Novan, Inc.
Q4 2008 Earnings Call Transcript
Published:
- Operator:
- Greetings and welcome to the Noven Pharmaceuticals fourth quarter 2008 earnings conference call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Joseph Jones, VP of Corporate Affairs for Noven Pharmaceuticals. Thank you. Mr. Jones, you may begin.
- Joseph Jones:
- Thank you operator and good morning everyone. Earlier today we announced our financial results for the fourth quarter and full year 2008. On the line to discuss our results and answer your questions are Peter Brandt, Noven's President and CEO; Mike Price our Chief Financial Officer; and others from Noven's senior management team. Before we begin let me remind you that some statements today including our guidance will be forward-looking. Those statements will be made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act. Many factors may cause our actual results to differ significantly from the guidance and other forward-looking statements provided today. Please consider the risks, uncertainties and cautionary factors discussed in our press release and in our SEC filings. During the course of this call we'll refer to certain non-GAAP financial measures including adjusted net income and adjusted earnings per share. Please see our earnings release available at noven.com for a reconciliation of these measures to their comparable GAAP measures and for an explanation of why we consider these measures useful. On that point I do have one item of clarification before I turn the call over to Peter. This morning we reported GAAP earnings per share for the fourth quarter of $0.37. This includes $7.2 million in one-time license revenues in Q4 that we said would be recognized in Q4. We said that on our last earnings call. The First Call consensus for Noven's first quarter is $0.24. Not surprisingly six of the seven analysts reporting an estimate for Noven also includes a $7.2 million in their estimate. So we believe the apples to apples comparison is most appropriately Noven's $0.37 for the quarter compared to FirstCall's $0.24. There has been an indication this morning that some are comparing our adjusted $0.21 which carves out the $7.2 million to the $0.24 consensus which includes it. This is absolutely not an apples-to-apples comparison. With that now I'd like to turn the call over to Peter Brandt.
- Peter Brandt:
- Thank you Joe and good morning everyone. Let's review the topics we plan to cover today. I'll begin with an assessment of the progress we've made over the course of 2008 and the challenges and opportunities ahead in 2009 and beyond. Mike will review our 2008 financial results and will provide financial guidance for 2009. I'll offer some concluding remarks and then we'll get to your questions. To keep this efficient, we plan to focus on new developments in our business and to keep our discussion of issues that we've covered before short and to the point. Overall 2008 was a good year for Noven financially. Our results achieved in the face of several considerable and costly challenges in business realities demonstrate the substantial resilience and earnings power of our underlying business. Let's start with the bottom line, EPS. In the fourth quarter of 2008 we reported GAAP earnings of $0.37 per share compared to $0.04 per share in the fourth quarter of 2007. As you know from our release, our results included special items in the fourth quarters of both '08 and '07. Mike will review each of these but the major item in 2008 fourth quarter as Joe just mentioned was the recognition of $7.2 million in license revenues related to the return of rights to our developmental amphetamine patch. We indicated that item was coming on our last call and I know you factored that into your models. Excluding that and other special items, adjusted EPS in the fourth quarter of '08 would have been $0.21 versus adjusted EPS of $0.14 in the fourth quarter of 2007. So in Q4 we saw a growth in adjusted net income of about 50%. Now let's do the same analysis for the full year. For 2008 on a GAAP basis we reported earnings of $0.87 per share compared to a net loss of $1.84 per share in 2007. You recall the major item reducing 2007 results was the $100 million charge for in process R&D related to the JDS acquisition. Excluding special items we would have reported earnings of $0.79 per share in '08 versus adjusted earnings of $0.94 per share in '07. So year over year we saw an underlying decrease in adjusted net income of 18%. Now Noven achieved many positive things in 2008 and we'll get to them in a few minutes. But just as we do in managing our business let's start with a candid discussion of two issues that contributed to the year-over-year decrease in adjusted net income. They represented two of our biggest challenges in 2008 and they represent two of the biggest opportunities for us to enhance profitability and shareholder value in 2009 and beyond. The first issue was a poor gross margin in our transdermal manufacturing operations and the second was an operating loss at our commercialization unit Noven Therapeutics. The good news for our income statement in 2009 however is that we are well positioned to address both issues in the year ahead. In fact, progress is already apparent in our fourth quarter results and our 2009 guidance will reflect this. As you'll hear from Mike, based in part on our expectations of success in these two areas, we're targeting GAAP EPS for 2009 in the $0.85 to $0.95 per share range while continuing to fund Mesafem and other development programs that should drive growth for the longer term. Taking these issues one at a time let's start with the transdermal gross margin. Between a manufacturing equipment failure in the first half of 2008 and the continuing high cost of producing Daytrana given the products peel force issues that I'll review shortly, our gross margin for the year in transdermal manufacturing was only 18%. The equipment issue was promptly resolved in the first half of '08. The Daytrana issue impacted the full year and profoundly reduced profitability. Specifically in 2008, our cost of goods sold for Daytrana exceeded our net sales of the product by about $7 million and frankly, that's only part of the impact of the peel force issue on the year. So let's not lose focus on the true profitability of the underlying business. Excluding about $7 million in charges relating to the equipment failure and the Daytrana peel force issue our company-wide gross margin for 2008 would have been about 40% instead of the 33% we reported this morning. So what is the peel force issue and where do we stand in fixing it? Simply put consumers have had difficulty peeling the relief liner from certain Daytrana patches. This has resulted in a number of voluntary product recalls by Shire with Noven bearing much of the related costs. Importantly, this has not been a safety issue and the voluntary recalls have not interrupted product availability at the pharmacy and throughout Daytrana has continued to bring important benefits to patients with ADHD offering once daily coverage with the unique ability to shorten dosing as needed by removing the patch. Here's the opportunity for 2009. We, Noven and Shire working together believe we've identified solutions to the peel force issue and we're well along in testing to confirm that we have the fix. We manufacture test products incorporating the solutions in the second half of 2008 and we believe the stability data we have generated to date supports our view that the solutions do in fact address the issue. If our testing is successful and we have no reason to believe it won't be we plan to begin producing new products in the third quarter of 2009. Now I say plan because we'll need FDA's agreement before incorporating the solution into commercial product. Subject to a green light from the FDA our current schedule calls for actual shipments to Shire to take place in the third or fourth quarter of 2009 and upon that the Daytrana margins should show further improvement. We have not, however, been sitting and waiting for that time to see improvements in manufacturing. In Q4 we developed and implemented new practices and procedures in transdermal manufacturing that helps improve efficiencies and reduce scrap associated with the existing Daytrana production and those efforts along with the Q4 adjustments in the Daytrana reserve contributed to Noven's overall 43% gross margin for the quarter. Be assured that we've taken appropriate measures to address our financial exposure to future Daytrana recalls and to be clear, as we have said before, we do expect additional product to be voluntarily withdrawn. In the third quarter of '08 we established a reserve to cover existing Daytrana product that may be withdrawn between now and when we ship the fixed product in 2009. This reserve along with the new product release testing implemented in Q4 of '08 should substantially reduce our overall exposure to future recalls as we work to implement the solution relieve the related expenses and meaningfully improve profitability in transdermal manufacturing. The second issue that weighed on our 2008 results and offers opportunity in 2009 is a profitability of Noven Therapeutics. In short, this business unit operated at a loss in 2008 and we have committed to shareholders that we will manage this unit to profitability in 2009. Here are the facts. In 2008 Noven Therapeutics had net product sales of $24.5 million and cost of goods sold of $8.0 million including about $3.8 million of acquisition-related amortization residing in cost of goods sold. So our gross margin on these sales including amortization was 67%, excluding amortization it was 83%. In either case although not particularly exciting from a revenue growth standpoint the Noven Therapeutics projects offer the highest gross margin of our commercialized products. So how do we look at this business and specifically what do we mean when we refer to this unit as operating at a loss or profit? Internally we evaluate the performance of Noven Therapeutics based on segmentsβ profit or loss. To get there we consider gross profit from the unit's product less its selling and marketing expenses. In short we ask are the products funding the infrastructure that sells them. We don't include acquisition-related amortization or an allocation of G&A because these amounts won't change based on decisions in sales and marketing and we don't include R&D primarily because these programs are managed separately, stand alone from the commercial infrastructure and move the entire organization forward. On this basis in 2008 Noven Therapeutics hosted a $2.4 million pretax loss. Again, that is $16.4 million in gross profit less $22.6 million in sales and marketing expenditures adding back $3.8 million in amortization. This loss, of course, was expected and built into our 2008 guidance. All along we have described 2008 as an investment year for the launch of Stavzor. Stavzor has been on the market since August of 2008. Although itβs small size and easy to swallow soft gel formulation is undeniably providing a benefit to patients and now β we now have enough prescription data for Stavzor to know that the product will not achieve our prelaunch forecast for 2009. With data to help us predict what Stavzor and Noven Therapeutics other products are likely to achieve in 2009 we're adjusting our strategies and spending for the year to meet our firm commitments of delivering a profit at this unit in 2009. More specifically, at Noven Therapeutics we're targeting an improvement in pre-tax contribution from that unit of $5 million in 2009 compared to 2008 levels. We expect to achieve this commitment through a mix of spending reductions and somewhat modest revenue growth at Noven Therapeutics, all of which are reflected in our 2009 financial guidance which we will get to shortly. To be clear, we said previously that this would be a short runway of evaluation and it has proven to be so. There will be no delay in adjusting our strategies and adjusting our spending. In fact, Q4 reflects initial activity, adjustments and improvements. So execution is already underway and we're confident that we will meet our commitment to shareholders. Make no mistake, however, taking a unit from loss in a profit in this matter is not a strategy on which to build a business and certainly Noven Therapeutics existing products alone will not drive the level of growth that we're targeting over the longer term. In that regard our business development group continues to pursue product opportunities to leverage the Noven Therapeutics sales infrastructure and enhance profit. This is one of our principal objectives in 2009. Turning to other areas of our business there has been no shortage of activity and progress in 2008. I'll start with Novogyne where our market leading Vivelle-Dot estrogen patch continues to drive growth. Year-over-year the JV delivered a 15% increase in net revenues and a 25% increase in pre-tax income. In 2008 total prescriptions for Vivelle-Dot increased 6% compared to 2007 while the overall hormone therapy market decreased 5%. Vivelle-Dot share of total prescriptions in the transdermal and topical estrogen market grew from 53% in December, 2007 to 57% in December, 2008. For the same period our Vivelle-Dot share of the 1.4 billion US estrogen therapy market gained a full percentage point to 11%. So our lead product continues to demonstrate consistent prescription and market share growth in what is a sizable albeit slowly declining overall market. One specific point on the JV that Mike will cover in more detail, Novogyne's fourth quarter results are not indicative of growth in the underlying business. The growth in gross sales of Vivelle-Dot in the quarter was largely offset by a one-time true-up to the allowance for sales returns. So Q4 results don't reflect what we consider to be Novogyne's true run rate. As I mentioned, Vivelle-Dot's prescriptions continued to increase in the mid-single digits which is the key to focus on in modeling that business. So clearly this continues to be a growing and profitable business and our 2009 guidance will reflect that. Turning to the pipeline, we have an update on our Mesafem Phase II study and our other projects are progressing as we described on our November call with one exception that I'll describe shortly. Mesafem is our low dose oral paroxetine mesylate product in development for vasomotor systems or VMS. As you'll recall, our pipeline streaming process identifies Mesafem as our highest priority development project. Our market research confirms there is a significant need for a nonhormonal product like Mesafem dealt to a large group of women who suffer from VMS but who are not candidates or who have concerns about hormonal therapy. The compound used in Mesafem paroxetine mesylate is the same compound used in higher doses for depression. Because it is not a new compound paroxetine has a well characterized safety profile. Phase II studies published by third parties suggest that paroxetine can be effective for hot flashes in the approved antidepressant strength of 10 milligrams and above. We are well under way with a Phase II randomized placebo controlled study evaluating Mesafem at doses lower than those currently approved for other paroxetine indications. While we believe that the existing Phase II data are compelling and suggest that lower doses will be efficacious, other than our study we're not aware of any clinical work to date at doses below 10 milligrams. So the primary purpose of our Phase II study is to show efficacy signal below 10 milligrams. Patient enrollment began in fourth quarter and is going very well. In fact, we're approaching completion of enrollment well ahead of schedule and we expect to have data to share with you in the third quarter of 2009. If the study is successful, we'll be in a position to either continue development on our own or partner the product on favorable terms. As I mentioned, all but one of our other projects we reviewed in November are progressing as described on our last call. In February, however, we were disappointed to learn that our development partner for one of our five partnered compounds determined not to fund further clinical development of the patch they engaged us to develop. It's frustrating because this decision came after completion of a successful PK study of our patch formulation. We're told the decision came down to a mix of market factors facing the commercialized oral version of the compound as well as our partners internal budgetary constraints and because this is our partner's proprietary compound we have no ability to advance the project on our own. This development does illustrate the difficult reality of a partnering model in today's pharma industry where one party can do its job to perfection as we believe we did here and yet the business issues of the other bring the program to a halt. So it is absolutely critical to supplement that model with internal development and commercialization capability. On that front we continue to push forward as aggressively as possible with internal unpartnered projects in our transdermal development pipeline, all of which are in Phase I or earlier. Our areas of therapeutic focus include women's health and CNS with projects targeting psychiatric indications, Vivelle-Dot, life cycle management and other areas. As we have said in the past we do not expect the product to be commercialized from our pipeline in the 2009 pipeline but I'll reiterate that we do expect 2009 and 2010 to be years of high activity with respect to our partnered and internal products advancing into and through the clinic with Mesafem Phase II data in the third quarter of 2009. Now I'll turn the call over to Mike Price, our CFO.
- Mike Price:
- Thank you, Peter, and good morning. I plan to focus on 2008 fourth quarter results in my review given that the major events of the first nine months of the year were covered on our prior calls and in our SEC filings. Full year 2008 results will also be detailed in our Form 10-K which we plan to file with the Securities and Exchange Commission next week. There were three special items in the 2008 fourth quarter all of which were excluded from a non-GAAP earnings per share described by Peter and presented in our press release. The first is the recognition of $7.2 million in license revenues related to the return of amphetamine development rights to Noven. The second is a $1.8 million reserve related to a previously disclosed patent infringement case relating to Daytrana. And the third is a $500,000 decrease in our Daytrana reserve. As background you'll recall that in the third quarter of 2008 we established a $4.3 million reserve for existing Daytrana product that we determined was at risk of exceeding the peel force specifications during the product's shelf life. In the fourth quarter based primarily on a better than expected casting rate in our screening test we determined that it was appropriate to reduce that reserve to $3.8 million which primarily resulted in a decrease to Daytrana cost of goods sold in the fourth quarter. Now on to fourth quarter highlights, as Peter reviewed our GAAP and adjusted earnings per share earlier in the call, I'll move right to the topline. Net revenues for the fourth quarter totaled $36.4 million and included $7.2 million in amphetamine revenue recognized during the quarter. Excluding the $7.2 million net revenues increased 26% over Q4 of the prior year primarily reflecting higher amortization related to Daytrana sales milestones, increased sales at Noven Therapeutics as well as higher sales of Daytrana and other transdermal products. Net sales of Daytrana with Shire totaled $3.3 million in the fourth quarter. Quarterly net sales of Pexeva and Lithobid were $4.5 million and $2.4 million respectively. We recognized about $400,000 in Stavzor net revenues in the fourth quarter. Recall that no material sales were recognized in Q3 which was the launch quarter. Since launch we have deferred $1.5 million of Stavzor net sales in accordance with our revenue recognition policy. Our consolidated gross margin as a percentage of net product revenues was 43% in the fourth quarter of 2008 compared to 28% in Q4 of '07. Drivers here included higher product revenue compared to Q4 of '07 including higher sales of Noven Therapeutics project which enjoy a higher margin than our transdermal products. The $500,000 Daytrana reserve adjustment which decreased cost of sales in Q4 benefited gross margin by about 2 percentage points. Beyond that we're very pleased to see that the new manufacturing procedures Peter referenced favorably impact our Daytrana production efficiencies in Q4. Total operating expenses in Q4 of '08 were essentially flat when compared to Q4 of '07. In the fourth quarter of '08 research and development expenses increased $1.2 million, sales and marketing expenses were $200,000 higher than in Q4 of '07 reflecting some of the strategy adjustments that Peter discussed earlier and G&A expenses were $1.2 million lower in Q4 of 2008 compared to the fourth quarter of the prior year but keep in mind that we charged the $1.8 million litigation reserve to G&A in Q4 of '08 and Q4 of '07 included separation payments totaling $3.3 million. So net of those items G&A expense was about $300,000 or 4% higher in Q4 of '08 compared to the fourth quarter of 2007. For the fourth quarter our equity and earnings in Novogyne increased 3% to $11.1 million concluding an outstanding year for the joint venture in which its full year contribution to Noven increased 27%. Peter hit some very important points with respect to Novogyne's fourth quarter results that I'd like to underscore. Fourth quarter net revenues of the joint venture were reduced by a one-time true-up to sales return allowances. The take away here this is a one-time adjustment. There is no fundamental change to the business. So rather than modeling based on Q4 allowances we suggest that you use sales returns allowances estimate up slightly less than 2% of gross sales for 2009. Noven finished the year with a strong balance sheet, cash on hand, no long term debt and no borrowings under our credit facility. In the current market this is a good position to be in. At December 31, 2008, Noven had $62.9 million in cash and cash equivalents and $15.5 million in auction rate securities. This compares to just $14 million in cash and cash equivalents and $54.4 million in auction rate securities of December 31, 2007. Over the course of the year we successfully liquidated $39 million of these investments all at par value and are very pleased to report that an additional $3.7 million of these investments have been called to redemption at par value later this month. I note that in the fourth quarter of 2008 the $500,000 temporary impairment that we recorded in our first quarter was reclassified as other than temporary. Consequently we charged it to other income and expenses and you'll find that on our income statement identified as loss on auction rate securities. Just so there's no confusion that $500,000 unrealized loss is included in our adjusted EPS for the quarter and year as presented in our press release. Now I'd like to provide our financial and other guidance for the full year of 2009. So let's begin with net revenues. For full year 2008 excluding the $7.2 million in amphetamine revenues we reported net revenues of $101 million. For 2009 we're forecasting net revenues of $110 million to $115 million. We expect about $26 million of that amount to be licensed in contract revenues. At this time we're not providing sales guidance by product. Now on to gross margin for 2008 our consolidated gross margin at the percentage of total net product revenues was 33%. For 2009 we expect our gross margin to be in the 38% to 42% range. Note that we would expect a higher gross margin in the second half of 2009 than in the first half reflecting our expectation that our gross margin on Daytrana should begin to show further improvement by Q4 of '09 following commercial production of product incorporating the peel force solution. In 2008 our research and development expenses totaled $15.5 million. For 2009 we expect them to be in the low to mid $20 million range. This increase includes a continuing investment in our methadone development program as well as scheduled clinical programs for certain transdermal formulations including clinical work on an amphetamine patch. In 2008 our consolidated SG&A expenses totaled $60.1 million including $4.8 million in Daytrana charges and a $1.8 million litigation charge. For 2009 we're forecasting our SG&A expenses to be in the mid-$50 million range. At Noven Therapeutics as Peter described we're committing to approve a pre-tax contribution from that unit by $5 million in 2009 transforming the 2008 loss into a profit in 2009. In 2008 our equity and earnings at Novogyne totaled $45.6 million. For 2009 we're forecasting equity and earnings to be in the low to mid-$50 million range based on our expectation for pricing and continued prescription growth for Vivelle-Dot. In our view there should be no dramatic changes to the joint ventures operating expenses in 2009. We're forecasting fairly nominal interest income in 2009, something in the $1 million and we expect that our tax rate in 2009 will be consistent with 2008, say in the 34% to 36% range. By taking each of these items of guidance in consideration as Peter indicated earlier we're targeting fully diluted earnings per share for 2009 in the $0.85 to $0.95 range. Finally in 2009 we expect to use approximately $5 million to $10 million of cash as we continue to invest in Mesafem and other programs continuing to drive longer term growth and with that I'll turn the call back over to Peter.
- Peter Brandt:
- Thank you, Mike. Final item I'll cover before turning to your questions relates to changes across the Noven organization during 2008. It comes down to three things, new people, new focus and a new mindset. Only half of the management team is new to Noven over the past 18 months and all bring with them significant industry experience and a history of successful execution. During the year with the new team's help and with resources from across the company we prioritized our opportunities and focused our resources. We focused on those opportunities that can enhance shareholder value in the near term like fixing Daytrana and delivering a profit at Noven Therapeutics and those that will benefit the longer term like critical adjustments to the Mesafem development strategy that lower costs and reduce risk. And lastly the mindset and actions of the organization now reflect aligned objectives a keen sense of urgency and accountability and a commitment to the flawless executions of our strategy. Now I'll ask the operator to begin the question-and-answer portion of the call.
- Operator:
- Thank you. We'll now be conducting a question-and-answer session. (Operator instructions) Our first question comes from Tim Chiang from FTN Equity Capital. Please pose your question.
- Tim Chiang:
- Thanks. You mentioned an FDA green light requirement for the Daytrana patch. What does that, I guess, signify? Does it require an FDA reinspection?
- Jeff Eisenberg:
- Tim, this is Jeff Eisenberg. I'll take that question. What we described as an FDA green light is really the culmination of a process that's been going on for quite a while now. We've mentioned before that we continue to gather with our colleagues in Shire to be in an active dialogue with the FDA on this Tight Release [ph] issue. The dialogue continues as we speak and as part of that dialogue we have been providing information to the agency, providing data to the agency and ultimately the dialogue in the process will include a filing as well. That's why we described green light and agreement for what we'll ultimately need. What we said today and what we'll reiterate is that the timing we expect this process to culminate is later this year when we expect to be producing product and incorporate the solution we believe that we found and we believe that our testing confirmed to the Tight Release issue.
- Tim Chiang:
- I think Shire had also indicated that they planned on marketing Daytrana at some point into the European market, I mean, is that basically all hinging upon this new release liner being greenlighted by the FDA?
- Jeff Eisenberg:
- Yes and this is Jeff again. That is correct that Shire has indicated they plan to launch and market Daytrana in Europe. We have been very clear that β and they have, in fact, have an application pending, we have been very clear that we expect their ultimate decision to launch the product, to in fact, is at least in part dependent on our ability to fix this issue which will include getting clearance from FDA.
- Tim Chiang:
- Okay, great. Thanks.
- Joseph Jones:
- Tim, this is Joe. I would just add that Shire also said publicly that they plan to file a supplement to the Daytrana NDA potentially expanding the indication from pediatrics to include adolescents. So there's a potential patient population expansion down the road as well.
- Tim Chiang:
- Just one follow-up then, with the amphetamine patch are you still working on it and what is your own intention with the product?
- Peter Brandt:
- We're very excited about that patch. It's actually a patch that obviously we have experience with and have a fairly high level of comfort that we're going to be able to successfully get a new formulation into operation on that. Jeff, did you want to add anything to it?
- Jeff Eisenberg:
- Peter, no. I think you've covered it. We announced Tim on the last call that when we reacquired the patch that was part of our, that would become a critical part of our pipeline, we also described then and we reiterate now that that patch has really been a project that Noven had even before we did the deal with Shire. We had started working on that patch before we engaged in the Daytrana transaction. So we were quite excited to get it back and to take it forward in our internal pipeline.
- Tim Chiang:
- Okay. Great. Thanks.
- Peter Brandt:
- Thanks, Tim.
- Operator:
- Thank you. Our next question is coming from Ken Trbovich from RBC Capital Markets.
- Ken Trbovich:
- Hi. Couple of questions to clarify, earlier in the commentary there was a point made about what the gross margins would have been on the transdermal, I guess I'm a little confused, is that the margins on the rest of business or is that the margins including Daytrana at a normalized level?
- Peter Brandt:
- Ken, I'll start and ask Mike to chime in with us I think you are right, in the remarks we cited two different sets of margins. One had to do with specifically the transdermals and then the other one was the overall gross margin for the company and Mike I think the ones where we were comparing and contrasting the reported numbers with what the true underlying numbers were the gross margins for the overall company. You want to repeat those, Mike?
- Mike Price:
- Right. On a consolidated basis, Ken, for the fourth quarter margins were 43% consolidated and for the full year they were 33% and at the transdermal segment I'll go ahead and give you this flavor, transdermal in the fourth quarter, they were 29% compared to 13% a year ago in the fourth quarter and for the full year at transdermal they were 18% compared to 33% for all of '07 and Noven Therapeutics, by the way, we had 72% margins in the fourth quarter compared to 60% last year and for the full year 67% at therapeutics compared to 66% the prior year.
- Ken Trbovich:
- Okay. And then just in terms of the actual margin improvements that you anticipate and obviously most of the margin improvements are going to be coming from the transdermal segment in '09, how much of that is dependent upon volume increases for Daytrana?
- Peter Brandt:
- Very little, very little, if anything. It's a continuation of the improved production processes that we're seeing an impact of in the fourth quarter of 2008 as well as putting into place the revised fix, if you will, of Daytrana solution in the latter part of 2009. I would argue it's not at all volume dependent.
- Ken Trbovich:
- Okay. And then following up on Tim's question about the amphetamine patch, is that included in your R&D guidance? Are the clinical trials included in the R&D guidance for that product in '09?
- Peter Brandt:
- Yes, that is correct.
- Ken Trbovich:
- Okay. And then as far as it relates to the litigation reserve, can you help us understand the nature of the reserve, what it covers, what it doesn't cover and especially as it relates to the litigation perhaps proceeding to an actual trial later this year, should we expect those costs to go higher in '09?
- Peter Brandt:
- Absolutely and I'll ask our General Counsel Jeff Mihm to take a crack.
- Jeff Mihm:
- Let me give you some background on litigation and then I'll turn it over to Mike on specific points on the reserve. As you know, we previously disclosed that Noven and our partner Shire are parties to a patent infringement lawsuit and in this case the plaintiff is claiming that Shire and Noven infringed upon a patent with the active ingredient, Methylphenidate in the Daytrana patch. The change as you noted is scheduled for trial in October of this year in the fourth quarter of '09 and as you know we established a $1.8 million reserve related to this case in the fourth quarter of 2008. So while the outcome of any litigation can't be predicted and, of course, we can't give any guarantees or assurances here, I would note that Noven believes the allegations in this lawsuit are without merit and when I say that, specifically both Noven and Shire believe that patent in question isn't valid and moreover, that the active ingredient in our product does not infringe upon the patent and this is not an after effect analysis both Shire and Noven were well aware of the patent before we decided to launch the Daytrana product. So needless to say we are pursuing vigorously the defense of this case and with interest. With that let me turn it over to Mike on the FAS 5 analysis.
- Mike Price:
- Thanks, Jeff. With respect to accruing for this matter, of course, we follow the accounting guidance which is FAS 5 and you have to go through an analysis to determine exactly what your exposure is. We've gone through that analysis and while we're confident that we'll prevail if we take this all the way through conclusion and litigation, we felt that it was prudent to put a reserve on it because it is going to cost money to resolve this issue one way or the other. So we did accrue $1.8 million in the fourth quarter.
- Ken Trbovich:
- Okay and I apologize when you say accrued it does that mean you didn't incur actual expenses in '08?
- Mike Price:
- We have reserved for costs that we will occur in the future, potential costs in the future. So no, the only costs that we incurred during 2008 were litigation related costs.
- Ken Trbovich:
- Okay. And I guess what I'm confused by is there any insurance at all that covers the cost of litigation? Does this reserve represent the difference or is there essentially no insurance coverage?
- Mike Price:
- We think we have no coverage with respect to this issue.
- Ken Trbovich:
- Okay. And does the 1.8 cover all the litigation expense you anticipate for '09 or is there potential that there's going to be additional quarterly amounts that are not included in the reserve or charged against the reserve?
- Mike Price:
- No. As of the balance sheet date, Ken, this is our best estimate of what the exposure is and beyond that I can't really give any assurances that the cost may not exceed that during 2009.
- Ken Trbovich:
- Okay. And then a follow-up on the Novogyne side, you guided the sales return allowance of 2%. Obviously the fourth quarter of last year was dramatically different from that. Is there a reason or can you give us guidance around the allowance for sales?
- Mike Price:
- Sure, sure. That's a great question and I'll tell you what I can. Novartis is responsible for the accounting at the joint venture level and during the fourth quarter it became apparent that actual returns of Vivelle-Dot were higher than we'd been estimating and consequently we had to make the catch-up adjustment or a true-up adjustment in the fourth quarter. So that's not a fair picture to take the rate that you see in the fourth quarter and apply that to your model in '09. Consequently we thought it was appropriate to give guidance in our actual estimated returns rate. It is slightly less than 2% of gross revenue.
- Ken Trbovich:
- Okay. And I guess what's throwing me off on that, when you say the 2% that's still less than the '07 level and I guess that's why I'm puzzled. If the return rate was higher than was anticipated, how do we end up with guidance that's lower than prior years?
- Mike Price:
- Well, I think if you go back and take a look at the numbers for '07, you'll see that the rate in '07 was slightly less than 1% of gross revenues and as a result of the fact that higher actual returns exceeded our estimates, we have revised our estimate on a go-forward basis to slightly less than 2%.
- Ken Trbovich:
- Okay. And you're going off of gross revenues for the JV, what about the sales allowance itself? I know this is a sales return allowance but has there been a change as well in the accounting for the sales allowance?
- Mike Price:
- No. There are no other changes.
- Ken Trbovich:
- Okay. And then just one final question as it relates to the plans for Noven Therapeutics, if either through cost cutting or revenue growth you're not able to get to the profitability target, how long do you continue to continue to look at that business as being viable?
- Peter Brandt:
- I'll gladly take this one. When we look at Noven Therapeutics, I don't think we're under any delusions here. I mean you need differentiated products to really succeed in the marketplace and in particular in an ever increasingly cost contained marketplace, which clearly the US marketplace is and will become even more so as we go forward. So when we look at the Pexevas and Stavzors of Noven Therapeutics we recognize that those are products not nearly as well differentiated as the ones that we would envision really driving growth for this company. So we took action beginning in the fourth quarter and have continued that type of action to ensure that we live by that commitment to make its profitability. That is going to be driving our actions, from not just a quarter-to-quarter basis but literally a day-to-day basis. There is very little room for error on our part in terms of sitting back and watching this. This is something that we are actively managing, as I said on a daily basis. So bottom line in this, if we don't believe that we can make the profitability number, we will take further actions to make sure that we make the profitability number and if that means it's not coming in revenues that means it will come in further expense reductions.
- Ken Trbovich:
- On the expense side guidance for '09 you said some of it is coming from revenue growth and some from expenses. Are those expenses discretionary in the sense of sales promotion expenses or are they personnel related?
- Peter Brandt:
- It is everything involved in the promotion and sale including personnel related on the Noven Therapeutics side.
- Ken Trbovich:
- Okay, thank you.
- Peter Brandt:
- If I can hark back one second to Noven Therapeutics but back to Vivelle-Dot the questions are right on target with the fourth quarter number. I think we feel it's important not to get lost in the analysis, though, is the very strong prescription performance of that product. In particular not just in the quarter but when you look at the full year for 2008, if you go back even looking at full year '06, full year '07 and now full year '08, the trend has changed to the positive on Vivelle-Dot. So if you take new prescriptions, '06 full year growth was 5.7%. '07 full year new prescription growth of only 4.7%. So it came down slightly and then this past year '08, it's up to 8.3% and you'll see a similar pattern in total prescriptions where the '08 growth exceeds that of '06 let alone '07. We really would strongly encourage folks to look at the prescriptions as more of a driver of what we think the underlying business will look like as we go forward.
- Operator:
- Have all your question been answered?
- Ken Trbovich:
- Yes, they have. Thank you.
- Operator:
- Our next question is coming from Scott Henry from Roth Capital Partners.
- Scott Henry:
- Thank you for taking my question. I thought it was a pretty good quarter all in all and more importantly, Peter, I think you've brought a welcome new change of direction to the company over the past few quarters which is reflected in the '09 outlook and a new focus on profitability that perhaps has been lacking in the past. So shifting on to questions, just a couple broad based questions, first there has been talk about trying to bring leverage to the Novogyne joint venture with Novartis, has there been any progress on perhaps thinking about adding products to that division?
- Peter Brandt:
- There have been and, Scott, thank you for your comments, also, but and then if I don't cover it all, Jeff, please feel free to jump in with this. The conversations as you would guess between Noven and Novartis are frequent and they, certainly on the Noven side we are continually interested in a number of things. First and foremost, is there a way that Noven can get more bang for the buck out of the joint venture? We'd love to have more of that hitting our P&L as opposed to our friends at Novartis but we understand from their point of view they like arrangement the way it is. In terms of bringing products into the equation there are a few different ways we're approaching this. One is a full bore effort on the part of Noven and Novartis which is life cycle management of the existing compounds primarily Vivelle-Dot and I will ask Jeff if you wanted to comment a little bit about that, but in addition to that, both sides through their business development efforts do look at the opportunities to bring in external compounds into the joint venture. I don't want to mislead you, Scott. I would not characterize it as a high priority for our partners at Novartis to take their business development resources and find entities that would be shared with us in the Novogyne joint venture. So it is primarily on our shoulders I would argue to try to find opportunities that make sense for the joint venture and there quite honestly what we then grapple with is if we find a good opportunity even though it may fit beautifully into the infrastructure of Novogyne under what terms would we bring it into the joint venture? Out of the goodness of our heart, we wouldn't necessarily want to give up half of the profit of a given entity that we'd be bringing in. But, Jeff, do you want to add anything to that?
- Jeff Eisenberg:
- Sure. I actually think you have covered pretty well the work that Novartis to look outside for entities to bring in. I do want to circle back to some of the comments you made about the Vivelle-Dot prescription numbers because very clearly people should understand those have not happened by accident. So while we continued to look outside for new opportunities to bring in, the fact is that Anthony Venditti who is actually here, maybe Anthony can speak to this, has taken some action internally to improve the operations of the Novogyne sales and marketing group because again as Peter noted, it's not necessarily β and we said this for a while, it's not imminent necessarily that we're going to be able to add a product to the joint venture. So we don't just look outside for future growth opportunities. So Anthony, you want to talk a little bit about what you're doing internally?
- Anthony Venditti:
- Good morning. My name is Anthony Venditti, I've been with Noven for the past seven months and we've looked at a lot of operational issues within Novogyne and have focused our efforts on truly the high performing are the most profitable doctors to our business driving our utilization and when you look at the most recent trends over the first five or six weeks of this year we've actually achieved some of our highest levels ever as it relates to the term I'm going to use is called new tube brand RXs. These aren't just refilled RXs but they're truly new patients coming to the fold and if you look at the Vivelle-Dot and CombiPatch which is the combination product that we promote we've actually seen some of our highest levels compared to any time historically and if you look at our NRX growth just in the first few weeks of this year, we're very confident in the overall numbers as it relates to the prescription growth for the remainder of this year. So if I were to summarize, there have been some very fundamental operational issues that we've employed over the past few months that we believe are going to pay dividends to continued strong RX growth over the remainder of this year.
- Jeff Eisenberg:
- Scott just circling back to Peter referred to life cycle management as well and that is something that we are on a daily basis actively engaged in here at Noven and together with our colleagues at Novartis looking for any and all opportunities to meaningfully extend the life of the Vivelle-Dot and create new product opportunities that allows us to continue to grow the brand.
- Scott Henry:
- Are there any updates on the next generation Vivelle-Dot patch or when we may expect to get an update on that?
- Jeff Eisenberg:
- No our approach, Scott, on R&D updates is when we have human data, positive human data to share, you will then get specific updates on our progress in that area. Until then, again as I just mentioned we are actively working on a number of opportunities, but we haven't reached the point where we're prepared to share data.
- Scott Henry:
- Okay.
- Peter Brandt:
- As you would guess Scott, internally in our developmental areas, we have Mesafem, we have Vivelle-Dot, life cycle management and we've got the amphetamine patch and those are our top three critical areas of focus.
- Scott Henry:
- Okay. On a different pipeline product, Intrinsa, I saw a release just the other day about some kind of negative feedback on Intrinsa in Europe. I don't know if you've seen that but I'm just curious if things are in fact, still moving ahead on Intrinsa, or if that has had any impact on the program?
- Jeff Eisenberg:
- Hi. This is Jeff. I'll try to address that. I think it really is a question that should be addressed by P&G but I'll comment because we saw the same news report, it wasn't a report of a regulatory agency. It was one physician's opinion that maybe the data on Intrinsa doesn't show sufficient efficacy for him to recommend using the product for hypoactive sexual desire disorder. You may recall that even in the US when the Advisory Committee met on Intrinsa in December of 2004, the Advisory Committee did find that the product was efficacious but it wasn't a unanimous vote. There is at least room for debate on how efficacious the product is. So I don't think this was really anything that is currently new. Procter & Gamble continues to sell the product in Europe.
- Scott Henry:
- Okay. And then just the final question for me and this is a little bit more of a bigger picture question for Peter. I mean clearly you focused heavily on making Noven Pharmaceuticals, that division, profitable but when I look at the full income statement, and I look at your '09 guidance, I still see, almost $2 a share of income coming in from Novogyne alone or if you taxed it would still be about a $1.50 per share. At the same time, guidance is still well below that. So I think you could argue that the entire base business can be a little bit of a drag on Novogyne. How do you think about that particularly on the G&A side because, I mean, I would really like to think that 2009 would be the absolute last year that you are a net cash user?
- Peter Brandt:
- I would share that thought. I mean I think that's going to be dependent upon obviously where we are with some of our developmental opportunities and what is the cost associated with those, but the heart of your point, Scott, I strongly embrace. We took the approach of looking at what were the absolute critical drivers of our business and our P&L and therefore the value to our shareholders throughout the end of 2008 and so far early in 2009. So that's where we have, I would argue attacked the issues of making Noven Therapeutics profitable. I would even argue that Anthony and his efforts have attacked the issue of making Novogyne as efficient and as effective and as profitable as can be despite the fact that that's the one everybody looks at and says well, that's in good shape. let's focus on other things. We have spent an awful lot of time focusing on obviously the Daytrana issue and manufacturing costs associated with that, more work to be done there. We continue to focus on the efficiency, effectiveness and ability to get things across our goal line in our R&D organization. Now that does not say that we're done. I mean this is an attitude or a mindset that have to and will and is pervading through every aspect of not only our company but our P&L. I share a belief that when we look at our G&A number, although, there are things that we look into G&A that are not exactly indicative of a large infrastructure, but when we look at our G&A number it is something that is high on our radar screen, on my radar screen to make sure that we were effectively addressing as we go forward not just throughout 2009 but literally over the next couple of weeks and months.
- Scott Henry:
- Thank you. I appreciate the color on that.
- Peter Brandt:
- Thank you.
- Operator:
- Thank you. Our next question is coming from Andrew Hilgenbrink from Jefferies & Company.
- Andrew Hilgenbrink:
- Thanks, guys, for taking the question. Most of my questions have been answered but along the lines of business development are you looking at opportunities that are more predominantly on the transdermal business or are you looking off into therapeutics and if so in the therapeutics are there any specific, I guess, therapeutic areas?
- Peter Brandt:
- Sure. Okay, let me try to get into a little bit of detail here and I think it kind of came across in some of the remarks we offered up earlier this morning, when you look at business development activities on the transdermal side, you can come at it from two different ways and we are coming at it from both of those ways. One is that we take compounds and we develop them internally. When we get them to the point where we have a proven product if you will then we can look to either commercialize it through Noven Therapeutics or to partner it. That's the process that we took with Vivelle-Dot and that's the process we took with Daytrana and both of them quite successful deals for Noven. Now, the other way we try to do is partner early with other pharmaceutical companies on their proprietary compounds to take that compound and deliver it through a transdermal delivery system. Those partnerships can either succeed or fail for a lot of factors other than our ability to actually get that compound delivered through a patch into the skin effectively. So when we look at business development opportunities on the transdermal side, while we continue to look at both, I believe it makes more business sense to continue to focus more heavily on internal development and then getting to the point of making a decision as to whether we engage through business development other companies like we've done again with Novartis and Shire on those compounds or to develop it ourselves. Other side of business development without a doubt is looking for any entity in particular orals that we could commercialize through Noven Therapeutics and we are focusing on women's health and CNS in terms of the therapeutic areas in which we're operating but to connect the dots to some of the comments that we have made earlier, we don't consider Pexeva and Stavzor a platform. I mean we have an infrastructure in Noven Therapeutics that we hope to leverage and to continue to make more profitable, but those products in and of themselves don't constitute, because again their lack of relative differentiation a platform from which we feel that it is obvious we must only look in CNS to be able to find product opportunities. Does that help or does that answer your question?
- Andrew Hilgenbrink:
- Yes, it does. Thanks. And one other along the lines of the P&G collaboration. P&G mentioned they plan to sell the pharmaceuticals unit. Have they approached you as to whether you'd be interested in purchasing the testosterone patch or do you plan to somehow keep that collaboration going even if the business unit were to be divested to some other company?
- Jeff Eisenberg:
- Andrew, this is Jeff Eisenberg. We really can't comment on P&G's strategy with respect to its pharmaceutical business. To answer the second part of your question, if somebody were to come in and buy that business, presumably they would buy it partly because they are interested in Intrinsa we would absolutely intend to continue working with a successor company if that happens but we can't comment on the P&G strategy.
- Andrew Hilgenbrink:
- All right. Well, thank you.
- Operator:
- Thank you. Our next question is coming from Patty Bank from Pacific Growth Equities.
- Patty Bank:
- Good morning. Just a couple quick product related questions. First on Novogyne, I assume that the fourth quarter gross margin was affected a little by the true-up. Did you give guidance for that in 2009 or could you give guidance for the gross margin for Novogyne?
- Mike Price:
- Okay. This is Mike. You're absolutely right that the lower margin in the fourth quarter of 79% was lower than the 80% reported for the full year and it was impacted by that true-up and no, we have not offered guidance for '09 today.
- Patty Bank:
- Okay. And then did you give the reason for why there was the higher return? Did I miss that? Was there something unique about the quarter or the product or something going on in the market?
- Mike Price:
- No. I don't think it has anything to do with that. I think it was an issue of the estimate was just lower than the actual returns coming in and we have made a true-up adjustment in the fourth quarter or at least Novartis did with respect to the accounting at the joint venture level and we've adjusted that return rate on a go-forward basis to almost 2%.
- Patty Bank:
- Okay. And on Mesafem if the Phase II didn't work out in your favor just wondering is there any other like Mesafem, any other potential indications that have been talked about or earlier work done on it?
- Peter Brandt:
- To be honest with this one, a little bit too early for us to answer that question. Obviously we have high hopes that we won't be faced with that situation. It's going to depend in large part, I know it's an obvious answer but what our Phase II data show.
- Patty Bank:
- Right.
- Peter Brandt:
- That's going to dictate and at that point, as we're trying to be as a company, we have every intention of being quite transparent about what comes out of our Phase II data on Mesafem including what are therefore the strategic options for the company going forward.
- Patty Bank:
- Then just a quick question on Stavzor, I know you've mentioned a couple of times about the lack of product differentiation, was there anything else there that you can kind of talk in broader sense about any implications for the sales force in general, whether the sales force wasn't sized the right way, whether it was just their lack of being able to sell that product or anything else that we can take away?
- Peter Brandt:
- And Anthony please add anything, to be very clear about it, I believe the sales force was sized appropriately and I believe the effort behind the product was absolutely wonderful. I mean, this is not my opinion for lack of sizing, lack of effort and better yet for lack of good strategy that was implemented I thought quite well. One of the things that when you look at where Stavzor is going, you've got Depakote and you've got Depakote ER and both Depakote and Depakote ER are facing very severe generic competition and to be quite blunt that happened earlier and to a higher level and particularly on the ER side than I think we had hoped for or anticipated when we originally began thinking about the Stavzor opportunity. Anthony, do you want to?
- Anthony Venditti:
- I think Peter has summed it up there quite nicely. I mean between those generic coming fast and furious and price eroding and then also just what's going on in the general economy as it relates to the cost benefit analysis it's been a very difficult road to hoe.
- Patty Bank:
- Okay. Just lastly one point of clarification, I jumped off a little bit, the $0.85 to $0.95 for 2009 EPS guidance that compares to the $0.87 in 2008, is that correct?
- Mike Price:
- We reported adjusted earnings of $0.79 and in my opinion I think that would be an appropriate comparison, $0.79 in '08 to the $0.85 to $0.95 in '09.
- Patty Bank:
- Okay, great. Thank you.
- Operator:
- Thank you. Our next question is coming from David Steinberg from Deutsche Bank Securities.
- David Steinberg:
- Thanks. In looking at the recent pricing sheets it looks like you took about a 10% price increase on Vivelle-Dot last month. I guess the first question is that correct? If it is, looks to be above normal were you making up for some lesser increases in the past, do you have a lot of flexibility to raise price? Could you continue to raise price at these levels going forward? Thanks.
- Peter Brandt:
- Well, I'll take a crack at it again and then Anthony can come in, I see you are reading it correctly, it was an increase just slightly underneath 10%. We took that in the early part of 2009 driven completely by looking at the different market opportunities and the pricing associated with the opportunities out there and believing that we had market room, if you will, to be able to put that type of price increase forward, our pricing strategy is almost always dependent upon the market environments at the time. What are competitive agents priced at, what are their discounting or reimbursement strategies, and what new entrants [ph] have come in at what level of pricing. So, we're certainly comfortable obviously, comfortable enough that early in '09 we took that increase. Further increases, whether it's 12 months from now or whenever are going to depend upon the same market factors.
- Anthony Venditti:
- And when you look at our competition, we are very much in line with the other branded products on the market as it relates to the price on a daily basis.
- David Steinberg:
- Okay. And then finally what sort of Medicare exposure do you have, if any, to that product?
- Anthony Venditti:
- This is Anthony Venditti. Actually Medicare, we tend to have a much younger patient population. So when you look at the product mix there is very little as it relates to Medicare. If you were compared to a Premarin-like product they tend to have much higher utilization in the Medicare segment.
- David Steinberg:
- Great, thanks.
- Operator:
- Thank you. (Operator instructions) Our next question is a follow-up coming from Ken Trbovich from RBC Capital Markets.
- Ken Trbovich:
- Thanks for taking the follow-up. I just wanted to go back to the pretty incredible margin improvement that you had with gross margins overall in the fourth quarter and I guess part of what troubles me is that it wasn't implied at all in the guidance that you guys had provided, good part through the quarter and so what I'm trying to understand is to what extent this margin improvement was driven by patches simply not failing the peel force test and therefore having less grasp as opposed to some of the manufacturing improvements that you talked about implementing during the quarter?
- Mike Price:
- Ken, this is Mike Price. I think certainly it was driven by the improvements that we talked about. I think the $500,000 adjustment to the Daytrana reserve did have an impact. I think the margins would have been lower by about 2 percentage points.
- Ken Trbovich:
- Yes. But I mean they still would have gone from 28% to 40%, it is still a great improvement even without that reserve adjustment.
- Mike Price:
- Right.
- Ken Trbovich:
- And I guess maybe turn the question around a different way. What I'm trying to understand is how predictable or consistent are the margins that we can anticipate, between now and the time you actually implement the peel force solution? In other words, is there a chance that when we roll into the next quarter or the second quarter there just happens to be higher peel force failure rates and therefore the margins dropped back down again?
- Mike Price:
- Ken, I think to answer that maybe we can talk about the guidance that we offered out and if you take a look at the guidance for gross margins we indicated that they should range between 38% and 42% and slightly lower in the first part of the year compared to the second part when we hope to introduce the new improved product but certainly we've factored these issues into our guidance and still think we're going to come up to within 38% to 42% for the year.
- Ken Trbovich:
- Okay. And then just one final question on the Daytrana changes that you're anticipating making, is this something that is as simple as a CDE-30 that you'd submit and make the changes in the manufacturing process without comment from the agency or is this something that you think for whatever reasons might entail some sort of basic interaction studies or PK studies that might also have to be submitted to the agency?
- Jeff Eisenberg:
- Ken, it's Jeff Eisenberg. We're not anticipating that which is why we've offered the timeline we've given. I'd rather not get into the specific details. As you recall, Shire owns the NDA for this product, so we are working very closely with Shire but ultimately the interaction of filing would be a Shire initiative. I'll just circle back to the timing we've offered and we believe that this process that we're engaged in with the agency which has been very constructive, very open and I think very supportive frankly, we believe will come to a conclusion later this year.
- Ken Trbovich:
- Okay. Thank you.
- Operator:
- Thank you. At this time we have no further questions. I'd like to turn the call back over to Mr. Jones for any closing comments.
- Joseph Jones:
- Thank you very much, operator. If any of you have additional questions throughout the day, we'll be available today and in the days ahead. As Mike mentioned earlier, we'll be filing our 2008 Annual Report on Form 10-K later this week that will give you more information on β I'm sorry, next week which will give you more information on almost everything we talked about today. And for your information, we'll be presenting at the Barclays conference in Miami Beach on March 11. On March 17, we'll be at the Cowen Conference in Boston. So if you plan on attending either of these events we'd be very pleased to see you there. So thank you once again for joining us this morning and continuing to track our progress. Operator, would you please provide the replay information and conclude the call?
- Operator:
- Yes. This does conclude today's teleconference. If you have missed any portion of today's call you may call in to 877-660-6853 with the pin number, the account number of 286 and a replay ID of 313659. The replay will be available until March 8. Thank you. Again this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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