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ICU Medical Inc. (NASDAQ:ICUI)

Q3 2009 Earnings Call

October 19, 2009 4:30 pm ET

Executives

John Mills – ICR

Dr. George Lopez – Chairman and President

Scott Lamb – Chief Financial Officer

Analysts

Matt Dolan – Roth Capital

Junaid Husain – Soleil

Stephen Simpson – Northland Securities

James Terwilliger – Duncan Williams

Mitra Ramgopal – Sidoti

Operator

Welcome to the third quarter 2009 ICU Medical Incorporated earnings conference call. (Operator Instructions). I would now like to turn the presentation over to your host for today’s call, Mr. John Mills, Senior Managing Director for ICR, Incorporated. Please proceed, Sir.

John Mills

Thank you. Good afternoon everyone and thank you for joining us today to review ICU Medical’s financial results for the third quarter ended September 30, 2009. On the call today representing ICU Medical is Dr. George Lopez, Chairman and President, and Scott Lamb, Chief Financial Officer.

We will start the call by reviewing key operating and financial achievements for the quarter. Then Scott will discuss financial results. Dr. Lopez will wrap up the call with an update on the company’s revenue and earnings targets for fiscal 2009 and a discussion of current business trends. Then the company will open the call for your questions.

Before we start, I want to touch upon any forward-looking statements made during the call. Please be aware they are based on the best available information to management and assumptions that management believes are reasonable. Such statements are not intended to be a representation of future results and are subject to risks and uncertainties. Future results may differ materially from management’s current expectations. We refer all of you to the company’s SEC filings for more detailed information on the risks and uncertainties that have a direct bearing on operating results and performance and financial conditions.

With that, I will now turn the call over to Dr. Lopez. Go ahead, Doc.

Dr. George Lopez

Good afternoon everybody and thank you for joining us today. Third quarter results were in line with our expectations and we are pleased with our financial and operational accomplishments for the first nine months of this year as our market leadership and unbeatable value proposition continue to drive strong demand for our products around the world.

We reported third quarter sales of $54 million. Sales were driven by double digit improvements custom sets and new products. International revenue was up 53% while sales from domestic distributors and direct sales posted an increase of 98%. We also reported solid net income of $6.3 million or $0.42 per diluted share. We ended the third quarter with $123,400,000 in cash, cash equivalents and investment securities, no debt and we generated $38.5 million of operating cash flow for the first nine months of this year.

On August 31, we completed the purchase of the commercial rights and physical assets of Hospira’s Critical care product line. Upon closing, we entered into a multiple transitional service agreement with Hospira for distribution and light manufacturing support which will 18 months or less to transition all Critical care operations to ICU. Overall, the entire transition is going as planned and we are excited about the opportunities ahead of us for the Critical care product line.

During the third quarter we started adding more sales force to handle Critical care and our goal is to hire up to 25 direct sales people and additional marketing and support staff to expand Critical care operations. We expect that by completely controlling worldwide responsibility for the product line we are now in a much better position to leverage our network of customers and strategic partnerships to regain market share for our new full line of Critical care products.

Because the transition is going as planned, we believe that during 2010 we will begin to utilize our product innovation and marketing advantages to identified areas in this market that have been ignored or underserved in the past. We continue to diversify our sales channels and when looking at our sales after the acquisition revenues from Hospira was 45% of overall sales for the third quarter compared to 71% a year ago.

Hospira has been and will continue to be a very important distribution partner for our company for many years to come. We are comfortable with the current percentage of sales through our direct sales force and outside distributors and the opportunities we see in the future with Hospira.

Before I go into more detail about our future outlook I would like to turn the call over to our CFO, Scott Lamb.

Scott Lamb

Thank you Doc. Before I begin let me remind all of you that the sales numbers we are covering as well as our financial statements are available on the Investor portion of our website as well.

As we discussed on our second quarter conference call the Critical care sales to Hospira from July 8, 2009 through August 31, 2009 were deferred and revenue was not recognized for these shipments. The deferred revenue of $1.9 million on the balance sheet as of September 30, 2009 represents the gross profit associated with the Critical care and custom Critical care sales through Hospira from the time of signing to closing the asset purchase agreement. The company will recognize the gross profit on the deferred revenue when the inventory is sold to the end customer, the majority of which should happen over the next two quarters.

Our total revenue for the third quarter of 2009 was $54 million compared to revenue of $54.7 million for the third quarter a year ago. Net income totaled $6.3 million or $0.42 per diluted share compared to net income of $7.6 million or $0.52 per diluted share for the third quarter of 2008. We received an additional $0.08 per diluted share due to a favorable tax rate of 21% during the quarter. This decrease in tax rate was primarily attributable to additional tax credits recognized in the third quarter.

Excluding the additional tax rate benefit we would have achieved earnings per share of $0.34 for the third quarter which was in line with our expectations. For the nine months ended September 30, 2009 our revenue increased over 9% to $161.7 million compared to revenue of $148 million in the same period last year. Our net income for the first nine months of 2009 grew 25% to $19.1 million or $1.27 per diluted share compared to net income of $15.3 million or $1.05 per diluted share for the first nine months of 2008.

Additionally, we generated $11.9 million in cash flow from operating activities during the third quarter and $38.5 million for the first nine months of 2009.

Our third quarter sales by product category were as follows; Totaling $20.5 million, sales from CLAVE comprised 38% of our third quarter total revenue and were basically flat year-over-year. CLAVE performance was in line with our expectations as some of our customers conservatively managed their inventory and Hospira implemented their inventory management strategy due to their previously announced project fuel initiative.

We expect CLAVE to achieve year-over-year growth of the mid to high single digits for the foreseeable future.

Custom sets, which include custom oncology, custom infusion and custom Critical care represented 36% of our total third quarter revenue and increased 2% to $19.4 million compared to $18.9 million a year ago. Sales of custom sets during the quarter were driven by custom infusion sets which increased 25% year-over-year. This strong upside trend was largely offset by a 49% decrease in custom Critical care due mostly to the two months of deferred revenue from the Critical care transaction and a 25% decrease in custom oncology as sell through caught up with sell in product pipeline.

Last year, as with any successful product launch, we experienced a sell in period which increased overall sales for 2008. As we look into 2010 we expect our sales from these products to achieve stronger year-over-year growth. Standard critical care products decreased 29% to $7.4 million compared to $10.4 million for the third quarter a year ago. Again, this decline was mostly attributable to the transaction of purchasing the Critical care product line from Hospira. Standard critical care products contributed 14% to our total sales yet we expect this ratio to be greater as we fully recognize these sales going forward. Standard oncology products grew 75% in the third quarter to $1.6 million compared to the same quarter a year ago.

Now moving to our third quarter sales by distribution channel. U.S. sales to Hospira were down 40% to $21.4 million primarily due to the acquisition of Critical care which resulted in a 95% year-over-year decrease in Critical care to Hospira. Excluding Critical care, sales to Hospira declined by 6% due to a decrease in CLAVE, CLC and oncology.

Sales by domestic distributor and direct sales grew 98% to $18.8 million year-over-year due to Critical care as well as strong contributions from custom sets, CLAVE and new products. International sales were up 53% to $12.6 million and were driven by CLAVE, custom infusion sets and oncology products as well as Critical care.

During the quarter we enjoyed strong demand for our products in Europe and the Pacific Rim. Third quarter 2009 international sales represented 23% of our total sales compared to 15% a year ago.

In the third quarter of 2009 our gross margin were 46.4% compared to 45.6% a year ago. Favorable exchange rates contributed 2 percentage points in our gross margin in the third quarter of 2009 compared with the third quarter of 2008. This was offset by expenses in our Salt Lake City manufacturing facility related to our investment in new manufacturing processes related to our IPS initiative.

SG&A expenses totaled $16.8 million compared with $13.6 million for the third quarter last year. The increase in SG&A was primarily attributable to our investments in sales and marketing initiatives, the higher compensation and benefit costs and higher legal patent costs. To take full advantage of the Critical care acquisition we hired 13 additional direct sales employees with additional sales support and marketing and customer service professionals.

The SG&A increase during the third quarter was in line with our previous estimates and we continue to expect our SG&A expenses for the full year 2009 to be approximately 29-30% of total revenue.

Research and development expenses were $700,000 for the third quarter of 2009 compared to $900,00 a year ago and $600,000 in the second quarter. As planned, we started to gradually increase our investment in research and development in the second half of the year to support our innovative strategies. This year-over-year decrease was primarily attributable to our focus on core projects during the quarter and the elimination of development work on the device for detecting coronary artery disease. We expect our R&D expense to be approximately 1-2% of total revenue for the full year 2009.

Our third quarter operating income totaled $7.6 million compared to $10.5 million for the same quarter a year ago. On a year-to-date basis, our operating income increased 43.5% to $27 million or 16.7% of sales compared to $18.8 million or 12.7% of sales a year ago.

Finally, moving to our balance sheet and cash flow, as of September 30, 2009 our balance sheet remained very strong with $123.4 million in cash, cash equivalents and investment securities. This equates to approximately $8.33 per share. We also had over $188 million in working capital. Our capital expenditures totaled $3.3 million during the quarter of 2009.

Lastly, as of today we are down to less than $1 million from $81 million in auction rate securities. Now I would like to turn the call back over to Dr. Lopez.

Dr. George Lopez

Thank you Scott. We are very proud of our accomplishments to date and are confident in our company’s future. Now I will provide updated guidance for the full year 2009 and discuss a few metrics for 2010.

Due to strong demand for our core products both domestically and internationally and as the transition of our Critical care acquisition progresses as expected, we are narrowing our previously announced revenue guidance to a range of $223 million to $228 million for the full year 2009. We also continue to estimate our gross margins to be in a range of 46-47% for the full year 2009. Beginning in 2010, as we communicated to you on our second quarter conference call we expect the new Critical care revenue to put downward pressure on our overall gross margins in 2010 but to increase our gross profit dollars.

On the operating expense front we will continue to incur additional expenses related to the Critical care sales force. However, we should be able to leverage this investment over the longer term and increase our operating margins.

Turning to the earnings per share guidance for the full year 2009, we are increasing our diluted earnings per share guidance for the fiscal year 2009 to a range of $1.74 to $1.79 compared to the previously announced guidance of $1.62 to $1.71. This increase is due to improved operating results and the additional $0.08 related to a more favorable tax rate of approximately 21% in the third quarter of 2009. For modeling purposes, we expect our tax rate for the full year to be 33%.

We believe capital expenditures including the additional investment in our facility in Slovakia to be approximately $19 million in 2009. We have begun construction on our new plant in Slovakia and expect to have it operational in the second half of next year. Our operating cash flow is expected to total approximately $45 million in 2009.

In conclusion I would like to say we are pleased with the progress we have made so far. We believe our company is well positioned to capitalize on our market leadership, premier industry relationships and our Critical care acquisition.

Now I would like to turn the call over to you for questions.

Question-and-Answer Session

Operator

(Operator Instructions) The first question comes from the line of Matt Dolan – Roth Capital.

Matt Dolan – Roth Capital

On the Hospira transition and specifically looking at the Critical care line that number came in still pretty strong despite the transition for a month and a half. Maybe you could break out that $7.4 million as to when those sales came through. Then touch on the rest of the business in terms of how we really derive an underlying growth figure for the quarter?

Scott Lamb

Well we completed the transaction on August 31 so as of September 1 we started recognizing sales for the Critical care product line. Those sales would have been what Hospira previously would have recognized on their sales to the end customer. So we have a full month of sales for Critical care.

Matt Dolan – Roth Capital

At the end user price?

Scott Lamb

At the end user price. That is correct.

Matt Dolan – Roth Capital

Looking at the rest of the business it looks like CLAVE was flat again sequentially although up pretty nicely year-over-year. Maybe just walk us through, especially as we look into Q4 is it going to require a double digit growth both sequentially and year-over-year and clearly the transition will help but what are you hearing generally that gives you confidence some of the inventory issues we saw earlier in the year aren’t going to come back and you will return to some normalized growth rate outside of obviously the Critical care piece that is in the middle of the transition?

Dr. George Lopez

Outside of Critical care, we still believe that CLAVE for example will continue in the foreseeable future to grow in the mid to high single digits. As we look at our sell through data it is up where we expect it to be and it is doing very well. It is still going very strong. This was mainly due to Hospira’s project fuel and as we announced in our second quarter conference call we expect Hospira’s CLAVE sales to be flat to slightly down for the second half of this year. Sell through is still going very strong.

Matt Dolan – Roth Capital

One thing you didn’t mention in the prepared remarks is Premier. Any updates for us there? Any traction that you have seen and what are you expecting to be able to bring or sell through ICU products in 2010 because of that relationship?

Scott Lamb

It is going very well. We saw some low hanging fruit in the third quarter but as we mentioned in the past the fourth quarter is when we should start to see some significant growth coming from the Premier relationship and we are still bullish on that relationship and the opportunity it represents.

Dr. George Lopez

To put some color on the CLAVE numbers, as Scott mentioned we actually see the sales tracing to the hospital. Our sales tracing, we know exactly what Hospira is selling to whom and in what quantities. We see the actual shipments. Those are going strong in the high single digits.

Matt Dolan – Roth Capital

So that is what gives you confidence that the growth you saw in Q3 is on the low end of things?

Dr. George Lopez

Hospira reducing inventory with project fuel and really the number that really counts is how many customers are buying the products. That number is increasing. Is that number flat? The number is increasing so the numbers we saw in oncology versus the sell through are two different numbers. We can sell to the distributor what the customers are buying.

Matt Dolan – Roth Capital

On the strategic side it looks like the Hospira transaction is tracking well. Any concept of what other uses of cash might be out there whether it be acquisition possibilities, products for distribution or a buyback?

Dr. George Lopez

Stock purchase. Open market stock purchase

Matt Dolan – Roth Capital

Is that in the works?

Dr. George Lopez

In the works.

Operator

The next question comes from the line of Junaid Husain – Soleil.

Junaid Husain – Soleil

Just so I have it clear in my head then, the $7 million or so you saw in the quarter on Critical care that is all in the month of September?

Scott Lamb

That is correct.

Junaid Husain – Soleil

Doc, more high level, as we head into what could be a very nasty flu season, there have been some interesting reports out there suggesting that Critical care wards could become overwhelmed with Swine Flu patients. When you look at your Critical care product lines, which product lines have you seen or do you expect to see the greatest purchasing behavior?

Dr. George Lopez

Custom sets. Most of our custom sets are designed for the ICU and the Intensive Care Unit is where you are going to see most of the patients, where the sickest patients will be admitted. They will end up in the ICU. We expect to see custom sets increase.

Junaid Husain – Soleil

As you have been talking to hospitals in the month of September, what is the sense as we get into this very nasty flu season? Do you expect the orders to start to pick up in the back half of the year?

Dr. George Lopez

The fourth quarter is usually our busiest season anyway so you can almost count on that because that is when the most people end up in the ICU with flu season and just the standard flu. I don’t know if enough vaccine for H1N1 is going to make it to the clinics fast enough. Bottom line is we expect some pretty much of an uptick in the fourth quarter and that will be in custom sets.

Junaid Husain – Soleil

X swine flu, help us understand how you grow out the Critical care business? Is it through product development? Is it through geographic expansion? Is it through greater channel access? What are you looking at over the horizon?

Dr. George Lopez

We would like to stall that to the next earnings conference call because we have some things in place but we would like to postpone that question to a deferred quarter in January. We will give you a very specific roll out and specific numbers in what we think we can do but it is really early right now. The most important thing is to make sure that the acquisition and the merger goes smoothly. It is lucky for us we are not having to merge in the manufacturing process. All we have to do is merge in the distribution process and that alone is an [inaudible]. It is going very, very well.

Junaid Husain – Soleil

If we could talk a bit about your relationship with Hospira, obviously Hospira is in the midst of its efficiency initiatives through project fuel. If we look beyond Hospira’s divestment of Critical care, how else has project fuel impacted you? Obviously on CLAVE just a little bit in this quarter but as you look out beyond Critical care and beyond CLAVE how does it affect you?

Dr. George Lopez

The initiative as far as better management of their inventory and the divestiture of Critical care that is how it affects us. I think project fuel is going to make Hospira even stronger and that will only benefit us as we go forward in our partnership with them.

Scott Lamb

One way it benefits us is as Hospira moves to reduce the number of SKU’s, the number of product lines to be more efficient and increase their profitability that will allow us more opportunity for customization. As they reduce the number of sets the customer still wants the different configurations and that gives us the opportunity to manufacture more of them. So we think that works hand in hand. They become very profitable by narrowing their product lines. We expand our market share by making custom sets that fill those small niches.

Operator

The next question comes from the line of Stephen Simpson – Northland Securities.

Stephen Simpson – Northland Securities

I was curious now that the Hospira deal is done, can you give us a sense of what you think the new normal is going to be on your inventory levels going forward?

Scott Lamb

I think it is too early to tell on that and obviously we will as we transition from Hospira’s distribution to our own distribution model we look to bring inventory levels down but at this point it is too soon to say by what amount.

Stephen Simpson – Northland Securities

Could you give us any more information on customer counts? Could you for example quantify the number of customers you have gained just from your own direct sales efforts or from these distribution relationships like with Premier and Med Assets?

Scott Lamb

I can’t give you an exact number for that but obviously as our sales grow through not only the Premier opportunity but also through Critical care and Med Assets as well, those increases in customers will obviously show through with an increase in revenue. I don’t have an exact customer count for you.

Stephen Simpson – Northland Securities

I know you have been talking about hiring up to 25 people dedicated to Critical care. Did I hear correctly that 13 of those are hired already?

Dr. George Lopez

Correct. One thing I would like to say about the acquisition of Critical care, our call point for ICU is the intensive care unit. It is natural for us to take over that call point. It allows us to sell our other products while we are in the ICU. So it makes it much more efficient for us to do. We have a full line of Critical care products to sell now opposed to just custom sets.

Stephen Simpson – Northland Securities

Are you getting any push back from customers for some of these new oncology products like the [Genie] just because of the overall hospital environment? Has the door for new products somewhat shut because of the environment or do you think that is not a factor at this point?

Dr. George Lopez

I think yes or no. I think there is initial push back in some places and in some institutions there is none. But that product line is growing at a pace of about 48% to 50% pace right now. We are very happy with the growth of oncology. There is some push back because of general conditions of the market but we expect that product line to do very, very, very well.

Operator

The next question comes from the line of James Terwilliger – Duncan Williams.

James Terwilliger – Duncan Williams

Could you talk a little bit about the growth opportunities outside the U.S.? You put up very nice growth in your international markets. Can you talk a little bit about what is driving that growth?

Dr. George Lopez

Oncology. In one word, oncology. The oncology products we launched them earlier in Europe for example so they had a head start on our launch in the U.S. and they are doing very, very well. So one word, oncology. Secondly, oncology custom sets. In fact we are building the plant in Slovakia to be operational in the second half of next year just specifically to build custom sets, mainly custom oncology sets for Europe.

James Terwilliger – Duncan Williams

So then is it mostly Europe? Is that where the majority of this growth is coming from?

Dr. George Lopez

A lot of it. Yes.

James Terwilliger – Duncan Williams

Is there anything, when you picked up the Critical care business line is there anything of note you can talk about from the R&D pipeline in that particular business?

Dr. George Lopez

As I said earlier on Critical care, let us do a formal presentation in the next earnings release. We will give you very specific what we are going to do and what our planned investments are and what areas. At this time the most important thing is to make sure we don’t lose any revenue and we make the transition smoothly without affecting our earnings per share. That is the highest priority.

James Terwilliger – Duncan Williams

When you acquired the Critical care business and during this transition can you talk about the behavior of your competitors? When you talked about the 13 sales people that came over did you lose any sales people in that transition as well?

Dr. George Lopez

We got everybody we wanted. We didn’t want everybody but we got everybody we wanted.

James Terwilliger – Duncan Williams

How did the competitors behave during that transition?

Dr. George Lopez

Couldn’t really tell you. I don’t have an answer to that one. Keep in mind the competitors, there is really only one large competitor in Critical care in the U.S. and that is Edwards was very good. They are a very well managed company. They outnumber our sales force by a large magnitude. You can bet we will not do a frontal attack on Edwards. It will come from a flanking maneuver which we will talk about. We will not do a frontal attack. I always say God is on the side of the numerically superior.

James Terwilliger – Duncan Williams

The Critical care products you picked up, do they have any exposure on these Premier contracts?

Scott Lamb

I’m not quite sure I understand. Our products are on Premier.

Dr. George Lopez

Critical care is on premiere now.

Operator

The next question comes from the line of Mitra Ramgopal – Sidoti.

Mitra Ramgopal – Sidoti

Going back to the sales force expansion, is it fair to assume by the end of 2009 you pretty much have the numbers you want in place until 2010 as more or less seeing that investment pay off?

Scott Lamb

We are still short.

Dr. George Lopez

By the end of the year we hope to hire all the additional critical care sales people. As far as the other product lines go that is always the case where we look at the opportunity versus what we have out there selling. We could adjust it accordingly.

Mitra Ramgopal – Sidoti

In terms of the tax rate I believe you said it is going to be 33% for 2009. We have to model our 2010, what would sort of be a reasonable number?

Scott Lamb

35-36% barring no changes by [Congress].

Mitra Ramgopal – Sidoti

Coming back to the guidance, it was raised today, is it just the overall business you are encouraged on or is it something in the Premier agreement in the fourth quarter?

Dr. George Lopez

No, as we get closer to the fourth quarter we get better visibility to our numbers.

Mitra Ramgopal – Sidoti

Finally, anything out of the healthcare reform you think could have an impact on the business? The one thing I am hearing is the medical device packs for example.

Dr. George Lopez

We don’t know anything more than you do at this stage. We have heard there are going to be exempt certain sizes. We don’t know any more than you do. If medical companies are taxed we will all be in the same boat together.

Mitra Ramgopal – Sidoti

Are you products more likely to be exempt than others or it doesn’t matter?

Dr. George Lopez

I would hope so.

Scott Lamb

It depends on what changes are made or what the final tax bill looks like.

Dr. George Lopez

We raised our guidance because we are very confident of these numbers. That is the only reason we raised them.

Operator

The next question comes from the line of Matt Dolan – Roth Capital.

Matt Dolan – Roth Capital

One follow-up. On this transition you have indicated the critical care operation is tracking in line with your expectations. I think you have characterized maybe $30-35 million in added revenue next year. Maybe another way to ask some of the questions that were prodded earlier is what percent of conversion do you anticipate given that sales number for next year out of critical care? Meaning what percent of accounts do you expect to keep versus lose?

Dr. George Lopez

We expect to keep the majority. There is certainly a loss built into next year. We don’t expect to keep all of them.

Matt Dolan – Roth Capital

So more than 50, less than 100%?

Dr. George Lopez

That will get you there.

Operator

There are no further questions at this time. I would like to turn the call back over to management for closing remarks.

Dr. George Lopez

Thanks everyone for participating in today’s call. We look forward to updating you on our 2009 progress in the fourth quarter call in early February. As a reminder, management will be marketing a number of cities towards the end of October and attending a number of investor conferences this quarter. We certainly hope to see you there. Thank you.

Operator

Thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect. Good day.

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