In this paragraph, Ryan Weispfenning, Vice President and Head of Medtronic Investor Relations, welcomes viewers to the company's Fiscal ‘24 Second Quarter Video Earnings Webcast. He introduces the speakers for the event, provides a brief overview of the agenda, and mentions the availability of financial statements and an earnings presentation. He also mentions that some statements made during the webcast may be considered forward-looking and that the company does not undertake to update them. Finally, he clarifies that all comparisons are on a year-over-year basis and that revenue comparisons are made on an organic basis.

In the past four quarters, there were no significant acquisitions that affected the company's or individual segment's revenue growth. References to revenue changes and share gains or losses are compared to the first and third calendar quarters of 2023 and 2022, respectively. Non-GAAP financial measures can be found on the company's website. The EPS guidance does not include any charges or gains. The CEO discussed the company's strong performance in the second quarter, with mid-single-digit revenue growth across multiple businesses and geographies. New product launches and recent regulatory approvals give confidence for continued growth. The company is also focusing on transformation and investing in innovative technologies for future growth.

In the third paragraph, the company discusses their Q2 results and their focus on three categories of businesses: established market leaders, synergistic businesses, and highest growth businesses. They highlight the strong performances of their Cranial & Spinal Technologies, Surgical, and Cardiac Rhythm Management divisions, which made up nearly half of their revenue and grew 6% organically. They also provide details on their AiBLE ecosystem and Mazor robotic system, as well as their leadership in the intraoperative imaging and navigation space. In the surgical division, they saw broad-based strength with double-digit growth in hernia and electrosurgery and mid-single-digit growth in advanced stapling and wound management.

Cardiac Rhythm experienced 4% growth, driven by strong performance in cardiovascular diagnostics and cardiac pacing. The micro-leadless pacemaker franchise saw a 13% increase, thanks to the launch of the next generation devices in the US. The 3830 lead, the only approved lead for conduction system pacing, also saw strong double-digit growth. The recent FDA approval of the Aurora EV-ICD system, which offers the benefits of a traditional ICD without leads in the heart or veins, is a game changer in the single chamber ICD space. The device is significantly smaller and lighter than its competitors, as demonstrated by a model given to reps. This provides a much better option for patients.

In the fifth paragraph, the company discusses their advantages over competitors and their potential for growth in the market. They also highlight the success of their synergistic businesses, including aortic, coronary, cardiac surgery, and endoscopy. They expect their cardiac ablation solutions to be a significant driver of growth in the coming years, particularly with their pulse field ablation catheters. They are currently ramping up manufacturing and expect to complete a pivotal trial for FDA submission soon.

In Single Shot PFA, the company has received CE Mark for their PulseSelect catheter and it will be available in early 2022. They are the only company with approved catheters for both Single Shot and focal PFA. The FDA is currently reviewing their PulseSelect submission and they expect to be one of the first companies with a PFA catheter in the U.S. market. With their PFA catheters, the Affera Map/Nav system, Arctic front cryo solution, and differentiated flex cath cross-transceptal system, they anticipate strong long-term growth in the EP ablation space. In the Structural Heart sector, the TAVR market is growing in the high-single, low-double-digit range. In Q2, the company grew mid-single-digits, slightly below the market. However, they saw 4% sequential growth, indicating the strength of their product. In Europe, they grew high-single-digits and received CE mark for Evolut FX. In Japan, they continued to gain market share and grew in the mid-30s. Their Evolut platform has shown superior valve performance compared to surgery in randomized trials extending up to 10 years after the initial procedure. The company's Evolut low-risk trial, which compared Evolut to best-in-class surgery, showed a 26% reduction in death or disabling stroke at four years.

The company's Evolut FX transcatheter valve has shown better outcomes compared to surgery, which is compelling to physicians and patients. The company expects this data, along with the global rollout of Evolut FX, to drive TAVR growth above market. In neurovascular, the company saw strong growth in flow diversion, driven by their innovative Shield Technology. The company also increased their installed base for their Hugo robotic system and has received FDA approval to start a pivotal trial for a new indication. Surgeons appreciate the system's features, including Touch Surgery Enterprise Digital Technology, and the company is continually developing their connected digital ecosystem. They expect Hugo, equipped with advanced digital capabilities, to be a significant growth driver in the future.

Medtronic's open console and modular design, along with its leading position in minimally invasive surgery and instrumentation, its connected digital ecosystem, and its world-class surgical training program and partnerships, will help increase the low penetration of robotic surgery globally. In the diabetes division, the MiniMed 780G system is gaining traction with high adoption rates and positive outcomes for users. The company saw 7% growth in its diabetes business, driven by recurring revenue from CGM and consumable sales. In the U.S., the 780G launch has been successful with over 30% sequential increase in pump sales and high CGM attachment rates. This gives the company confidence in seeing significant growth in CGM and consumable sales in the U.S. and a return to year-over-year growth in the second half of the fiscal year. Medtronic expects diabetes to continue driving meaningful growth for the company.

In the intensive insulin management space, the trend is moving towards smart dosing through AID systems or smart MDI. As the only company investing in a complete ecosystem of differentiated technology for people with diabetes, the company is well positioned to take advantage of this trend. In the second quarter, the company saw a 5% growth in revenue, with diversification across portfolios and geographic regions. The company remains focused on delivering sustainable mid-single-digit growth, as seen in the past four quarters. Western Europe, Japan, and emerging markets all saw positive growth, with strong results in various businesses.

In the second quarter, the company saw growth in various regions, with the highest growth in the Middle East and Africa and South Asia. China's growth was lower than expected due to delayed VBP. Despite a decline in gross and operating margins, they were still ahead of expectations. This decline was mainly due to currency and inflation. The company is working to improve efficiency in their expense structure. They have also prioritized investments in fast-growing markets and have a track record of returning capital to shareholders. The company has raised their full-year guidance for organic revenue growth to 4.75% and expects third quarter growth to be in the range of 4% to 4.5%.

The company is expecting an unfavorable impact on revenue due to currency fluctuations, but their third quarter guidance shows acceleration and they expect this trend to continue in the fourth quarter due to recent product launches. They anticipate growth in the second half of the year in various areas, such as diabetes, medical surgical, neuroscience, and cardiovascular. Margins are still impacted by currency and inflation, but the company is focused on driving efficiencies and improving margins. The company has raised their fiscal 2024 non-GAAP diluted EPS guidance.

The company is pleased with their performance and expects a few challenges in the second half. They are grateful for their employees and their impact on patients. The potential impact of GLP-1 drugs on the company's markets is discussed, but it is not expected to have a significant impact on Medtronic's growth. Bariatric surgery is still considered the best option for addressing obesity.

The company expects the current decline in bariatric procedures to stabilize and return to growth by 2025, and their diabetes business is primarily focused on Type I patients with limited growth potential in Type II patients. The company has overcome challenges in their growth and has established a track record of mid-single-digit revenue growth. They have recently received product approvals and expansions that offer significant market opportunities.

The company is focused on capitalizing on the massive opportunity presented by the large number of people with hypertension worldwide. They are working on improving their revenue and efficiency, and have implemented a transformation to ensure sustainable growth. They are also leveraging their scale and technology to increase their market presence. The company is committed to creating value for shareholders and will only be taking one question per analyst during the Q&A session.

The article discusses a session with several executives from a company, including the EVP and Presidents of various portfolios. The first question is about the company's guidance for the second half of the year and the long-term plan for 2025. The executives mention that most headwinds have been mitigated and the markets are stable, with procedures back to normal growth and staffing issues under control. They also mention stable pricing and working through issues in China.

The company has made significant changes to their global operations and supply chain, resulting in improved performance and a stronger pipeline. The second half of the year is expected to see growth acceleration with the return of their diabetes business and new product approvals. The company is not ready to give specifics for FY ‘25, but they are focused on delivering mid-single-digit revenue growth.

The company has set a new full-year guide for this fiscal year of 4.75% growth, with the expectation of continued strength in product approvals and launches. There are some potential challenges in terms of inflation, currency, and tax reform, but the company is focused on driving offsets and maintaining discipline on expenses. However, the company remains committed to its long-term goals of mid-single-digit top growth, leverage down the P&L, strong free cash conversion, and a growing dividend, which will ultimately deliver a double-digit total shareholder return. The company has already made progress towards these goals and is confident in the durability of its strong pipeline and programs in place.

The company is focused on driving leverage down the P&L in order to achieve faster EPS growth than revenue growth. They are still early in the planning process and will provide more guidance on FY '25 later. The CEO also mentioned the potential of GLP-1 drugs and how they are seeing positive results in patients.

The company has done a lot of work on the impact of new drugs on their bariatric surgery market and they do not foresee a significant impact on their growth outlook. The decline in bariatric surgery has stabilized and is expected to improve in the coming year. The Chief Medical Officer, Dr. Laura Mauri, provides more detail on the Select trial results and explains that while it is an important advancement for obese patients with cardiovascular disease, it will not have a significant effect on the growth of cardiovascular procedure volumes. This is due to the high number needed to treat, which sets a high bar for treatment compared to other guidelines.

The lack of effect on cardiovascular death and high discontinuation rates due to side effects have hindered the adoption and coverage of a new treatment. The only positive effect was on non-fatal MI, and there were interesting findings in the trial regarding higher BMI populations and the North American subgroup. The company updated their models using different assumptions and inputs, but the overall impact on the growth of cardiovascular procedures is minimal.

The speaker mentions that the analysis does not include the potential growth in markets like PFA or Ardian, which could lead to a larger patient population eligible for cardiovascular procedures. There is also potential for growth in the diabetes market due to longer survival and lower BMI, but the company's focus remains on Type I diabetes. The speaker also mentions that there is evidence from Select that suggests a potential slowdown in insulin dependency for pre-diabetic patients, but this is offset by the low penetration of AID in Type II diabetes and the large patient population in need of basal insulin. The company remains optimistic about the growth and market profile in diabetes.

The speaker is responding to a question about the potential impact of certain drugs on Medtronic's growth. They mention that certain areas, such as Type II hypertension, AFIB, and obesity, are underrepresented in the medtech industry. They have done extensive analysis on this and do not see these drugs affecting Medtronic's growth in the short or long term. The next question is about two specific products: Ardian and the TITAN 2 IT&S trial. The speaker congratulates the team on the approval of Ardian and mentions the extensive data they have on it. They then turn the question over to Sean to discuss the ASP and reimbursement pathway. For the TITAN 2 IT&S trial, the speaker mentions completing the six month primary endpoint and the possibility of FDA wanting 12 month data. They also discuss the form factor and positioning of IT&S in relation to sacral neuromodulation.

The speaker discusses the significant drop in blood pressure seen in patients using a new treatment, and the excitement among physicians and patients about its potential. They mention the upcoming visit of a patient who has been on the treatment for years. The speaker then addresses the reimbursement process and the response from Medicare and private payers, who are interested in the long-term data on the treatment's effectiveness.

The Medicare population is important for the company and they will use alternative pathways for temporary add-on payments. They plan to avail themselves to the T-Set pathway for transitional coverage for emerging therapies. CMS is also considering other refinements to covers with evidence development programs. The TITAN 2 study was a six month follow-up but they will continue to follow the patients for 24 months to gather more data.

The company has recently received three significant product approvals and expects them to contribute to mid-single-digit growth. These products are differentiated and serve large and growing markets, demonstrating the company's commitment to sustainable growth.

The speaker discusses the company's efforts to address internal issues and improve their fundamentals in order to achieve durable and reliable mid-single-digit growth. They also mention the success of their high-growth markets and the expansion of their installed base in Europe for their robotics product. The U.S. clinical trial for the product is on track and they are not giving a specific timeline for FDA approval.

The company is excited about the recent approval for their hernia IDE, which will allow them to enter the general surgery market in the United States. They have a strong presence in hernia repair and see potential for growth in this area. They are currently focused on building experience in Europe and expanding their instrument portfolio before launching in the US. The company is not providing specific dates for approval but is confident in their progress. They also briefly mention their patient monitoring respiratory interventions spin, but do not provide any updates on it.

During a recent conference call, Kristen Stewart asked about any updates on the company's focus and the potential for mergers and acquisitions. The CEO, Geoff Martha, responded that their main focus is still on maximizing shareholder value and there are no major updates to report. He also mentioned that they have the capabilities to do bigger deals, but their main focus is still on smaller acquisitions. However, with the current market conditions, they may consider larger deals in the future.

The speaker states that the company is not currently focused on any major deals and will not be signaling any in the near future. They then take a question about the company's performance in the third quarter and mention that they saw strength throughout the quarter and are tracking to expectations. The last question is about competition in the surgical robot market, to which the speaker responds by mentioning a competitor's recent showcase and stating that the company is not concerned about competition.

The speaker is asked about their technology offering and competition, and they mention their differentiated program with an open console and modular design. They also mention the increasing interest in robotics and the expansion of the field. The company is focused on changing the dynamics of the market and incorporating other technologies such as interoperative imaging and AI-based planning.

The speaker discusses the impact of Touch Surgery Enterprise, a digital platform with AI technology, on the competitive dynamics in the spine market. They mention how competitors have fallen by the wayside and how Medtronic has the expertise and capital to succeed in this space. They also mention their confidence in competing against Intuitive in the surgical space and their plans to drive change in the industry. The speaker ends by thanking the audience for their support and wishing them a happy Thanksgiving.

This summary was generated with AI and may contain some inaccuracies.