Achieve Life Sciences Inc (ACHV) 2006 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen and welcome to the Sonus Pharmaceuticals third quarter 2006 conference call. [OPERATOR INSTRUCTIONS] As a reminder this conference is being recorded today Wednesday, November 8, 2006. I would now like to turn the conference over to Pamela Dull, Director of Investor Relations. Please go ahead.

Thank you, and good afternoon, everyone. We appreciate you joining us today for Sonus' third quarter conference call. As a reminder, this call is being recorded and broadcast live on our website at www.sonuspharma.com. A replay of the webcast will be available through the same link. With me this afternoon are Mike Martino, Sonus' President and CEO, Alan Fuhrman, our Chief Financial Officer, Dr. Richard Daifuku, our acting Chief Medical Officer and Vice President of Preclinical and Clinical Research; and Dr. Elaine Waller, Vice President of Regulatory Affairs and Quality Assurance.

We'll use the following agenda for today's call. First, Mike will give us an update on key objectives for the third quarter including patient enrollment in the Phase III trial of TOCOSOL Paclitaxel. Second, Richard will provide an overview of progress with TOCOSOL Camptothecin, our second oncology product candidate. Next, Alan will review financials for the third quarter. Then Mike will summarize our prepared comments. Finally, we'd be happy to take your questions.

Before we begin I would like to remind everyone that some of the statements made today may include projections, estimates, and other information that might be considered forward-looking. These statements are based on current expectations and assumptions that are subject to risks and uncertainties. Actual results could differ materially from our predictions and estimates as a result of various risk factors including those identified in our Form 10-K for 2005 and our Form 10-Q for the third quarter of 2006. Copies of which can be accessed on our website. With that, I will turn the call over to Mike Martino.

Thanks, Pam. Welcome, everyone. The third quarter was marked by an increased level of activity and excitement at Sonus and on multiple fronts. We have continued to make excellent progress with TOCOSOL Paclitaxel, TOCOSOL Camptothecin, and other new product candidates in our pipeline. Today we'll focus on providing an update on the achievement of two specific key objectives. First, reaching our patient enrollment target in the Phase III trial of TOCOSOL Paclitaxel, and second initiating a clinical development program for TOCOSOL Camptothecin.

Regarding enrollment in the Phase III trial of TOCOSOL Paclitaxel, I am pleased to report that we have exceeded the number of patients required under the study protocol. We anticipate closing enrollment within the next week and we will have enrolled in excess of our stated target of 800 patients. Completing enrollment will mark an important achievement for Sonus. I want to congratulate and thank the dedicated and hard working team that has made this happen. We believe that we will have adjudicated data from the Phase III trial in the third quarter of 2007 and our goal remains to submit the new drug application to the FDA by the end of 2007. On TOCOSOL Camptothecin we were pleased to announce that the first patient was treated in the Phase I program at the end of September. We are excited to have moved a second product candidate into the clinic, and I will now turn the call over to Richard to give us a few more details on that development program.

Thanks, Mike. TOCOSOL Camptothecin is a new entry in the same drug class as the approved Camptothecin analog Irinotecan and Topotecan. These products are used in the treatment of colorectal, lung, ovarian, and cervical cancers and has estimated annual worldwide sales of over $1 billion. Irinotecan and Topotecan are active cytotoxic agents in a variety of solid tumors. However, these products have demonstrated gastrointestinal toxicities that may limit their clinical utility. Our objective with TOCOSOL Camptothecin is to provide a ready to use product that has enhanced efficacy and improved tolerability compared with a commercially available product.

We were delighted to initiate the Phase I program for TOCOSOL Camptothecin at two leading cancer centers in the United States. Sarah Cannon Research Institute in Nashville and Fox Chase Cancer Center in Philadelphia. The single-agent study is expected to enroll up to 51 patients with advanced solid tumors. The study will investigate the safety profile of TOCOSOL Camptothecin at different doses in order to determine the maximum tolerated dose in pharmacokinetics in humans. The Phase I study is also designed to observe active tumor effects with TOCOSOL Camptothecin. Formulated with our proprietary TOCOSOL technology, TOCOSOL Camptothecin is a new chemical entity invented by Sonus scientists consisting of vitamin E, chemically conjugated to SN-38, the active ingredient of Irinotecan. Compared to Irinotecan in preclinical studies, TOCOSOL Camptothecin provided a longer half-life and greater exposure to the active drug, SN-38, improved antitumor activity without an increase in severe toxicities, and finally less frequent dosing without reducing anti-tumor activity.

In summary, the longer half-life, greater exposure to SN-38, and improved antitumor activity demonstrated in every clinical model may translate into increased clinical efficacy and dosing flexibility without sacrificing safety. Moving this promising product candidate into clinical development marks a significant milestone for Sonus. We're optimistic that TOCOSOL Camptothecin may have the ability to improve outcomes in patients treated with Camptothecin based drugs. With that I'll turn the call over to Alan for a review of our financials.

Thank you, Richard. I'll briefly review the financial results for the third quarter which we reported in our press release this afternoon. For the third quarter of 2006 we reported a net loss of 6.3 million, or $0.17 per share compared with a net loss of 8.9 million, or $0.37 per share, for the third quarter of 2005. For the first nine months of 2006, Sonus reported a net loss of 16.5 million, or $0.49 per share, compared with a net loss of 17.8 million, or $0.80 per share for the same period of 2005.

For comparative purposes remember that Sonus signed a partnership agreement with Schering AG in the fourth quarter of 2005, so no revenue was recognized prior to that date. This contributed to the lower net loss for the 2006 third quarter and year to date financial results. For the third quarter of 2006, we recognized 4.9 million in revenue under our collaboration agreement with Schering which includes 3.5 million from reimbursable expenses for work related to the development of TOCOSOL Paclitaxel, and 1.4 million for amortization of the upfront license fee.

For the first nine months of 2006, we recognized a total of 16.5 million in revenue, including 12.4 million from reimbursable expense for TOCOSOL Paclitaxel development, and 4.1 million for amortization of the upfront license fee. We ended the third quarter with 60.9 million in cash and no long term debt. Our projected burn rate for 2006 is approximately 20 million versus our prior guidance of 30 to 32 million. This change reflects a number of factors, including higher levels of reimbursement from Schering for costs related to the Phase III pivotal program and manufacturing expenses for TOCOSOL Paclitaxel. In addition, our payments to Schering in Q4 for nonpivotal clinical trials will be less than planned. We expect these expenses to shift into 2007. Given our expense plan for the fourth quarter and expected collection of accounts receivable we anticipate ending 2006 with approximately 58 to 60 million in cash, which provides us with the resources to operate into 2008. At our year-end conference call we will provide guidance on our planned 2007 burn rate. That completes the snapshot of our financial results. And I'll turn the call back to Mike.

Thanks, Alan. And in summary we're pleased that 2006 is shaping up to be another year of solid progress. First, completion of enrollment in the Phase III trial marks another key milestone in the development of TOCOSOL Paclitaxel. Second, our collaboration with Schering AG is proceeding as planned and we are continuing to make good progress in mapping out and implementing global development plans for TOCOSOL Paclitaxel. Third, we were delighted to initiate the clinical development program for our second product candidate, TOCOSOL Camptothecin. And finally, we're also making exciting progress in moving at least one additional new oncology product candidate from discovery into preclinical development. I'd like to thank you for joining us today. As always, we appreciate your interest and support. Would you please open the line for questions.

Thank you. [OPERATOR INSTRUCTIONS] Our first question, Mark Monane with Needham and Company.

Greetings from New York City, another rainy town.

Hi, Mark.

Perhaps you could go over the state-of-the-art of the CLGB data to start off with and how you plan to proceed with that in accordance with clinical trial that's currently in progress.

Sure, Mark. Thanks for the question. We'd be happy to do that. I think there are at least two dimensions to the answer for that, one related to the status of the data and our assessment of that data, and I'll ask Richard to address that. The second related to the regulatory process for that, and Richard will turn that over to Elaine. Richard.

Sure. Delighted to answer that question. We right now have the data in-house from CLGB, and we have gone through it and we have found the data to support what has been announced at the ASCO 2004 conference so we have confirmed, if you will, the data that they presented, and we're in the process of working on a regulatory submission, and I'll have Elaine go over that.

Yes, Mark. Well, it is certainly our goal to reach concurrence with the FDA prior to submission of the NDA that the CLGB data are a reviewable data set. We, as Richard mentioned, we are certainly planning to do that. We could also anticipate that the FDA may defer their evaluation of those data to the NDA review.

That's very helpful. Question on the -- I know the Company has its lead indication, but I know that TOCOSOL Paclitaxel has an opportunity in nonsmall cell lung cancer, ovarian cancer, and then one of my -- excuse me, one of my favorites, bladder cancer. Can you go over the status reports and indications other than the lead indication?

Well, let me address the first part of that, and I'll turn it over to Richard to discuss the status of the bladder trial. With regard to additional indications, consistent with previous discussions, Mark, indeed our agreement with Schering and our planning to date with Schering contemplates that we would pursue at least one additional indication for this product. We have been in the process of deliberating the various options. I think the likely outcome is that Schering will manage that trial, although we would continue to collaborate on it. And at this point I think it would be premature speculation to venture a guess as to what that indication will be. As we've talked previously, there are trade-offs, obviously, between the two potential indications you have addressed. I think nominally nonsmall cell lung is probably the largest single market category for taxanes. However, taxanes are typically used in combination with things like platinum agents and the treatment of nonsmall cell lung cancer. So that would require combination trials that are obviously more complicated. Additionally, though, and on the other hand, in lung, it is quite likely, probable, even, that the endpoint would be a time-based endpoint, and perhaps survival and the awful news from the patient's perspective, the good news from clinical trial management perspective, is that that period is not terribly long with nonsmall cell lung cancer. The largest market opportunity, manageable endpoint but a combination trial.

Ovarian on the other hand nominally is a smaller market opportunity at least initially. On the other hand the survival period tends to be much longer, so from a chronic disease treatment perspective the market opportunity may be larger than it appears at first blush, especially if you have a convenient, easy to use and tolerable drug like TOCOSOL Paclitaxel. It's also possible that the ovarian trials could be designed as single-agent trials. The trade-off is -- the other side of the longer survival period is that they would be much longer trials to conduct and monitor. So, I hope that's helpful. Richard will give you some color commentary on the trade-offs, although again, I think it would be premature and inappropriate for me to speculate on what the next indication would be. And perhaps now I will turn it over to Richard to talk about the bladder trial.

Yes, very good. We, as we mentioned we have finished the enrollment of the patients in the bladder trial, and, however we are awaiting, if you will, the time for the patient's meeting, the primary endpoint for the trial, which is the ORR response rate, and as we've stated, we will have these data around towards the middle of next year. I must admit that one issue that is out there for us a little bit is that in our competing abilities to analyze data from trials, we are obviously prioritizing the data from our pivotal 1075 trial ahead of the announcement of 1073, which is our bladder cancer trial, and so it's possible as well that that may have some effect on our ability to present those data.

And I would just offer an additional comment on that. We have reiterated today that our goal remains to submit the NDA on TOCOSOL Paclitaxel in metastatic breast cancer by the end of 2007. We believe that's a doable objective but it also is an aggressive objective. It was an agressive objective from the very beginning and as I think everyone knows, we've had a month completing enrollment in the trial has taken a month longer than we had expected. So that puts additional pressure on what had been an aggressive plan from the beginning. Given that, I think you can expect us to place even greater focus on completion and analysis of any and all work necessary to support that NDA, so we can achieve that time line and that puts significant pressure on a Lean organization. We simply don't have a lot of resources sitting around that have excess capacity that we can assign these other things to. At the same time I think you can count on the fact that if we see signals on the bladder trial that suggest that that needs to move up in priority we would do that. However, we also continue to believe that registration for bladder would require an additional trial. So it's awfully tough to convince ourselves that we ought to be moving that up in the queue at the expense of those things that are necessary to support the aggressive NDA program.

I think that was a good discussion on the trade-off. You went over it well. The last question is first of all, let me start with congratulations on finishing the enrollment to you and your team, Michael.

Thank you.

And then ask, intrigued by your headline and by Pam's headline of exceeding the number of required patients. Do you have a final count to go over with us, or when will we see that number?

Well, I can tell you today that we have enrolled in excess of 800. It's really a complicated geometry, because our 800 number included a -- what we felt was a comfortable cushion to cover the statistics, allowing for things like patient attrition between screening and enrollment and randomization and allowing for attrition due to suboptimal baseline images that would render analysis on that patient difficult if not impossible. So we have built a pretty conservative geometry around the number of patients required.

At this point we're comfortable that we have exceeded all of those parameters. The reason, frankly, that we have not yet closed enrollment is frankly as a courtesy to investigators and patients that have already screened for this trial, and we want to give them a period of time to randomize and be treated. Now, obviously we need to put a fuse on that, because while we'd like to be generous, on the one hand, on the other hand that adds to pressures on our time lines. So those are the things we have had to balance and trade off and assess as we've tried to decide, number one, where are we against where we need to be in the trial. And number two, what and when are we prepared to announce that.

Thanks very much for the added information. Congrats on the progress.

Thanks, Mark.

Thank you. Our necks question comes from Matt Kaplan with Punk Ziegel.

Thanks for taking my call. Couple of follow-up questions. With respect to the potential timing for the start of additional studies whether they be combination studies or other indications, when do you think Schering or you will start some of these studies?

Well--.

With TOCOSOL Paclitaxel.

You need to divide those studies into at least two categories. In the first category, I think specific to Mark's and your question I think we've been pretty consistent from the beginning in terms of saying that it is not likely that we would initiate an additional registration study until we had at least the top-line data from 1075. And that continues to be the position. So frankly, we would like to be in a position to initiate a second registrational study mid to late next year, assuming that we stay on schedule with the data availability from 1075, and assuming that that data is positive. So that's the first part of the answer. And again, a second registrational study won't start until we have the data from the first registrational l study.

The second part of the question, though, relates to studies to support the launch of TOCOSOL Paclitaxel under 1075, as well as studies to advance the registrational development of TOCOSOL Paclitaxel in countries outside the United States. Conduct of all of those studies is a Schering responsibility. We would continue to fund studies supporting the launch in the U.S. 50/50. Schering is funding studies outside the United States to support registration outside the United States 100%. It is simply not appropriate for us to discuss studies that Schering has initiated and discussed, and all I can say is that we are very pleased with the progress that they are making in continuing to further the development of the product in that regard, both with regard to studies to support the NDA and the launch of the product and with regard to studies to support registration outside the U.S.

So Schering has already initiated some additional supportive studies? For example, they could be looking at combinations of Avastin or Herceptin or something like that?

Matt, additional studies have been initiated, and that's really all I'm free to say at this point.

Okay. Couple other questions. With respect to the Schering and Bayer merger when is that supposed to be officially completed?

Well, I can say I know perhaps a little more, if anything more, than you know on that, based on public disclosures where Bayer Schering has said that they expect to announce and at least begin to implement the integration towards the end of this year. I think from our perspective, we have not yet seen an impact of that integration, neither positive nor negative on the development plans for TOCOSOL Paclitaxel. Our collaboration with Schering continues to be productive, and our perception is that they continue to view this product with a high sense of importance within their oncology portfolio, and that they continue to view the development activities with a high and appropriate sense of urgency.

Great. Thanks. And then one other follow-up question to Mark on the bladder cancer study. It was my impression earlier this year that there was a potential that we could see some data from the bladder cancer study, obviously depending on enrollment, late this year, early '07. And now it's kind of mid '07 that we're going to see some -- potentially see some data from it but obviously it's second tier in priority. Since's an open-label study do you get a running analysis of that or do you wait for all patients to be completed and then run the analysis in terms of the objective response rate?

Richard?

Yes. Well, the answer to that is that we get some data in on an ongoing basis and that's mostly actually safety data. Obviously we get reports of SAEs and the like pretty much as they occur. In other instances, though, particularly related to efficacy, we simply will be gathering those data next year for the most part because that's when they will be mature, and it just makes a lot more sense to do it. And so we won't do it after the patients have completed the whole study, so we're doing, if you will, an interim analysis after the patients have -- or we expect that most of the patients will have met the endpoint of -- or at least response rate, tumor response rate, best way to put it, and that will be -- in the first part of next year, then we'll have to analyze those and present them, but it is possible that we may -- part of the issue here is that we may have some delays in implementing that given, again, the difficulties that we foresee in competition, if you will, with the 1075 breast cancer protocol.

Okay.

And I think the only other color comment, I would offer for you and others is that perhaps we are learning a painful lesson with regard to the creation of expectations. It's like the old anecdote of making a job offer to somebody where you say, well, we'll pay something you in the range of 80 to $100,000, and what the applicant is hearing is $100,000, and what you really mean is $80,000. You're correct. Your expectation on this was hat we said was we'd have data at the end of this year, or early next year. In retrospect, end of this year was aggressive. As Richard said, we're likely to have it early next year but rather than create another sliding scale of expectations where the market is hearing the earlier date and we're really meaning the later date we're just putting one expectation out there that we think we have a good chance of meeting if not beating.

And I don't want to leave Alan out of this discussion.

We'd hate to do that as well.

Thanks, Matt.

With respect to fourth quarter, do you expect R&D and G&A levels to remain flat from what we saw in the third quarter? It seems like you're only going to burn about $2 million in the fourth quarter.

Yes. So I think, to answer that--.

They should go down dramatically.

Our spending level will stay about the same. The big difference is we expect to collect a fair amount of money from Schering when you see our 10-Q that's been filed, we have about $9.6 million--.

In receivables.

Yes, in receivables. And I think we'll collect the majority of in that Q4. So that's the big difference. Then the rest of our spending levels should be relatively flat.

Okay. Great. And when do you think you'll have a little bit more guidance for '07?

Well, we'll have to have our conference call prior to March 10, so I imagine we'll have our conference call traditionally we'd have it a few days in advance of the deadline for our 10-K, so it would be early March.

Okay. Great. And congratulations again on the completion of the enrollment.

Thanks, Matt.

Thank you. Our next question comes from Vinny Jindal with ThinkEquity. Please go ahead.

Hey, guys.

Hey, Vinny.

Just wanted to ask a quick question on competitive advantage. I'm sure that some discussions have occurred with Bayer and or Schering about how the drug would be competitively positioned and that the difference in infusion time is a pretty big difference relative to the other taxanes on the market. I was wondering if you could go through with us what the administration schedule is for Taxol relative to other therapies and new therapies for metastatic breast cancer in terms of when they're induced. Is a shorter infusion of Taxol actually beneficial, are or does the patient have to sit around and wait for other therapies to be infused at the same time?

Thanks for the question, Vinny. I would make an overall comment before turning it over to Richard that not only do we continue to discuss competitive positioning of the product but we continue to pretty aggressively survey the market to try to understand what products are being used and why, and what products are not being used and why. And so that gives us the ability to continue to refine our own product positioning belief. And, you know, I would say in general that we continue to believe that TOCOSOL Paclitaxel will be a pretty competitive product, assuming that we meet at a minimum the noninferiority efficacy threshold with the safety profile that we expect and with convenience and ease of use.

And on that last point I'd really encourage you to think about convenience and ease of use as kind of a package of benefits, where the ready-to-use nature of the product eliminating the need for 20 to 30 minutes of pharmacy prep time, eliminating the dependence or the concern on product stability for the other products once they are reconstituted. In addition to the 20 to 30 minutes of pharmacy prep time, they have to be used within a certain period of time or according to the label they would be unstable beyond that period of time. Then the actual administration time is the third level of convenience and ease of use. So it's really a package of benefits there. I'll turn it over to Richard to ask a specific question on Taxol infusion.

There's a slight difference obviously between the Taxol label which is based on every three week Taxol, 175 milligram administered over three hours, and the use of Taxol in weekly dosing where typically the doses are in the range of 80 milligrams and -- per square meter, and administered typically over about an hour or so. So our infusion time is substantially shorter than that. I should say that in addition, we're in the process of differentiating our product preclinically as well from the other taxanes because we believe there are a number of attributes preclinically that we have demonstrated that would potentially position it as being more effective as well as safer.

Could you go through what some of those attributes might be?

Well, yes, we have done some work currently and, in fact, we're preparing a publication on this, that our drug is formulated -- it's a stable formulation of what we're calling nano droplets, they typically are in the range of 40 to 80 nanometers in size, and it's the ideal size to participate in what is known in the literature as enhanced permeability and retention. These narrow droplets will go through the tumor vasculature, which tends to have a wider finesse strait than the normal vasculature and penetrate the tumor tissue, and then the drug will reside there because of poor lymphatic drainage. We also have some evidence from some preclinical studies that we get higher tumor levels of our drug than Taxol, so all that kind of meshes together. In addition, we've done some preclinical studies in animals comparing our drug to Abraxane and Taxol from a standpoint of neurotoxicity and we are in the process of preparing an abstract on that one, and, in fact, we have shown that our drug is less neurotoxic.

Yes. Is there, then, a difference in the preferred droplet size that leverages the leaky vasculature of tumors and the size of an albumin molecule, each of which would be retaining Paclitaxel in some form?

Well, that's a good question. The ideal size for EPR, according to the literature is about 50 to 60 nanometers. So it's fair to say that we bracket that. If you look at Taxol, it interacts, the cells of Taxol are very small, for example, but they interact with lipoproteins and become rapidly very large in the range of a few hundred nanometers. On the Abraxane side it's a little unclear but the literature suggests that the interaction with albumin, or the way it's formulated is a reversible, if you will, binding to the albumin, so presumably as soon as abraxane gets into circulation it is no more bound to albumin than Paclitaxel is from any other source. Paclitaxel generally is over 90% albumin bound. That's what's confusing. So arguably any taxane or any paclitaxel can participate in spark if that's what you're trying to get to.

Got you. That makes a lot of sense.

Thank you.

And you had mentioned that you're preparing abstracts. Are those for particular meetings?

Well, we haven't submitted yet, so I should be a little careful, but we're in the process of doing that and we expect those to come out in the course of 2007 but I don't want to give you any dates yet. Once we have them accepted we'll be a lot more willing to do that.

Fair enough. Thanks so much for entertaining the questions, guys.

Thanks, Vinny.

Thank you. Our next question comes from David Miller with Biotech Stock Research. Please go ahead.

Hi. Thanks for taking my questions and congratulations on finishing enrollment.

Hi, David. Thank you.

Do you have some idea when we might see the first data from the TOCOSOL Camptothecin trial?

I can address that one as well. It's a little bit of a difficult thing for us to answer. And it's not that we're not very time-line sensitive, but as you know in the Phase I it's highly dependent on the number of cohorts that we end up enrolling. To some degree the more successful you are in pushing the dual tire the longer it takes. So we would think there's a chance that we would have those data towards the end of 2007 but I don't really want to commit to that. I don't know if Mike has something to say beyond that but I would want to be careful about really giving you a date.

Okay. Then kind of the general regulatory path for that particular drug. Are you going to follow a similar regulatory path that you have with TOCOSOL Paclitaxel where you kind of duel approach it at a 504b2, and then as well superiority or do you have something different in mind?

Well, because this is a new chemical entity it would not qualify for a 505b2, so we would be taking the more traditional NDA approach with TOCOSOL Camptothecin.

Okay. And I think you may have already answered this in response to Matt's questions, but your guidance was is that you expected to have one or two market development, quote, unquote, Phase II trials launched by the end of 2006. Are you still on track for that, or has Schering already started those?

I think what the comment was, was we expected to initiate a number of studies related to either support of the NDA or launch of the product. And the answer to the question is, yes, studies have been initiated, and further studies are planned for initiation in 2007. Again, all of those studies are really Schering-sponsored studies, and so it's really inappropriate for me to comment on them at this point beyond that.

Okay. That's fine. I understand that. And then finally, have you had any kind of substantive discussions with anybody from the Bayer management team yet? I know the last time we talked you were still -- you hadn't had much contact with those folks outside of the Schering folks.

The answer is we have not. Now, it's important to note that a number of those Schering folks have been confirmed as ongoing members of the senior team at Bayer Schering. But what I would have to say is that from their perspective, Bayer Schering are continuing the business as usual until the full integration is announced, and that our counterparts at Schering who have been involved with the project at this point continue to be involved, engaged, committed, enthusiastic, energetic, all of which is especially appreciated, given that having been through mergers at larger companies before I know that there's a huge potential for them to be distracted. But I have to say to date that we -- if that distraction is there, it has not manifested itself in their discussions with us, nor in their work on our project.

Okay. Great. Thank you very much.

Thanks, David.

thank you. [OPERATOR INSTRUCTIONS] We have no questions. Do you have any closing remarks?

Yes, thank you. To wrap up I'd like to mention our next opportunity to speak to you will be at two upcoming investor conferences. On November 29, we'll be presenting at the Lazard Capital Markets Life Sciences conference in New York City, and we'll also be participating in the RBC Capital Markets healthcare conference, this is being held in mid-December also in New York City. Our presentations at these conferences will be broadcast live and archived on our website. That concludes our call today, and we thank you for joining us.

thank you. Ladies and gentlemen, this concludes the Sonus Pharmaceuticals third quarter 2006 conference call. If you would like to listen to a replay of today's conference please dial 1-800-379-7444, or 303-590-3000 and enter access number 11074216. Once again, for a replay of today's conference please dial 800-379-7444, or internationally at 303-590-3000 and enter access number 11074216. You may now disconnect. Thank you for using ACT conferencing.