Jazz Pharmaceuticals PLC (JAZZ) 2010 Q2 法說會逐字稿

Good afternoon. My name is Anesia, and I will be your conference operator today for the Jazz Pharmaceuticals second quarter 2010 earnings conference call. This call is being recorded. All lines have been placed on mute to prevent any background noise. After the speakers' remarks there will be a question-and-answer session. I would now like to turn the call over to Ms. Ami Knoefler; Executive Director, Investor Relations and Corporate Communications of Jazz Pharmaceuticals.

Good afternoon, and welcome to the Jazz Pharmaceuticals second quarter results conference call. I'm pleased to be here today, having recently joined the Company to lead the Company's Investor Relations and Corporate Communications activities. With me today are Bruce Cozadd, Chairman and CEO; Kate Falberg, Senior Vice President and CFO; and Bob Myers, President. Following some introductory comments and updates from the quarter we will open the call up for questions.

Before we begin I would like to remind you that remarks we may be making today on the call about future expectations, plans, and prospects for Jazz Pharmaceuticals constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements related to Jazz Pharmaceuticals' financial performance and growth potential, including 2010 financial guidance; statements concerning future product sales; statements related to Jazz Pharmaceuticals' JZP-6 product candidate, including future clinical and regulatory matters, the upcoming advisory committee meeting and the potential approval and commercialization of JZP-6 in the United States and other countries; statements related to the future product development and growth, including statements related to establishing a new supplier for sodium oxybate and future development of new dosage forms of sodium oxybate; statements relating to the protection of intellectual property and patents; and the sufficiency of Jazz Pharmaceuticals' cash resources.

Any statements we may make today on the call that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Jazz Pharmaceuticals' actual results to differ significantly from those projected, including without limitation those risks and uncertainties detailed in Jazz Pharmaceuticals' filings with the Securities and Exchange Commission, including under the heading Risk Factors and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, which are available on our corporate website.

Our second quarter 2010 financial results were reported in a press release issued earlier today. We plan to file our Form 10-Q for the three months ended June 30, 2010, with the SEC soon. These documents will also be available on our corporate website. Now, it is my pleasure to turn the call over to Bruce Cozadd, our Chairman and CEO, for an overview of the quarter.

Thanks, Ami. Good afternoon, everyone, and thank you for joining our call. We had a busy second quarter, with several developments related to both our current commercial products and our pipeline. But at the core of our results are strong financials, record top- and bottom-line performance, and changes in our capital structure that position the Company for future growth and success.

With the recent refinancing of our debt, the transformation of our balance sheet is now complete, and we have continued confidence in our future earnings potential as demonstrated by our increased product sales and increased adjusted net income guidance.

Before Kate Falberg reviews our results and Bob Myers provides further color on the quarter, I would like to highlight several recent key developments that showcase the strength of our growing business.

First, we announced today that we received two new distribution patents for sodium oxybate. These patents, which are listed in FDA's Orange Book and have expiration dates in 2024, broaden the intellectual property protection for Xyrem. We anticipate that one or more of our distribution system patents will also cover the final distribution system for our JZP-6 product for the treatment of fibromyalgia if approved by the FDA. With these new patents, our overall patent protection for sodium oxybate is substantially strengthened and now includes six patents, five of which are Orange Book listed.

UCB, our partner for Xyrem and JZP-6 in Europe, announced last week its EMA filing for JZP-6 for fibromyalgia in Europe. As a reminder our collaboration with UCB would provide for a significant milestone of up to $25 million upon approval and royalties on future product sales starting at 15%.

During the quarter, data from the JZP-6 clinical program were presented at key relevant medical meetings. Most recently, data from the Phase III program were presented at the Associated Professional Sleep Society's meeting and the European League Against Rheumatism, or ULAR, meeting. Results of our clinical studies of JZP-6 will also be presented at the ACR meeting in November in Atlanta.

Without a doubt, the most significant area of focus during the quarter has been planning for the upcoming August 20 FDA advisory committee meeting and the potential launch of JZP-6 in fibromyalgia, a debilitating condition for patients, and a disease with significant impacts on the healthcare system.

As a reminder, JZP-6 is the first GABAB and GHB receptor agonist for the potential treatment of fibromyalgia and has demonstrated a statistically significant reduction in both pain and fatigue and improvements in sleep quality and daily function in two pivotal Phase III clinical trials.

At this time, our team is well along in final preparation for the advisory committee meeting in support of the JZP-6 NDA. Given the compelling efficacy data and well characterized safety profile from our two Phase III studies in over 1,100 patients, combined with our plan to utilize an effective proven REMS process that leverages our experience over the past eight years with Xyrem, we believe there is strong rationale for JZP-6 to be approved as a new treatment for fibromyalgia. Following the advisory committee meeting we plan to issue a statement on the outcome that afternoon, and to subsequently hold a conference call on the following business day, Monday, August 23.

Also during the second quarter we continued to advance our oral tablet formulations of sodium oxybate. We believe that a tablet formulation would be more convenient for many patients. Our ongoing work regarding the new tablet forms includes evaluating the safety and pharmacokinetics of a tablet form of sodium oxybate taken twice nightly.

We also continue development of a once-a-night tablet formulation. We remain excited and encouraged by the opportunity for oral tablet formulations of sodium oxybate, particularly in light of the potential launch of JZP-6 for fibromyalgia.

Also on the R&D front, during the second quarter we completed an internal portfolio review process. We have made several decisions regarding the existing portfolio, which will I briefly summarize. Regarding JZP-4, or elpetrigine, our sodium and calcium channel antagonist for potential treatment of epilepsy and bipolar disorder, given the size of the epilepsy market and the prevalence of bipolar disorder, we see an important unmet need that we believe JZP-4 may address. We will continue to seek a partner for this program.

Following our assessment of JZP-7, our ropinirole gel product candidate for the treatment of restless leg syndrome, or RLS, we have decided to no longer pursue the JZP-7 program.

Turning to JZP-8, or intranasal clonazepam, our candidate for the treatment of recurrent acute repetitive seizures in epilepsy patients, we are proceeding with ongoing formulation work for this product candidate, and we see a compelling opportunity, given the size of the market and need for new convenient modes of treatment that more acceptable to patients and caregivers than the currently approved rectal product.

As a potential intranasal treatment, JZP-8 could offer a significant advantage to patients suffering from acute repetitive seizures. We have previously completed a Phase II study with encouraging results, and we remain excited about the potential of this product candidate to play an important role in patient therapy. We hope to have further insights in this program early next year and to proceed with further clinical development once the ongoing formulation work is complete.

Before I wrap up, let me emphasize one point. We will be making comments in this call about our ongoing commercial business, including our promotion of Xyrem for the treatment of cataplexy and EDS and narcolepsy. We will also be discussing our JZP-6 program, aimed at registering sodium oxybate for treatment of fibromyalgia and its potential launch in 2011.

Please understand that these are distinct initiatives. As an organization we remain firmly committed to compliant on-label promotion of sodium oxybate for its approved indications. I know our employees all share that commitment.

Finally, I would like to emphasize my overall excitement about where we are at this point in the year and the progress we are making on so many fronts at Jazz Pharmaceuticals. We continue to show growth in profits and cash flow, and we have a bright future ahead, with financial flexibility and multiple product opportunities that will help fulfill our mission of helping patients.

Now, let me turn the call over to Kate, who will discuss financial results for the quarter and review our updated guidance for 2010.

Thank you, Bruce, and good afternoon, everyone.

Our second quarter 2010 financial results were reported in a press release issued earlier today. Looking at our results for the second quarter, total revenues increased 8.6% to $40.5 million from $37.3 million for the 2009 second quarter. As a reminder, included in total revenues are net product sales, royalties, and contract revenues.

Net product sales for the second quarter increased 49% to $39.5 million from $26.5 million in the 2009 quarter. Net sales of Xyrem grew 51% to $33.7 million from $22.4 million in the year-ago second quarter. The increase in Xyrem sales was primarily due to the impact of price increases and to a lesser extent a 6% increase in prescription volume.

Gross margin on product sales in the second quarter of 2010 was 93%, compared to 90% in the second quarter of 2009. Net sales of Luvox CR rose 41% to $5.8 million from $4.1 million a year ago in the second quarter, primarily driven by volume growth of 25% and, to a lesser extent, by price increases.

Of note, royalties and contract revenues for the second quarter were $1 million compared to $10.8 million a year ago. The 2009 second quarter included a $10 million milestone in contract revenues from UCB Pharma related to the completion of the second Phase III study for JZP-6 in patients with fibromyalgia.

Total operating expenses for the second quarter of 2010 increased 2% to $29.9 million compared to $29.2 million for the 2009 second quarter. R&D expenses in the second quarter decreased 29% to $8 million compared to the year-ago quarter. This was primarily due to the reduced level of clinical trial activities for JZP-6, as our pivotal Phase III studies were underway during the same period in 2009.

Importantly, R&D spending in the second quarter of 2010 was primarily focused on activities supporting our new drug application for our JZP-6 product candidate, as well as activities related to the development of oral tablet forms of sodium oxybate.

SG&A expenses in the second quarter increased 25% to $17.1 million. The increase was primarily due to our investment in preparations for a potential launch of JZP-6 in fibromyalgia if approved by the FDA. The increase also reflects higher compensation costs related to hiring of employees as well as non-cash stock-based compensation expense.

In the second quarter of 2010, we had two significant transactions associated with the prepayment of our 15% senior notes. During the quarter, we prepaid the entire $116.5 million balance of senior notes, utilizing proceeds from a public offering of common stock, a new term loan and cash. In May, we used the net proceeds from the public offering to prepay $53 million in principle on the notes.

In June, we prepaid the remaining $63.5 million principle amount of the notes, using a combination of cash and a new three-year $50 million term loan. The new term loan bears interest at a floating rate which was 5.75% as of June 30, 2010.

With the full repayment of the 15% debt, the second quarter includes a $12.3 million loss on extinguishment of debt, which reflects prepayment penalties, fees, and writing off the unamortized debt discount. As a result of this charge, we reported a GAAP net loss for the second quarter of $6.4 million or $0.18 per diluted share. This compares to net income of $2.2 million or $0.07 per diluted share in the second quarter of 2009.

Non-GAAP adjusted net income for the second quarter of 2010 was $10.5 million, or $0.28 per diluted share, compared to a non-GAAP adjusted net loss of $4.6 million, or $0.16 per diluted share, in the 2009 second quarter.

As a reminder, the non-GAAP adjusted figures back out amortization of intangibles, which is primarily related to the original acquisitions of Xyrem and Luvox CR; loss on extinguishment of debt related to our recent financing activities; non-cash interest expense, which is related to a debt discount and debt issuance costs; stock-based compensation expense and contract revenues, which reflect milestone payments received from UCB in prior periods.

We encourage you to review the table reconciling our GAAP net income or loss and earnings per share to the related non-GAAP adjusted figures provided in our press release issued earlier today, which is available on our website under the Investors tab.

Turning to the balance sheet. There were significant changes during the quarter, given the impact of the financing transactions. We reduced long-term debt from $116.5 million to $50 million, extended the final maturity date from June 2011 to June 2013, and reduced the interest rate from 15% to a floating rate initially set at 5.75%. Our ending cash balance as of June 30 was $9.6 million, which reflects the use of $20 million of cash on hand for debt repayment in the quarter.

With these improvements on our balance sheet and anticipated cash flow from operations, we believe we have sufficient resources to fund our business moving forward and to leverage opportunities for future growth, including the launch of JZP-6 if approved by the FDA. In fact, as you can conclude from our adjusted net income guidance, we expect our cash balance to increase throughout the year, and we anticipate ending 2010 with a cash balance of approximately $25 million to $30 million.

Given our strong first-half results, improved profitability, and cash flow generation, as well as our greater visibility into the second half of the year, we are updating our full-year 2010 guidance as follows.

We are increasing our total net product sales guidance to a range of $156 million to $162 million from prior guidance of $152 million to $160 million. This reflects an increase in Xyrem sales guidance to a range of $132 million to $136 million from prior guidance of $128 million to $132 million. We are also tightening the range on expected Luvox CR net sales to $24 million to $26 million from $24 million to $28 million. We continue to expect gross margins to remain above 90%.

On the expense side we are tightening the expected range on SG&A expenses to $70 million to $75 million from $68 million to $75 million. We are also tightening the expected range on R&D expenses to $28 million to $32 million from $28 million to $35 million. Our guidance range for GAAP net income per diluted share is now $0.32 to $0.41. And finally, we are increasing our guidance for adjusted net income per diluted share to a range of $1.05 to $1.15 from $0.80 to $0.95, which is a sizeable increase.

This new guidance reflects both the impact of recent financing activities, and the overall strength and momentum of our current commercial business. I'm extremely pleased with the progress we have made during the quarter to strengthen our financial position and pave the way for future growth.

I'll now turn the call over to Bob Myers, our President, to provide you with updates on the commercial area of our business.

Thanks, Kate. Good afternoon, everyone, and thanks for joining our call. I'll start by adding some color on the second quarter results from a commercial perspective, and then focus my comments on JZP-6.

As Kate described, the second quarter was a very nice quarter for our core business. We continue to see growth in our Xyrem and Luvox CR products, which have driven our record sales results in the second quarter, a 49% increase in net sales over the second quarter of 2009. This sustained growth in prescriptions and sales of our currently marketed products is an important cornerstone of our strategy moving forward. Our core business significantly contributes to our current financial bottom line and our future earnings potential.

For Xyrem, we are pleased to see the 6% growth in Xyrem bottle shipments to patients for the second quarter of 2010 compared to the second quarter of 2009. We also saw growth in the number of new patients starting Xyrem therapy. In the second quarter of 2010 compared to the first quarter of 2010, there was an 8% increase in the number of new Xyrem patients.

In addition to increasing awareness about Xyrem's unique attributes among our target prescribers, an important objective of our commercial strategy for Xyrem is to facilitate patient access and commitment to therapy. Our updated Xyrem coupon program, which ensures low monthly out of pocket costs of $100 or less for approximately 96% of the Xyrem patients, is a key factor in the success of this strategy.

It is also great to continue to report that approximately 80% of our Xyrem patients have monthly out of pocket costs of $50 or less. As a result of our recently updated Xyrem coupon program, we are pleased to see that a number of patients have decided to reinitiate Xyrem therapy after previously discontinuing therapy.

As a reminder, patient eligibility for our Xyrem coupon program is verified by a central pharmacy, making it very convenient for the patient. There is no paperwork for prescribers or patients to complete. The coupon is automatically implemented by a central pharmacy when the pharmacy determines the patient's eligibility.

In the second quarter we also continued to make progress in preparing for our change of supplier for the active ingredient in Xyrem, which as you know is sodium oxybate. You will recall that our current supply contract for sodium oxybate expires at the end of 2011.

As a result, we have been preparing to transition to our new supplier, Siegfried, to ensure uninterrupted supply of sodium oxybate. We have been pleased with the progress that Siegfried has made to date, and from a financial perspective this change in suppliers is not anticipated to have an impact on our projected Xyrem gross margin of greater than 90%.

Let me now comment briefly on Luvox CR. As Kate mentioned, we saw significant Luvox CR volume growth of 25% this quarter, driving record net sales.

Our volume growth bodes well for renewed efforts in 2010 to move Luvox CR up in the treatment paradigm, so physicians consider Luvox CR as the first treatment to be used for their patients suffering from Obsessive Compulsive Disorder or OCD.

As an update, on our FDA approved indications for Luvox CR, earlier this year we submitted a labeling supplement to the FDA to remove the SAD indication from the approved Luvox CR label. As a reminder, the strong heritage of Luvox in the immediate release formulation is for the treatment of OCD. Based on the data that are available to us, the vast majority of prescriptions for Luvox CR have been written for OCD.

Removal of the SAD indication from the Luvox CR label, if it occurs, is not expected to have a significant negative impact on Luvox CR product sales. In fact, since our submission to the FDA in the second quarter, our sales force has not been actively promoting Luvox CR for the SAD indication.

From a financial perspective, by removing SAD indication for the approved label, our Phase IV trial requirements from the FDA would be eliminated. These Phase IV trials would have been a significant expense for our Company.

Now, as Bruce mentioned, we have recently completed a portfolio review of our pipeline projects. Coming out of that review, we have made several decisions regarding plans for our development portfolio. Of course the most significant and most advanced of our new product opportunities remains JZP-6. A product that we believe, upon FDA approval, has the potential to provide an important new treatment option for the patients who suffer from fibromyalgia.

So let me provide a more detailed update on JZP-6. JZP-6 is the first GABAB and GHB receptor agonist for the potential treatment of fibromyalgia. In our two pivotal Phase III trials, JZP-6 has demonstrated a statistically significant reduction in pain and fatigue, and improvements in sleep quality and daily functioning. Fibromyalgia is a serious disorder with significant unmet medical needs. In our market research, physicians have consistently told us that they are not satisfied with the impact of currently available therapies and these physicians are continuing to look for new approaches to help their patients.

We are continuing to actively prepare for the launch of JZP-6 after FDA approval. Our prelaunch preparation is focused on building a strong brand message for physicians that highlights the unique mechanism of JZP-6 and its distinct effects on fibromyalgia management. If approved by the FDA, JZP-6 would become the first GABAB and GHB receptor agonist for the treatment of fibromyalgia.

In both of our prospectively defined pivotal Phase III trials, in both of the doses that we studied, JZP-6 demonstrated reductions in both pain and fatigue while showing improved sleep quality and improved daily functioning. These are significant patient benefits on the most debilitating effects of fibromyalgia.

In preparation for our launch of JZP-6, we have added senior leadership to our talented commercial team. We are pleased to have recently brought on board a new Vice President of Marketing, Russell Cox, to help lead a strong marketing team focused on maximizing our launch effort for JZP-6.

Russell most recently was Chief Commercial Officer at Ipsen and has over 20 years of experience in specialty pharmaceuticals and biotech. His experience includes leadership of several commercial teams into emerging markets with complex distribution and reimbursement environments that have translated into successful product launches at Ipsen, Johnson & Johnson and Genentech.

Also from a commercial perspective, we are currently in the process of identifying the appropriate size and focus of our sales force for the launch of JZP-6, as well as the types of programs they would need to effectively market and promote this unique new product to the medical community treating fibromyalgia.

Importantly, I would like to emphasize that, upon FDA approval, we plan to launch JZP-6 solely through our own specialty sales force. Upon FDA approval, we are planning to expand the size of our existing specialty sales force to provide sufficient reach and frequency to the target physicians treating fibromyalgia patients.

We are confident that our own expanded sales force can effectively identify and target these physician specialists, including rheumatologists, pain specialists, neurologists, and sleep doctors. We expect to complete our sales force sizing analysis and territory alignment in the coming weeks. After a successful launch of JZP-6 to specialty physician audiences, we will explore arrangements that may expand the sales effort behind JZP-6.

In conclusion, this is an exciting time for our Company. Xyrem continues to help more and more narcolepsy patients, and sales continue to grow. Today, we raised our Xyrem sales guidance for 2010 for the second time this year. Upon FDA approval, we will expand our sodium oxybate franchise by successfully launching JZP-6 into the fibromyalgia market.

Given the important recent intellectual property developments that Bruce outlined at the beginning of our call, our patent protection for the sodium oxybate franchise has been significantly strengthened. As we look to the future, we expect that sodium oxybate, including our new oral tablet formulations, will be a meaningful and growing franchise for us for years to come.

And with that, I would now like to turn the call back to our operator to begin our question-and-answer session. Thank you.

(Operator Instructions). And the first question comes from the line of Corey Davis with Jefferies. Please proceed.

Thanks, and good afternoon, everyone. So regarding this upcoming panel meeting, I'm assuming the biggest issue is going to be simply the risk of diversion in the context of the benefit to patients. So I guess to that end, what are you going to be able to say to the panelists, to the FDA about your eight years of experience? What kind of data can you point to, what kind of data capture do you currently use that would be imposed and expanded for a fibro indication?

I mean, in other words, how can you prove to panelists that there would have been X number of cases, but we caught them in time, so it didn't happen other than just showing how the program works? Are there hard numbers you can put on to stuff like that?

So, Corey, I think we -- first of all, we agree with your characterization that this is really about benefit to patients versus risk. I think that is true of all products that come before FDA. And we do have a lot of numbers based on our experience with the REMS for Xyrem. That is data that we have collected. That is often data that was previously provided to FDA, certainly more provided in conjunction with the prosecution of the JZP-6 NDA.

We have also published in peer reviewed journals some of our earlier data. So there is a lot of data. You are right to say we can't show data on what didn't happen. We can just show data on what did happen, but we think that data is very compelling.

Can you share any hard numbers, like how many cases of diversion actually did happen as per how many patients have been treated with this collectively?

So we will be providing data, we have provided data in our briefing book, which will become public before the meeting next week, and we will certainly be sharing that information at the meeting. But we are not going do that on today's call.

And I will just say generally we are getting awfully close to an advisory committee meeting, and there are probably a lot of questions that could be asked on this call about the specifics of our presentation that we are probably going to decline to answer.

We will certainly be glad to refer people back to things that have been made public before -- clinical trial results, posters that have been presented at medical meetings, the paper I just referenced -- some of that is public information. But we are probably not going answer a lot of specific questions about our committee presentation for next week.

All right. Well, before the next person asks you about the committee presentation next week, I will spare you and ask one more about JZP-4 partnering and JZP-8 continuing development. Can you remind us of what data you actually do have in hand, what kind of proof of concept stuff? Is there proof that these two things work in the indications you are pursuing?

So I think I will take the second part of your question, which is what data is available, and I will turn it over to Bob to comment if he would like on partnering. I think what we have disclosed before on JZP-4 is that we have done at least two human proof of principle clinical studies, one in patients and one in normals, making sure that we got appropriate response consistent with effectiveness against epilepsy models that have been well validated, tested with other approved and experimental epilepsy treatments.

We have also disclosed previously that we have done significant formulation work to make that a once daily formulation. I think that is probably all we have said about JZP-4.

On JZP-8, as I mentioned earlier, we have done a number of studies up to and including a Phase II study, which did show promising results and have caused us to be confident moving forward with that program.

Corey, this is Bob. In terms of the portfolio review, it is a relatively recent exercise that we have completed, as we promised you midyear we would be doing our portfolio review. So we are now going out and starting our partnering process for JZP-4, and you should not expect to see any imminent announcements. We are going to be starting that process now and hope to move forward with the partnering discussions.

Okay. Great. Thanks, everyone.

You're welcome.

The next question comes from the line of Rich Silver with Barclays Capital. Please proceed.

Sorry, I'm not sure if this was asked before, but the status of the open label continuation trial that was completed, I'm just wondering if the results are going be reported or are just going be part of the advisory panel discussion?

Rich, the question had not been asked. But in terms of the open label study, we have submitted safety data to the FDA in support of our NDA, and the interim data has been analyzed, but we have not completed the final analysis.

Okay. And then in terms of the guidance raises, we have now had two quarters in a row. Is that based on underestimating script growth, conservativism, driving that raised guidance in particular on Xyrem?

So, Rich, we are continuing to see nice growth in patients for Xyrem. As you heard from both Kate and myself, we saw a 6% increase second quarter of 2010 over second quarter 2009. You will recall that first quarter of 2010 over first quarter 2009 was a 5% increase.

So we are, as we have said before, expecting to see single digit growth consistently throughout 2010, and we are very pleased by that progression. So going forward we do continue to expect to see that level of growth continue. And obviously we are excited about the launch of JZP-6 in 2011.

And was there growth in Xyrem on a sequential basis?

Yes. So second quarter over first quarter did grow. I don't have that number in front of me, but it was a nice growth.

Script growth?

Correct.

Okay.

And, Rich, just to be clear, back on the overall guidance increase, of course that reflects continued strong operating performance as well as the beneficial impact of taking out the 15% debt.

Okay. And in terms of the development work you are doing on the tablet, give us any sense of timing, at least on the twice a night version?

No, Rich, at this point we haven't given specific timing. We will come back to that in the future. We have pointed out to people that clinicaltrials.gov has shown that we have been actively conducting clinical work, but really for competitive reasons we have wanted to not say too much publicly about exactly what we are doing on the solid formulation side.

Okay, thank you.

(Operator Instructions). The next question comes from the line of [Stacy Yang] with [Petstone Investments]. Please proceed.

Hi, good afternoon, everyone. A question with regards to the commercial strategy of launching JZP-6. Would you expect JZP-6 to have the same trade name as Xyrem or use Xyrem as the trade name, or do you expect a different trade name?

That is a great question. This is Bob speaking. We have proposed in our NDA that we would have a separate brand name for JZP-6. There is obviously an ongoing discussion with FDA, and we are hopeful to have a second brand name, and we are continuing those discussions.

Thank you.

This concludes the question-and-answer session for today's call. I would now like to hand the call over to Ms. Ami Knoelfer for closing remarks.

Great. Thanks, everyone, for joining our call. As a reminder, our Chairman and CEO Bruce Cozadd will be presenting this Thursday at the Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals conference. And also, as mentioned, we currently intend to hold an investor update on the outcome of the FDA advisory committee meeting on Monday, August 23, the first business day following the meeting. Thanks, and have a good day.

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