West Pharmaceutical Services' CEO Presents at Bank of America Merrill Lynch Health Care Conference (Transcript)

| About: West Pharmaceutical (WST)

Call Start: 16:00

Call End: 16:31

West Pharmaceutical Services, Inc (NYSE:WST)

Bank of America Merrill Lynch 2013 Health Care Conference Call

May 15, 2013 04:00 pm ET


Don Morel – Chief Executive Officer

Bill Federici – Vice President and Chief Financial Officer


Rafael Tejada – Bank of America Merrill Lynch

Rafael Tejada – Bank of America Merrill Lynch

Good morning. My name is Rafael Tejada, I’m an analyst with the Bank of America Merrill Lynch Life Sciences team. Up next, we have West Pharmaceutical Services Company presenting. And presenting from the company is Don Morel, CEO of the company, taking questions for the company, we also have Bill Federici, CFO of the company.

So, with that Don?

Don Morel

Thank you very much Rafael. And again thanks to Bank of America Merrill Lynch for having us back again at this year’s conference. Mike’s handing out copies of the presentation, first order of business of course to call your attention on the Safe Harbor Statement posted on the front regarding our forward-looking statements. The slides are also posted on our website under investors, and you can review it there as well.

I’m going to zip through the first part of the presentation quickly, talk a little bit about the history of the company, talk about growth drivers, and the outlook for our business.

For those of you that don’t know West. We just celebrated our 90th Anniversary. We are a manufacturer of components and devices that get consumed in the injectible drug markets, and take a look at our customer list as to who’s who, the major vertically integrated multinational pharma companies, the biotech companies, the generic guys, and medical devices. So, very nice spread of the business within our customer base.

2012 was a record year for the company. Revenues came in at just under $1.3 billion, split roughly about two thirds in the packaging systems group and a third in delivery systems. Packaging is the traditional West’s core business with the components that go into small volume parenteral components that go into disposable medical devices.

The delivery systems group is the group where we are developing a series of proprietary delivery platforms and also have a fairly substantial contract manufacturing business. The contract business has the focus on our existing customers like Lilly and, Novo for their devices that go into the insulin market. The differentiators, that we are a components integrator and systems developer as opposed to the other side where we’re a components manufacturer.

Our core business is a terrific business, we’d love to have this business private. We have terrific barriers to entry with regard to the regulatory barriers and with regard to our footprint around the globe to serve our customers.

On the delivery systems side, it’s the intellectual property that’s in the devices, and I’ll talk to those in just a second.

It’s no mystery to this group what’s happening in the pharma markets around the world in terms of growth within our key markets. United States was flattening out a little bit, you’re looking at low-single digit growth and Europe again, low kind of single-digit growth to flat.

In our emerging markets, India and China, we’ve seen double-digit growth in the units over there over the last three to four years, and we expect that to continue. Japan, in terms of scripts, relatively flat, that market is served by our Japanese partner Daikyo.

So, when you look at the injectible markets and what’s happening, what’s going to drive growth, in our core markets we have a very substantial share in the biologic space which is key to us, insulin we supply the three major manufacturers of injectible insulin with their components for packaging in a large number of their pens to Novo, Santa Fe, and Lilly. We basically are selling north of 90% of their packaging needs and a category that’s growing very nicely, very strong position in generics as well.

The regulatory environment is one that is getting stricter for our customers that’s driving the high value part of our business very strongly. We expect that to continue into the foreseeable future. The drivers for the device side, you’re looking at a lot more care being delivered at the site of delivery whether it’s your home or the bedside where the patient can do it themselves, you’ve got issues around needle safety, dosing accuracy, and ease of use with patients that have their mobility compromised. All of the work that we’re doing in terms of our product development is aimed in this area.

The other driver I’ll talk a little bit about are the issues that are arising with glass in terms of primary packaging for certain drugs. We think we’ve got a solution there that has been on the market for a number of years, and it involves a novel resin developed by our Japanese partner, which we expect could be a driver as well.

For those of you wondering about the Affordable Care Act and its impact on West, we are in somewhat of a unique situation. If it’s fully implemented, we benefit; if it’s not fully implemented, we benefit.

And the reason is that if it’s fully implemented, you have got a large number of people coming in, they’ll be getting vaccinations, they’ll be getting primary care. If it’s not implemented, then we have got advantages in terms of continued growth in the biologic space in the other high value drugs.

This is one of the more important slides. I’ll show you our strategy has not changed through the last four or five years. On the packaging side of the business, we intend to grow through increasing the value that we sell to our customers. We don’t necessarily need large unit volume growth to have substantial growth on the top line.

We’ve got opportunities to expand in China and India, seeing just a moment that we’re putting new facilities into each one of those locations to serve those markets, although we’ve been there for more than 25 years, and then looking at how we make our operations more efficient.

On the delivery system side, it’s the commercialization of the Crystal Zenith resin, it’s building our safety and administration business, and it’s also building our position in self-dosing devices. So, those three points under each one of those categories are going to drive our business for the next five years.

I talked earlier about the high-value products. The bubble in the upper right hand quadrant is the one you should be most concerned with. This is a market that’s grown in double digits for us over the last five years, and we’ve also seen margin expansion, thanks to that part of our product category being the driver for the business.

So, our expectation is that we will see mid-to-high single digit growth in this business and also be able to expand our margins in the 30 to 50 bps range for the next three to five years.

The device business is a little different. This is one where the proprietary portfolios have been slower, and in the first quarter of this year, it was about 25% of our sales. The margin is lower, basically because of our contract services. We expect this to go north at a considerable rate, and in the late 2015, early 2016 timeframe driven by the commercialization of CZ and some of the other products in development.

I will talk quickly about what’s happening in Asia. We have one plant in China that we’ve been operating since 2010. Our second plant came online in the first quarter of this year. We have been working our way through the validation runs for our customers and expect to begin shipping commercially from that plant at the end of the second quarter.

We’ve broken ground on our first facility in India, we expect this to begin production in 2014 from that metal seals and in 2015# for rubber products. The reason those two plants are key is that they will take some of the burden off our Singapore facility, which we expect to reach capacity at the end of this year or early part of next year. So, thanks to the growth in that market, significant amount of expansion in terms of our production capability.

This is one of – the second slide, it’s important strategically. As we move the company from being predominantly a component supplier into integrated delivery systems, this gives us the opportunity to participate in the way that the drug is actually delivered in the patient. It differs from our components business and that we will not grant exclusivity in the components business, we sell those across the spectrum of people on a single therapeutic category.

On the delivery systems time, we’re often asked to provide exclusivity to a device, because the customer sees it as an opportunity to differentiate, but it also carries a great deal of revenue potential for us as we look forward.

I' talked about Daikyo, quickly this is our Japanese partner, a number of issues have risen with glass packaging over the last couple of years. It turns out that many drugs are incompatible with glass packaging. The industry is looking for a solution that not only eliminates silicon oil as a processing aid from biologics, but also to eliminate the problems with breakage that occur inside auto injectors and optimum processing for drugs that will be authorized.

This product is about $45 million in sales for our Japanese partners. It’s been approved on a number of products in Japan including calcitonin and growth hormone. In the United States, it’s the principal vial that’s used for Zometa.

So, our expectation is that the large number of drugs that are undergoing pre-stability and stability testing at the current time, some of those, not all are going to be utilizing CZ in that 2016 timeframe and into the future, we have great hopes for this product.

The second area that’s key is SmartDose. SmartDose is what’s called the patch injector, and this is our strategy wrapped up in a nutshell. The primary containers made of CZ, the elastomeric components of course are made by West Daikyo. They contain the FluroTec coating that promotes barrier, inhibits interaction with the drug. The cartridge goes into the device which is a patch like a band-aid to the patient’s abdomen. They push the button and it delivers a bolus dose that is programmable by the customer of anywhere between 2 mL to 5 mL over a period that can be 30 minutes to up to several hours.

The nice thing about this is, it’s very simply used, the dosing accuracy is ensured, injects subcu, but it opens up formulation options for our customers that might have had a very viscous drug in an 1 mL format, and now in a 2.5 mL format and could be much easier to deliver.

Our expectation is that this device will be in a human clinical trial by the end of this year. But you can see how it brings together our component business and a delivery platform that’s proprietary to West into a single product.

2012, as I said was a great year for the company. Sales were up just over 10% for the year, nice expansion and our gross margins. It was a record year in terms of revenue and earnings for the company with our adjusted earnings per share coming in at $2.76, a substantial improvement over the last year or the year before $2.33.

A number of good things happening on the expansion front as I had mentioned, our first quarter of 2013, very strong quarter again, earnings up nicely over the prior year. Our organic growth was actually a little bit stronger than as shown in the $0.87 versus the $0.83. We had a very substantial inventory build in the first quarter of 2012, that if you normalize for that, our growth would have been up on the earnings side even more in 2013.

Business is very strong, our backlog is at historically very high levels, record levels in fact at about $375 million. It gives us great visibility on a quarter basis. Little bit of visibility into the third quarter as well, demand is holding. Those backlogs were about 15% versus the prior year period. Growth has slowed a little bit because of our lead times extending out, but still up roughly about 3% versus the end of the year as well.

Looking forward, our expectations are that the high-value products will continue to grow in the double-digit range. We’re thinking that we will see overall average price increases by the end of the year of a couple percent. But the way that our backlog has developed, it’s composition is a very high percentage of high value products. It’s going to be another very good year for the company.

We are expecting our margins to be hit a little bit by the startup of the China facility that will improve obviously as volumes begin to flow through the plant and absorption improves. But in the next year, we’ll also be moving down a little bit by the Indian facility, but those are all good things. We typically build capacity about two to three years in advance with the market developing in those areas or demand developing in those areas, and we expect those plants to fill up relatively quickly.

The takeaway messages from today before we get to the Q&A, our products are designed into the customer’s portfolio, the regulatory barrier is a substantial one. For us, to have a competitive product, takeaway our business, they have to do stability over a two-year period and it costs them roughly about $300,000 to $350,000 to do that.

We still produce products today that we sell that were designed by Herman West himself over sixty years ago. The value added part of the portfolio was growing fantastically well. The FDA is improving in terms of their turnaround times and drug approvals. The bio-pipeline is very strong. Number of products coming through into phase 3 that will be getting approval, we help over the next couple of years will also help drive the business.

We were very well positioned in the Asian markets, India and China, to serve our multinational customers and also pick-ups like bits of local business. We’ve got a terrific balance sheet. Our net debt to total capital is in about the 25% range. We use all of our operating cash flow to fund our capital expenditures as well as pay a dividend. We’ve increased the dividend now for 20 consecutive years, nice little future to the stock.

As the management team, terrific group of folks. We’ve been together now for some of us more than 20 years, which is hard to believe. But the way that we are incentivized, we think aligns us very tightly with our shareholders with an emphasis on not only revenue growth but on improving our returns on invested capital.

So, with that, it’s been kind of a whirlwind tour. Rafael had asked me to get to the Q&A in 15 minutes, and I’ve done it in just under 14, so, thank you very much. We’d be glad to answer any questions.

Question-and-Answer Session

Rafael Tejada – Bank of America Merrill Lynch

That’s perfect, Don. I’ll start up with a couple of questions and open it up the floor. And before jumping to, I guess, getting a better look into the different performance by segments, I just wanted to get your perspective in what you’re seeing by in market trends by customer – and by customers such as our Pharma and Biotech customers, and also what you’re seeing in the different geographies and in Americas and Europe and Asia?

Don Morel

Yeah. In terms of geographies, we’re seeing very substantial growth in our European markets. Last year was a very strong year, first quarter we were up over 10% again there. North America has moderated slightly off of a very strong year last year. That is in the mid kind of single digits range.

Asia continues to be a real driver for us, albeit off of the relatively small base between India and China, those who have grown 20% to 25% a year for the last five years, we see no reason for that to change. The peripheral countries in Asia, that Singapore serves; Australia, Philippines, and others, kind of in that mid-to-high single digit range as well. So, overall growth as we saw in the first quarter was about 7%.

Now, that’s on the pharma side. On the device delivery side, we’ve seen strong performance out of our contract manufacturing. Hopefully, that will continue for the future, and we saw a nice uptick in CZ orders and demand on the device side as well, so their growth was kind of in the 9% range for the first quarter.

Therapeutic categories, biotech, insulin, and products of natural origin like that have been superb growers, and we expect that to continue into the foreseeable future. The composition of the backlog is very encouraging because the high value products tend to dominate. Growth in the disposable device sector has been flat, it’s zero or maybe 1%, which is not unexpected.

Rafael Tejada – Bank of America Merrill Lynch

Great. And you discussed your backlog and mentioned how it’s at high levels. Can you talk a little bit about how customers today are managing their inventories? In the past, we’ve seen some fluctuation in the amount of lead times that they provided to the company.

Don Morel

Yeah, a couple of things are happening. The strengthening of the backlog really started at the end of 2011. So, in the third and fourth quarter of 2011, we started to see a ramp up, and we believe that was due to customers having work inventories down so far after the 2008, 2009 period that they began to pull back to the historical levels and then maybe a little bit more, and that has continued through the first quarter of this year.

So, without doubt, we have seen customers rebuild inventories to at or above prior 2008 levels to where they’re more comfortable. The drivers for that were one supply chain risk worries after the Fukushima tsunami, and a lot of people losing single point of supply in their chains because of the companies around the Fukushima area.

Second was that the FDA coming into many manufacturers of injectibles, and shutting them down creating shortages in certain categories. So, we think we’ve seen a little bit of ordering for them to do their trial runs and get their operations back up.

But also a benefit from folks ordering and getting higher volumes to pick-up orders that they would not have picked up before this day, so a couple of drivers there. The big question on everybody’s mind is how long will that continue. We honestly don’t know, what we do know is that as we watch the backlog carefully and we launch the composition of the backlog. Certainly for the foreseeable future orders are strong.

Rafael Tejada – Bank of America Merrill Lynch

Now, switching over to the pharma packaging segment. Looking at Q1 results, that segment’s sales have been pretty strong, and it seems like it is being driven by the value-add services that the company provides. So, can you just comment a little bit about what’s driving companies to seek out these value-add services, and noting that a lot of times, you carry – these carry a premium to some of the other services that you provide.

Don Morel

Yeah. Again, the answer is in kind of two categories. The first of which is that we’ve seen strong growth in insulin and biologics, and the high value categories really came about because of demand for cleanliness in those categories. So, continued growth in those areas in particular has been driving the value added segment, and in large part the packaging business.

The second part of it is that as the regulatory authorities around the globe get stricter and stricter in terms of the purity of the drug themselves, customers are coming and converting their alliance from standard products that they are using FluroTec and Westar and eventually NovaPure– so that they can get rid of the regulatory risk in terms of packaging their products.

So, in this particular area, because of the FDA’s demands on the cleanliness of the components being used, they’re naturally pulling many of our customers up that chain naturally. So those two things are driving the value add.

Rafael Tejada – Bank of America Merrill Lynch

And can you just comment on also who are the competitors in this space and why they keep going back to West Pharma?

Don Morel

Traditionally, we’ve had two competitors in the developed Western markets, and I’ll focus on Europe and the US to begin with. There is a Swiss Holding Company, Daetwyler, which earns a pharmaceutical packaging segment that was called Helvoet and now has been remaining Daetwyler.

They probably have about 18% to 20% share on the markets where we have about 70% in those two markets. The other competitor was a small French owned company Stelmi which was recently acquired by Aptar.

Stelmi is very strong in Europe but not much of a base around the globe. West is really the only company serving the injectible segment that has a global operating footprint in terms of manufacturing in all major areas.

But more importantly, offering technical customer service and regulatory support in those geographies as well. So, on the rubber side, it’s really those two. It changes when you get to India and China, you have many indigenous smaller firms that are producing there.

Rafael Tejada – Bank of America Merrill Lynch

And delivery systems segment, CZ is one of the most exciting opportunities for the company, and can you just talk a little bit about the feedback that you’re getting from customers that are evaluating this product and also noting that the company has made probably like about one of the biotech companies that is now evaluating the – formally evaluating the product.

Don Morel

Yeah, it’s a product we’re tremendously excited by. We think that eventually the industry which has been predominantly glass will in large point go to plastic refills, not the disposables that you would see a saline flush where there is something like that. Those are going to be polypropylene, but the demands of the biologic market are going to drive syringes that have more break resistance, have no silicon, have no Tungsten. That assures that they’re product is going to be more pure when it’s actually delivered.

We have one customer doing a human trial with a 1 mL long insert syringethat’s the West product that’s unique where the needle is staked into the syringe, but does not use any glue which is also a potential contaminant.

We have four customers that are on formal stability which kind of triggers the clock for commercialization. And we know more than 100 products which have gone through pre-stability testing to the best of our knowledge, none of which have encountered any problems. That does not trigger the clock because it’s not formal stability, but it gives them an indication of how their molecule will behave in the package.

So, we’re tremendously excited by this as I said, it’s a product, it’s relatively mature in the Japanese market. The Japanese technologically in terms of packaging have tended to lead the West by several years. It’s in a number of injectibles in the vial format as well, zoledronic acid is one where it’s incompatible with glass and the only way to get it to market was to actually put it into the CZ. So, we have high hopes for it.

When it will hit the market, we don’t control our customer’s timing, even when they finish the stability, the timing of them completing their applications for the FDA is in their hands, but a good guess on the 1 mL long is probably in that very late 2015, early 2016 timeframe.

Rafael Tejada – Bank of America Merrill Lynch

Great. Now I just want to open it up to the floor and see if there are any questions. And Dereck.

Don Morel

Yeah, Derek.

Unidentified Analyst

What’s the margin differential on glass to CZ?

Don Morel

A glass syringe typically right now is probably about $0.50 to $0.60 all in for a standard syringe. The glass producer’s reaction to what’s happened in the market is actually to offer a super glass offering by tightening tolerances and improving the cleanliness.

It’s probably going to sell for any order of about $2, CZ is a bit higher than that. The expectation for us is CZ should probably drive a margin on average at high volumes, north of 50%. If you look at the glass guys, they’re probably a little bit lower than that, may be mid-40s.

Unidentified Analyst

So, there has been a lot of emphasis on safety syringes, safety products, I mean, you have an offering there, can you talk about some of those offerings and some of the competitive landscape here?

Don Morel

Yeah, North American landscape is really quite simple, expect (inaudible) ourselves, BD bought SSI, we have a couple of offerings in this space. One, that we call Eurist which is sold to our customer. Santa Fe goes on their heparin offering. We’ve developed a second one which is also a passive system which we have the ability to sell broadly around the globe, not locked up in any way.

It’s one that’s getting more and more attention, you’ve got legislation starting to emerge with regard to needlesticks. So it’s a product that we have high hopes for, so two offerings in this space and relatively limited competition.

Unidentified Analyst

And in Europe, I know the Vincent Legislation joined to push the safety needle stuff there?

Don Morel

Yeah, that, I mean, is being pushed in acute care environment, so it’s a simple thing to put a passive guard on a syringe in acute care environment, so you don’t have the risk of hepatitis C infection or AIDS or anything like that.

They’re strongly encouraging it in operating rooms and venues like that. There are some states that are legislative here as well, so our expectation is eventually, it will become a requirement especially in acute care environment.

Unidentified Analyst

And Don, you mentioned smart dose has been another emerging opportunity for the company. So, how should we think about the market opportunity for that product, and also can you talk about – there might be some, and you know some quotas that prevent you to talk specifically about the customers that are evaluating this product, but can you talk generally about the sort of indications that are being sought out for this product?

Don Morel

Yeah, unfortunately, we’re tightly bound on confidentiality by the customers that are evaluating it. The applications are fairly broad. There are a number of molecules that haven’t come to market because they have formulation limitation. So, anybody that’s got a nice molecule that can be delivered in a larger volume, but not in the smaller volume because of viscosity concerns, it is going to be a candidate for the device.

I’m a little low to talk about therapeutic indications. I think that might give an indication as to the customers as well, but the economics for us are very different than our traditional business. so we think at volumes, this would retail – sell to the customer for between $30 to $35 a unit, so a drug that’s 2 million to 3 million units annually, clearly it is a game changer in generating $90 million to $100 million of revenue. That’s what it means to us. So, we’ll wait and see, clinical trials, hopefully will start at the end of the year and we will have some good news after that.

Unidentified Analyst

And where is the company in terms of manufacturing capability for both SmartDose and CZ?

Don Morel

CZ is currently in production in our Scottsdale facility. We have got the capacity for about 7 million to 8 million units there, three cells are currently in place. We can add capacity quickly because we built out the clean room to accommodate about 36 million units. So, we’ll be ready to go when the orders start to come in for that. The SmartDose is being actually manufactured by our partner in Israel, the first volumes will come out of Israel, and we expect eventually once things ramp up that we will bring production back into Scottsdale as well.

Unidentified Analyst

And one for Bill. How should we think about the CapEx associated with building capacity for a lot of these products? What is baked in into 2013 guidance and how should we think about CapEx growth and thereafter?

Bill Federici

For 2013, we have talked about $120 million to $150 million in total and that breaks out about $60 million to $65 million of maintenance CapEx, which will continue to grow as the base grows; $15 million to $20 million of IT spend on infrastructure upgrading of technologies.

The rest of it is growth capital, we’ve got a slug going into just finishing up the China facility that Don talked about as well as the India facility which is now being built out, and we expect to have the infrastructure completed and the facility completed by around the first quarter of 2014. Absent that and an upgrading of the plant in Kinston transforming it from a disposable medical device component plant to more of a pharma plant, that takes care of the kind of the bricks and mortar part of our CapEx story.

The rest of the growth capital impacting systems is going to be spent in the areas that Don talked about representing the high value products. So, what a capacity for Westar. The vision systems that are necessary to optically look for either particulate or how to speck product on the line as opposed to inspecting it after, clean room finishing capacity for being able to bag off our product in a very, very clean environment to keep particulate levels down, all those things on the packaging systems side.

On the delivery systems side, the main focus would be on preparing and continuing to elevate the capacity levels for both CZ and SmartDose. Initially, in Scottsdale and then eventually for CZ and some of the other high value proprietary products, some capacity in Ireland at some point in time in the future.

Unidentified Analyst

In the past, the company has discussed its long-term aspirational goals in terms of topline and margin expansion. So can – any optimal fair what kind of growth is the company looking for?

Don Morel

That’s not a real update. The last update was I think in early part of last year, November for the yearly goals. But we’ve already achieved the goal earlier for the packaging side of the business. The operating margins are north of 21% to 22%. Now, we expect that business has a chance to be a $1 billion by the end of the year.

The real driver is 2017, we expect the delivery systems side to be somewhere between $600 million and $800 million in revenue with about $250 million that’s driven by CZ.

But more importantly, the operating margin growing from kind of the mid-high single digits into the 19% to 20% range, so that’s still our goal for that part of the business.

Rafael Tejada – Bank of America Merrill Lynch

And just to wrap up, I’ll borrow a question from Derek. Well, if I pull up your stock chart, I mean, it’s been on nice trajectory, but even with that, I’m wondering whether there are any misconceptions about the company or anything that Wall Street is not getting right about West Pharma?

Don Morel

That’s a loaded question. So, the one thing I think that’s key and we’ve always tried to put out through the base is that we’ve got a wonderful core business. The future business in CZ is sexy, and the devices are sexy, but it’s lumpy, it’s lumpy because of the sample orders with the validation testing, it’s lumpy because of the orders for the clinical testing.

You can watch that quarter-to-quarter, it can go from 0 to 10 million very quickly. But the core business and the way that we have structured the core business is performing beautifully. And that’s like an aircraft carrier, once it has gone, it just keeps on going. So we pay a lot of attention to that, I think that business has got a lot of likes for the future, injectibles are going to be with us for a long-long time, the best way to get a drug into the body and get it acting quickly. So never underestimate the strength of our core business.

Rafael Tejada – Bank of America Merrill Lynch

Perfect timing. Thank you.

Don Morel

Thank you, Rafael.

Bill Federici

Thank you.

Don Morel

Thank you.

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