Jazz Pharmaceuticals plc (JAZZ) Q2 2013 Earnings Report, Transcript and Summary

Katherine A. Littrell - Vice President of Investor Relations Bruce C. Cozadd - Co-Founder, Executive Chairman and Chief Executive Officer Kathryn E. Falberg - Chief Financial Officer and Executive Vice President Russell J. Cox - Chief Commercial Officer and Executive Vice President Jeffrey K. Tobias - Chief Medical Officer, Executive Vice President of Research & Development and Head of Research & Development

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division Michael W. Schmidt - Leerink Swann LLC, Research Division Douglas D. Tsao - Barclays Capital, Research Division William Tanner - Lazard Capital Markets LLC, Research Division David Amsellem - Piper Jaffray Companies, Research Division Ami Fadia - UBS Investment Bank, Research Division Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division Gene Mack - Brean Capital LLC, Research Division Ken Cacciatore - Cowen and Company, LLC, Research Division Gregory B. Gilbert - BofA Merrill Lynch, Research Division

Welcome to the Jazz Pharmaceuticals Second Quarter 2013 Earnings Conference Call. Following an introduction from the company, we will open the call to questions. I will now turn the call over to Kathy Littrell, Vice President of Investor Relations at Jazz Pharmaceuticals.

Thank you, Catherine. Thank you for joining the Jazz Pharmaceuticals PLC Investor Conference Call. Today, we reported our second quarter 2013 financial results, and provided an updated in 2013 financial guidance in the press release. The release is available in the News and Events section of the company's website. With me for today's call are Bruce Cozadd, Chairman and CEO; Kate Falberg, CFO; Russ Cox, Chief Commercial Officer; and Jeff Tobias, Head of R&D and Chief Medical Officer. Following some introductory remarks, we'll open the call for your questions. Before we begin, I'd like to remind you that some of the statements we will make on this call relate to future events and our future performance and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. References to what to expect, believe, intend to or will do, plan, estimate or other statements referring to future events or results are intended to identify these statements as forward-looking. These statements include expectations and projections relating to financial, commercial, development, regulatory and intellectual property matters, including our 2013 financial guidance, growth prospects for our products and the availability of sufficient supply of our products to meet demand. Statements that are not historical facts are forward-looking. These forward-looking statements involve numerous risks and uncertainties that could cause actual results or our results to differ materially. These results -- these risks and uncertainties are identified and described in our press release, the investor presentation accompanying this call, and under risk factors in the form 10-Q, for the quarter ended March 31, 2013. We expect to file our 10-Q for the second quarter shortly. We undertake no duty or obligation to update any forward-looking statements we make today. On this call, we will discuss several non-GAAP financial measures including adjusted net income, adjusted combined SG&A and R&D expenses, adjusted earnings per share and adjusted effective tax rate. Please -- let me go on, we believe that these non-GAAP financial measures are helpful in understanding our past financial performance and potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures. Reconciliations of GAAP to adjusted financial measures are included in our press release issued earlier today, which is available on our website. I'm now going to turn the call over to Bruce.

Thanks, Kathy, and thank you, all, for joining us today. We're pleased with the significant growth of the top and bottom line during the first half of 2013. In the second quarter, we saw continued record sales for Xyrem and Erwinaze. Our total revenues increased 68% to $208 million compared to the second quarter of 2012. We realized adjusted net income of $88 million in the second quarter of 2013, reflecting the significant top line growth and attractive margins in our business. GAAP net income for the quarter was $42 million. We remain committed to creating shareholder value. We're focused on continued solid commercial execution, and we're making targeted investments to continue to drive growth of our core products. We're making R&D investments in Lifecycle Management for our current growth products, as well as development of new molecules in our pipeline. And as part of our ongoing growth strategy, we are actively engaged in evaluating corporate development opportunities that could add to our commercial products or pipeline. To further these objectives, we are adding key people to our worldwide organization to further strengthen our capabilities and ensure that we have a scalable infrastructure to support our plans for future growth. I'll update you now on 3 products in our current portfolio that we believe have the highest growth potential, the Xyrem, Erwinaze and Prialt, and provide an update on key commercial and clinical development progress during the quarter. Kate will then review our results for the second quarter and provide updates to our financial guidance. Xyrem. Xyrem remains a key driver of our growth. In the second quarter of 2013, we were pleased to achieve 12% volume growth compared to the same period of 2012. The average number of active Xyrem patients grew to approximately 10,700 this quarter compared to 9,850 in the same period of 2012. Our efforts last year to expand our prescriber universe have contributed to continued growth during 2013. During the quarter, we continued to see prescription growth from the mid-and low-decile physicians and we added approximately 2,500 physicians to our call universe. We believe this expansion of our call universe is important to our objective to sustain the strong growth of Xyrem. During the second quarter, we supported ongoing education efforts to raise awareness of the diagnosis and treatment of narcolepsy patients through a comprehensive disease-state education such as Narcolepsy Link and our continuing medical education event at the June SLEEP Meeting, which had more than 500 attendees. We've invested in select research and development initiatives, including supporting 8 abstracts presented during the recent SLEEP meeting, many of which highlighted the increased burden of illness in patients with narcolepsy, including co-morbidities, and significantly higher cost of health care and drug utilization. We continue our efforts to strengthen and broaden our intellectual property related to Xyrem, 2 new patents issued in June. This gives us 13 U.S. patents related to Xyrem's stable and microbially-resistant formulation, its manufacturing process and its method of use, including its restricted distribution system. Additional patent applications are pending, including applications we filed around new discoveries related to Xyrem, which, if issued, could extend our patent estate beyond the life of the current patents. We are pleased to report that earlier this month, we received a close-out letter from the FDA with respect to the October 2011 warning letter issued to the company. As you may recall, the warning letter was related to certain aspects of our adverse event reporting system for Xyrem and drug safety procedures. And we responded to FDA with a comprehensive review of our activities to strengthen our policies, procedures, personnel and systems. For background, the FDA issues a close-out letter once they've completed an evaluation of corrective actions undertaken in response to a warning letter and conclude based on their evaluation, the corrective actions have addressed the violations contained in the warning letter. We believe that this marks the completion of the FDA's review of our systems and procedures related to the October 2011 warning letter and associated Form 483s. We continue to invest in Lifecycle Management for Xyrem, as well as development of new potential products that may improve upon Xyrem. Our preclinical efforts on JZP-386, the deuterium-modified sodium oxybate license from Concert, are ongoing. We plan to submit a regulatory filing by year end to support a first in human trial. Now let's turn to Erwinaze, which continues to perform very well. We are pleased with the strong growth of this product as we continue to add new accounts and seek consistent reordering patterns. We believe that our efforts to educate health care providers on identifying hypersensitivity reactions to E. coli-derived asparaginase in acute lymphoblastic leukemia patients and to reinforce the importance of continued asparaginase therapy, have supported greater utilization of Erwinaze. We believe that our short-term growth will be driven by these efforts, while for longer term growth, we believe that the evaluation and the adoption of an asparaginase activity assay into ALL protocol as part of a therapeutic drug monitoring process will be important, as well as increased utilization in the adolescent and young adult population. In May, we advised investors that our most recent batch of Erwinaze was out of specification and that we were working to avoid supply disruption. We are pleased that we received approval from the Medicines and Healthcare Products Regulatory Agency in the U.K. for a batch-specific variation, which means that this batch is approved for use in the U.K., other markets that accept the U.K. approved packaging and markets where Erwinaze is provided on a name-to-patient basis. The FDA has also allowed the distribution of this batch in the U.S. We anticipate that these regulatory approvals will prevent the potential supply disruption this year that was of concern at the time of our May investor call. And we continually -- continue to carefully manage available supply to meet patient demand. We're also working with the manufacturer of Erwinaze to evaluate potential steps to increase the supply of Erwinaze over the longer term to address expected growing worldwide demand. We are also pursuing R&D initiatives to support our oncology franchise. We have completed patient enrollment in our ongoing trial evaluating the intravenous mode of administration for Erwinaze, and anticipate data in the fourth quarter. We are also working with hematologists and oncologists to design a study in adolescent and young adult patients and are targeting the start of this study for late this year. Finally, we're pleased to announce that we received fast-track designation from the FDA for Asparec, a PEGylated recombinant Erwinia-derived asparaginase molecule to treat patients with acute lymphoblastic leukemia. Based on data from our ongoing Phase I study in adults in Europe, we are working with potential investigators to start our next study in children as quickly as possible. Next, I'd like to comment on Prialt, our non-opioid intrathecally-administered drug for adults with severe chronic pain. Our NAVIGATOR program provides integrated pharmacy and reimbursement services, including patient-specific reimbursement assessment and enhanced pharmacy services, as well as access to our specialty pharmacy. Enrollment into this program is progressing with over 90% of accounts enrolled. While we've seen growth in the number of accounts enrolled thus far, we recognize this is a time of transition and sales in the second quarter were impacted by the transition to an exclusive specialty pharmacy. The reimbursement services have been well received by patients and their physicians. Beyond The NAVIGATOR program, we're pleased to announce further collaboration with Medtronic, the market leader in intrathecal pumps. In May, we announced our initial collaboration with Medtronic, which was focused on implementing joint speaker, physician education and training programs. We anticipate hosting around 50 joint speaker programs in 2013. During the second quarter, we expanded our partnership to include the sales force collaboration that leverages the strengths of Medtronic's drug delivery sales representatives and our Prialt specialty sales consultants to target opportunities to meet the needs of customers and their patients. Our sales consultants will promote the general positioning of the SynchroMed II Infusion System, and Medtronic representatives will promote the general positioning of Prialt. We also launched our Prialt registry, known as PRIZM, or Patient Registry of Intrathecal Ziconotide Management, to evaluate the effectiveness of Prialt therapy for the management of severe chronic pain through the reporting of patient outcomes. We plan to enroll approximately 140 patients in this observational study in the United States. The first investigators site was initiated in June. Although we are early in the implementation of these initiatives, we believe that they position Prialt for future growth. Kate, let me now turn the call over to you.

Thanks, Bruce, and good afternoon, everyone. Beginning with the top line, total revenues for the quarter were $208 million compared to $124 million in the same period last year. This increase was primarily driven by inclusion of revenues from the acquired use of pharma business and increased sales of Xyrem. We expect strong top line growth to continue and are raising our guidance today to reflect total revenues in the range of $860 million to $880 million, up 47% to 50% on an actual basis, and 29% to 32% on a pro forma basis from 2012. Net sales of Xyrem for the quarter were $134 million compared to $89 million in the second quarter last year. We were pleased with year-over-year volume growth of 13.5% for the first half of 2013, reflecting solid growth in the active patient pool. We continue to see higher utilization of our coupon program since we made the program more favorable to patients last summer. This has resulted in higher gross to net deductions which are likely to continue to impact year-over-year net sales comparisons this year. We implemented a 14% price increase on July 15. Based on the new price and our expectation of low-double digit volume growth for the year, we are raising our Xyrem net sales guidance for 2013 by $20 million on the lower end and $15 million on the upper end to a new range of $560 million to $570 million. This range represents year-over-year growth of 48% to 50% in 2013. Turning to Erwinaze, second quarter worldwide net sales were $45 million, up 36% from pro forma net sales of $33 million in last year's second quarter. We are pleased with the strong demand that we have observed, particularly in the U.S. Because we are now more confident about our ability to supply the market this year, we are raising our guidance for worldwide Erwinaze sales by $20 million on the lower end and by $5 million on the upper end, to a new range of $170 million to $180 million. This range represents pro forma year-over-year growth of 29% to 36% in 2013. Net sales of Prialt were $5 million in the quarter. On a pro forma basis, net sales were $6 million for the same period in 2012. As Bruce said, net sales were impacted by the transition to an exclusive specialty pharmacy, part of the NAVIGATOR program for Prialt that became effective during the quarter. We mentioned on last quarter's call that we expected to make our annual shipment of Prialt to [indiscernible] for the European market in mid-2013, and we made that shipment in July, and this will be reflected in the third quarter net sales. As a reminder, sales of Prialt have a high after-tax margin. Net sales of our psychiatry products were $12 million in the second quarter, down from pro forma net sales of $20 million for the same period last year. Second quarter 2013 net sales were impacted by continued generic competition for Luvox CR and low-dosed FazaClo. We have an update on Versacloz, our new product for treatment of patients with treatment-resistant schizophrenia and for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizo-affective disorder. We currently anticipate launching the product in the first quarter next year which is when we now expect to have received launch quantities from the third-party manufacturer who licenses Versacloz to us. Combined SG&A and R&D expenses for the quarter totaled $87 million compared to $60 million for the same period last year. Adjusted combined SG&A and R&D expenses for the quarter were $71 million or 34% of revenues compared to $44 million or 35% of revenues in the second quarter last year. Note that operating expenses in the second quarter last year included only about 2 weeks of expenses from the use of pharma, which impacts the year-over-year comparisons. On a sequential basis, adjusted combined SG&A and R&D expenses increased by $8 million over the first quarter of 2013, as we geared up the number of investment initiatives across the company, including investments in Xyrem awareness and professional education initiatives, medical education, sales and promotional expenses, R&D investment primarily relating to clinical studies, corporate development evaluations and integration preparedness. Worldwide headcount increased to approximately 660 as of June 30 compared to 605 at the beginning of the year, as we're expanding our operations this year to enable continued growth of our business. As a result of our plans to continue to make appropriate investments, we are increasing our guidance for adjusted combined SG&A and R&D expenses to a total of $280 million to $290 million, or 32% to 34% of revenues. Turning to taxes. Our adjusted effective tax rate for the second quarter was 18%. We continue to expect our 2013 adjusted effective tax rate to be in the high-teens. The GAAP effective tax rate for 2013, which is impacted by various noncash items, is expected to be approximately 36%. We reported adjusted net income of $88 million or $1.43 per share for the quarter, compared to $66 million or $1.09 per share for the second quarter a year ago. In 2013, we continue to expect substantial growth in the bottom line as reflected in our guidance of $381 million to $393 million of adjusted net income. We're increasing our guidance for adjusted EPS to a range of $6.20 to $6.40, which represents growth of 29% to 33% in 2013. Our liquidity position remains strong as we ended June with $504 million in cash, plus an undrawn $200 million revolver. I'll note that networking capital has increased significantly this year due largely to growth in accounts receivable, primarily related to a change in payment terms with a large customer in connection with the elimination of a prompt paid discount, as well as the timing of income tax payments. In June, we amended our credit agreement and repriced our term loans and revolver at attractive interest rates. The interest rate on our term loans is currently 3.5% compared to 5.25%, previously. We also were able to secure more favorable covenants and other terms in the amended agreements. We expect to generate significant cash from operations over the balance of the year, and intend to use a portion of that cash to continue with our previously announced $200 million share repurchase program. We began our share repurchase program in May, and as of June 30, we had acquired approximately 846,000 shares for $54 million at an average price of $63. In closing, we are very pleased with the strong results for the first half of this year, the momentum in our business and our preparedness for potential new corporate development transactions. Thank you for joining us on the call today. I'll now ask the operator to open the line for your questions.

[Operator Instructions] Your first question, which is in the line of Louise Chen from Guggenheim.

First one I had was on business development. Sounds like you're increasingly positive on the prospects for doing a deal. You mentioned it a couple of times and I noticed some language in the press release, so I was just curious, first of all, how should we think about the access to capital you have for M&A and business development? And then are you seeing better opportunities in pipeline drugs or commercial products, where is your focus here? And then second question I had was on Erwinaze. And speaking with you all, it seems like the sustainability of those sales and the product opportunity may be underappreciated. So just curious, will you comment more on that and also the market opportunity for Asparec.

Okay, Louise. Let's start with the business development question and maybe I'll ask Kate to comment on access to capital and a little bit about where our current focus is.

Thanks, Bruce. So I would say that we've got excellent access to capital. I commented that our cash balance is north of $500 million, and we have a $200 million undrawn revolver. We also have, as you can see from our profit figures, you can see that our leverage ratio is very manageable. So I think today, we've got very good access to attractively priced capital to finance good transactions. In terms of where we've seen good opportunities, pipeline versus commercial, we've said all along and we continue to say that our first priority is looking at products that are currently on the market or near to market. And so, as we orient our BD activities, that's where we're spending most of our time. That said, we do also look at development stage assets that could become complementary to existing products. And I would say across the board, we do see a number of opportunities that could be interesting. And we remain optimistic, as you pointed out, and we've done a lot of preparedness work so far this year to make sure that when we execute that next transaction, we're ready.

And Louise, on your question about Erwinaze being underappreciated, your word, not mine, although I like that word. We're really thrilled with how we've performed in our first 12 months post the EUSA acquisition which closed last June. And I think we're seeing really good momentum in Erwinaze, if you look at what's happened in the fourth quarter, first quarter and second quarter, and I think we've got the team together that's going to continue to execute on that opportunity. And as I said, I think we're making the right investments to continue that momentum, even looking beyond the place we're spending all of our time right now, which is just making sure people recognize, appropriately recognize hypersensitivity reactions to E. coli asparaginase. In terms of the market opportunity for Asparec, I think we've mentioned there are couple of advantages to that product as we move it through development and hopefully onto the market. One of those advantages being the PEGylation, which offers the opportunity for reduced dosing frequency, which would clearly be a positive in treaters and patients. Obviously, it has some other advantages to us, too, including the production technology. And we also have, we think, a potentially better margin on that product, long term. So even if it only replaced the current market, it would be a big plus, but I think it has the potential to be a better product on a couple different dimensions.

The next question comes from the line of Michael Schmidt from Leerink Swann.

I had a follow-up on business development. I was wondering what your most recent thoughts are on divestiture of the psychiatry business and whether if you choose to do that, whether that would change or affect your tax rate in any way? And my second question is on Xyrem, I was wondering if there are any updates on the legal process for Roxane and whether you could provide some more color on growth with Xyrem. It sounds like you may increase your call universe, if I understood that correctly, in your prepared remarks over the rest of the year.

Yes, so Michael, I think I have no comment on the first question. We are actively promoting FazaClo HD. We also have good continuing sales of FazaClo LD, and as Kate said, we're frankly gearing up for a product launch coming up. So probably not the right time to talk about a divestiture of that business and I'll punt on your second part of that question, what it would do to tax rate for the same reason. On the Xyrem legal process, not a lot of update. We continue to be involved in ongoing litigation with the 2 ANDA filers. And we're still a ways away from critical dates as we've laid out before in those matters. We did obviously announce our receipt of a couple more patents recently amidst comments about our continued effort on that front. But frankly, not a lot new developments, I would say, since our last call. And Russ, maybe I'll ask you to address Xyrem growth prospects and call universe.

Yes. So we're currently seeing nice growth with Xyrem from the lower deciles, and so as we've looked for potential opportunities to grow Xyrem, we see that through different methods of triangulation and buying data, we've learned that there is about another 2,500 physicians that we potentially could add to our call universe. We have effectively done that and now calling out to see what percentage of that is actually real and meaningful. So we'll report in that in the quarters ahead, but we're certainly looking at what potential could be there.

The next question is from Douglas Tsao from Barclays.

Just following up on that last question. Perhaps, Russ, what types of physicians would be the expanded -- just perhaps a little bit more color in terms of what kind of doctors these are and generally who they're treating and why you think they might be good targets for Xyrem?

Well, if you look at the 2,500, about 500 of those are deemed Board-Certified SLEEP physicians. And we believe those 500 potentially have the most upside for us. Given that balance of them are an amalgamation of pulmonologists, neurologists, psychiatrists, handful of GPs, FPs. So to get into the profiling process, we'll take a little bit of time for us to understand how much is really there. But that 500 that we see as BCS, Board-Certified SLEEP medicine certainly potentially have some upside.

Okay. And then Bruce, in terms of the manufacturing issues for Erwinaze, obviously it's good to hear that you are actually going to be able to sell that lot. I was curious if you were able to determine what exactly went wrong to create this variance and whether this has been addressed?

Yes, good question, Doug. And I think as I've said, at least preliminarily around the time of last call, what I can say a little more umph now is, we do believe we understand what happened. And that what happened was sort of a batch-specific issue as opposed to an ongoing general process problem or uncertainty for production on an ongoing basis. So that gives us comfort that we don't have a continuing problem. We have cautioned people and you'll see in our risk factor language in the 10-Q that we're operating without as much excess capacity as we'd like. And what that translates into in practical terms is we can't build up the kind of the safety stock we'd love to have for a product that's as important to these patients as Erwinaze is. And therefore, while that one issue in my mind doesn't go into the continuing bucket, it's still important that we don't have any other issues that we continue to manage production with our partner very well and that we continue our efforts as we said we are continuing our efforts to look for ways to continue to expand that available capacity. So that we do have more comfort going forward that we won't run into a similar issue in the future. So I think it's good news certainly with respect to this one batch. We don't see it as a continuing problem, but it's also incumbent on us to do a really good job managing our supply situation so that we can continue to see the kind of growth we've seen with the product. And ultimately, our ability to treat more patients with ALL.

Okay. And then just one final question. Kate, in terms of the guidance on spending, we've obviously saw higher spend this quarter. And you seem to be guiding for a higher spend for the rest of the year in terms for both SG&A and R&D, or certainly on a consolidated level. I just wonder if you could provide a little color in terms of what is -- drove the spend this quarter, and sort of how we should think about it in the balance of the year, and in particular for the respective third quarter and fourth quarter, any trends that we should be cognizant of when we are modeling?

Yes, so Doug, in my prepared remarks, I listed a number of investment initiatives that we're making to support near-term and longer-term growth of the business. Investments in support of Xyrem, Erwinaze, their clinical trial activities associated with the pipeline. Medical affairs spending. I also highlighted that we've undertaken an initiative across the company to do some appropriate beefing up of some functions to make sure that when we do identify that next BD transaction, that we've got all the back office systems and processes that we need. So we're intentionally investing to be ready. So I would say that another thing I highlighted is the growth in headcount, it's up about 10% year-to-date. And so as we've got more people on board, more people are able to help us continue to invest more. So I think what we're trying to signal with the increased expense guidance is that people should not be expecting operating expenses to go down in the second half of the year as we likely expect them to trend up a bit.

And I think, Doug, one of the things you're seeing is some of the leverage in our model that were increasing expenses, but not decreasing our margins. And that's a great thing when you've got the kind of top line revenue growth we've got. And so as we sit here and manage the company and make short-term decisions about what we're going to spend this year, we think it's the right and smart thing to do for us to make some of those investments that we think will have payoffs, not just in this year but in years to come, and we're confident we're doing that.

Bruce, just a quick follow-up, should we interpret this as a signal that you're sort of taking the luxury of higher sales to reinvest in the business?

I wouldn't phrase it exactly that way, Doug. The key when we make an investment is that we're confident we'll make a good return on that investment. And the fact that we do have more sort of available room to invest is part of the equation, but it's not the whole equation. And if we weren't confident that some of the investments we're making would continue to drive growth, then it wouldn't be a good idea to make them. But we'd have to go through it product-by-product, but it's really a bullish line, I think, for where we see these franchises going.

The next question comes from the line of Bill Tanner from Lazard Capital Markets.

I have a few. Kate, just back on your comments as it relates to where the company is investing. I'm wondering, I don't know if you care to provide any more color as to how much of that incremental investment either percentage or dollar wise, is being directed towards the core business or the base business and how much of that is being directed towards prepping for future business opportunities?

Well, I think the only directional guidance I could point you to, as you can see, the breakout between R&D and SG&A in our financials and so you can see that R&D did tick up second quarter over first quarter. And we mentioned today that the various trials that are underway and planned. And so I think you can expect over time as we've always said, some increase R&D spend. But as far as trying to give you some breakout any further of the SG&A spend, I don't think that's something that we're prepared to do today.

Okay. And then maybe a question for Russ or a couple of questions for Russ. Just curious if there's any change in the Xyrem calling effort that's been made. I think, as I recall, there are 80, 85 or so sales reps and it sounds like with an incremental 2,500 physicians that could be targeted, that seems like something that's reasonable to contemplate. So just curious if anything has been done or what's the anticipation for potentially, I guess, putting more feet out there?

Yes, Bill. As you know, we've been adding physicians to our universe for some time now. And with that, we've continued to see that those physicians that we've added, a percentage of them actually had been bearing fruit. We did add a handful of reps actually during the course of the last 6 months just to see if there were some incremental benefit. And so we're going to look at this next 2,500 and see what's there. If we think that there's more there, we could consider doing more. But at this point in time, I really want to make sure we understand exactly what's there.

And then I appreciate the fact that it's relatively soon after the recent price increase, but just be interested in any reaction that you've seen in the market and then as to whether or not there's been a change in the trend in prior auth [authorization], it seems like, as I recall in the past, maybe the rate of prior auth has going up, but the ultimate approval for on-label has not really changed.

Yes, Bill. It's been a short period of time so a little too early to call. But having said that, we continue to see prior auth go up about a point a month and that's been pretty consistent for some time now, and we haven't seen any overall changes.

Okay. And then I guess the last question. Maybe, Bruce, just on you mentioned to close out the warning letter, anything noteworthy in that other than it's been closed out?

I think I'll stick with it's been closed out, which we're thrilled about. We know FDA is always balancing a ton of priorities at any moment in time. And so we frankly had some uncertainty which we shared with all of you about what the ultimate timing of that would be, given our early in the year request to get to close out. I'm frankly impressed they got to it on this timeframe, I'm appreciative they got it on this timeframe. But this reflected a lot of hard work on the parts of many, many people in our company, and collaboratively with our Central Pharmacy which does a great job for us with this drug. And I think this recognizes changes we made quite some time ago. And our job is to make sure we continue to do a great job with that going forward. And to make sure that, as we look at not only our existing franchises, but our expansion opportunities through corporate development, that we're well positioned to do a good job on this across our portfolio.

The next question comes from the line of David Amsellem from Piper Jaffray.

A question on Prialt. How do you get the sales moving? Do you think that it's just a function of more promotion and the initiatives you're talking about -- you talked about earlier in your prepared remarks? Or are you encountering some real deep-seated biases that stem from the products checkered history, how should we think about that?

Yes, I'll start, and I'll let Russ fill in. We identified an action plan for Prialt quite some time ago which had a number of components we felt we needed to execute on. One was making sure we addressed concerns we saw raised in our market research on the reimbursement side to make sure we were doing all we could to make sure that a perceived reimbursement difficulty is even more than actual reimbursement difficulties didn't dissuade doctors from using Prialt where it would be a good alternative for their appropriate patients. So we've done a lot in that regard, and much of that, we put under the banner of the NAVIGATOR system that we've rolled out, and which, at this point, is essentially up fully rolled out, although that's a fairly recent phenomenon. We also said we needed to give physicians experience using this drug to make sure they understand how you bring new patients on, how you titrate patients, particularly those physicians who have little experience or frankly had a negative experience quite some time ago on the initial launch of the product. And so getting that registry trial open, which it now is, I think, gives some of those physicians an opportunity to not only get experience with the product, but frankly, to collect data as part of that, share that data amongst that group and ultimately publicly so that people have a better understanding for current use of the product. The newest piece of the puzzle, which was only announced in May and we sort of expanded later in the second quarter is the collaboration with Medtronic. And honestly, while we're early in that, we're pretty excited to be working together with Medtronic on this. I think both companies have an interest in making sure that these patients who really are at need of the best possible therapy understand that they and their treaters understand there's an alternative to the traditional approach of using opioids. And that for some patients, Prialt is going to be a great answer. And so if you combine all of these efforts, which we just went exclusive on specialty pharmacy in the second quarter, we just initiated our first site for the registry in the second quarter. We just kicked off the Medtronic collaboration in the second quarter, yes, we're pretty excited about where we can go from here. But all of those initiatives required a lot of work to get them, to the point where they were operational. We've had people working on these initiatives, in some cases, more than a year. And now is our opportunity to see what we can do, having done the experiment we wanted to do, which is addressing those things that we thought were limiting the current use of the product unnecessarily.

Okay, very helpful. Just switching gears to the deuterated Xyrem and development with Concert. You mentioned the IND filing. I guess the question is, when is the earliest, we could potentially see the first look at some PK data from the product? And just give us a sense of what the next steps are after the IND?

Yes, David, let me have Jeff to address that.

So David, actually we're looking at a couple of different regulatory path. Given the fact that we're calling JZP-386 the deuterated Xyrem, is a Schedule I drug. There are certain DEA regulations, et cetera, that apply to sites in the U.S. so that IND is not really the gating factor here in the U.S. We're also looking at other regulatory territories such as Europe and whether or not we can do it a little bit faster going there. So that's ongoing and we're going to be seeing how that plays out over the next several months. As far as when you're going to see data, it really is very dependent on which patent are being the most fruitful. And so, but don't start looking for data well into next year, I think.

The next question comes from the line of Ami Fadia from UBS.

A couple of questions. Firstly on Xyrem. You talked about some couponing programs that are impacting the gross to net. Could you elaborate a little bit more around what's that impact, maybe, as a percent of sales? Secondly on the patent, the addition of patents that are -- currently have been applied for and then you kind of indicated on the call that you expect those patents to take Xyrem's life beyond the existing patents. So if you could care to elaborate on what type of patents those are? And then lastly, if you can give us an update on FDA discussion, the discussion with FDA on the REMS program for Xyrem.

Okay, let me ask Kate to take the first one on the gross to net for Xyrem.

So the comment that we made was, the fact that we've made our coupon program more generous to patients last summer has resulted, as you would expect, in increased utilization of the coupons. And we record that expense in our gross to net. So as a deduction from net sales, and a deduction to arrive at net sales, I should say. And so the impact has been a slight uptick. I don't think I want to quantify it exactly for you, but a modest uptick in our overall gross to net for Xyrem. And we've said, historically, that Xyrem gross to net were -- tended to be in the low-double digits, and so it's up just slightly from that.

On your question on additional patents where we filed that have the potential for a patent life beyond the life of already issued patents, I think I'll decline to specify at this point what types of patents those are. If and when those move not to be patent applications, but actual patents will have something to talk about. But the point I was trying to make by bringing that up is not every one of our additional patent applications necessarily is in the families of the patents that have already been issued where we tend to get more patents with the same expiration dates. And you can imagine if we're talking about ongoing work we're doing now, or recently, potentially you've got very, very significant new patent life, but that obviously depends on what happens at the PTO. On your question about where we are with the FDA on REMS, really no additional update at this point, conversations continue. I think we said at the time of the last call, we were in discussions, we couldn't really predict when those would get all the way to completion, which would be ultimately reflected in all of you seeing updated label in REMS to reflect that final agreement. We're obviously not there yet. And there isn't a hard and fast timeline I could give you for when we'll get there. We're interested in finishing that process, but we need to work closely with FDA to make sure we do that in the best way.

Great. Just a separate question on corporate development. What is your philosophy in terms of what types of products you might like to bring in? Is there any therapeutic focus or would you look for some type of an opportunity to leverage the existing sales force or not? And then just lastly, is it possible to give us a split of the U.S. versus O-U.S. sales for Erwinaze?

Yes, I'll take the first one and maybe ask Kate to take the second one. So on the first one, in terms of what types of products are most interest to us, we've tried to be clear in helping people understand how to look at our business model. And what we think we're good at and where we think we can add real value. And that's really the area of highly specialized products, products that would be sold to a fairly narrow audience of physicians where we can take a relatively small but highly trained sales force and go into a specialist physician population, and really be get a good outcome for patients with a differentiated product. In the case of Erwinaze, which absolutely fits that model beautifully, it didn't happen to be in the therapeutic category we were already in. And so you could argue that it didn't leverage an existing sales force. That's true. We effectively brought in a new sales force, but that sales force consisted of slightly over 20 people. While at the same time, I would say we did leverage many other parts of our organization in terms of the types of expertise we bring to a specialty sale, and I don't just mean commercial resources but resources across the company. So that continues to be true as we look at new products, we will look at new therapeutic categories that fits that model. But no doubt, if we could find products that also happen to fit our existing therapeutic expertise and would leverage existing commercial sales force, because that would be great. We're not against that, but we're not limiting ourselves to that. And Kate, why don't you take the Erwinaze question.

Yes. So we have commented in the past that U.S. Erwinaze sales for more than 3 quarters worldwide sales. And we've also noted that growth rate of sales is higher in the U.S. than ex-U.S. And so we would expect somewhat of a trend upwards in that U.S. mix.

The next question comes from the line of Annabel Samimy from Stifel. Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division: Just on the Erwinaze topic again. Have you, in the past, given any granularity on the number of patients that are on Erwinaze right now, the same way you give for Xyrem? And separately, could you -- you have some nice traction this quarter in terms of volumes. Can you characterize where the growth is coming from? Is it from just increased education of the nurses and recognizing hypersensitivity or is it increases in -- or changes in oncology protocols in terms of incorporating grade 2 hypersensitivity reactions into the protocol and treating earlier?

We have never given any detailed information in terms of patient numbers. And the reason for that is just tremendous variability in terms of numbers of doses that patients receive. What I can tell you is the growth is actually coming from a number of places. I will first say the sales team has really executed well, and they're fully resourced at a point where they're maximizing the opportunity. But if you look at exactly where it's coming from, you're seeing clearly an increased recognition of hypersensitivity. So doing a really nice job in education and training. But also adding new accounts and we've consistently seen new accounts come on board every quarter. And so some of the additional growth is coming from there as well. So pretty pleased with the first half of this year with Erwinaze.

The next question comes from Gene Mack from Brean Capital.

I Wanted to just follow up on earlier question about deuterated JZP-386. I'm just wondering, is there any -- do you have any additional clarity at this point on what -- how many pivotal trials and what sort of patient populations you might need to include for 386? Was that really going to be driven off the PK data or will you even know or is it just completely kind of a decision that the FDA is going to kind of come up with without really much -- without being really well informed from the PK data and just saying, well this is what it is and then -- in other words, will that pivotal program sort of done in a vacuum black box FDA decision-wise or is there anything about the PK data that will drive it, and can you talk about what you might think it would look like at this point?

I'll make some background comments, and then I'm going to ask Jeff to comment a little bit further. My background comments would be, if you look at the Xyrem development path, Xyrem showed strong efficacy with great statistical significance in relatively small numbers of patients. So if you're imagining the JZP-386 could have the potential to also be a very effective treatment for narcolepsy patients, I think and we don't know yet, because we don't have the data. But if that were to be the thesis, the assumption would be that from an efficacy standpoint, you wouldn't be looking at huge trials. Safety experience, you obviously want in a broader group of people as will be true of any program. In terms of how FDA and Jazz would use data or not to inform that decision, let me turn that over to Jeff.

Sure. So not dissimilar from any other development program, you want us to have good communications with FDA as you go along in the program. So discussions held during a pre-IND meeting helps inform you as to how they're thinking and what type of studies you need to do. But you are absolutely right. Much of it is going to depend on the data that we come out of the first PK study. And that will drive how extensively you can leverage the Xyrem data to provide that basic information on efficacy and safety, where you might be able to have a more streamlined approach to be able to confirm that with some additional trials. But again, it's difficult to say without those data. But we do hope that we can leverage the Xyrem data to make this a more efficient development path.

Okay. And then just for Russ, I'm wondering if you can give us any sort of color on how the AI biotech assay is tracking. Have you been able to get anything, any anecdotal from the field on how adoption of that assay is tracking? And then maybe have you guys been able to identify any other sort of new approaches to educating physicians on hypersensitivity and catching it early, [indiscernible] hypersensitivity as well?

So let me take the first part of the question, and I'll turn it over to Russ. On the AI biotech assay, I think the important thing to remember is that treatment of pediatric ALL patients is highly protocolized. And we think significant impact of the availability of that assay over time would probably come from adoption of protocols that include use of that assay. Having the assay become available in the first quarter this year was a necessary precondition for that and certainly enables people to think about of moving in that direction, but I don't think we'll see significant commercial impact, really, until it becomes part of that overall treatment approach across institutions. Russ, you want to talk about the hypersensitivity identification?

Yes, and I would just say that therapeutic drug monitoring is something that is done in Europe. And clearly, we're starting to see small number of physicians embrace that, and I think that, that goes hand-in-hand with the assay over time. So I think that it's very early days, but there's potential there. And then I think that overall, hypersensitivity identification is really just a matter of really hand-to-hand combat in the field and our people training and identifying and looking for and getting more comfortable with, and I think that we've done a very nice job with that. So we continue to see some growth there.

The next question is from the line of Ken Cacciatore from Colin.

But I would assume that your tax status is starting to gain a bit of attention out there. So I was wondering if you could just talk to us theoretically the value of this to you versus the value of it to others, and are you having to spend more and more time in discussions with folks as I would assume that, again, the lights have gone on that you all are quite in an interesting place with your tax status.

Ken, I the think you asked that in a perfectly artful way. There certainly has been some more attention, if you mean attention like media articles and other things. Having a competitive corporate tax rate and platform we think is critically important to us. We thought that when we originally combined with Azur, we thought that as we continue to grow as a company and certainly part of our ongoing strategy for creating value. We think it makes us a competitive bidder for other assets, and really allows us to maximize our investment in things that we think drive return for our shareholders and benefit patients. So it has enormous value to us as we think about where we are today and where we can go as a company, and we like our strategy for creating value. Could it also unlock value in other ways by being useful to someone else who wanted to combine forces with us? Absolutely. But I think our strategy is a good one for driving a lot of growth, top line, bottom line and ultimately a shareholder value. That's the plan we're executing on, and beyond that, probably not for me to comment.

And we're just going to take one further question from the line of Greg Gilbert from Merrill Lynch.

Maybe a little different twist on that, Bruce. I'm guessing you would acknowledge that we're in a unique time in the industry in terms of consolidation and how tax structure fits into that, and maybe how investors are rewarding that theme. I'm curious to know if that's -- if you agree, a and b, if that's shaping the kinds of deals you're considering now versus what you would have looked at 1 year or 2 ago. My other question is about Asparec and when is the soonest you could file that, recognizing you're not going to predict that as the base case, when is the fastest that you could get that filed?

Let me take the last part first and ask Jeff to comment a little bit on Asparec timeline, although you're going to be disappointed in his answer because we've really haven't said anything beyond what you're doing right now. But with that, Jeff, why don't you take that?

Right. Just to set the context for you, with the initial data that we've had from the Phase I study in Europe, were able to now begin discussions with the physicians here in the U.S., talking about a study in pediatric in the target population. We are in the middle of those discussions and negotiations, so I can't really tell you how that's going to come out as far as the structure and design of the trial. But certainly, they are moving forward. We are encouraged by that and think that we should be able to talk about some of the more specific issues related to that trial. I hesitate because when we're dealing with these types of groups, there's a lot of bureaucracy involved and things tend to move with quite a snail pace.

Greg, on your other question. Is this a unique time with respect to industry consolidation? Well, since I was in Wall Street in the '80s, I'm told every couple of years it's a unique time for consolidation. And everybody wants to diversify and then everybody wants to un-diversify, and then people want to go into specialty direction and then they want to go on a primary care direction, and then they want to go international, and then they want to be domestic. And so sure, it's a unique time for consolidation. But in the grand scheme of things, I don't think it changes what makes companies successful in this industry, which is ultimately having products that they bring to market through their own initiative or through deals that really meet a patient need, are differentiated, can be commercialized efficiently, which we focus on a lot through our model. And so, maybe there's a current wave of interest in one type of deal, but I don't think it changes the long game of what makes companies successful. And it has the types of deals we can look at, change over time? Absolutely, and in a great way. The addition of new capabilities to our company through the deals we've done, the expanded top line, the expanded margins, very helpful cash flow, the strengthening of the management team, I think have all put us in a position where we really can consider a broader set of opportunities today than we ever could have in the company's past. Now we still have to use some good discipline to choose the right opportunities from among that expanded set. But I really do think it puts us in great position. And I -- maybe tax rate is one small piece of that equation, but it's not all of it. The expertise we've shown in our strategy, I think, is a big piece of that, and I think we talked about all the investments we're making in Prialt where we think that can go, I think that's going to be a great story for people to watch. But I think people have already seen what we can do with Xyrem and they've seen what we can do with Erwinaze, and I think in addition to being smart in terms of what deals we do choose to pursue, we have a great story to tell potential partners in terms of how we can execute once we do complete the transaction. And I think that's important, too.

I would now like to turn the call over to Ms. Kathy Littrell for closing remarks.

All right. Well, thank you, everyone, for joining us today. We look forward to hearing from you if you have any further questions. And again, thanks for joining. Have a great evening. Bye-bye.

Thank you for joining in today's conference. This concludes the presentation. You are now disconnected and have a very good day.