expect the discount rate to return to what it is historically due to the resumption of normal hospital operations and people resuming treatment for serious Cardiovascular diseases. Unlike other industries that rely heavily on disposable income, these devices represent an inelastic, non-option purchase. The implied discounted share price is an average of using Sales Growth and Operating Margin as the driver for the Price / Sales multiple. Ticker ANGO MMSI CSII Current Price 10.47 34.55 40.00 52-Wk Low– High 7.48–23.21 19.50–63.64 26.00–55.22 CY19 Sales $270.6 $994.9 $264.4 P/S 1.5x 1.9x 5.3x Target Price Rank 17.88 High 44.18 High 43.02 Moderate Note: Data as of April 12, 2020 Rationale for Rankings: • Angio Dynamics ranks highest because by selling off their Fluid Management business mid-2019, they can focus on higher-margin business. Combined with devices in the pipeline driving sales, they are poised to see P/S expansion • Merit Medical Systems is also poised to perform well. Being the most mature company out of the three while generating operating income, they are poised to recover from the pandemic and continue to develop their product line. Their current multiples suggest they are fairly valued for their growth and margin profile, but strong fundamentals will drive growth in the stock price • Cardiovascular Systems is the most moderate of the three. They have several products in clinical trials and experiencing the highest revenue growth. However, their current P/S multiples suggest investors are already paying a fair value based on future expectations of sales growth 11 Appendices Appendix A: Historical Operating Income Operating Income CSII Revenue % Revenue Growth ANGO Revenue(1) % Revenue Growth MMSI Revenue % Revenue Growth Total Revenue % Revenue Growth CSII Gross Profit % GP Growth % Gross Margin ANGO Gross Profit(1) % GP Growth % Gross Margin MMSI Gross Profit % GP Growth % Gross Margin Total Gross Profit % GP Growth % Gross Margin CSII Operating Income ANGO Operating Income(1) MMSI Operating Income Total Operating Income CSII Mkt Cap ANGO Mkt Cap MMSI Mkt Cap Total Mkt Cap CSII P/S ANGO P/S MMSI P/S Industry P/S 2010 71.5 2011 80.2 12.3% 223.4 2.8% 359.4 21.1% 663.2 13.3% 2012 92.7 15.6% 279.7 25.2% 394.3 9.7% 767.1 15.7% 2013 2014 2015 2016 2017 2018 2019 116.4 158.3 178.0 191.5 207.4 231.2 264.4 25.5% 36.0% 12.4% 7.6% 8.3% 11.5% 14.3% 340.2 357.8 346.4 357.6 344.6 349.0 270.6 21.6% 5.2% -3.2% 3.3% -3.6% 1.3% 2.2% 449.0 509.7 542.1 603.8 727.9 882.8 994.9 13.9% 13.5% 6.4% 11.4% 20.5% 21.3% 12.7% 906.1 1,026.2 1,066.6 1,153.1 1,279.9 1,463.1 1,530.0 18.1% 13.3% 3.9% 8.1% 11.0% 14.3% 4.6% 53.6% 63.2 14.1% 78.7% 129.5 2.2% 58.0% 166.2 27.6% 46.2% 360.4 14.9% 54.3% 71.2 12.7% 76.8% 147.6 13.9% 52.8% 182.8 10.0% 46.4% 403.1 11.9% 52.6% 90.1 26.5% 77.4% 169.7 15.0% 49.9% 194.4 6.3% 43.3% 455.8 13.1% 50.3% 125.5 39.4% 79.3% 182.2 7.4% 50.9% 225.2 15.9% 44.2% 534.6 17.3% 52.1% 142.6 13.6% 80.1% 173.2 -4.9% 50.0% 235.8 4.7% 43.5% 552.9 3.4% 51.8% 155.6 9.1% 81.2% 174.9 1.0% 48.9% 265.0 12.4% 43.9% 596.9 8.0% 51.8% 169.4 8.9% 81.7% 171.9 -1.7% 49.9% 326.3 23.1% 44.8% 669.0 12.1% 52.3% 188.4 11.2% 81.5% 186.5 8.5% 53.4% 394.8 21.0% 44.7% 771.2 15.3% 52.7% 212.4 12.7% 80.3% 156.0 0.5% 57.6% 432.4 9.5% 43.5% 802.2 4.0% 52.4% (16.4) 21.6 32.5 37.8 (9.2) 18.4 39.8 49.0 (18.0) 17.4 35.6 35.0 (26.4) 21.4 33.6 28.6 (32.5) 26.9 40.7 35.1 (47.6) 9.8 38.6 0.8 (16.6) 19.9 37.0 40.3 0.1 22.3 64.9 87.3 1.7 28.1 73.3 103.1 (7.5) (9.4) 54.5 37.5 217.4 296.8 585.6 55.3 77.5% 126.8 58.3% 130.2 43.9% 313.7 175.0 160.2 335.3 973.0 1,117.7 297.9 854.4 744.1 1,107.0 1,473.5 408.8 367.5 395.7 632.3 676.5 392.5 611.5 592.0 770.2 577.2 512.9 527.5 508.2 642.9 850.8 832.7 1,379.7 2,307.3 3,193.1 2,038.3 1,096.7 1,055.2 1,239.3 2,248.2 2,645.0 1,523.0 2,845.5 3,643.3 5,070.4 4,089.0 2.4x 1.9x 1.7x 1.9x 2.0x 1.6x 1.5x 1.6x 3.6x 1.4x 1.3x 1.6x 8.4x 1.9x 1.4x 2.5x 7.1x 1.9x 1.7x 2.6x 1.7x 1.1x 1.5x 1.4x 4.5x 1.7x 2.3x 2.5x 3.6x 1.7x 3.2x 2.8x 4.8x 2.2x 3.6x 3.5x 5.6x 2.1x 2.0x 2.7x Note: Calendar Year Financial Data (1) Note: ANGO sold its Fluid Management in Q2 2019. Revenue, Gross Profit, and Operating Income in 2019 are 10-K reported numbers for core, un-sold business. Growth rate in 2019 is the growth YoY (from 2018) in the portion of ANGO not sold. 12 Appendix B: Cross-Sectional Analysis Cross-Sectional Analysis CSII ANGO MMSI Projections % Revenue % Gross Profit P/S Growth Margin 5.6x 14.3% 80.3% 2.1x 2.2% 57.6% 2.0x 12.7% 43.5% Intercept Slope Rev Growth 1.50 17.99 Gross Margin (2.85) 10.08 Appendix C: 2021 Projections Operating Income CSII Revenue % Revenue Growth ANGO Revenue % Revenue Growth MMSI Revenue % Revenue Growth Total Revenue % Revenue Growth CSII Gross Profit % GP Growth % Gross Margin ANGO Gross Profit % GP Growth % Gross Margin MMSI Gross Profit % GP Growth % Gross Margin Total Gross Profit % GP Growth % Gross Margin 2019 264.4 14.3% 270.6 2.2% 994.9 12.7% 1,530.0 4.6% 2020 237.9 -10.0% 243.6 -10.0% 895.4 -10.0% 2021 317.2 20.0% 278.8 3.0% 1,094.3 10.0% 212.4 12.7% 80.3% 156.0 0.5% 57.6% 432.4 9.5% 43.5% 802.2 4.0% 52.4% 162.4 254.8 68.3% 119.3 80.3% 167.3 49.0% 330.8 60.0% 475.6 36.9% 43.5% 13 Appendix D: Price Target Implied Share Price CSII ANGO MMSI # of 2021 2021 Rev Implied Implied Share Shares Rev Growth P/S Price 35.2 317.2 20.0% 5.1x 45.91 37.69 278.8 3.0% 2.0x 15.06 55.21 1,094.3 10.0% 3.3x 65.32 CSII ANGO MMSI Implied Implied Share P/S Price 5.3x 47.34 3.2x 23.70 1.5x 30.45 2021 GP Margin 80.3% 60.0% 43.5% CSII ANGO MMSI Discounted Avg Share Price Avg Share Price Discounted Average Share Price CSII 46.63 43.02 ANGO 19.38 17.88 MMSI 47.88 44.18 Avg Share Price 46.63 19.38 47.88 Discounted Avg Share Price Avg Share Price Discounted Average Share Price CSII 46.63 43.02 ANGO 19.38 17.88 MMSI 47.88 44.18 14 Sources https://www.who.int/cardiovascular_diseases/resources/atlas/en/ https://markets.businessinsider.com/news/stocks/global-cardiovascular-devices-industry-review-20142019-forecast-to-2022-1028522572 https://www.cdc.gov/heartdisease/facts.htm https://www.heart.org/en/news/2019/01/31/cardiovascular-diseases-affect-nearly-half-of-americanadults-statistics-show 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