Interview with: Alan W. Milinazzo, President and CEO - featuring: their orthopedic products, offering a broad line of minimally invasive surgical, as well as non-surgical, products for the spine, reconstruction, and trauma market sectors that address the lifelong bone-and-joint health needs of patients of all ages, helping them achieve a more active and mobile lifestyle.

Orthofix International N.V. (OFIX-NASDAQ)

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Orthofix International has been more aggressive in their inorganic growth strategies, acquiring a spinal implant company, while putting in-place plans to accelerate organic growth through product development activities in their R&D organization

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Healthcare
Medical Appliance & Equipment
(OFIX-NASDAQ)


Orthofix International N.V.

10115 Kincey Ave, Suite 250
Huntersville, NC 28078

(704) 948-2617

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Alan W. Milinazzo
President and CEO

Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFOinterviews.com
Published - January 4, 2007

BIO:
Alan Milinazzo, 46, is a 24-year veteran of the medical device industry. He joined Orthofix International as Chief Operating Officer in September of 2005, and became the company’s Chief Executive Officer on April 1st of 2006. He was also named to the company’s Board of Directors on December 5, 2006.  He comes to Orthofix from Medtronic, where he was Vice President of the company’s Vascular business and also Vice President and General Manager of their peripheral and coronary businesses. Prior to leaving Medtronic Mr. Milinazzo led the launch of the company’s drug-coated stent products, and was actively involved with several mergers and acquisitions. Mr. Milinazzo also spent 12 years at Boston Scientific in a variety of roles, including as Vice President of Marketing for SCIMED in Europe.

Company Profile:

Orthofix International N.V., a global diversified orthopedic products company, offers a broad line of minimally invasive surgical, as well as non-surgical, products for the spine, orthopedics, and sports medicine market sectors that address the lifelong bone-and-joint health needs of patients of all ages, helping them achieve a more active and mobile lifestyle. Orthofix’s products are widely distributed around the world to orthopedic surgeons and patients via Orthofix’s sales representatives and its subsidiaries, including Breg, Inc. and Blackstone Medical, Inc., and via partnerships with other leading orthopedic product companies, including Kendall Healthcare. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Orthopedic Research and Education Foundation, Rutgers University, the Cleveland Clinic Foundation, and National Osteoporosis Institute
.

CEOCFO
: Mr. Milinazzo, you have been with Orthofix for a short time, first as COO and now as CEO; what attracted you to the company?
Mr. Milinazzo: “What attracted me was that the company was in a terrific position with regard to its financial strength and it participated in very attractive markets; sports medicine, general orthopedics and a subset of the spine market being the bone growth stimulation market.”

CEOCFO: What has changed under your leadership?
Mr. Milinazzo: “We have taken on an approach where we are more aggressive in our inorganic growth strategies. We have acquired a spinal implant company since I have been onboard, a company called Blackstone Medical Inc., and we have also done some licensing on some other technologies. We have also put into place different strategies with regard to our organic development plans, to really begin to accelerate new product development through our R&D organizations. Those are probably the two major changes since I have been onboard.”

CEOCFO: What would you like to add to the mix going forward?
Mr. Milinazzo: “I think in the three primary markets that we participate in we would want to continue to just focus on the product areas where we can compete at a number-one and number-two market share position. Obviously, for the spinal implant business that is years out, but we believe we can move up the charts by steadily growing our business in a healthy manner from both an organic and a non-organic perspective. I would also like to see us continue to improve our international performance, where our results have been softer than we would like..In the 3rd quarter of 2006 we did show an improvement in our international business, so I’m encouraged that we will be able to continue to show improvement in this area over the next several quarters. Another area of focus is operational improvements; continuing to reduce costs where it makes sense, for example by increasing our inventory turns, but also by making additional investments in areas where we think it will benefit us in the long run, such as our R&D capabilities.”

CEOCFO: Will you tell us about the orthopedic products industry in general?
Mr. Milinazzo: “With our orthopedic business we have really started to focus in on three key areas. We are looking at the fixation business, and within the fixation business for us that is both external and internal fixation. We also work on deformity correction products, which are products designed for smaller patient populations; limb lengthening products or devices to treat pediatric angular deformities, for example. And finally we have our bone growth stimulation products. We participate in a very lucrative segment of the orthopedics market, that being post-surgical bone growth stimulation for non-union fractures. Our orthopedic business is really about those three dimensions: fixation, deformity correction and stimulation.”

CEOCFO: Why those three areas?
Mr. Milinazzo: “Those are areas where we feel we have something to offer the market; both in terms of innovation as well as our distribution system, which is tailored to those product areas. Specifically with our innovation, we have historically done a lot of pioneering in the external fixation area, and we feel like we can continue to innovate in that market segment. In addition, we have some novel internal fixation products, both nailing and plating systems, that we are just now bringing to the markets, particularly in the U.S. I think the opportunity to add value to the market is what keeps us focused there.”

CEOCFO: Please elaborate on some of Orthofix’s newer products.
Mr. Milinazzo: “There are a couple different areas, and one is on the spine side with our stimulation products. We continue to be rewarded by being the only company that has an FDA approval for a bone growth stimulator for the cervical spine. Having approval for a cervical stimulator has been a terrific success for us in terms of both market share growth as well as revenue. Also in the spine sector, through the acquisition of Blackstone we have a novel set of minimally invasive surgical instruments and products. We also now have a unique biologic product, which is an adult stem cell product that is very novel in the marketplace. On the orthopedic side, we’ve recently introduced a couple of things in the deformity correction area and we are also bringing new internal fixation nailing and plating systems to the market. Finally, in the sports medicine market we have a new line of functional knee braces called Fusion, which has won accolades from our customer base, and is contributing to our revenue growth in this segment. In each of those areas there is something interesting and new to talk to our customer base about, and innovation and new technology are important aspects of the markets in which we participate.”

CEOCFO: How big a part of the business is the R&D segment?
Mr. Milinazzo: “There are two answers to that question. The first relates to legacy Orthofix prior to the Blackstone announcement that we made in August this year (2006). Most recently, we have been spending about 3 or 4 percent of revenues on R&D. Historically, in the orthopedic segment, you might see more like 6 to 7%. You could argue that we have been an efficient company with R&D; however, I would say that we certainly could expand that - we probably need to increase that spend in the future. When you add Blackstone to the mix, Blackstone on a standalone basis has been spending 10 to 11 percent of revenues on R&D. So, the combined company will spend about 5 to 6 percent of revenues on R&D going into 2007. But, that will likely increase as we work to bring Blackstone’s artificial cervical disc to market over the next few years.”

CEOCFO: Education of physicians and surgeons is a big factor, what do you do there and how do you get people to pay attention to Orthofix?
Mr. Milinazzo: “We have a wonderful training facility in Verona, Italy; it is a neat location. We train over 1,000 physicians a year through that facility, primarily focused on fixation techniques, although increasingly also with the deformity correction techniques that we offer. The majority of those physicians are outside the US, although we do have some US physicians that come over to train and teach. Going forward we will expand that from just pure orthopedic training. Additionally, we are planning to expand our training capabilities here in the U.S. This will become a more important aspect of the spine industry over the next several years as new procedures and technologies like minimally invasive surgeries and motion preservation devices are developed.”

CEOCFO: You mentioned that you have been a bit soft on the international side; what has happened there and how do you regain the share you need today?
Mr. Milinazzo: “We have focused the organization on growing revenue as well as streamlining costs. So, we have changed compensation programs and incentive systems within our distribution system. We have stripped away some of the responsibilities of some member of our management team that were non-revenue generating responsibilities, so they can really focus on delivering quality products, on time, and in a cost-effective manner. The second thing is that we have launched new products. Some of the internal fixation products that I had alluded to earlier are really focused on some of our key international markets. The third thing we did was hire a new president of our international division. We also reorganized into three distinct global business zones so that we will be able to leverage off what some of the individual countries are doing successfully within a specific geographic zone. Therefore, the leadership and the structure has been refined to focus on driving top line growth.”

CEOCFO: Tell us about your recent novel agreement with UnitedHealthcare.
Mr. Milinazzo: “We have an exclusive agreement with UnitedHealthcare (a UnitedHealth Group – NYSE: UNH company) to provide spinal stimulation products, and the way United is looking at this is they are evaluating the clinical and economic benefit for patients that undergo spinal fusion procedures. Typically, only about 20% of patients who have one or more risk factors are actually prescribed a spinal stimulator after a fusion procedure. The spinal stimulator for patients that have these risk factors will enhance the patient’s chance of a successful fusion from around the mid-60’s to the high 80’s from a percentage success standpoint. In terms of outcomes, if a primary procedure costs something like $20,000, and a revision might cost another $40,000, we can significantly reduce the likelihood that a revision will be necessary by having the physician prescribe a spine stimulator post-surgically for less than $3,000. That’s a tremendous benefit for the patient from a recovery perspective, and an economic benefit for the health care system from the payor’s perspective. That’s the value proposition we have to offer the marketplace. Of course, we also expect this will provide a boost to our revenue picture, although it is too early yet to quantify that benefit. We will also be very interested in knowing what the clinical and economic outcomes are as well, based on the data that United will be collecting.”

CEOCFO: You just joined the board of directors at Orthofix; how does that change things for you?
Mr. Milinazzo: “Well, instead of having to convince ten people of my good ideas, now I only have to convince nine people. My responsibilities as a CEO, certainly from a compliance and a regulatory standpoint, are already fairly rigorous and that doesn’t really change in my capacity as a board member. It certainly enhances the opportunity for two-way communication between the board and senior management, which I think is very important in ensuring the sharing of different perspectives. It was also somewhat bittersweet because the board member who retired, and whose place I took, has been a very key part of the company’s history and was in many ways a key architect in building Orthofix into the company it is today.”

CEOCFO: Is your management team in place now?
Mr. Milinazzo: “I think we are 90% there. We have a couple of key positions that are still open and I suspect that in the early part of the year we will fill those. However, right now we have 90% of our management team in place. We have taken some of the strong talent that already existed at Orthofix and moved them into key roles where their experience was needed, while we’ve also brought on some folks to compliment those individuals, to round out the organization and bring us new capabilities, such as our business development function. When I recruited our new international president, I specifically went out and tried to find somebody with a deep knowledge of the spinal implant business so that we could take advantage of the acquisition that we made just a few months ago.”

CEOCFO: What is ahead 2-3 years down the line for Orthofix?
Mr. Milinazzo: “Hopefully, we will continue to see the sort of success we have begun to see in the past couple of quarters; balanced, increased growth in all of our businesses, including double-digit growth in our spine segment as a result of the Blackstone acquisition. We want to participate on a very high level, in fact, around 60% of Orthofix’s revenues prior to the Blackstone acquisition were from products that have a number one or number two-market position. I believe we can see continued strong top line growth, as we continue to work on organic improvements coupled with additional new business development opportunities. At the end of the day, we want to continue to bring shareholder value while we also excite and reward our employees. We are right where we planned to be at this time as we look at our internal goals. We have a lot to accomplish as we move forward but, so far, all indicators are that we are progressing at the pace and in the direction that we expected we would.”

CEOCFO: Why should potential investors be interested and what might people miss when they first look at the company?
Mr. Milinazzo: “I think we are a company with a tremendous runway. If you look at the markets that we compete in, specifically spine and orthopedics in general, and also the sports medicine segment, we believe there’s tremendous upside for us, because those markets are so big, and should continue to benefit from factors like the aging of the baby boom generation and the development of new technological innovations. Our ability to grow our businesses through market share increases as well as through the expected continuation of growth across the markets in which we participate is very healthy. If you look at our balance sheet, you will see that we have a strong financial situation, even though we have taken on some debt to do this acquisition. We still generate a good amount of cash, so our debt repayment ability is very solid. What people may miss is that, for a small cap company, we are very strong financially and we are in very attractive markets. That sometimes is lost on people when they look at us because people tend to think of Orthofix as being an external fixation company only or a stimulation company only. In fact, we are much broader than that and our financial strength is much greater than a typical company with our market cap.”

CEOCFO: Do you have any final thoughts for our readers?
Mr. Milinazzo: “I think it is a terrific time to keep an eye on Orthofix. We’ve just made a transformational acquisition, and we’ve taken steps to strengthen and build our infrastructure in anticipation of additional organic and inorganic growth opportunities. So, we’ve got the wind in our sails and our employees are energized about where we are in the evolution of our strategy.”


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“If you look at our balance sheet, you will see that we have a strong financial situation, even though we have taken on some debt to do this acquisition. We still generate a good amount of cash, so our debt repayment ability is very solid. What people may miss is that, for a small cap company, we are very strong financially and we are in very attractive markets. That sometimes is lost on people when they look at us because people tend to think of Orthofix as being an external fixation company only or a stimulation company only. In fact, we are much broader than that and our financial strength is much greater than a typical company with our market cap.” - Alan W. Milinazzo

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