VNUS Medical Technologies, Inc. Q4 2008 Earnings Call Transcript

Feb.10.09 | About: Vnus Medical (VNUS)

VNUS Medical Technologies, Inc. (VNUS) Q4 2008 Earnings Call Transcript February 10, 2009 5:00 PM ET


Brian Farley - President and CEO

Peter Osborne - Vice President, Finance and Administration, and Chief Financial Officer

Scott Murcray - Chief Accounting Officer and Controller


Tom Gunderson - Piper Jaffray

Benjamin Andrew - William Blair & Company, LLC

Analyst for Benjamin Andrew - William Blair & Company, LLC

Matt Dolan - Roth Capital Partners LLC

Greg Brash - Sidoti & Company


Ladies and gentlemen, thank you for standing by. Welcome to the VNUS Medical Technologies fourth quarter 2008 conference call. At this time, all participants are in a listen-only mode then we will conduct the question-and-answer session and instructions will be given at that time. (Operator instructions) As a reminder, this conference is being recorded today Tuesday, February 10, 2009. I would now like to turn the conference over to Scott Murcray, Controller and Chief Accounting Officer. Please go ahead.

Scott Murcray

Thank you. Welcome to VNUS Medical Technologies regular teleconference on quarterly financial results. Joining me today is Brian Farley, President and Chief Executive Officer; and Peter Osborne, Vice President, Finance and Administration, and Chief Financial Officer.

Approximately one hour ago, we released our financial results for the fourth quarter ended December 31, 2008. In today's call, we will discuss our business and financial highlights for the fourth quarter of 2008. We will also provide our business outlook for the first quarter and full year 2009. After our prepared remarks, we will open the call for questions.

The statements that will be made today on this call may contain certain forward-looking statements that involve a number of risks and uncertainties. Words such as expects, believes, intends, plans, estimates or variations of such words and similar expressions are intended to identify such forward-looking statements and such statements in this conference call will include statements regarding the outlook for VNUS's revenue and earnings, gross margins, commercial success of VNUS's licenses, operating expenses, new product development, marketing programs, foreign currency fluctuations, global investment markets, and pending patent litigation.

Investors are cautioned that actual events or results may differ materially from VNUS's expectations based on various risks and uncertainties. Information concerning risk factors that may affect VNUS's forward-looking statements can be found in the press releases issued by VNUS and VNUS's filings with the Securities and Exchange Commission including its annual report on Form 10-K filed with the SEC on March 14, 2008 and its quarterly report on Form 10-Q filed with the SEC on November 18, 2008. Copies of VNUS's press releases and additional information about VNUS are available on our corporate web site at

Investors are cautioned not to rely on forward-looking statements. VNUS is providing this information as of the date of this conference call and expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.

Now I would like to turn the call over to Brian for a summary of our fourth quarter and more recent business highlights. Brian.

Brian Farley

Thank you, Scott and thanks everyone on the call for joining us today. It is truly a pleasure to be reporting VNUS's financial and business results for the fourth quarter of 2008 as Peter Osborne and I discuss our financial results which significantly over achieved our guidance, I would like to start by providing some background on the guidance that we provided on October 29 for the fourth quarter. Our guidance for the fourth quarter was for revenues of $24.0 million to $25.3 million representing annual growth of 17% to 23% and annual product revenue growth of 12% to 18%. However, actual revenues generated in the fourth quarter of 2008 of $27.2 million translate to annual revenue growth in the quarter of 32% and product revenue growth of 26% while operating expenses increased just 12%.

There were four factors that influenced us to be cautious in providing our fourth quarter guidance; first was some uncertainty regarding the future impact of the weakened economy on our business; second was that Medicare had not yet published the 2009 fee schedule; thirdly, we had just dramatically increased our market share in the third quarter presenting challenges for immediate further share growth and lastly, we were comparing to a very strong performance in the fourth quarter of 2007. It turned out that although we remain cautious about the economy, still to date, we have not observed the economy having a miserable impact to our business. In fact, doctors verified for us throughout the fourth quarter that they were seeing the normal Q4 increase in Closure procedures.

Our level of caution regarding 2009 reimbursement was also overly conservative as we learned the next day after our earnings call when the published 2009 Medicare reimbursement numbers were published that these numbers turned out to be favorable to our business compared to our competitors. As for our concern that we had a difficult comparison quarter, we are pleased that this concern was also unfounded as we grew product revenues 26% in the fourth quarter, very similar to the 25% increase in product revenues achieved in the third quarter of 2008.

Our market share estimates indicate that 45% of the US procedures were performed with our Closure products in the fourth quarter of 2008. This procedure share is identical to our estimate for the third quarter of 2008 and we estimate VNUS's product revenue market share decrease 2% each points to 65% after having surge in the third quarter from 59% to 67%. We believe this is due both to strong sales of our ClosureFAST catheter and the previous surge was also due in part to a competitor, AngioDynamics, that reported modest quarterly revenues for laser ablation products in our third quarter and this was while they were absorbing they recently purchased Diomed business.

This recent reduction in VNUS's market share is in our opinion only a numerical anomaly caused by AngioDynamics reporting much stronger laser ablation revenues during our fourth quarter after such a modest prior quarter. We believe that because of the multiple quarters required for AngioDynamics to integrate the Diomed business. An appropriate way to look at shifts in market share is to compare numbers over six-month period from the second quarter to the fourth quarter of 2008. Looking at market share from that perspective, we estimate VNUS increase our product revenue share from 59% to 65% over six months. What is not clear from these numbers is that we believe that we continue to take market share in the fourth quarter as measured by the majority of new users choosing the purchase of radiofrequency generator over a laser and by the decisions of laser users to begin performing radiofrequency vein ablation using our Closure products.

An interesting outgrowth of this market share analysis is that in the final months of 2008, the number one and two companies in the market both reported strong in the VNUS product sales indicating that the market for vein ablation is resilient and growing well. We are also aware of user surveys that have polled doctors who are using the VNUS products and both surveys confirmed that the flow of vein patients in the doctors' practices has not been negatively impacted by the economy. Clearly, our fourth quarter result showed this to be true. Together the surveys and the strong revenue growth from our recent quarters validated that the type of patients who are treated for chronic venous reflux disease are those with the therapeutic need. These patients seek relief of symptoms because of a medical necessary condition that significantly detracts from their quality of life if their venous reflux is left untreated.

Another positive sign for our business was that accounts that ordered in both the fourth quarter of 2008 and 2007, with those accounts, cash or unit sales increased by over 14% between the two quarters. This can be thought of a metric that is similar to growth in same store sales. The 14% increase in catheters from same store sales is an increase from the prior two quarters which showed accounts increasing their catheter ordering by approximately 12% when compared to the year ago quarter. The Q4 increase in same store sales is mostly likely due to the normal increase in fourth quarter procedures from patients who have met their co-pay max on deductibles for the year and who want to receive a treatment before the end of the year. Looking at where the overall quarterly unit growth is coming from, in the fourth quarter, approximately 60% of our quarterly catheter unit growth in the United States came from new accounts and 40% came from this increase in utilization as reflected in same store sales increases.

Positioning our Company for improving profitability while maintaining good revenue growth has been the key focus for our management team, in the fourth quarter, we achieved just that. Operating profitability of 13.7% of revenues compared to 8.3% in the third quarter of 2008 and compared to 0.3% in the fourth quarter of 2007. Patent litigation expense in the quarter reduced operating profitability in the quarter by two percentage point and is expected to be an ongoing expense throughout 2009 as we continue to vigorously defend our intellectual property rights. Peter will review an additional detail on the factors that influenced our profits for the quarter and for the year.

One of the key developments in the fourth quarter was the publication by CMS of the 2009 Medicare reimbursement rate for endovenous ablation. The 2009 Medicare reimbursement for radiofrequency vein ablation performed in an office setting was that at $1,699 which is $299 more that the payment for laser vein ablation and represents an improvement from 2008 in reimbursement differential. By comparison in 2008, the Medicare payment for radiofrequency ablation in the office was $255 more for a radiofrequency than laser ablation. For hospital outpatient procedures performed in 2009, the hospitals reimbursed at $2,893 for Medicare patients which is $1,086 more than the payment for laser vein ablation. These reimbursement levels allow us to continue to be competitive in 2009.

Our research and development staff has continued to make good progress at bringing new products to the market. We plan to launch in the second quarter of 2009 a product line extension to the ClosureFAST catheter. This catheter provides a bright light at the catheter tip to allow easy tip visualization through the skin. This should make the catheter even easier and faster to use than the current model by allowing our user to always quickly position the catheter both initially and in each successive ablation segment. This should be especially done official for new users while they were being accustomed to using ultrasound to image the catheter in the bang.

Another product that eliminates the need for [Tumesa] anesthesia is currently scheduled for first human use later this month. This is approximately two months later than expected and caused by some delays in the international clinical trial approval and enrollment. These are behind us now and we look forward to beginning the Phase I clinical trial which if successful, we expect to then continue with a Phase II clinical trial for a potential 2010 product availability if all goes well with clinical results.

Our third product in development is next generation model of our perforator ablation catheter which incorporates the best features of our ClosureFAST catheter with the feedback of our bipolar RFS device for perforator vein ablation. We expect our next generation perforator ablation device to be used in patients near the end of 2009 to first user. Lastly, we plan to release to the market in the second half of this year a product to assist doctors with varicose vein removal. Varicose vein removal is also known as “phlebectomy” and commonly performed at the adjunct procedure with vein stripping surgery and with endovenous vein ablation. Our product in this field is not expected to generate significant revenues but may provide a useful tool to help doctors save time and remove varicose veins more thoroughly.

These are just of the products we have in our new product pipeline which is as full as ever. Disposable catheter and device unit growth increased to 36% in the fourth quarter compared to 26% in the third quarter of 2008. This increase in proprietary catheter and device unit is especially noteworthy when compared to the strong performance in Q4 of 2007. Our unit sales in RF generators were also very solid with 115 RF generators sold in the fourth quarter compared to 100 in the third quarter of 2008 and compared to 122 in the fourth quarter of 2007. In addition to the 115 RF generator sold in the fourth quarter, another approximately 20 RF generators in the fourth quarter were placed into service either through our capital commitment agreement or our laser swap for an RF generator.

All together in 2008, we sold 429 RF generators and placed an additional 95 units through various other deals with customers. By comparison in 2007, we sold 370 RF generators and in 2006, we sold 302. These numbers reflect a large number of new doctors attracted to our radiofrequency vein ablation products as well as the good health of the market for minimal invasive treatment of venous reflux disease.

International product sales continue to be the fastest growing segment of our business. In the fourth quarter, international revenues were 13% of product sales and grew 50% from the fourth quarter of 2007. With the completion of 2008, we now estimate the size of the market for vein stripping and endovenous ablation procedures to be 1.3 million procedures annually in the 40 countries in which our products are sold. Of the 1.3 million, we estimate that nearly one million of the procedures are vein stripping surgery and approximately 308,000 procedures are performed with endovenous vein ablation. Although most of the endovenous procedure volume continues to be in the United States with an estimated 260,000 endovenous procedures performed in 2008, European markets now are more open than ever to adopting minimally invasive alternatives to vein stripping surgery.

As a next step to the expansion of the market in Europe, we expect to French health authorities to publish the position reimbursement payment levels for radiofrequency vein ablation late in the first quarter of 2009 and to publish the reimbursement for the hospital in the second quarter of this year. This means that our financial opportunity to penetrate the 90,000 billable procedures in France will start to be more significantly realizable in the second half of 2009. In addition to France, we are targeting other large international reimbursement opportunities we expect to see additional approvals for public health insurance coverage of our procedure in 2010.

Before I wrap up and turn the call over to Peter, I would like to summarize some of the major results for VNUS in 2008. Starting a year ago, we guided 2008 revenues to be $82 million to $86 million and the actual results for our product revenues came in at $88.3 million. In addition, royalty revenues for the year were $12.9 million. VNUS was essentially able to achieve or over achieve all of our financial and operating goals in 2008. Let me list those out for you.

We first grew product revenues faster than guidance. We gained significant market share. We validated our intellectual property receiving nearly $13 million in royalty payments at a high royalty rate. We improved our competitive position by completing a randomized trial demonstrating that our ClosureFAST catheter resulted in less pain bruising and few adverse events than treatment with laser ablation. We refilled our product pipeline. We saw our largest competitor filed bankruptcy. We became the only technology approved in France for minimum invasive of venous reflux with no invasive treatment of venous reflux. We saw an improved difference in 2009 Medicare reimbursement for radiofrequency ablation compared to laser ablation. We increased the strength of our balance sheet and we demonstrated very good market growth and the medical need of treating venous reflux is great enough to overcome the headwinds from a slowing economy. Lastly, we demonstrated steadily increasing profitability along with the capability to grow operating profits much faster than revenues.

Now, I will turn the call over to Peter for his review of our financial results from the fourth quarter and our business outlook for the first quarter and full year 2009. Peter.

Peter Osborne

Thanks, Brian. For the fourth quarter, net revenues were $27.2 million, including $26 million of net product revenues and $1.2 million of royalty revenues. Net products revenues are derived from the sale of disposable endovenous catheters and devices, RF generators, and accessory products. Royalty revenues are derived from the licensing of certain patents previously subject to an infringement lawsuit. Total net revenues increased 32% from the prior year, and increased 18% sequentially. For the fourth quarter, net product revenues increased 26% from prior year and 19% sequentially. Compared to a year ago, we experience the 36% increase in catheter and device unit sales while compared to prior quarter, we saw a 26% increase.

Sales of disposable catheters and devices accounted for approximately 79% of fourth quarter net product revenues. Sales of RF generators accounted for 7% with accessories and other revenue representing the remaining 14%. By comparison in the fourth quarter of 2007, sales of disposable catheters and devices accounted for approximately 76% of net product revenues. Sales of RF generators accounted for 11% with accessories and other revenue representing the remaining 13%.

International sales increased 50% from a year ago and accounted for approximately 13% of fourth quarter net product revenues compared to 11% for the fourth quarter of 2007 and compared to 11% sequentially. Had foreign exchange rates remained constant from the fourth quarter of 2007 through the fourth quarter of 2008, our revenues in the fourth quarter of 2008 would have been $0.5 million higher. Similarly, had foreign exchange rates remain constant from the third quarter of 2008 through the fourth quarter of 2008; our revenues in the fourth quarter of 2008 would have been $0.2 million higher. In Q4 2008, we sold into 40 different countries versus the comparable period in 2007 of 37 countries. The year-over-year increase in international sales was seen in RF generator sales and even more so in catheter unit sales. Of our international sales, approximately 73% of revenues were denominated in a foreign currency.

We are particularly pleased that we ended the year with annualized sales per rip of $2 million resulting from a focused efforts we have placed on value added sales activities and sales performance management. Our average U.S. catheter pricing and average U.S. RF generator selling pricing did not change when compared to the prior quarter. The Company expects U.S. catheter and RF generator pricing in the U.S. to remain steady in 2009. Our RF generator is a modest capital purchase which many of customers can afford with their own financial resources. We have not seen any diminished interest in our RF generator because of liquidity issues by our prospective customers.

Similarly, the ClosureFAST catheter is used in elective but medically necessary procedure to asymptomatic patients exhibiting venous reflux that is documented by duplex ultrasound scan. Consequently, our Closure procedures covered by approximately 120 insurance covering approximately 240 million covered lives in the U.S. and is unrelated to the procedures performed in the aesthetics market. We continue to correct the rate which our customers performed the Closure procedure in the office versus the Hospital, 53% of new customers added in the fourth quarter in the U.S. performing the Closure procedure in the office compared to 55% of new customers added in the third quarter. U.S. customers performing the Closure procedure in the office represented approximately 69% of the unit volume of catheters for the fourth quarter compared to 68% in the prior quarter.

Excluding upgrades, laser swaps and trade-ins, we sold 115 RF generators worldwide in the fourth quarter of 2008, compared to 122 in the fourth quarter of 2007 and 100 sequentially. The number of U.S. customers ordering catheters in 2008 was 1,590 versus 1,376 in 2007, an increase of 16%. Royalty revenues in the fourth quarter of 2008 were $1.2 million, slightly above our earlier guidance of $0.9 million to $1.1 million. The Company expects lower royalty revenues in the first quarter of 2009 which will progressively increase to total $4.9 million to $5.5 million in 2009.

Gross margins for the fourth quarter were 68.9%, an increase of 3.1 percentage points from 65.8% for the fourth quarter of 2007, primarily due to the recognition of $1.2 million of royalty revenues recognized in 2008 and manufacturing efficiencies achieved since the introduction of ClosureFAST in the first half of 2007. Gross margins decreased 0.7 percentage points from 69.6% for the prior quarter, primarily due to two product mix trends. The first being higher comparative overall international revenues at lower ASPs which was further impacted by strong sales into our distribution channel and secondly, total product revenues growing at an overall faster rate in relation to royalty revenues which have a 100% margin contribution effect.

The Company expects to continue its manufacturing process improvements and partner with its vendor in the supply chain to achieve decreasing production costs. Fourth quarter operating expenses were $15 million or 55% of net revenues compared with $13.5 million or 65% of net revenues year-over-year and with $14.2 million or 61% of net revenues sequentially. Fourth quarter operating expenses include $1.4 million of non-cash stock-based compensation compared with $0.4 million year-over-year and $1.3 million sequentially.

Sales and marketing expenses were $7.2 million, up 4% from a year ago, primarily due to higher stock base compensation expenses and international sales and marketing expenses and up 6% sequentially. Research and development expenses were $2.8 million, up 25% from a year ago primarily due to headcount increase and higher stock-based compensation expenses and up 11% sequentially.

General and administrative expenses were up $5 million, up 16% from a year ago primarily due to higher stock-based compensation expenses and up 3% sequentially.

Operating income for the fourth quarter was $3.7 million or 13.7% of net revenues compared with an operating profit of $67,000 or 0.3% of net revenues for the fourth quarter a year ago and with an operating income of $1.9 million or 8.3% of net revenues sequentially. Interest and other expenses net was a loss of $3,000 compared with $0.9 million of other income year-over-year and with $24,000 sequentially. The decrease is primarily attributable to overall declining yields on cash, cash equivalents, and investments, and foreign exchange translation losses on net assets resulting from the strengthening of the US dollar.

Net income includes a provision for income taxes of $0.2 million principally for Californian income taxes. The Company is not able to utilize its California net operating loss carry forwards and credits because of the two-year suspension of Californian net operating loss carry forwards and limitation of tax credits which was implemented by the state of California on September 18, 2008. Net income for the fourth quarter was $3.5 million or 15% of net revenues compared with net income of $0.9 million or 4% of net revenues a year earlier and net income of $1.6 million or 7% of net revenues sequentially.

Fourth quarter net income per share was $0.21, based on 16.6 million fully diluted weighted average shares outstanding. This compared with a net income per share of $0.05 in the fourth quarter a year ago, based on 17 million weighted average shares outstanding and third quarter 2008 net income per share of $0.10, based on 16.8 million weighted average shares outstanding.

Adjusted EBITDA for the fourth quarter of 2008 was earnings of $5.6 million as compared to earnings of $0.8 million in the comparable quarter of 2007 and earnings of $3.6 million in the third quarter of 2008. The Company expects to be in a fully taxed EPS position on a GAAP basis during 2010. Accordingly, the Company has provided supplemental disclosure of fully taxed EPS as a long-term measure of growth in earnings on a comparable constant per share basis, absent the utilization of net operating loss carry forwards and one-time events, such as the payment of royalties in the second quarter of 2008 that related to periods prior to 2008.

Earnings per share if fully taxed at 38% would be $0.14 for the fourth quarter of 2008 and $0.07 per share in the third quarter of 2008. Net revenues for 2008 were $101.2 million, an increase of 43% compared with $70.9 million for 2007. Excluding $8.7 million of nonrecurring royalty revenues, net revenues in 2008 increased 30% compared to 2007. Net product revenues in 2008 grew 25% compared to 2007 and annual unit sales and unit catheters and devices increased 38% compared to 2007. The 2008 net income was $13.5 million or $0.81 per share compared to 2007 net loss of $5.5 million or $0.36 per share. Excluding $8.7 million of nonrecurring royalty revenues in 2008, net income per share was $0.33 compared to net loss of $0.36 per share in 2007. Net income for 2008 and net loss for 2007 included patent litigation expenses of $2.3 million and $5.2 million respectively.

On the balance sheet at December 31st, 2008, we had cash and cash equivalents and investments totaling $85 million, an increase of approximately $21.8 million from a year ago, primarily due to royalty income and cash generated from improved operating results and an increase of $6.8 million sequentially primarily due to improved operating results. Accounts receivable days outstanding at the end of September were 42 compared with 50 days year-over-year and 48 days sequentially. We expect day sales outstanding to range from 42 to 48 days in the first quarter.

Inventories increased $1.3 million from a year ago and decreased $1.2 million sequentially. Our inventory levels at the end of December represented approximately five annual turns, which compares to approximately five annual turns year-over-year and five annual turns sequentially. We expect inventory to remain constant in the first quarter and annual inventory turns to range from four to five for the quarter.

Now, I will provide a first quarter and full year 2009 business outlook, which takes into account the risk factors regarding forward-looking statements cited at the beginning of this call. A quick of introduction to our guidance for 2009, the low end of our range of our guidance reflects the Company's estimates if the economy begins to negatively impact our business in 2009. The mid to upper range will take our expectation for normal business growth without any significant drag from the economy. We currently estimate that our first quarter 2009 net product revenues will range from approximately $22 million to $23 million, translating to year-over-year growth of 17% to 22%. We expect international revenues to comprise approximately 15% of total quarterly sales and expect approximately 82% of these transactions to be denominated on a foreign currency. Royalty revenues are expected to range from $0.9 million to $1.1 million.

Gross margin is expected to range from 68% to 70% in the first quarter. First quarter operating expenses are expected to range from $16 million to $17.1 million. The increase in operating expenses from the fourth quarter is primarily due to increase sales and marketing expenses and general and administrative expenses of approximately $1.6 million attributable to increase costs associated with the investments we are making in our business which I will describe a little later and increase stock compensation expense. The global credit markets continue to impact the yield on our cash, cash equivalents and investments and the strengthening of the U.S. dollar in the short term will continue to fix our foreign currency denominated transactions. We expect interest and other income mix to approximately $220,000 in the first quarter of 2009.

First quarter net income is estimated to range approximately from $0 million to $0.1 million, or earnings of $0.00 to $0.01 per share. The number of weighted average shares outstanding used to calculate estimated earnings per share for the first quarter is expected to range from approximately $16.8 million to $16.9 million. Net income includes expected patent litigation expenses of $450,000 to $600,000 and stock compensation expense of $1.3 million to $1.4 million. We expect adjusted EBITDA for the first quarter to range from $1.5 million to $1.7 million. Fully taxed EPS is expected to be approximately $0.00 per share. Our operating expenditures in the first quarter and full year include continuing investments as previously announced in sales and marketing in our business both domestically and internationally to take advantage of emerging opportunities we feel would benefit the business in 2009 and beyond.

These investments include additions of six to eight persons to the U.S. sales force and additional several hires to augment our international marketing and sales teams and an investment in the vein practice development group aimed working with our physician customers that grow successful vein practices. Compared to 2008, these initiatives are expected to increase annual operating expenditures approximately $2 million for the additional sales and international stock and $1 million for the practice development growth but will also be generating additional revenue for the business.

First quarter is a seasonally slow quarter for the business but we are guiding to attractive year-over-year revenue growth ranging from 17% to 22% and an operating margin improvement that is approximately six percentage points better than a year ago but also at the same time continuing our sales and marketing investments as described earlier to capture the opportunities for the future. We currently estimate that full year 2009 total net revenues to range from $107 million to $111 million and net product revenues to range from approximately $102.1 million to $105.5 million. This translates to year-over-year growth of 16% to 20%. Royalty revenues are expected to range from $4.9 million to $5.5 million.

Total 2009 revenue in comparison to 2008 after adjusting for the nonrecurring royalty payments is similarly expected to grow in the 16% to 20% range. Gross margin is expected to range from 69% to 70% for the full year, approximately 0.5% to 1% lower than the previous trend due to weakness of the European currencies related to 2008. Operating expenses are expected to range from $64 million to $66 million including patent litigation expenses of $1.8 million to $2.3 million and stock compensation expense of approximately $5.6 million.

Sales and marketing expenses are expected to increase approximately 15% to 18% compared to 2008. Research and development expenses are expected to increase approximately 3% to 5% compared to 2008 and general and administrative expenses are expected to increase approximately 6% to 8% compared to 2008. These full year operating expenses include additional cost of our business described earlier in sales and marketing. The Company expects the annual effective tax rate in 2009 to be approximately 12 %.

Full year net income is estimated to range approximately $9.5 million to $11.6 million or earnings of $0.55 to $0.69 per share. The number of weighted average shares outstanding used to calculate estimated earnings per share is expected to range from approximately 16.9 million to 17.2 million. We expect adjusted EBITDA for the full year to range from $18.2 million to $21.2 million. Fully taxed EPS is expected to range from $0.39 to $0.48 per share. Brian has already discussed the considerations we have given to the potential impacts of the global economy to our business. We remain cautiously confident that there are enough opportunities in the market and with our business to achieve an 11% operating margin for 2009.

Now, we will open the call for your questions. Operator?

Question-and-Answer Session


(Operator instructions) Your first question comes from the line of Tom Gunderson - Piper Jaffray.

Tom Gunderson - Piper Jaffray

Just a quick one that I missed, the percent of catheter sales in Q4 was what?

Peter Osborne

Catheter and device sales were 77%.

Tom Gunderson - Piper Jaffray

Okay, thanks. I am sorry I make you repeat. And then, Q1 2009 at breakeven and then strong earnings throughout the rest of the year, I got the numbers but I am just trying to put this together, Peter, I think what you said was Q1 has $1.6 million additional from Q4 due to the S&M and G&A charges and then I think that the total for the year increase would be $3 million. So, a little bit more than half of the increase is falling into the cost or falling in the Q1, can you help?

Peter Osborne

No, we do have additional increases in headcounts and other marketing activities related to ongoing regular sales activities, the $3 million that the Company referred to special one time program that are going to benefit the current year but more likely 2010 onwards.

Tom Gunderson - Piper Jaffray

But adding sales, I maybe misunderstanding, but I understand the vein practice development but adding sales people is an ongoing cost, right?

Peter Osborne

Yes, over the whole year.

Tom Gunderson - Piper Jaffray

Right, okay. So, I guess I will go back to my core question here is, could you explain a little more as to why you are only “breakeven” in Q1?

Peter Osborne

So, the 1.6 that you are referring to that is in comparison to Q4? And that is, roughly a million of that is due to the sales and marketing program activities we have described and the other expenses are due to increased stock compensation expense. If you recall our Q1 stock compensation expense in 2008 I think was $0.4 million and it is going to be roughly expected to be $1.4 million for Q1 2009.

Tom Gunderson - Piper Jaffray

Got it. So, of the $1.6, $0.6 is non-cash and the other million is cash.

Peter Osborne

Yes, correct.

Tom Gunderson - Piper Jaffray

Okay and then last question, Brian, on France you talked about both physician and hospital payment amounts that are coming out end of the quarter Q2. Can you give us a little bit more color what has to be accomplished? What kinds of smaller steps happen before we hear that or are these just radio silence from France until the government issues something?

Brian Farley

Yes, it is in the hands of the economist and the French health authorities right now and there will not be, as far as we are aware, any preliminary announcements until the actual publication. The best information we have indicates that we expect end of March that the position payment schedule will be published and one or two months later, no later than three months later but most likely in April or May, the actual payment schedule will be published. There is really not much to do between now and then other than what we are doing which is we are taking a couple dozen accounts that we currently have in France and working with them more closely. We are seeing more and more interest in France as doctors are preparing for the date where public health insurance is available and some of those doctors are trying to get ahead of the curve by learning the procedure, building their practice so they are best positioned in their local area to provide the minimally invasive alternative to stripping.

But for the most part of the business, we will remain modest in the first half of the year and there is not much that can be done other than wait for the publication result from the French health authority.


Your next question comes from the line of Ben Andrew - William Blair & Company.

Analyst for Benjamin Andrew - William Blair & Company, LLC

It is actually Matt for Ben. I just want to drill down on guidance a bit, specifically a couple of things between U.S. and O-U.S., if you kind of breakdown the numbers and these are relatively rough numbers but looking to 2009 product revenue guidance, I am coming up at about $89 million in the U.S. that is versus about $80 million in the U.S. for 2008. I know what you guys said about the ranges of impacts from the economy but that is about 11% growth. Just generally what you are thinking for the market here in the U.S. in 2009 or does that include a bit of share taking as well or how can we think about the U.S. market?

Brian Farley

We believe that we will be able to see better growth in that in the U.S. We anticipate that the U.S. growth will be closer to in the order of 18% year-over-year so there might be just one or two percentage points somewhere in the rounding of the international, the U.S. distribution of revenues that is shifting the calculation that you are suggesting. But as we forecast 18%, we are really expecting to take market share. At the same time, we are cautious about the economy. We do not want to be naïve to think that if things worsen that it will not impact us. We are fortunate that it happened and clearly our guidance range includes an element of some conservatism on the potential for the economy to start impacting our business growth.

It is hard to, I think, we were all tempted to do the Microsoft thing and not provide guidance for 2009 but we resisted that temptation and at the same time, I think it is legitimate to point out the most recent history is pretty good as the predictor and the most recent history suggests that Q3 and Q4 2008 growth rate in the market remain consistent and high and so the rate of slowing of our market is less than we had previously anticipated and unless the economy impacts us further, it should be about where we were targeting.

Analyst for Benjamin Andrew - William Blair & Company, LLC

Okay and then internationally, again, using kind of the same rough estimates. It looks like for product revenues in 2009; it is going to be about $14 million out in the U.S. and then outside the U.S. for 2008 was around $9 million. So if you think about that kind if growth, I am sure there is a big chunks that are generator sales but it looks like there is a fair amount of catheter growth in those numbers. Is most of that coming out of France and then if I am doing my calculations relatively correct which is the big assumption but that represents roughly about 6% penetration in those 90,000 cases in France. Is that kind of how we can think about it?

Brian Farley

We would love to say that France is a great opportunity for us in 2009 but we have not carried that thinking into our forecasting. We are going to be cautious about France until we actually see the publication and reimbursement numbers and understand that there is economic viability for doctors who choose to do the procedure on their hospitals to buy the catheter. So you can assume that in the international numbers that we have given you that France has modest growth in the second half of the year, off of the low base. It is still going to be hard to even come up on the radar screen frankly, probably until 2010 unless we are fortunate with the reimbursement numbers being very attractive or with an incredible execution job in France.

Please recall that we, at this point, we only have two employees in France so we do not have a lot of leverage there like we would for example at Germany where it suddenly become issue in public health insurance approval in which case we literary have over 100 accounts immediately being able to expand their volume by a 5X factor to accommodate all the publicly insured patients that come to their practice. So, look at the international growth, first of all your 2008 numbers are a little on the low side, maybe, but the growth internationally should be north of 30% year-over-year and it will be heavily driven by just where it has been in the last two years which is direct sales in Germany and the U.K. along with the continuing really good traction in our distributable markets primarily in Europe and a few Asian countries.

Analyst for Benjamin Andrew - William Blair & Company, LLC

Okay and then, you address this a little bit as far as the new doctors coming into the space but it appears that we are getting close to a kind of like 300 to 280 coming in every year. It seems that way in 2008. Is there a lot as far as patients coming in to the market? Where do these doctors be coming from?

Brian Farley

Yes, as far as where the doctors are coming from, for us, our numbers and our increases in sales of RF generators are very heavily driven by vascular surgeons around the world and this is because so much of our growth is outside the United States. Within the United States, a lot of our growth is a combination of the multi specialty aspect of our business which includes vascular and general vascular surgeons but also interventionalist like cardiologist and some intervention radiologist although that is a small part of our business today. So it is pretty broad base in the United States but very much vascular surgery driven outside the United States.

As far as the numbers, year over year over year, I think you should anticipate that radiofrequency generator sales for us will not grow dramatically year-over-year from this point forward. They will grow a little bit more in consort with additional selling personnel but at some point, they will level off and the business will become even more catheter-driven than it already is. I think as Peter indicated we were only at 77% of sales in the last quarter from RF generators which for an end of year quarter is on the low side but it is not that we are all disappointed by our RF generator sales, we are not. Instead, we just got that as large critical massive disposable business that is overshadowing the capital business.

Analyst for Benjamin Andrew - William Blair & Company, LLC

Okay then one last quick one, any update on litigation, just any kind of date so we kind of start to look forward to?

Brian Farley

There is a Markman hearing for claims construction scheduled in August of this year. There will bea court mandated mediation section that will be scheduled between now and then and those are the really, the next two dates to think about and like a concluding about litigation but there is really nothing to further add except that we have prepared into our financial. The expectation that we are going to continue to prosecute this case to the full extent as we had in our previous case and it has that impact of, in the range of around $2 million of litigation expense this year for us and I think, as you know Matt, from past experience that number has a fairly wide range on it depending on what we see as the case progresses.


Your next question comes from the line of Matt Dolan - Roth Capital Partners LLC.

Matt Dolan - Roth Capital Partners LLC

A follow up on the guy that is one with respect to the timing of revenue, obviously we are seeing a dip down in Q1 of 2009 which is what we saw last year as well but can you help us think about how you are thinking of the year on the whole in terms of contributions from the sales in marketing programs here in the U.S. as well as France should seasonality play out as we have seen historically or I guess using 2008 as the best proxy or are you backend loading some of the revenue there to account for some of those initiatives.

Brian Farley

There is some backend loading really from several things. It is not heavily backend loaded just because the contribution from additional sales people, the contribution is from the practice development group. The contribution is from new products which are the three elements of what I would say incremental growth for us. They really start to have a modest impact cumulatively in the third and fourth quarters but not large numbers. We are talking about in the order of 1% to 2%, 1% to 1.5% maybe maximum impact for the year. The sales people generally take six months to become effective. We added two in the fourth quarter. We are in the process of adding more this quarter in the United States. We are just in the process of adding additional sales people in some of our direct sales operations in Europe. So it will take a little time for them to start making a contribution.

Similarly with the market development group, the practice development group I should say. Those individuals that we partner with are still working on the early stages of their business development so that they can start generating some revenue in the second half of the year and new products similarly as we launch our ClosureFAST with aiming beam in the second quarter. That we will along with the other products be a second half effect.

Matt Dolan - Roth Capital Partners LLC

Okay and maybe on the new product side of things. Can you help maybe rank some of those in terms of importance to the Company and what they mean either revenue per procedure, added revenue per account or something along those lines? How should we think about each of those three or four that you listed off for us?

Brian Farley

We have not established any pricing plans for these and until we have our first human use experience, we are going to be unable to provide any further information on that. I just want to make sure you are aware that the contribution from the new product is modest from the standpoint of how it incrementally moves revenues upward and so it is sort of not in the noise level but it is in the range of what we are already citing for the year of revenues.

Matt Dolan - Roth Capital Partners LLC

Okay, fair enough. And then on the operating margin side of things, we have talked about kind of mid teens target here, a little bit longer term. You were close to that in Q4. As we look out beyond 2009, will these initiatives you are putting into place be accretive to that previous target level? How should we thinking about your goals financially speaking here over the next couple of years?

Peter Osborne

With these initiatives that we have looked at or have to pass particular hurdle and we are looking at contribution to the operating margin at all times and so we expect in sort of outer year, if I could use your expression here Matt that operating margin will be the higher mid teens and we expect these initiatives today to really start bearing fruit in 2010 and 2011.

Matt Dolan - Roth Capital Partners LLC

Okay, great and finally, Brian, on the international side, I think we have handled France pretty well, I think it might be helpful to touch on what the next country or two you might expect and when we could see that in the procedure volume in those geographies and then I will drop. Thanks.

Brian Farley

Sure, the next significant targets for us, for international reimbursement are Germany and Japan. We are hoping to access the 170,000 additional German procedures that are currently being done with vein stripping by obtaining public health insurance approval some time in 2010 in Germany. And similarly, we anticipate Japanese MHWL approval and reimbursement approval allowing us to market in 2010 in Japan which should access an additional 40,000 procedures of available market. So, in total those two countries alone access another 210,000 and then there are a handful of smaller countries that are in the range of about 10,000 procedures in each country that we will also be targeting. So, all in all it will be a substantial increase to where we stand today because today, even counting France which is not truly operational yet on a public health insurance level but if we did account it, we will have a 190,000 procedures outside United States that are available to be treated for minimally invasive technology like ours through the public health insurance process.

So, it is definitely a great opportunity for us by 2010 and more than double the available market for publicly insured patients internationally compared to where we are today.


Your next question comes from the line of Greg Brash - Sidoti & Company.

Greg Brash - Sidoti & Company

I just wanted to touch on the $1 million of marketing expenditures in Q1. Is that a sort of a one-time hit in the quarter and will not continue through the rest of the year? How would you think about it?

Peter Osborne

Let me recap the response I had. Out of $1.6 million additional Q1 2009 expenditures, you can think of it roughly as an extra $800,000 related to deferred comp and the remainder is roughly another $800,000 related to the $3 million annual additional operating expenditures we are expecting to incur with our marketing and sales programs.

Greg Brash - Sidoti & Company

Okay, how many reps are you looking to add here in Q1? Is it all 68 or that can be spread out throughout the year?

Brian Farley

The 68 will be spread out so what we have in Q1 is the full effect of the two hires from Q4 combined with plan for another couple of hires in Q1.

Greg Brash - Sidoti & Company

Okay and then just looking at the economy in sort of the procedure growth, obviously it has been holding up well. Has there been any I guess either positive or negative trends that you saw throughout the quarter? I mean procedure volumes held up through December and maybe if you could comment on how they held up through January?

Brian Farley

Yes, we can basically verify that. If we had not had access to newspapers, CNN and internet, we will not know there was an economy problem if you just look at our numbers and frankly in talking to physicians which we had extensive opportunities to do in the November, December timeframe at the various medical meetings and just as a channel check, we would continue to hear the inconsistent story which is that the doctors were seeing the normal up tick in the fourth quarter due to patients coming in to get a treatment before their co-pay deductible was reset for 2009. We did and we always see this, we did get the occasional doctors saying, "Yes, my business is down some," and that was offset regularly and sometimes more often than offset by doctors who say, who told us that their practice is growing nicely.

And one of the reasons that we reported for the very first time here, the same store sale which was 14% higher in the fourth quarter of 2008 compared to fourth quarter of 2007 was to help people get a better understanding that this is broad based. This is from the surveys, from polling doctors and from our numbers that the up tick in utilization and the up tick in procedure volume are real and of course it is spending the 14,000 or so committed account that we have. So there is really nothing else to say other than we still remain cautious. We really need to be a prudent business management team and pleased that we have seen a direct impact yet but I think we all are aware that there were another 500,000 to 600,000 job losses reported this month and these are the kind of things we will keep an eye on.

At this point, we look like from what we have seen, if you look at the 2008 job losses of 2.6 million with the most recent report, this translates to about 1.2% of the health insured population in the United States that had lost the job for the last 13 months. And if you figure that each of them supporting another two individuals, that 1.2% grows to 3.6% of the health insured population that no longer has maybe the economic report that they had previously had but not all of them are going to start receiving medical care but that gives you a general idea of the potential for our drag on our growth or in any growth of companies like ours. We will not expect by any means that that 3.6% would be something we have to contend with but if you look at the range of revenue guidance we have provided, it does account for a good portion of that as a potential in the case as it starts to pick up and become a factor in subsequent quarters.

Greg Brash - Sidoti & Company

Okay, that is great. That is very helpful and then just one last question to clarify, the international revenues in the quarter, were they around $3.4 million? Am I in the ballpark there?

Brian Farley

Yes. They were.


Thank you and at this time, I would like to turn the call back over to Mr. Farley.

Brian Farley

Thank you. First of all, I would like to apologize for the length of our earnings call. It is an exception and we will try not to repeat that. In summary, we are very pleased with our fourth quarter and full year 2008 performance. However, we are especially pleased that the market for minimally invasive treatment of venous reflux continues to grow so well as we enter our 10th year of marketing the venous Closure product family. 2008 has been a remarkable year when nearly everything with our business went well. This motivates us to even further keep up the strong performance as we enter 2009. In 2009, our focus will be heavily directed at international sales and marketing, international reimbursement, launches and clinical trials of new products, leveraging a medical journal publication of the recovery trial of randomized results, laser versus ClosureFAST. We will also be focusing on further developing the U.S. sales team, taking market share, helping doctors grow their vein practices and most importantly, vigorously depending our patent right. We look forward to reporting our progress on these items as we discuss 2009 result for future earnings calls. This concludes VNUS's teleconference on fourth quarter 2008 results and we look forward to speaking with you again while we report our first quarter 2009 result. Thanks again for joining us today.


Ladies and gentlemen, that does conclude our conference for today and we thank you for your participation and at this time, you may disconnect your lines.

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