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Executives

Jim Conway - President and CEO

David Jonas - CFO

Analysts

Ernest Andberg - Feltl & Company

Tyson Bauer - Wealth Monitors

Beth Lilly - Gabelli

Rochester Medical Corp. (ROCM) F2Q11 (Qtr End 03/31/11) Earnings Call May 5, 2011 4:30 PM ET

Operator

Good day ladies and gentlemen and welcome to the Q2 2011 Rochester Medical Corp. Earnings Conference Call. My name is Colby and I would be your operator for today. At this time all participants are in listen-only mode. We will conduct a question and answer sessions towards the end of this conference. (Operator's Instructions) As a reminder this call is being recorded for replay purposes.

I would now like to turn the call over to Mr. Anthony J. Conway, President and CEO. Please proceed sir.

Jim Conway

Thank you. Thanks for joining Rochester Medical second quarter conference call. I am Jim Conway, the Company's President and CEO. And with me is David Jonas, Rochester Medical’s Chief Financial Officer.

First I will provide a high level review of our second quarter and speak to our outlook for Rochester Medical and then Dave will provide you with more on our results. Then I will give you a quick summary and then we will take your questions.

Before starting let me remind you that we will be making some forward-looking statements today and I would refer you to the Safe Harbor statement filed in today's press release and also to the risk factors section in the Company's annual report on Form 10 K for the year ended September 30, 2010.

These statements further clarify the risks and uncertainties that are associated with the forward-looking statements. Now before we review the financials, I would like to first explain the new labels for our sales categories. What we had formally refer to as branded sales will now be referred to as direct sales. This terminology better characterizes our growing product line, now that we have closed on the Laprolan acquisition.

We will continue to sell products directly out of the Rochester medical brand, our Laprolan, which sells Rochester medical brand products also sells other unique brands that we have under license or contract.

In addition as many of you know products sold under our Script-easy prescription brand in the U.K. often carry other manufacturers' labels. As far as sales to private label customers we will continue to refer to that segment as private label sales as before.

Regarding the direct sales category we will also be breaking out direct sales into our two sales channels; home care and acute care. Acute care represents sales to hospitals and homecare refers primarily to sales to individuals in the home as well as to home health care distributors. This new break out of direct sales by channel will give more clarity to the fact that most of our sales are to the home care market.

And that should help investors better assess our growth as we continue to penetrate this market which we estimate comprises about two-thirds of the $1.5 billion opportunity for our products in North America and Europe.

At the same time we are making meaningful inroads into the acute care market, which presents an excellent opportunity in its own right. Currently 73% of our US direct sales and 95% of our direct sales in Europe and the Middle East are via the homecare channel.

Turning now to our revenue performance; In terms of constant currency we reported sales of $12.9 million, a 29% increase over last year. This growth was due to 37% growth in direct sales while our private label sales grew 8%. The Laprolan acquisition coupled with strong sales in the US and the U.K. rolled the growth in direct sales. This strength was partially muted by the slippage of a large international tender order out of the second quarter and into the second half.

In terms of GAAP earnings we reported a loss of approximately $1.3 million. On a non-GAAP basis after striping out acquisition costs and certain non-cash expenses we reported a loss of $437,000 which is generally inline with our expectations considering the increase in selling and marketing expenses.

Now let me turn it over to Dave for further details.

David Jonas

Thanks, Jim. I am going to spend a few minutes highlighting the results reflected in our just released second quarter earnings release. Ease of discussion, unless otherwise noted order all sales information will discussed in constant currency. I am doing this to exclude the impact of foreign currency exchange in order to show a true reflection of our sales growth.

Foreign currency has a benefit of approximately $102,000 in the second quarter was a drag of about $20,000 in the first half. As Jim mentioned, total sales rose 29% to $12.9 million from $9.8 million a year ago. Total sales in the U.S. increased 16% to $4.7 million from $4.1 million and solid strength in direct sales.

Total sales outside of the U.S. mainly in the Europe and Middle East which I will refer to as the EME region increased 41% on a very healthy growth in direct sales. In large part due to acquisition of Laprolan partially offset by decline in private label sales.

Geographically, 37% of our sales in the second quarter were in the U.S. compare to 42% last year with 63% of our sales outside the U.S. compared to 58% last year. The reason for the change from last year is clearly due to Laprolan acquisition. Bottom-line, these results indicate that we are executing well in both our U.S. and international businesses.

Total sales for the first six months of the year totaled $23.8 million versus $28.1 million last year, an increase of 19%. Shifting to direct sales which is the main engine of our current and future growth, total direct sales increased 37% in the second quarter over the prior year’s quarter.

U.S. direct sales for the second quarter were $2.5 million versus $2.2 million last year, a 16% increase. This growth was fueled by the strength in our three pipelines as follows. Intermittent catheters sales grew a robust 27% followed by a 12% growth rate in our male external catheters line. And importantly, our Foley catheter line grew 9% in the market we estimate to be roughly flat suggesting we are steadily taking share.

FemSoft sales were slight as we are still early in the launch and early in introducing the product via our homecare sales force. We continue to be optimistic about this product, but conservative in our expectations.

As Jim mentioned, our U.S. drug sale segment is comprised of two channels, our homecare sales channel and our acute care sales channel, with homecare making up 73% of U.S. direct sales in the quarter.

Let me give you some granularity on our performance in each of these segments. The acute care led to grow this quarter rising 28%, and the homecare grew 12%, with the strength in our three pipeline is benefiting acute care to a greater extent this quarter, albeit off a smaller sales base. Both homecare and acute care markets are important to our growth; and are different in their customers and calling points, selling cycles and reimbursement levels.

So the sales force expansion that Jim discussed allows us to provide materially better coverage of both of these unique channels. Although the sales expansion is still getting tractions, these new sales people are already beginning to build the clinical relationships that will drive our future U.S. growth.

Turning now to direct sales outside the U.S., I’ll be speaking about performance in EME regions as sales to countries outside these regions still remain modest. In total, our Q2 direct sales in the EME region were $7.4 million versus $5 million last year, an increase of 48% excluding currency.

Our business in the U.K. and the Netherlands grew more than $3.2 million this quarter. This improvement was partially offset by the timing of certain shipments, the key one being the Middle East tender order that Jim mentioned. We fully expect to book these orders in the second half and we expect to see continued growth in this area.

Now, let’s take a look at our private label business where sales were up 8% in total versus the prior year. We continue to have a number of excellent private label partnerships around the world as ordering patterns in this business are inherently lumpy, its good to look at the year-over-year results on a fourth quarter rolling basis.

On this basis, sales were down 2.7% in the latest fourth quarter period versus the comparable fourth quarter period before that. While we continue to focus on building our higher margin direct sales business on a global basis, private label sales will remain an important and moderately growing business, although it will become a smaller percent of our mix overtime.

Now let me turn to review the remainder of the P&L as well as our balance sheet and cash flows. Gross margins; our second quarter gross margin was 49.5% versus 47.3% last year, improvement of 220 basis points. The addition of Laprolan was the biggest driver in this improvement.

On the other hand, increased oil prices in recent months have and will continue to put pressure on our costs. Given all that, I still anticipate our margins to slowly improve and volumes of our intermittent and Foley products increase resulting significantly higher efficiencies and lower per unit fixed costs. In the first half of the year, gross margins were 49.4% versus 46.2% last year.

Our operating expense increased 57.7% in the second quarter to $7.7 million from $4.8 million last year. This quarter's increase was a mix of recurring and non-recurring items. Specifically items include $255, 000 of non-recurring M&A costs related to the Laprolan transaction and $177, 000 of once a year non-cash expense from stock option compensation.

A majority of the rest of the increase relates directly to the costs associated with the added headcount in the US, the operating expenses in our new operations in Netherlands. I fully expect our spending in the next couple of quarters to flatten near to $7 million per quarter range.

Sales and marketing costs rose 75% from last year and comprised 39% of sales versus 29% last year. A direct reflection of our investment in future growth, especially in our US sales and marketing effort as well as in the Netherlands.

Research and development costs for the second quarter were up 4.2% and represent 2% of sales which was down from last year's ratio of 2.5%. The spending is directly related to new product development and the cost can vary depending on what part of a cycle our products are in especially as they relate to outside testing services.

Administrative costs for the second quarter were up 37.5% from last year, this increase comes almost entirely from the previously mentioned costs associated with the Laprolan acquisition. Excluding these transaction related costs, administrative costs in the quarter were 16.7% of sales versus 17.8% last year.

Finally, we reported an after-tax GAAP net loss of $1,259,000 or $0.10 per diluted share versus a loss of $351,000 or $0.03 per diluted share last year. I believe the non-GAAP adjustment shown in the reconciliation section of our press release are very helpful in understanding Rochester Medical's operating results.

Excluding the tax affected adjustments for material non-recurring costs and intangible amortization and stock option compensation expense, our second quarter non-GAAP net loss was $437,000 or $0.04 per diluted share compared to a non-GAAP net income of $140,000 or $0.01 per diluted share over last year. This entire loss can be attributed to our US sales force expansion.

For the first half of the year, our non-GAAP net loss was $147,000 or $0.01 per diluted share compared to a net income of $287,000 or $0.02 per diluted share last year.

Concerning our balance sheet which continues to be very healthy our cash position stands at $34.3 million. This is down about $1.2 million from the fiscal year end mostly due to increased inventories to anticipate top line growth and capital expenditures to enhance our manufacturing processes. Cash generated from operations has been used to pay down the debt incurred from our 2006 acquisition in the U.K.

I am happy to say we will make our last payment in June. As for the Laprolan acquisition we financed it with our operating line and fully intend to use cash generated from operations to pay this off as well. We currently have about $9 million available on the $25 million line.

To summarize, fiscal 2011 has gotten off to a strong start for Rochester Medical with numerous accomplishments in place to drive our growth going forward. We've added 36 sales and marketing people in the US to help accelerate growth and expanding direct sales business.

We successfully purchased immediately accretive operations in Netherlands, that being Laprolan and we continue to bring innovative new products to market. We remain on track to achieve our aggressive plan to double sales and create meaningful profit by fiscal year 2013.

I will now hand it back over to Jim for some final comments before we answer your questions. Thank you.

Jim Conway

Thank you, Dave. Before taking questions I want to discuss some of the other good things going on at Rochester Medical. I am pleased to announce that we launched a new HydroSil Intermittent Catheter configuration into the U.K. market in March. This advanced technology Catheter includes a proprietary mechanism to help the user grip the virtually friction fee surface, thus making insertion and handling much easier. The device is getting an excellent reception and we have plans to introduce it into other markets later in the year.

Also beginning April, our unique FemSoft female incontinence care device is now being carried by the US homecare sales force and while we remain tempered in our sales expectations for FemSoft we are cautiously optimistic about its long-term potential. Also as we announce in today's release, we have signed a new partnership agreement with Teleflex Incorporated to carry our Strata-NF Anti-Infection Foley Catheter.

Teleflex will sell the Catheter under the Rochester Medical Brand into most European countries. Additionally, we have talked in the past about the need to bolster our investor relations effort, particularly as our outlook anticipates strong growth potential. I am happy to report that after an extensive evaluation of a number of capable firms, we’ve recently engaged Westwicke Partners to help us to expand and sharpen our IR effort.

We will be working with one of Westwicke’s managing directors, [Terrace Hulbert] who is a CFA and has 17 years of experience as a medical technology analyst and investor. In fact when Terrace was on the sell side, she actually covered us. So we appreciate her historical familiarity with the Rochester Medical story.

Now looking ahead, we expect to organically growth our direct sales with continuing major focus on the European and US market place. Most of the growth will in the home care market, but we also expect solid acute care gains. The growth will result both from market share gains, with our superior offerings and from an expanding market size as the general population ages. We also expect introduce more product advancements, which will further help us gain market share.

To sum up, we have made great strides in the first half of fiscal 2011. It has been a very active six months. A significant acquisition, a major expansion of our sales and marketing effort, new product introductions and a new sales contract, which kept us very busy. I think we’re well situated for solid growth going forward. We expect to be operating profitably by this fiscal yearend.

Looking ahead, consistent with our three-year outlook, we are strongly focused on growing the top line, flattening our expenses and generating profit.

Thank you, and now we’ll take your questions.

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of Ernest Andberg with Feltl & Company. Please proceed.

Ernest Andberg - Feltl & Company

Jim, Dave, how are you?

Jim Conway

Hi, Ernie, great.

David Jonas

Hi Ernie.

Ernest Andberg - Feltl & Company

I am not quite sure where to start. I know that you’re cautious about wanting to discuss the precise contribution from Laprolan in your numbers, Dave. But given that Laprolan was going to be immediately accretive even excluding the, even excluding the $1 million jump in sales and marketing from the new sales guys over the last year, I am surprised that the implications for the loss in your core business, legacy business. Can you help me understand where that gains from a little bit?

David Jonas

It's a little bit Ernie. Part of it is the M&A cost obviously.

Ernest Andberg - Feltl & Company

Well, it's only $250,000 I think.

David Jonas

$255,000 and there is a $177,000 worth of once-a-year stock option grant.

Ernest Andberg - Feltl & Company

Yes. We know those always come in the quarter.

David Jonas

Right. And this quarter historically that’s way between that and year-end cost from insurance cost as well, with the annual meeting and annual report orders. So, this quarter is a heavy quarter on the spending anyway and you have the M&A on top of that. That’s what makes, it's all this.

Jim Conway

Well, the other side of that, in this quarter alone, the increase in the U.S. sales force cost us about $1.1 million over the same quarter last year. So, it was about 1.1 million additional expense in their.

Ernest Andberg - Feltl & Company

Yes, you mentioned that.

Jim Conway

And there is really negligible contribution this quarter from that increase. We expect to see that start ticking in this quarter in the extended care in the fourth quarter or maybe even as late as first quarter for the acute care. So, a very significant investment.

Ernest Andberg - Feltl & Company

Okay. And talking about direct sales, I think you said that Foley was up 9% which is the acute care market?

Jim Conway

Acute care was actually up 28%.

Ernest Andberg - Feltl & Company

Well, that was what I was trying to reconcile.

Jim Conway

Yeah.

Ernest Andberg - Feltl & Company

28%, when your Foley business was up $0.09.

Jim Conway

We sell all three product lines into acute care and Foley obviously is our entrée if you will into acute care. But we sell all three product lines and actually have nice growth in the hospital market albeit 9% in Foley’s.

Ernest Andberg - Feltl & Company

Okay. That helps me understand the difference there. Dave, you used your line to pay for the Laprolan acquisition, how should I expect interest expense to go up here and then trail down as you are paying off the line with out of cash flow?

David Jonas

I mean this can all change based on what happens. But right now our plan is to pay down about $2 million a year and right now it's a variable floating interest rate that’s based on the 30 day LIBOR. And right now it's at 1.375. So that's our interest for flow right now and that we’ll call a change if they are going to happen to interest rates and our cash needs.

Ernest Andberg - Feltl & Company

In planning, is the $2 million paid quarterly or is it an annual amortization?

David Jonas

We’re going to pay it quarterly; we will pay it $0.5 million a quarter.

Ernest Andberg - Feltl & Company

Okay. So on average we go down $0.5 million a quarter and that's how I can look at the interest side of the equation. Okay, okay, thank you very much.

David Jonas

Thank you, Ernie.

Jim Conway

Thank you.

Operator

(Operator Instructions) Your next question comes from the line of Tyson Bauer with Wealth Monitors. Please proceed.

Tyson Bauer - Wealth Monitors

Good afternoon gentlemen.

Jim Conway

Hi Tyson.

David Jonas

Tyson.

Tyson Bauer - Wealth Monitors

A couple of quick questions. One can you give us a little background information in regards to the relationship now with Teleflex and is that something we should expect to expand as we go forth and is that under their name or is it under still your name?

Jim Conway

Yeah, a good question. They will be selling our anti-infection Foley under the Rochester Medical name. They currently sell our male external catheters also under the Rochester Medical name; so we've got a great relationship there.

Just a little background on Teleflex in Europe; they are the largest seller of Foley catheters in that region, larger than anyone else. It’s the Roche division. So they feel that they can do quite well with this and it remains to be seen, but we've just signed a contract and they already have some sales. So it could be promising.

Tyson Bauer - Wealth Monitors

Okay. And you do share a director, correct?

Jim Conway

Actually we don't share a director anymore, we share a CEO, our director, Benson Smith is now the CEO of Teleflex. But he is still a director of Rochester Medical.

Tyson Bauer - Wealth Monitors

Okay. Dave, when you talked about getting some profitability it seems like it’s got to come completely from that top-line which will then obviously result in better margins. Is that the case; is there any particular line items we should pay closer attention to than others in getting that top-line growth and seeing how successful that sales and marketing is going?

David Jonas

Absolutely, we have all our investments which is in U.S. direct and European direct. That’s where our sales growth is going to come from and obviously if we think we start operating profitably by the end of this year, we are going to have to get over that $14 million market quarter which is kind of where our breakeven point as right now, if we are going to spend $7 million a quarter operating this.

Tyson Bauer - Wealth Monitors

And would you say you have a better headstart in Europe as opposed to domestic?

Jim Conway

Yes, I would say that’s a fair read.

Tyson Bauer - Wealth Monitors

Any chance of any CMS adjustments and in the year, are we waiting for the cycle before we can get back and front of them?

Jim Conway

We don’t see any adjustments in the near-term. We are trying to get the fence of the reimbursement adjusted and we’ve actually started to enlist the health of our US senators from Minnesota, so it’s kind of tough to get them to change that, but we remain optimistic. The reimbursement rate is incorrect and I think that sooner later with the right minds, sitting around the table we will get it corrected.

Operator

Your next question is follow up from the line of Ernie Andberg. Please proceed.

Ernest Andberg - Feltl & Company

Jim, you are not the first company to be affected by the political turmoil in the middle east and you said that a significant order slid out of the first quarter or out of the second quarter end into the second half. Is that your thinking or is there some advanced knowledge that that the whoever the tender is for specifically [real] come through.

Jim Conway

We are in very close communication, Ernie. We remain very confident that it will come through and we remain very confident that we will be the ones that win it, now that’s not a 100% ever, but we are as confident as you can possibly be.

Ernest Andberg - Feltl & Company

Is it business you can in the past?

Jim Conway

Correct.

Ernest Andberg - Feltl & Company

All right. Can you discuss, is it as big as a breadbox kind of question?

Jim Conway

Pardon?

Ernest Andberg - Feltl & Company

Well, how big is it?

Jim Conway

It’s over a $0.5 million, that one order.

Operator

Your next question comes from the line of Beth Lilly with Gabelli. Please proceed.

Beth Lilly - Gabelli

I wanted to just give clarification on the operating expense. Dave talked about the operating expenses running at about $7 million a quarter, is that correct?

Dave Jonas

Yes.

Beth Lilly - Gabelli

Okay. And you foresee that through the end of this year in the next year or how long is that going to run at that level?

Dave Jonas

For sure, but the next couple of quarters and if it does go up in the quarters after that, it’s not going to be a lot. It will go up incrementally.

Beth Lilly - Gabelli

From that $7 million?

Dave Jonas

From that $7 million, yes.

Beth Lilly - Gabelli

Okay, why we have, so this is a permanent step up in your cost base then?

Dave Jonas

Well most of that is the operating expenses, addition from Laprolan and the step up on the (inaudible) marketing staff here in the US. So it was outside of Laprolan, it was all part of the plan actually.

Beth Lilly - Gabelli

Yes. Okay, so which number, for example this quarter it ran at 7.6 or 7.7, so that will come down and where is it going to come down? In G&A or marketing and selling?

David Jonas

G&A.

Beth Lilly - Gabelli

G&A? Okay. Alright, and then I wanted to be just clear on this. So, the revenues in the quarter grew 29%, what part of that is organic and what part of that is Laprolan?

Jim Conway

Well, we are not going to identify exactly what Laprolan is, but to recall what we've already put out publicly, we stated that the first 12 months of Laprolan, we expect would be about the same sales level as the previous 12 months which are public. So that previous 12 months was about $10.1 million or $10.2 million.

So what we can tell you that is from January 1st to the December 31st, we would expect that to be about the same and then start growing after that; and that’s kind of the guidance that we gave earlier and we will stick to that because we don’t want to break out any country specifically other than the U.S., North America.

Beth Lilly - Gabelli

Okay.

Jim Conway

We have to give it out in terms of Europe and Middle East. But that should tell you what you need to know, figuring it out where we’re going forward.

Beth Lilly - Gabelli

Okay. Alright, and then I just want to be clear about this. So by the fourth quarter, you anticipate being GAAP earnings positive, correct?

Jim Conway

That’s correct.

Beth Lilly - Gabelli

Alright, so that implies a substantial growth in revenues? Not substantial, but if your cost base permanently $7 million now.

Jim Conway

Our cost will be going down and the top-line will be going up.

Beth Lilly - Gabelli

Yeah, yeah. Okay, okay. That's great. Alright and then one another question, in terms of the expansion, plant expansion and everything, can you talk about in terms of what your needs are going forward and, I think you talked about potentially expanding your facility?

Jim Conway

Yes. We will likely be building a new facility in the next fiscal year on the campus here in Stewartville, and expanding our production capacity primarily related to intermittent catheters given our projections.

Beth Lilly - Gabelli

Okay, alright. And then one another question and that is, no change with the sense of I mean you are still, you are now trying to work with the centers or as now really get (inaudible)?

Jim Conway

That's where we are right now and like I say, I am still optimistic because I know that the rate to take [step] makes no sense at any level. It was calculated from a full starting point and walked all the way back through these strange formulas they have, all the way back to a 1976 price and then they index it forward every year with certain fee determined amounts to come to the reimbursement rate. And it just has no connection in reality, none.

David Jonas

It's actually less than what the reimbursing for our MEC catheter…..

Jim Conway

Yeah, that's a great point. Yeah, we get more for an MEC and an intermittent which is much less complicated and a less costly device.

Beth Lilly - Gabelli

Yeah. Okay, I think those were all my questions. Great, thank you very much.

Jim Conway

Yeah, thanks Beth.

Operator

(Operator Instructions) At this time there are no -- correction. Your next question is a follow-up from Beth Lilly. Please proceed.

Beth Lilly - Gabelli Investors

I just remembered one last question. Your relationship with Teleflex, they sell your male external catheter in Europe right now.

Jim Conway

Yes they do. We do to.

Beth Lilly - Gabelli Investors

Okay.

Jim Conway

We do too.

Beth Lilly - Gabelli Investors

Yes I mean that's interesting, can you talk about that relationship and do they have certain countries and other countries, how do you manage that and then what's going to be the relationship going forward in terms of selling the anti-infective catheter or the Foley catheter in Europe.

Jim Conway

Let me answer the last first. In the anti-infection catheter the countries that they have in mainland Europe are all major European countries except the U.K., they have no rights in the U.K. simply because we have a strong presence in the U.K. but they have a very strong direct hospital presence in the Foley market and all those countries. So like I said it looks promising.

The reason that they got to selling our brand goes back historically, they started out as a private label customer of ours some years ago, selling their brand of male external catheters into Italy. And so it was our catheter under their brand and they did very well in Italy and so they wanted to expand that into a number of the major European countries.

They understood after discussions that we wanted to increase our branded presence and so they agreed to sell them all under our brand and they converted the private label that was in Italy to our brand also. So it is working out very well for all of us.

Beth Lilly - Gabelli Investors

Perfect. Those are all my the questions. Thanks.

Jim Conway

Thanks.

Operator

At this time there are no further questions in queue.

Jim Conway

All right thanks everybody and will talk you next time.

Operator

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

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