Integra LifeSciences Holdings Morgan Stanley 24th Annual Global Healthcare Conference
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All right. Great. We're going to get started here. First of all, I'd like to welcome Integra LifeSciences and Stuart Essig to the stage here. We're going to unpack the story. There's been a lot of developments in the company, and I'm looking forward to the conversation. One thing there is the disclaimer readout that I have to do. Go to the Morgan Stanley website, you'll find it there. Maybe to start us off, Stuart, since returning as CEO, where have you focused your attention and what progress gives you the most confidence today that Integra will be successful over the long term?
I've been in the role now five months.
It's been very interesting. I've focused most of my time on working with our quality and operations people to make sure we continue to develop supply. We had a long period of time with quite a number of supply challenges because of some of the quality issues in one of our sites.
But we've been, in the last three quarters, bringing most of our products back, and I probably spend 70%-80% of the time with the ops group.
Okay, great. What are the biggest changes you've seen across the company that allows you to say, all right, the consistency of the business is coming back, and you feel like you have that predictability rebuilding.
We had close to 25 years of really quite extraordinary growth, both organically and from acquisitions.
But in the last four or five years, we've struggled with some of our quality system issues. What I'm really happy to see is that a lot of the work that we set out to do three years ago has been completed.
We have been working with a compliance master plan to basically harmonize the manufacturing sites. We have 17 manufacturing sites as a company. We have been putting in place common quality metrics and initiatives across all our sites. To the extent that we had out-of-compliance activities, we have been working very hard to repair them.
We have literally gone to the bottom of every one of our sites, brought in external consultants, former FDA-ers. In the last two or three years, we have had a number of very successful FDA audits. We have had our notified body in all of our sites every year.
We are just making good traction.
Yeah. We have said that on our warning letters, we will have, by the end of this year, all of our responses submitted.
We began producing SurgiMend, which is the third product that we wanted to bring back to market in our new Braintree site, and we began manufacturing in the second quarter.
We expect to launch that in the fourth quarter. So lots of operational progress. Still plenty more to go.
Yeah. But the reality is I haven't spent particularly that much time with our commercial team because they've done great.
They've held the business together through a period of great turmoil. And what I did say when I returned is we have a really nice opportunity to go back on the offensive.
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