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Healthcare Symposium: 6th Annual Gabelli Funds/Columbia Business

6th Annual Gabelli Funds – Columbia Business School Healthcare Symposium  November 15, 2024

Gabelli Funds and Columbia Business School co-hosted the 6th Annual Healthcare Symposium on  November 15th. The symposium addressed advances in surgical robotics, artificial intelligence, data  interoperability, and atrial fibrillation. The panelists consisted of senior executives from both public and  private healthcare companies.

Jeff Jonas currently serves as a  Portfolio Manager on multiple  open and closed end mutual funds  as well as a Medical Opportunities  hedge fund. He first joined the  firm in 2003 after graduating from  the Carroll School at Boston  College with majors in finance  and management information  systems. He was a Presidential  Scholar and earned his Chartered  Financial Analyst designation in  2006.

Professor Chan teaches the MBA  core Operations Management course  and the MBA electives, The US  Healthcare System: Structures and  Strategies; Healthcare Management,  Design, and Strategy; and The Analytics  Advantage. Her research is in the area of  healthcare operations management. Her  primary focus is in data-driven modeling  of healthcare systems. She is the  recipient of a National Science  Foundation (NSF) Faculty Early Career  Development Program (CAREER)  award, the Production and Operations  Management Society (POMS) Wickham  Skinner Early Career Award, and the  MSOM Young Scholar Prize.

Daniel Barasa is a Portfolio  Manager and analyst at  Gabelli Funds, covering  pharmaceuticals, managed  care, and healthcare services.  Previously, he worked as an  actuary at Cigna and New  York Life. Daniel graduated  summa cum laude from  Berea College with a BA in  Economics and Mathematics  and holds an MBA from  Harvard Business School. He  is also a Fellow of the Society  of Actuaries and a member of  the American Academy of  Actuaries.

Elena Meng joined GAMCO Investors  in 2024 as a research analyst covering  global Healthcare. Previously, she  served as Head of Asia Pacific  Research at Ridgetop Research. Elena  holds a BS in business administration  with a concentration in finance from  Binghamton University and holds an  MBA from Columbia Business  School where she was a member of the  Value Investing Program.

Rebecca Stern joined the firm in 2022  and contributes to its sustainability  efforts. Prior to that, she was a fellow  at the Harvard Kennedy School and an  employee of GAMCO in mutual funds  from 2012-2015. Rebecca’s  undergraduate degree is from Yale  University in environmental studies  and political science. She holds a PhD  from Harvard University in  environmental engineering.

Welcoming Remarks

Around the world, healthcare spending continues to grow faster than GDP, driven by an aging population,  new treatments, and inflationary pressures. In the United States, 56 million people or 17% of the population  are over the age of 65 and entering their peak demand years for healthcare. Older age groups are growing  even faster, with over 16 million people between the ages of 75 and 84, and over 6 million people aged 85  and older. Europe is seeing similar aging trends, while emerging markets are aging at even faster rates as  birth rates decline rapidly.

Spending Growing Faster than GDP: In the United States, healthcare spending grew 4.1% to $4.5 trillion  in 2022, the most recent year available. This represents just over 18% of GDP and is poised to continue to  grow to over 19.5% of GDP by 2030. Europe spends over €1.6 trillion or 10.4% of GDP—a lower percentage  of GDP, but those countries still struggle to fund their systems and deliver the care their populations demand.  Spending in emerging markets, while still low, is growing at double digit rates as the emerging middle class  demands better care for themselves and their families.

2024 Trends: This year has seen many challenges and opportunities in the market. Healthcare utilization  has increased as the COVID-19 pandemic has ended, which was initially thought to be simply pent-up  demand but is increasingly looking like the new normal. This has been a positive for hospitals, medical  device companies, and other suppliers, but a real challenge for employers and insurance companies that pay  for the care. The problem has been particularly acute in government programs such as Medicare Advantage  and Medicaid with relatively fixed annual payment rates.

Rise of GLP-1’s: One of the most significant trends impacting the market over the last several years has  been the development of a new class of medicines known as GLP-1’s for both Type II diabetes and obesity.  While still early in their launch and suffering from capacity constraints, this is expected to become the largest  drug class ever with over $100 billion a year in annual sales. The medicines have remarkable benefits on  cardiovascular health, kidney disease, sleep apnea, and many other areas as well. In the United States, these  drugs, along with better diet and exercise appear to have finally halted and even reversed the obesity epidemic  in this country.

Election Impact: The industry is closely watching the incoming Trump administration to see what changes  they may make to the healthcare system. The nomination of Robert F. Kennedy Jr. as Secretary of Health  and Human Services has introduced significant uncertainty into the market, given his skepticism around  vaccines, artificial food ingredients, and GLP-1 medicines. The nominee to run Medicare and Medicaid, Dr.  Mehmet Oz, favors the privatized Medicare Advantage program for seniors, but many Republicans would  like to see cuts and restrictions placed on the Medicaid programs in the states. This uncertainty has  significantly weighed on healthcare stocks since the election.

Drug Price Negotiation: 2026 will be the first year of drug price negotiation under the Inflation Reduction  Act. The initial top 10 drugs in the Medicare Part D program will see an approximately 22% reduction in  net price to seniors, saving a relatively modest $6 billion, which the industry can reluctantly live with. But  the program is poised to expand significantly in future years, including to Medicare Part B drugs, and it is  unclear if or how the new administration will continue this program.

Mergers and Acquisitions: The outgoing Biden administration and their appointees in the Department of  Justice and the Federal Trade Commission were very clear about their tough scrutiny of healthcare deals.  Despite that, 2024 was an average year for the number of mergers and acquisitions, but they tended to be  smaller and lower profile because of this. The incoming Trump administration has promised a lighter  regulatory touch, and as such we expect a significant increase in dealmaking activity.

Panel 1: Unlocking the Potential of Surgical Robotics and Artificial Intelligence

  • Jeff Jonas, Portfolio Manager, Gabelli Funds – Moderator

Panelists:

  • Gretchen Jackson, MD, PhD, Vice President, Scientific Medical Officer at Intuitive Surgical (NYSE: ISRG  $548.00). Gretchen is a past President of the American Medical Informatics Society and is an Associate  Professor of Surgery, Pediatrics, and Biomedical Informatics at Vanderbilt University. She has also  previously worked as the Chief Health and Science Officer for IBM Watson.
  • Joshua Stopek, PhD, Vice President Research and Development at HistoSonics. HistoSonics is a privately  held company developing the Edison Robot that uses a type of high frequency Ultrasound Energy to destroy  cancerous tissue, and may eventually be used for incisionless surgery. Joshua has previously worked in  various R&D roles at Medtronic, Covidien, and US Surgical.
  • Martin Martino, MD, MBA, Medical Director of Gynecologic Oncology and Robotic Surgery at Ascension,  one of the largest nonprofit hospital groups in the country. Mary is a past President of the Surgical Robotics  Society and has built surgical robotic programs at multiple hospitals while personally performing over 3200  robotic procedures.

Takeaways: 

  • $8 Billion Market: The market for surgical robotics is still in its early stages but is currently valued at  almost $8 billion dollars and is growing at a double digit rate, to an estimated $26 billion by 2032. Market  leader Intuitive Surgical has an installed base of over 12,000 robots and is seeing healthy double digit  growth in both installations and procedure volume growth. The cost of a new system at over $1.5 million  upfront plus an annual maintenance contract and consumable instruments has become more affordable over  time.
  • 5th Generation Robot: Intuitive Surgical launched its Dv5 robot in March of this year. The robot features  faster, more automated setup, improved ergonomics for the surgeon, and 10,000 times the computational  power. The system includes greatly expanded video recording and communication features, as well as  haptic feedback through the surgical instruments and artificial intelligence support. Early uptake has been  strong as the company ramps manufacturing and training into a full launch next year.
  • Incisionless Surgery: HistoSonics’ new Edison robot is in commercial launch to remove cancerous tissue  from the liver, where many cancers ultimately spread to. Future uses include kidney and pancreatic cancers,  and eventually most other soft tissue organs. The company is seeing strong uptake in the first year, with a  generous, dedicated reimbursement code that can support the system even at modest procedure volumes.
  • Cost issues fading: Hospital capital expenditure budgets have remained healthy, in part to keep up with  marketing the latest technology to their patients. Companies offer a range of financing methods including  leasing and per-procedure payment methodologies to encourage more widespread adoption. Cost savings,  which can sometimes be hard to measure, include faster discharge time, less blood loss, and fewer  complications.
  • Pre- and Peri-procedure imaging: Surgical robots can help surgeons plan and perform the procedure  with the help of a pre-loaded MRI, CT scan or other image. Technology can build a 3-D model of the case  in advance, showing where to cut and where to avoid, and this changes the treatment plan in up to 20% of  cases. HistoSonics’ Edison robot essentially automates the procedure once the surgeon identifies precisely  which tissue to remove. Intuitive Surgical’s Firefly imaging technology can measure blood flow and tissue  health during surgery to ensure optimal results.
  • Emerging Uses: Doctors who have fully adopted robotic technology are starting to treat emergency room  cases as well as a broader range of cancers including breast and thyroid cancer. New platforms also support  lung biopsy and cancer treatments, as well as orthopedic and brain surgery cases. Mobile and modular  systems also give surgeons and hospitals increased flexibility, versus the need for a dedicated robotic  operating room. Bariatric surgery has seen some negative impact from newer GLP-1 drugs on the market,  but is not going away.
  • Surgeon Feedback: Newer robotic systems give surgeons a wealth of data to improve their craft. They  can benchmark best practices around surgical time, instrument movement, and many other factors. Video  recording and sharing features allow surgeons to easily review their work and participate remotely in  surgeries, greatly facilitating the training of new surgeons. Connectivity solutions can support surgeons in  lower volume or rural areas and may eventually support fully remote surgery as legal and technical issues  get resolved.

Panel 2: Interoperability, Digital Transformation, and Enhancing Patient Care 

  • Daniel Barasa, Portfolio Manager, Gabelli Funds – Moderator

Panelists:

  • Michael Bouton, MD, MBA, Chief Medical Information Officer of NYC Health + Hospitals: Michael  is a practicing emergency medicine physician and the Chief Health Information Officer of NYC Health, the  largest municipal health system in the country. He completed residency at the Harvard Emergency Medicine  Program at Beth Israel Deaconess
  • Sara Dillon, Chief Data Officer of Henry Schein (NASD: HSIC $73.93): Sara serves as Chief Data  Officer at Henry Schein. She is responsible for, among other things, Artificial Intelligence capabilities  across the Henry Schein portfolio globally. Sara graduated with a BA degree from the University of  Pittsburgh.
  • Nick Frenzer, SVP and Chief Implementation Officer at Epic Systems: Nick is an implementation  executive at Epic. He is responsible for coordinating the company’s Population Health strategy and  execution. Nick graduated from Arizona State University with degrees in accounting, and served in the  United States Marine Corps   Josh Weiner, Senior Vice President, Enterprise Consumer Analytics at CVS Health (NYSE: CVS  $57.78): Josh is the SVP of Consumer Analytics at CVS. He is focused on using AI to empower consumers  to improve their health and navigate care. Previously, Josh developed biosensor algorithms and wellness  experiences at Meta. Josh holds a B.S. from Carnegie Mellon and an M.S. from Northwestern.

Takeaways: 

  • Progress towards improved interoperability and connectivity: When the concept of sharing records  across health systems was initially introduced over 20 years ago, it was considered legally non-compliant  by some providers. Fast forward to today, Epic shares hundreds of millions of records every week with Epic  and non-Epic sites, enabling better patient outcomes at lower costs. But there is still a lot of work to do –  there is too much variation at the local levels, with some localized geographies lacking the necessary  infrastructure to get connected. TEFCA (Trusted Exchange Framework and Common Agreement) is  expected to address this by creating a nationwide, standardized approach to health information exchange  across the US, and establishing a legal framework governing network interactions.
  • Change Healthcare Cyber-attack: Change Healthcare (part of UnitedHealth Group) was hacked in  February 2024, significantly impacting the operations of a wide section of the US healthcare system.  According to analysis by STAT, more than 172 million individuals in the US may have been impacted by  data breaches in 2024. The attack on Change Healthcare specifically impacted 100M people, the largest  healthcare breach in US history. Health systems get thousands of attacks a day and fend them off – in these  cases, it matters who you share your data with. As an entity you don’t just care about your strategy for  defense, you need to care about the strategy for entities that you are giving data to. Having basic security  features such as 2-factor authentication (which Change apparently did not) is table stakes. The attack also  highlighted the architectural failure in the system to have so much traffic going through one ANSI switch  (roughly 1/3 of all claims in US are processed through Change HC). Going forward, providers and other  entities are expected to rely on multiple vendors. HHS is also working to modernize HIPAA, which was  written before the innovations in cloud computing and use of AI in clinical decision-making.
  • Role of AI in advancing the healthcare system towards a more interoperable state: Different forms of  artificial intelligence are expected to play a key role in moving the healthcare system to a more interoperable  state. As the industry creates a more standardized approach to bringing disparate vast amounts of data  together, AI algorithms/Large Language Models (LLMs) will be deployed to do the analysis in a timelier  manner relative to what humans can do today.
  • Use Cases: Key AI uses include identifying what data to share to close gaps in care, automatically  transcribing conversations and making them accessible across different care groups (social workers, mental  health specialists, PCPs, referrals etc.) to address care coordination and fill patchworks in transition of care,  as well as responding to patient messages to help physicians focus on higher quality work (this has been  shown to reduce physician burnout by ~40% at several academic medical centers).
  • Limits of AI: AI shouldn’t be used in any setting that requires decision making; we still need humans to  make the decisions that affect clinical outcomes. Additionally, most AI models currently in the market do  not have a positive ROI. There should be a stronger push for wider adoption of AI algorithms that are  already FDA cleared – e.g. the FDA-cleared AI algorithms for diagnosing diabetic retinopathy; if result is  negative the ophthalmologist does not have to look at it and dedicates their time to only the positive cases;  the industry is working on similar algorithms for mammograms. On the flip side, the industry should de-emphasize algorithms that introduce administrative burden to the system, such as AI bots on the  provider/insurance sides that go back and forth disputing claim payments.
  • Innovations in drug development and value-based pricing: Interoperability will play a key role in  establishing real world efficacy and safety data that could be used to form the basis of negotiations with  pharma manufacturers to establish value-based pricing models for transformative (and expensive)  medicines such as cell and gene therapies. Additionally, given that these medicines tend to be utilized by  older members once they transition to government insurance schemes, interoperability could enable the  collection of data that would form the basis for more elegant risk sharing models that create innovative  ways to spread out the costs of these drugs as people navigate through different insurance schemes.
  • Genomics: Epic is doing interesting work mapping the human genome for common diseases that could be  useful in augmenting physician decision-making. Epic anonymized patient data and mapped it to a variety  of genetic studies, building a decision score for physicians to get answers quicker and at lower cost.
  • Dental Integration: There should be a larger emphasis on Medical – Dental integration especially from a  clinical data perspective. Extensive research strongly suggests that a wide variety of diseases including  diabetes, cardiovascular disease and maternal health issues could be addressed during normal dental  exams, which would improve patient outcomes and lower costs by avoiding complications.

Panel 3: Advances in Atrial Fibrillation Technology and Treatment

  • Carri Chan, Professor, Columbia Business School – Moderator

Panelists:

  • Joe Fitzgerald, MBA, EVP & Group President, Cardiology at Boston Scientific (NYSE: BSX $90.79). Joe  has spent over 30 years at Boston Scientific, starting as a sales representative before rising through the ranks  of the Endovascular, Cardiac Rhythm Management, and Interventional Cardiology divisions.
  • Larry Biegelsen, Senior Medical Device Analyst at Wells Fargo. Larry has followed the medical device  industry for over 15 years and previously worked at both Merck and Pfizer.
  • Elaine Wan, MD, Esther Adboodi Associate Professor of Medicine in Cardiology and Cardiac  Electrophysiology at Columbia University Irving Medical Center. Elaine does significant fundamental  research and has published over 80 manuscripts on topics such as heart failure, vascular dysfunction, and  arrhythmias.

Takeaways:

  • Underserved Population: There are at least 12 million people with Atrial Fibrillation in the United Sates,  including both symptomatic and asymptomatic patients, and well over 100 million worldwide. Atrial  Fibrillation is partly caused by genetic factors but primarily by age and lifestyle, contributing to stroke,  dementia, and other comorbidities. This represents a $13 billion market today, growing 15-20% annually  as treatment options become faster and easier for a wider range of physicians.
  • Current treatment: Historically the main treatment for Atrial Fibrillation has been medication  management and blood thinners to reduce the risk of stroke, which are helpful but carry significant side  effects. Older surgical interventions used heat or cold energy sources to isolate the portion of the heart  tissue with the arrythmia, but these were often extremely long and complex surgeries with widely variable  success rates.
  • Pulsed Field Ablation: This new technology uses electrical pulses to quickly and consistently isolate  arrythmias with minimal risk of damage to surrounding tissue. It won approval in Europe about three years  ago and earlier this year in the US. With safe, fast results Pulsed Field Ablation is quickly becoming the  standard of care and is freeing up significant surgical capacity to better treat this large, underserved patient  population.
  • Age Divide: New wearable and implantable technologies like the Apple Watch are improving diagnosis  of atrial fibrillation, especially amongst younger and asymptomatic patients, but have a high false positive  rate and consume significant physician time. Newer artificial intelligence tools could help predict disease  progression and improve diagnostic accuracy. As usual, early intervention is better but younger patients  often resist surgical procedures and lifestyle changes.
  • Left Atrial Appendage (LAA) is a small pouch attached to the heart where blood can pool, creating a  small but significant stroke risk. The recent OPTION trial by Boston Scientific showed that this appendage  can be closed at the same time as an ablation procedure to further reduce stroke risk and reduce the use of  blood thinning drugs, creating significant advantages for both patients and surgeons.
  • Renal Denervation: After almost 20 years of development and many failures, a minimally invasive  surgical procedure known as renal denervation is poised to help patients control their blood pressure by  improving kidney function in the body. The first two companies with regulatory approvals are still working  to win reimbursement coverage and to train doctors, but this could be a potentially multi-billion dollar  complementary market in the future, helping at least 25 million Americans who struggle to control their  high blood pressure.
  • Mergers & Acquisitions: For almost 20 years, large players have added interesting new mapping,  navigation, and ablation technologies to their portfolio through acquisitions. Not all have been successful  and regulatory and development cycles are very long, so change has been slow. However, the market is  fiercely competitive and continues to reward innovation with attractive financial returns.

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This whitepaper was prepared by Jeff Jonas, CFA, Daniel Barasa and Elena Meng. The examples cited  herein are based on public information and we make no representations regarding their accuracy or  usefulness as precedent. The Research Analyst’s views are subject to change at any time based on market  and other conditions. The information in this report represent the opinions of the individual Research  Analyst’s as of the date hereof and is not intended to be a forecast of future events, a guarantee of future  results, or investments advice. The views expressed may differ from other Research Analyst or of the Firm  as a whole.
 As of September 30, 2024, affiliates of GAMCO Investors, Inc. beneficially owned less than 1% of all  companies mentioned.
This whitepaper is not an offer to sell any security nor is it a solicitation of an offer to buy any  security.
Investors should consider the investment objectives, risks, sales charges and expense of the fund  carefully before investing.
For more information, visit our website at: www.gabelli.com or call: 800-GABELLI  
800-422-3554 • 914-921-5000 • Fax 914-921-5098 • info@gabelli.com

 

Rebecca Stern

Rebecca Stern

Research Analyst
Jeff Jonas

Jeffrey J. Jonas

Portfolio Managers, Research Analysts
Daniel Barasa

Daniel Barasa

Portfolio Manager
Katie Durkin

Katie Durkin

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