Johnson & Johnson Status update

You may begin. Good morning, and thank you for joining us.

This is Ryan Koors, Vice President of Investor Relations for Johnson & Johnson. Welcome to our OTTAVA investor call following the recent FDA approval. Following prepared remarks, we will have time for open Q&A. We anticipate this webcast will last approximately 45 minutes. Please note that we will only be taking questions on OTTAVA during today's call. Please be advised that this presentation contains forward-looking statements related to the OTTAVA robotic surgical system. The viewer is cautioned not to rely on these forward-looking statements, which are based on the current expectations of future events using information as of the date of this recording. They are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected.

The description of these risks, uncertainties and other factors can be found in our SEC filings, including our 2025 Form 10-K, which is available at investor.jnj.com and on the SEC's website. Today's call is intended to provide additional insights on the OTTAVA platform and the long-term opportunity we see ahead. With that, I will turn it over to Rocco and to Neda.

Good morning, everyone. My name is Rocco De Bernardis, and I'm the President of the OTTAVA program at Johnson & Johnson. Thank you for joining us today to talk about our most recent milestone with OTTAVA, receiving De Novo authorization in the U.S. We announced this news at the Society of Robotic Surgery annual meeting, and it was an incredible opportunity to celebrate with the many surgeons who have been instrumental to the OTTAVA program and who are leading experts and practitioners in robotic surgery. OTTAVA is not simply a new system. It is something we have built with purpose, persistence, and in partnership with surgeons and hospitals. With this launch, we're bringing hospitals and surgical teams a competitive system designed to adapt to their clinical approach while unlocking new potential in operating rooms, starting in the U.S. and then around the world.

I've been leading the OTTAVA program for nearly five years, and during this time, the program has truly accelerated, meeting each of its clinical and regulatory milestones to bring us to this first market approval. Today, I will share more about what makes OTTAVA truly differentiated and why this is a purpose-built foundation to open new possibilities in surgery. Before we get into the details, I also want to introduce my colleague, Neda Cvijetic, head of R&D for robotics and digital, who will provide more context today on the engineering and design of OTTAVA. First, I would like to share a short video that introduces OTTAVA.

As you could see right away in the video, OTTAVA is the first of its kind in soft tissue robotics. As Neda will explain, we engineer it that way from the ground up. Today, we will highlight a few key elements that differentiate OTTAVA. Our novel architecture, Twin Motion, which is a synchronized motion of the table and arms, automation from day one, our next-generation instruments, and Polyphonic, our open and secure digital ecosystem. Let's look at each one of these in detail. First of all, our novel architecture. While you might have heard us talk about this before, I hope that today it is clear just how different this is and how this can open capacity, workflow, collaboration, and innovation for clinical teams and hospitals. The regulatory pathway we took for OTTAVA is further evidence of the system's unique design.

We could not take a 510(k) pathway because there is no predicate device like OTTAVA. We like to say that with OTTAVA, we are breaking the mold. There are no booms and no carts. Instead, intelligent surgical arms are integrated into a standard-size operating table. Because of this, OTTAVA occupies 30%-50% less space than leading boom and cart-mounted systems. This can fundamentally change how we The operating room works and allows OTTAVA to fit seamlessly into almost any operating room. This design opens possibilities like improved patient access, an open, flexible environment, better visibility across the room, and more space for staff to move and work. This also means opening capacity for hospitals. Let me explain what we mean by that. Today, hospitals want to build the robotics programs to meet surgeons and patient demand.

Offering a multi-quadrant system with demonstrated reach and access for complex procedures, but in a significant reduced footprint, offers hospitals the potential to grow the capacity of their programs without updating infrastructure, because there is no need for sizable, dedicated operating rooms with OTTAVA. Feedback from our clinical trials has validated why this matters. In our first clinical trials, in five of the six trial sites, OTTAVA was used in operating rooms that previously could not accommodate a robot, including a room that was only 243 square feet in size. We heard from hospital leaders, "We couldn't fit another robot in that room." We heard from anesthesiologists how pleased they were with their ability to access the patient.

We heard from nursing staff, who commented several times when getting to the OR to set up for a case, "When does the robot arrive?" We heard from surgeons that increased line of sight around the OR made communication with bedside staff easier for how the team functioned. Now, let me turn it over to Neda to tell you more about the impact of our other unique features.

Thank you, Rocco. As Rocco mentioned, I lead the R&D teams across our robotics and digital programs within our surgery business. This is a group of fantastically talented individuals across engineering disciplines, including hardware and software development, human factors and design, systems integration, and with deep expertise in the science and technology behind our surgical instrumentation. These teams have created OTTAVA as a completely integrated hardware and software architecture. This architecture has unlocked a lot of potential. It is a great example of how engineering and human-centered technology design can remove friction. I like to say that our design quite literally means that the patient is at the center. We heard from experienced surgeons that when moving from handheld laparoscopic to robotic surgery, they had gained a lot, but also lost some things.

One of the things that they had lost is the ability to move the operating table seamlessly during surgery, using gravity to shift organs naturally instead of using retraction. With OTTAVA, the integrated table and arms can move together. This feature, Twin Motion, is the synchronized motion of the table and the arms, and it's activated by the push of a button. The table and bed move together and maintain the remote center of motion fixed, which means the instruments can remain unaffected, and the procedure can go on uninterrupted.

This capability is about uninterrupted workflows for clinical teams. Surgeons have told us that they have had to adapt the way they operate to a robotic system, and it should be the other way around. Twin Motion means no interrupting the procedure. There is no stopping, undocking, and repositioning. With OTTAVA, movement is continuous and native to the system because that's how we created it.