Jazz Pharmaceuticals plc (JAZZ) Q3 2012 Earnings Report, Transcript and Summary

Ami Knoefler - Executive Director of Investor Relations & Corporate Communications 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 and Executive Vice President of Research & Development

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division Rebecca M. Forest - Piper Jaffray Companies, Research Division Gene Mack - Brean Murray, Carret & Co., LLC, Research Division Ken Cacciatore - Cowen and Company, LLC, Research Division William Tanner - Lazard Capital Markets LLC, Research Division Michael W. Schmidt - Leerink Swann LLC, Research Division Michael Faerm - Crédit Suisse AG, Research Division Douglas D. Tsao - Barclays Capital, Research Division Oren G. Livnat - Jefferies & Company, Inc., Research Division Christopher Holterhoff - Oppenheimer & Co. Inc., Research Division

Good day, ladies and gentlemen, and welcome to the Q3 2012 Jazz Pharmaceuticals Earnings Conference Call. My name is Kirsten, I'll be your operator for today. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. I'd now like to turn the call over to Ms. Ami Knoefler, Executive Director of Investor Relations. Please proceed.

Thank you for joining the Jazz Pharmaceuticals PLC Third Quarter 2012 Conference Call. Earlier today, we reported our financial results and updated guidance in a press release. The release is available in the News and Event section of the company's website. Our press release included quarterly and year-to-date net sales data for our key products on a pro-forma basis for products acquired this year, as well as some detail on our discontinued women's health business. 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 prepared comments, we'll open the call for your questions. Please note that certain remarks we make on this call constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to future events, future financial results, growth potential, financial guidance, pipeline opportunities, future regulatory and intellectual property matters and other statements relating to our plans, expectations and intentions. These forward-looking statements involve numerous risks and uncertainties that could cause our actual results to differ significantly from those projected, including risks and uncertainties associated with our ability to maintain and increase sales of and revenue from Xyrem, such as the potential introduction of generic competition and changed or increased regulatory restrictions on Xyrem, our ability to effectively commercialize our other products, including Erwinaze and Prialt, our need to obtain appropriate pricing and reimbursement for our products in an increasingly challenging environment, our ability to successfully integrate and grow our combined business operations following the Azur Pharma and EUSA Pharma transaction, our ability to protect intellectual property rights with respect to our products, and the difficulty and uncertainty of pharmaceutical product development, clinical success and regulatory approval. These and other risks related to our business are detailed in the SEC filings, including under the heading Risk Factors in our quarterly report on Form 10-Q for the quarter ended June 30, 2012. Our SEC filings and reports are available on our website. We undertake no duty or obligation to update any forward-looking statements contained on this call as a result of new information, future events or changes in our expectations. On this call, we discuss certain non-GAAP financial measures, including adjusted gross margins, combined SG&A and R&D expenses, and earnings per share. 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. A reconciliation of GAAP to adjusted financial measures is included in our press release issued earlier today, which is available on our website. We expect to file the Form 10-Q for the third quarter shortly. I'll now turn the call over to Bruce.

Thank you, Amy. Good afternoon, everyone and thank you for joining us. The third quarter was another great quarter of growth and execution at Jazz. We posted record revenues of $176 million from continuing operations, which reflects our first full quarter of revenues after our acquisition of the EUSA Pharma. As noted in our press release, results from continuing operations exclude our women's health business, which we divested in mid-October, raising nearly $100 million and enabling us to focus on our core business. During the quarter, we made important progress towards integrating the EUSA operations and strengthening our business for the long term. I'll center my comments today on the 3 products in our current portfolio that we think have the highest growth potential, Xyrem, Erwinaze and Prialt. Xyrem's third quarter revenues were bolstered by 9% year-over-year volume growth. During the quarter, we averaged approximately 10,200 patients on active treatment, up from just over 9,000 in the prior year's third quarter. The growth in the average active patient pool supports our view that the underlying organic volume growth for the Xyrem business for the full year will be in the low double-digits. While our historical volume growth has been aided by improvements in persistency and compliance, we are now seeing an uptick in new patient growth, driven by new and previously infrequent prescribers. We attribute some of the increase in new prescribers to our efforts over the past year and a half to identify and add approximately 1,000 physicians to our call universe. We can trace the number of the new Xyrem patients directly to this group. We are continuing to work on appropriate physician-targeting and refining the call universe with a particular focus on board-certified sleep specialists. This broadening of the prescriber base bodes well for continued patient growth and underscores the success of our single-product-focused sales force and the positive outcomes we are seeing from our physician education efforts. Our medical affairs team continues to engage with KOLs and we have supported independent research that seeks to further characterize the burden of narcolepsy and which is expected to result in publications of interest to the sleep community. In early October, at a well-attended American Neurological Association conference session, Dr. Maurice Ohayon from Stanford presented the results of a Jazz-funded study characterizing comorbidities in approximately 320 patients with narcolepsy relative to a control group representing the general population. The patients with narcolepsy were found to have significantly higher levels of heart disease, hypertension, hypercholesterolemia, digestive system disease, and upper respiratory tract disease. Collectively these data highlight that the burden of this debilitating disease is often significantly greater than widely recognized, underscoring the need for building greater disease awareness. We're also continuing to work to enhance and defend our intellectual property around Xyrem. We announced in September the issuance of our 10th patent related to Xyrem, the 650 patent, a formulation patent that was subsequently listed in the Orange Book. In early October, we received the notice of allowance for a method-of-use patent related to the method of administering sodium oxybate. We have several additional patent applications on file relating to our restrictive distribution system. As a result of the 650 patent issuance, we filed a new ANDA suit against Roxane. Our existing ANDA suit against Roxane has been temporarily stayed while the court determines whether to consolidate the cases. That decision is expected at the end of the year at the earliest and discovery is expected to resume after the decision. As part of our continued commitment to patients with narcolepsy, we recently provided support and sponsorships at the Annual Narcolepsy Network Meeting in October. This meeting was attended by over 300 patients with narcolepsy and their supporters who gathered for information related to the disease. The meeting also provided our company representatives an opportunity to better understand patient needs. Turning now to Erwinaze. We were pleased that in the midst of integration, the worldwide commercial team continued to execute and sales for the quarter were on track with expectations. During the quarter, we have focused on building enhanced sales and medical affairs teams to support Erwinaze, and we've added dedicated reimbursement specialists for the product. Our efforts during the third quarter also included activity at several conferences. We spoke with various thought leaders at the children's oncology group annual meeting and have received inputs from various advisors to help align our future medical education plans with the interests of the pediatric oncology community. We also had a strong presence at APHON, the oncology nursing conference held in early October. Since nurses play a key role in observing the symptoms of hypersensitivity to E. coli-based asparaginase, they are critical to timely detection and response. During the conference, a former oncology nurse presented to a standing room-only audience about the importance of identifying hypersensitivity to asparaginase treatment. This also points to a key component of our Erwinaze strategy, the importance of investing in education about the identification and grading of symptoms of hypersensitivity, which can often be overlooked or masked with steroids or antihistamines. Current guidelines and protocols emphasize the benefits of switching patients to Erwinaze as soon as a grade 2 hypersensitivity reaction is observed. Our job is to make sure that relevant medical professionals are well-educated regarding the grading system and the recommended course of treatment through a combined method by our medical and sales teams. Two more Erwinaze updates. First, a clinical trial evaluating the IV administration of our existing formulation of Erwinaze, and expected to begin enrolling patients in North America soon, with a number of centers already open for enrollment. You'll recall that the IV-routed delivery can be more comfortable and less painful for patients. We look forward to advancing this program in the coming year. Also we're pleased that an abstract offered by our medical team has been accepted for presentation at the American Society of Hematology conference, which will take place in early December. This will be the first conference presentation of data from the treatment IND program, known as the Erwinaze Master Treatment Protocol or EMTP. The abstract will characterize the safety of Erwinaze in more than 900 patients treated in the EMTP protocol, the largest group of patients studied to date. Looking forward, we continue to believe that there is significant potential for increased sales of Erwinaze across several growth areas. First, we continue to see the near-term opportunity for growth within the pediatric population. For example, new hospital accounts continue to increase and a total of 45 new accounts have ordered Erwinaze since its U.S. launch last year. And there will be an increased commercial focus on hospitals that participated in the treatment IND program, many of whom have not yet reordered the product. Erwinaze reimbursement is excellent. Longer-term, we continue to see significant opportunity for this product. We are planning to invest in medical education to increase awareness of asparaginase treatment. And we are considering additional research to expand knowledge of asparaginase in the adolescent and young adult populations. On the oncology R&D front, we're pleased with the progress at our European Phase I study for Asparec, our PEGylated recombinant, Erwinia-derived asparaginase product candidate and we anticipate submitting our U.S. IND for Asparec soon. We are excited about advancing this candidate as it can provide another important treatment option for patients with ALL. I'll now move to Prialt, the only non-opioid intrathecally-administered drug approved for severe refractory chronic pain. Prialt sales for the third quarter increased by 9% compared to the year-ago third quarter on a pro forma basis. We continue to make progress in core areas of focus for Prialt, including optimizing our sales efforts and increasing medical education and medical affairs support for the product. Prialt remains a long-term growth opportunity for our company. In the past few months, however, the most significant development related to Prialt is the first phase of implementation of our new centralized distribution hub called the NAVIGATOR Reimbursement and Access Program. Our sales team of 30 representatives is calling on key accounts to facilitate transition of the business [Audio Gap] new system. We expect several important benefits from the hub for patients and physicians. The first is reimbursement support. When a patient enrolls in the NAVIGATOR program, an experienced reimbursement professional will conduct a complete review of that patient's insurance coverage, which may include services in addition to drug cost reimbursement. So before the physician and patient access Prialt, both of them will know all of the reimbursement options available to them. For patients with commercial insurance, the hub will accept an assignment of benefits relieving the physician of potential financial burden or risk. Another benefit of the hub model is the pharmacy's ability to provide information to the physician about the dosing and administration of Prialt at that time of filling each prescription. We also expect to obtain valuable information about how the product is being utilized, paving the way for future targeted programs to support Prialt. Finally, I want to mention an additional corporate initiative that demonstrates our support for patients and their communities, as well as the values that are deeply ingrained in our growing organization. Earlier this week, we announced our sponsorship of the Medicine Abuse Project, an important public awareness initiative to help fight prescription medicine abuse in teens. Our support for this project reflects a long-standing commitment to patients and to overall public safety. Kate, let me now turn the call over to you.

Thanks, Bruce, and good afternoon, everyone. Reported net sales for the third quarter were $174 million, up over $100 million from the third quarter last year due to the addition of products from the 2 acquisitions we completed this year and strong growth of Xyrem. Note that we achieved an additional $8 million in revenues in the quarter from the now divested women's health business, which is shown as discontinued operations. Net sales of Xyrem were $103 million in the third quarter, up 64% year-over-year. I'll point out that there was a price increase on August 3, so the quarterly run rate is expected to be higher than $103 million going forward. Regarding volume growth in the quarter, the year-over-year comparison was negatively impacted by having one less shipping day during this year's third quarter, but the underlying momentum in the business remains strong. Reimbursement overall remains strong for Xyrem. The trend towards increasing rates of prior authorizations continues, however the approval rates remain very high. During the quarter, we reduced the thresholds on our coupon program from $75 to $35 in monthly out-of-pocket expenses. This has been very well-received by patients and providers. Despite the lower threshold of $35, less than 1/3 of patients accessed the coupon assistance program during the quarter. Today we are confirming our guidance for full-year Xyrem net sales in the range of $375 million to $380 million. Worldwide net sales of Erwinaze were $32 million in the third quarter. You'll recall that this product was approved by the FDA in November 2011, so pro forma year-on-year comparisons are less meaningful. Last quarter, we provided 2012 guidance for Erwinaze and we remain comfortable with that guidance. We continue to be excited by this product and its growth prospects. Net sales of our psychiatry products were $21 million for the third quarter, up 7% year-over-year on a pro forma basis. In this group, LUVOX CR sales grew approximately 20% over the prior year's third quarter. On a pro forma basis, FazaClo HD increased 32%, and net sales of FazaClo LD decreased 17%. As a reminder, our psychiatry sales force continues to focus on maintaining LUVOX CR sales by calling on high-volume prescribers of medicines for OCD, as well as maintaining FazaClo HD sales by maximizing its share of the higher dosage strength in the face of generic competition for the lower dosage strength. We also continue to pursue regulatory approval of an oral suspension form of clozapine, for which the PDUFA date has been moved to February 2013, due to our submission of some additional CMC data. Adjusted gross margins for the quarter was 87%, reflecting the addition of products from EUSA, and the divestment of the women's health business. For the full year, we expect adjusted gross margin to be 88% to 91%. Note that our full-year adjusted gross margin guidance reflects approximately $17 million to $18 million of purchase accounting inventory step up, which would leave about $3 million on the balance sheet at year-end. Adjusted combined SG&A and R&D expenses were $58 million in the quarter or 33% of revenue. These expenses increased by $14 million compared to the second quarter, primarily due to the addition of expenses related to the EUSA Pharma organization, including R&D expenses related to development programs. For the full year, we expect adjusted combined SG&A and R&D expenses to be $200 million to $205 million. The effective tax rate on adjusted income from continuing operations was 11% in the quarter, bringing the year-to-date rate to 9%. On the bottom line, our earnings continue to be strong. As you can see from our results detailed in today's press release, we're providing EPS for the third quarter for both our continuing and discontinued operations. On a combined basis, third quarter adjusted earnings were $1.34 per share, which includes $1.29 per share adjusted income from continuing operations. GAAP EPS for the third quarter of 2012 was $0.55 per share. Turning to some noteworthy items on the balance sheet, as of September 30, the assets of the women's health business, including intangible assets, goodwill and inventories, were consolidated into one line item classified as assets held for sale. Our cash balance is currently approximately $300 million, which includes the proceeds from the sale of those assets. We will record the gain on the sale, which is estimated to be approximately $34 million to $36 million, in the fourth quarter in discontinued operations. As noted in our press release today, we have updated our guidance for the year to remove the previously expected full year's revenues and expenses of the women's health business. We are also now providing gross margin and combined SG&A and R&D expense guidance on an adjusted basis. Important to note is that the difference between our prior total revenue guidance and our current guidance is $30 million, which is entirely due to the sale of our women's health business. The same holds true for our adjusted EPS guidance range, which has decreased by $0.05 to $0.10, which approximates the full-year contribution from women's health. In closing, we are very pleased with our performance for the quarter and year-to-date. We have a strong financial position, fueled by the success of our specialty products portfolio and we are well-positioned to pursue additional growth opportunities that align with our strategy. Thank you for joining us on the call today. I'll now ask the operator to open the line for your questions.

[Operator Instructions] First question comes from Louise Chen from Guggenheim.

I had a few questions. First question I had is what type of return on investment have you seen for the companies that you have acquired? And then the second question I had was what type of internal metrics do you use to analyze business development opportunities? And the last question I had is just on your pricing for Xyrem. We've obviously had a lot of questions on that. How sustainable do you feel that is going forward?

Okay. So Louise, on your first question, which is the rate of return we've seen on the investments we've made in our 2 recent acquisitions, I would say very much too early to tell. We for each of these had a strong rationale for the acquisition, both for strategic as well as financial reasons. I think we're performing well on both of those acquisitions, in line with what we laid out at the time we did them. But of course these were intended to really play out over many years, as we combine portfolios and companies and really take advantage of the growth opportunities in the existing portfolio, as well as, particularly in the case of EUSA, pursue some of the R&D programs that are underway. So we'll watch that over a number of years but so far so good, but tough to judge an acquisition like these in a short period of time, particularly with the growth we project. In terms of the metrics we use for business development opportunities, again we're looking for things that provide a good fit, growable products that are differentiated with good periods of exclusivity, something that we believe we can do a good job with in terms of helping more patients but on a financial basis, something that's going to provide us a great return and our primary focus on that is really looking at cash. What we're paying upfront, what we're getting back over time, as opposed to a near-term earnings accretion or some other calculation like that. We're really looking for true economic return over time. On the pricing question, why don't I have Russ address that.

Sure. So Xyrem remains the only FDA-approved product for the 2 key symptoms of narcolepsy, both cataplexy and excessive daytime sleepiness. And we do not see that there's any significant changes in the landscape in terms of the monitoring that we do on a regular basis, whether it's curing, whether it's looking at changes in reimbursement. We do note and we mentioned earlier in the script that we have seen an increase in prior authorization. And so we can comment that payors are looking at us, but no major changes in terms of the environment and we continue to monitor what we want to do on price.

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

It's Rebecca Forest for David. It's been a while since you've talked about the line extension possibilities for Xyrem. So on that context, are you exploring a way to eliminate the middle of the night dosing or develop a full solid formation?

So Rebecca, you're right to point out it's been a while since we've given an update on this. You may recall that, particularly as we were heading into our attempt to expand the label in fibromyalgia, which was unsuccessful, we had talked about both moving to solid oral dosage forms and potentially exploring eliminating middle of the night dosing. Those programs were deprioritized when we got the response from FDA, in large part because our market research have shown that our narcolepsy patients prefer the liquid formulation. Fibromyalgia patients preferred potentially a solid oral dosage form. And also, as we looked at the benefits to the company of having new dosage forms over time, part of that benefit was relative to our existing franchise protection around liquid formulation and that was at a time when I believe we had 2 patents covering Xyrem, both of them formulation patents. As you heard today, we're up to 10 patents issued with additional patents working their way through the system. So for all of those reasons, those programs have not been a high priority for the company.

Okay. And then, could you give any progress or update regarding the outstanding warning letter?

Yes. Maybe I'll ask Jeff to comment on that.

Well as we've commented in the past, we've been making progress towards resolving and moving towards close out of the warning letters and we believe that we've done a substantial amount of those efforts and are moving toward that point. I'm very confident that we'll be able to complete this process and we're looking forward to, as we work with the FDA, getting this done in the near future.

Your next question comes from the line of Gene Mack from Brean Capital. Gene Mack - Brean Murray, Carret & Co., LLC, Research Division: [indiscernible] questions, I had a few. First, on Xyrem, just a little more detail on the status of litigation. Did you include both patents in your, I guess, refiling or just the first -- the formulation patents since it was in the Orange Book? And do you expect maybe the method of use patent to get Orange Book listing or just a few details around that?

Yes, Gene, so it was just the one patent. The other one is not actually issued yet. Gene Mack - Brean Murray, Carret & Co., LLC, Research Division: Okay. And do you anticipate once it's issued that it would get recognized by -- on the Orange Book or...

I can't comment at this point. Gene Mack - Brean Murray, Carret & Co., LLC, Research Division: Okay. And then on Erwinaze, you mentioned that you're considering additional research in adolescents, young adults. Can you just give us an idea what kinds of things you might to be considering? I assume it's some kind of a clinical trial design. What size do you think that would be or what kind of spend would you think that would be?

Yes, probably too early to comment on that, Gene, until we're ready to announce specific efforts. But clearly we see that in the AYA population, there is use of asparaginase, there are a number of people that believe the use of asparaginase in protocols in that population produces good outcomes for those patients. And we know that, like in the pediatric population, some percentage of those patients are going to have hypersensitivity to the E. coli-derived asparaginase. And so making sure that over time, there's good understanding of when to use the Erwinia-derived asparaginase, I think is important for those patients and we'll be working with appropriate thought leaders and others just to make sure that we generated the right kind of data to support proper use of the product. Gene Mack - Brean Murray, Carret & Co., LLC, Research Division: Great. Can you give us an idea of what you think the incremental adoption might be with the IV formulation? How that might play out?

Yes, that's a tough one. I'll turn it over Russ after I make some intro comments for anything he wants to say quantitatively. But I'd say the primary motivation to move to the IV formulation is really for the benefit of the patients that are using the drug. We like to think that the intramuscular injection is not a barrier to use. It is the recommended therapy under many protocols, we think it produces the right benefit in those patients. But we certainly do hear anecdotal stories of patients, or given that they're pediatric patients, sometimes it's parents, who make the decision that continuing to subject their kids to multiple injections per treatment with multiple treatments per week is a significant burden and, in some cases, maybe one that they're not willing to tolerate over time. Russ, do you want to add anything to that?

Yes, Gene, I would just remind you that, in Europe, it's used IV already. And what we learned from that experience is that in some patients, you would find that instead of maybe giving a partial course, you'd be more willing to give a full course. So there is potentially some assistance that we're going to get in a larger dose as a result of having the IV formulation. But in general, it's the same formulation and we don't see a lot of [indiscernible] from that effect.

Your next question comes from the line of Ken Cacciatore from Cowen and Company.

I had a question about have you had any communication with Roxane in terms of sharing settlement ideas or is it all just legal discussions? And if not, why wouldn't you have sat down? Is it just too premature to swap some thoughts? Clearly no one likes you guys all spending money on lawyers and it seems like there's clearly a very reasonable pathway forward. So wondering if you could comment on that? And then from a business development standpoint, wondering if you would ever consider buying or making a major acquisition with programs in development or is it always going to be on marketed products? And then I might have a follow-up.

So Ken, I'll take the first question and then hand it over to Kate on the business development side. So we're in ongoing litigation and as has been true of past comments, we're really not going to speculate on potential settlement conversations with Roxane. And in terms of your comment that nobody likes spending money on lawyers, we're confident we're making a very good investment there.

Ken, this is Kate. In terms of business development, we do absolutely look at things that are development-stage. And as you know, we've always said R&D is an important part of our strategy for long-term success. So our top priority continues to be products on the market or close to market but we do from time to time look at things that are in Phase II or even a little earlier if they're a great strategic fit.

Your next question comes from the line of Dale (sic) [Bill] Tanner.

Kate, you actually answered it at the very end but I just wanted to see where I'm thinking about this incorrectly. But it certainly seems like you guys maybe bumped up guidance a little bit for the business x women's health. I mean, if we just think about the contribution of the third quarter and assume that over the course of the year, obviously you took the guidance down by less than what that might imply. So wondering if that's -- if you could help me understand where that's not the right thinking?

Well, I would call it more on the order of fine-tuning, Bill. We've only got a quarter to go so it's getting easier to forecast this. But I wouldn't disagree with your general observation.

Okay. And then, Bruce or Russ, I had a question on Prialt, on the hub. I think when you guys have talked about the importance of it in the past, it has been from a reimbursement perspective. So I guess the question is, is it reasonable to assume with this hub in place that, I guess, the value proposition of Prialt will be more actively managed? You sort of understand what...

Yes. So I'll start and then hand it over to Russ. So I'll just point out, for the sake of being perfectly clear with you guys, that we try to say we're in the process of rolling this out, we certainly have accounts already signed up. We're pleased with what we're seeing but I hesitate to go all to way to, "Now that you've done that." Because it's in process and we'll continue to work on that in the weeks to come. Russ?

Yes. And Bill, the market research is very clear on Prialt, that the single biggest obstacle with the use of Prialt is fear of getting reimbursed. And so what the hub clearly does for us is it gives physicians a look at what is the potential options for patients. And so with that, I think that we're in a but much better position for them to make decisions about what's the right thing for patients as opposed to, "Am I going to get reimbursed?"

But I guess, maybe to ask the question a little bit more directly. It seems like this was an opportunity for the company to potentially change the -- increase the price of the drug. Is that something that we should think about is, at some point in time, is it still on the cards?

So I think we put the hub in place primarily to make sure that we were maximizing the opportunity to increase demand and overcome the obstacle that physicians have in terms of fear of reimbursement. I think from there, you have to look at what is the uptake and what we're learning from the hub. We're obviously going to get a lot of data and a better understanding of the kinds of patients. So no decision has been made beyond that.

Okay. And then maybe one last question. Just, Bruce, procedurally, from a legal perspective, obviously with the 650 patent, I think if you read the core documents, the discovery has been stayed and you did mention that you've got a number of other patents winding their way through the PTO. So is this something that is going to be a routine speed bumps to the progress of the ongoing litigation, that you're going to have patents issued? There are going to be P4 challenges, they're going to be consolidated in discovery and the trial writ large is going to be stayed?

Well again, we have patents on file and we're certainly optimistic that one or more of those will issue but until they issue it's kind of tough to say what will happen. And an even on the one that has issued, where we've been in the front of the judge on it, no decision has yet been made on whether that will be consolidated. So let's see where that turns out but I wouldn't say it's a safe assumption to just assume this is a repeating pattern. It's not necessarily true that all patents would need to be combined into one litigation.

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

I have one question on Xyrem. Is there any seasonality around volumes throughout the year? And secondly, could you comment on the dynamics following a price increase. I think at some point previously, you mentioned there is a higher discounting following a price increase. I was wondering if there's also an inventory effect maybe?

So Michael, historically, we've said we don't particularly see seasonality. We see differences between quarters in number of shipping days. We see some patterns relating to people clicking over into new deductibles on insurance, changes in payer plans that tend to happen more often in the first quarter than other quarters, but we don't think of it as seasonality in the way that you usually think of seasonality with drugs, meaning incidence of disease or the treatment pattern is changing over time. In terms of a particular pattern after a price increase, we haven't seen that. And I'll remind everybody that we actually are recording sales on shipments from the central pharmacy directly to patients. So there is no sort of pipeline effect as you may see with other drugs.

All right. Okay. And on the psychiatry business unit, I guess, there are 2 main near-term factors that may influence the business overall, the clozapine oral solution PDUFA date in January, and then the fate of LUVOX CR. It's not generic yet and we don't know when it may go generic. So I was just wondering how those 2 factors might influence your strategic decision around that business?

I would say for the psychiatry group right now we have a very clear focus, which is continuing to ensure that we're calling on LUVOX CR -- productive LUVOX CR writers, people who treat OCD and have shown that this is a product they use and also focusing very much on FazaClo HD where we don't currently have generic competition. You're right to say we've got a couple of things coming up in the next year that will obviously be important drivers of that business. One is the February PDUFA date for the clozapine oral solution and we'll see if we've got a launch coming up in the first half of next year, which could be a nice thing for us. And then we'll also be looking for potential generic competition on LUVOX CR. Of course we've been saying for a number of years that we can have competition as early as February on that product but, to our knowledge, no one yet has approval, which would be a necessary step before there would be generic competition. So we'll keep our eye on that as well.

Your next question comes from Michael Faerm from Crédit Suisse. Michael Faerm - Crédit Suisse AG, Research Division: I have a question on Erwinaze. Can you provide any color on volumes or penetration in a similar vein to the way you do with Xyrem? Just to help us understand where, sort of, overall penetration of the existing market stands?

Mike, it's a good question and if we had one simple metric we could give you we would include it in our disclosure like we do with Xyrem, where we give a sense for that. Really sales is the measure. There are a certain number of vials used here and unfortunately that doesn't correlate perfectly with number of patients because patients are different sizes, patients start treatment at different points along their whole asparaginase treatment protocol. At some point they perhaps switch from the E. coli-derived asparaginase to Erwinaze, so there's just tremendous variation across those patients that makes any sort of volume denominator, other than vials shipped times price per vial, not a particularly helpful measure. Michael Faerm - Crédit Suisse AG, Research Division: And just one other question on business development. Can you characterize, in general, what you're seeing in terms of quantity of available assets and attractiveness and sort of attractiveness of pricing of available assets in the categories that you look at?

Sure. I would say that there continue to be a number of interesting opportunities. Our BD group remains active in screening things that could be of interest. It's hard to answer the question about economics. You never really know the economics until you get into a negotiation and those don't happen all that often. So I don't know how to give you a good answer on that but I think, in general, we remain confident that business development is going to be an important driver of our growth in the coming years, as it has been in the past year and we continue to focus on it quite a bit.

Your next question comes from the line of Douglas Tsao from Barclays.

Just, Bruce, sticking to Erwinaze, I was just wondering if you could provide any color, what you might have seen or heard or maybe it might not have any effect in terms of Lundbeck's decision to stop manufacturing ankispar [ph]?

Let me suggest I hand that over to Jeff and Russ.

So obviously, that caused some degree of activity within the community because that are situations, although many people or many situations use ankispar [ph] as a long-acting PEGylated version, the Elspar version, the short-acting is going to be withdrawn from the marketplace or discontinued from the marketplace. So there are situations where that is the preferred asparaginase, and many of the groups are looking at their protocols and are evaluating how to revise their protocols in order to meet the needs of those patients. In some instances, we anticipate it would be with Erwinaze, others it maybe ankispar [ph] or some other drug.

Okay. And then just in terms of Prialt, Bruce, I was just curious, how many centers have been added to the NAVIGATOR system?

So we're really within the first 10 days of launch here, so it's small numbers. And so I would say that if you look at the overall landscape of where we want to be, we're about 10% to where we want to be right now.

Okay. And then just finally, I think you might have mentioned it or I missed it, was the volume growth for Xyrem in the quarter -- I know you mentioned that there was one less selling day, I was just curious if you gave the specific number?

Yes, Doug, it was 9% year-over-year.

Our next question comes from [indiscernible] from [indiscernible] Capital.

Just a couple. The first one is related to Xyrem. I'm wondering if you could give us a little bit more color on prior-year authorization, whether you're seeing the ratio for those -- for the prior authorization going up over the years or are they fairly stable?

Yes, so as we said in the script and Russ commented earlier, we have seen some increase in rate of prior auths. It's still less than half and less than what we see, for example, with Provigil, so we're not signaling a big issue here. But with our drug, as I would say is true of many specialty drugs, it's generally true that you're going to see more prior authorizations. Our focus, of course, is making sure that for patients who have been diagnosed with narcolepsy are getting appropriate treatment. That, that prior authorization is ultimately going to result in reimbursed drug.

And then a follow-up to that is that for the portion where you have to go through the prior authorization process, do you see the eventual approval or reimbursement comparable to the ones where you got approval the first part?

So we have not seen any changes to our overall reimbursement landscape. In fact, those 2 are prior auths, tend to be reimbursed at a similar rate to the overall group that is not prior auth. Typically it's just more of giving more documentation as opposed to whether it will ultimately get reimbursed or not.

Yes, just more paperwork to do.

Yes.

And next question is on Prialt. You have talked about the reimbursement process being a little difficult for physicians. Could you walk us through what does the physician have to do and is there any -- does the physician have to lay certain money upfront before -- and then they'll treat the patient before they actually get reimbursement? Could you walk us through that process a little bit?

Yes, sure. So this is buy-and-bill environment. So physicians are expected to go out-of-pocket. And in many cases if you look at the differences between, whether it's morphine or hydromorphone versus Prialt, the differences in cost are significant. And there are many patients that they feel they're not absolutely sure in advance whether they will be reimbursed. What the NAVIGATOR actually does in advance for physicians now is it gives them a look at exactly what the reimbursement is and allows the patients options in terms of -- before, it was really just you will get reimbursed or you won't get reimbursed and at what rate. Now they're also given some patient services potentially to help with potentially a co-pay and other things. So it really offers the physician a look in advance to make good treatment decisions as opposed to kind of flying blind.

Your next question comes from Corey Davis of Jefferies. Oren G. Livnat - Jefferies & Company, Inc., Research Division: This Oren Livnat for Corey. I wanted to dig into Erwinaze a little bit. You guys highlighted how complicated it is to sort of, I guess, run metrics on this thing because you have such a complicated set of variables and different sort of patients at different places in their cycles. So when we look at it and try to tease out growth or lumpiness in this, I can see that it's probably going to be lumpy but, for near-term growth, what do you guys really see as the upside driver? You've talked a lot about education and I'm just trying to understand, is it raising awareness of hypersensitivity at general, is that awareness low on an absolute basis? Or is it really about the nuances within hypersensitivity, like this silent inactivation and help people really understand that there might be a bigger problem than they think it is?

Oren, good question. I don't think it's that people don't understand the importance of hypersensitivity, as everyone treats the same thing as indicating a sufficient grade of hypersensitivity to change treatment. And there are, in fact, published guidelines for that. I would say we don't find a tremendous consistency in practice right now around that, across institutions, and so I think there is an opportunity to at least level the playing field and make sure everyone has the same understanding of what has been recommended in terms of recognizing hypersensitivity and making a treatment change more appropriate. That's certainly the nearest term focus for growth.

And maybe a good recent example of that is we had a pediatric oncology nurse meeting where we presented different case studies around the concept of grading hypersensitivity reactions and actually saw some increase in certain accounts, observing hypersensitivity as a result of that. So it's more of really what to look for, how to grade and then ultimately what to do about it. So that's a lot of the medical education taking place right now. Oren G. Livnat - Jefferies & Company, Inc., Research Division: All right. On Xyrem, to go back to the, I guess, not really the litigation side but on the regulatory side, I think most of us know you've got a one CP, an important one coming in probably next week or 2, for their deadline and maybe another month behind. I'm just wondering if, since we last talked about it, have you had any conversations with the FDA that give you any sort of color on where they might be leaning on the bioequivalence front?

Yes. So on both of the CPs we have on file, we're waiting to hear just like you're waiting to hear. Our working assumption is we'll hear on the clock that's been set up, which would be in the next week or 2 on the first one, and the first half of December on the second one but we're not expecting any particular dialogue other than getting a decision. Oren G. Livnat - Jefferies & Company, Inc., Research Division: All right. And just one simple modeling question. Any changes to long-term tax expectations?

So we haven't -- as you know, Oren, we haven't given guidance yet. In the past, we've talked about long-term tax rate in the mid-20s. I don't have any update to that number today. We're working through, kind of as we speak, our 2013 budget and so I would expect that we'll have real guidance for 2013 probably on our fourth quarter call in February.

Your next question comes from the Gene Mack from Brean Capital. Gene Mack - Brean Murray, Carret & Co., LLC, Research Division: Just on Xyrem. Russ, I believe you mentioned that there's still less than 1/3 of the patients accessing a coupon program. I'm just wondering, is that also limiting the actual scrips that are being processed or are these people just not using a coupon and what are your thoughts around that and maybe ways of increasing adoption of that?

No, it's just an issue of them not needing it.

Your next question comes from Chris Holterhoff of Oppenheimer and Co. Christopher Holterhoff - Oppenheimer & Co. Inc., Research Division: Just given sort of the efforts you're making with Xyrem, are you seeing compliances continuing to improve from that 70% or so you mentioned in the past? And then kind of where would you expect compliance will ultimately settle out at for them?

Yes. So we've commented that we've come a long way with compliance. If you think about a product that's dosed 2x nightly, I think that we're approaching thresholds of really maximizing compliance to a large degree. I do think that there are areas for improvement still on persistency that we continue to see build over time, so I don't think that we're 100% done but we're getting close on the compliance side. Christopher Holterhoff - Oppenheimer & Co. Inc., Research Division: Okay. Just to clarify, you said you think that it'll ultimately settle out at close to the theoretical 100% compliance?

No, you never get to 100%. And especially pharmaceuticals, if you're doing better than 80%, you're doing great. Christopher Holterhoff - Oppenheimer & Co. Inc., Research Division: Okay. And then just real quick on Prialt, I'm sorry if I missed it but did you disclose the number of new patient starts that you saw in the quarter?

Chris, we did not specifically disclose that and we haven't in the past either.

Your next question comes from the line of Bill Tanner.

Russ, just as I'm looking at a patient model or the patient numbers that the company has reported, it looks like for the last several quarters, there's been a sequential increase in new patient starts and I guess, I'm not really asking you to project out but I mean, this is something that you would attribute to the initiatives and I guess, I would ask, do you think a similar kind of a trend could at least persist over the nearer term?

I think it's a number of things that we've rolled out. I think the key initiative that we think allows us sustained growth in terms of new patients is that some of the new patients are actually coming from a new group of physicians. So if you remember, we went back about 1 year ago and we found about another 1,000 physicians based on claims data that were not previously being called on. We focused on that group heavily and we went to a single-product focus, with Xyrem. And the field has done a great job of cultivating those physicians and now a number of them are actually treating and contributing to the new patient growth. So it's not just the high prescribers that are ultimately driving our growth now, it's actually coming from some of the mid-deciles, which is encouraging because we think we've broadened our base of treaters.

And I think, on the last call, I think maybe I asked a question about if it was -- if your sales force was rightsized, maybe it was about 85? I mean, is that still the number of sales reps, or thereabouts, that you have and is there any contemplation that you might need to expand that?

Yes. We have 77 in the field right now and we continue to do the analysis on whether we think that, if we put more out, it would actually have an impact. At this point, we don't plan to make any changes.

We have no further questions queuing for you. I would now like to turn the call over to Ami Knoefler for closing remarks.

Thank you, Kirstie. In closing, a reminder that Jazz will be presenting at 2 financial conferences next week, Lazard on November 14 in New York City, and Crédit Suisse on the 15th, in Phoenix. Then later in the month, we return to New York on the 28th to present at the Piper conference. We hope to see many of you at one of these conferences. Thanks again for joining us today.

Thank you for your participation in today's conference. That concludes the presentation. You may now disconnect. Thank you and good day.