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Earnings Call: Q1 2012

May 8, 2012

Operator

Welcome to the Jazz Pharmaceuticals first quarter 2022 financial results conference call. Following an introduction from the company, we will open the call to questions. I will now turn the call over to Ami Knoefler, Head of Investor Relations and Corporate Communications at Jazz Pharmaceuticals.

Ami Knoefler
Head of Investor Relations and Corporate Communications, Jazz Pharmaceuticals

Welcome to the Jazz Pharmaceuticals first quarter 2012 financial results conference call. We reported financial results in a press release issued earlier today. The release is available in the News & Events section of our company website. Among other things, the press release includes a reconciliation of GAAP net income to adjusted net income for Jazz Pharmaceuticals plc, along with related per share amounts. 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.

Certain remarks we may make on this call constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the future events, future financial results, growth potential, 2012 effective tax rate, financial guidance, and the anticipated consummation of the proposed transaction between Jazz Pharmaceuticals and EUSA Pharma and the timing and benefits of the transaction.

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 the completion of the proposed acquisition of EUSA Pharma, including the timing and financing of the acquisition and risks related to disruption from the Azur Pharma merger and proposed acquisition of EUSA Pharma and related integration efforts, as well as risks and uncertainties related to Jazz Pharmaceuticals business generally, including our dependence on sales of Xyrem, competition, including potential generic competition, our ability to increase product sales, dependence on single-source suppliers and manufacturers, our ability to protect our intellectual property and defend our patents, and regulatory obligations and oversight.

These and other risks related to our business are detailed in our SEC filings, including under the risk factors heading in our annual report on Form 10-K for the year ended December 31, 2011, that we filed on behalf of and as successor to Jazz Pharmaceuticals, Inc. Our SEC filings and reports are available on our website. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements stated on this call as a result of new information, future events, or changes in its expectations. Please note that we expect to file shortly the Form 10-Q for the first quarter on behalf of Jazz Pharmaceuticals plc. Following some brief introductory remarks, we will open the call to questions, and now I'll hand the call over to Bruce.

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Thanks, everyone. The first quarter was a dynamic time at Jazz Pharmaceuticals. We achieved record total revenues of $108 million, fueled by the continued strong growth of Xyrem and the addition of new products in our portfolio from our merger with Azur Pharma. During the quarter, we completed the initial phase of integration of the Azur business, including the reorganization of our combined sales and marketing teams into four different product lines focused on narcolepsy, pain, psychiatry, and women's health. We're pleased with the momentum of these new, highly focused teams and continue to believe that increased specialization and focus will lead to better results. I'd like to thank our employees for their dedication during the merger process, as many embrace new responsibilities while maintaining our commitment to patients and to our company's values.

Now I'll make some comments about results and strategies for Xyrem and Prialt, as these are the current products we see as long-term growth drivers of our business, and then Kate will provide more details and summarize our updated financial guidance. Starting with Xyrem, as previously announced, we achieved 10% volume growth during the first quarter of 2012 over the prior year's first quarter, and the number of patients on active therapy reached a new high of over 9,500 during the quarter. This reflects focused efforts to maintain new patient growth and the results of ongoing programs to support both compliance and persistency. We continue to work with our exclusive central pharmacy to optimize its interactions with both patients and physicians, and we continue to roll out new programs to support the Xyrem brand.

Most recently, effective March 1st, we identified and rolled out to our sales force another wave of additional target physicians who treat narcolepsy patients, further increasing our target audience. Since we began this initiative to identify additional narcolepsy prescribers last year, we've increased our call audience by approximately 25% or about 1,000 new physicians, over 100 of whom have since enrolled in the Xyrem Success Program. These additional potential prescribers have resulted in meaningful increases in new patients on Xyrem therapy, with at least 50 new patients directly linked to this effort. We have also recently implemented a new patient support program called the Xyrem Patient Connection Program. This program provides new patients with the option to speak with someone who also has a diagnosis of narcolepsy and has personal experience with Xyrem therapy. Yet another example of our commitment to the narcolepsy community.

We are also increasing our work with the scientific and medical community related to narcolepsy and its impact on patients. We are increasing our investments in support of Xyrem across the company as we expand our support of medical education initiatives and increase our corporate commitment to serving patients with narcolepsy. We're hiring additional medical scientists, funding additional speaker programs and symposia with KOLs, pursuing additional publications, and funding narcolepsy patient support groups and a charitable organization that supports narcolepsy patients. We will have our largest presence to date at the upcoming APSS SLEEP meeting in Boston this June, where in addition to our commercial and medical affairs activities, we are sponsoring a physician education symposium on narcolepsy. Now turning to Prialt, our product for severe chronic pain.

We continue to focus on growing the existing business while we develop a broader strategy to maximize the longer-term opportunity for the product. Prialt sales volumes in the U.S. were up 8% year-over-year in the first quarter, which was in line with our expectations. Given that Prialt is the only non-opioid approved for intrathecal administration, its strong efficacy profile and the current very low penetration in the available pump market, we see significant potential to grow this product over time. We think that the optimal strategy for this product may include both changes to the existing highly fragmented distribution system and possibly generating new data. We have concluded that a more focused specialty pharmacy model may have advantages for patients and physicians, and we are in the process of planning for a possible change late this year.

Under Jeff Tobias' leadership, we are also evaluating whether additional clinical data might be useful to physicians and obtainable at a cost that makes sense. We expect to have more to say about our portfolio strategy later this year. Finally, we are pleased to have signed the agreement late last month to acquire EUSA Pharma, which we expect to contribute further to our top and bottom-line growth going forward. The EUSA Pharma business would add a significant growth product, Erwinaze, to our portfolio and bring some interesting research and development opportunities into our company.

The transaction meets our corporate development objectives and aligns with our commercial strength in delivering highly specialized products that require an expertise with targeted physician customers and a strong patient service capability. The transaction would leverage our existing commercial expertise and corporate structure and would be expected to generate a highly positive return for our shareholders with immediate accretion to our adjusted EPS. We've begun working with EUSA's management team to ensure a smooth transition and continue to expect to close the transaction in June. Now let me turn the call over to Kate.

Kate Falberg
CFO, Jazz Pharmaceuticals

Thanks, Bruce, and good afternoon, everyone. The year is off to a strong start, and today we are increasing our sales and earnings guidance based on strong Xyrem performance. Net sales for the first quarter of 2012 were $107 million, including contributions from the acquisition of Azur. Note that contributions from the former Azur business are included from January 18th, so they were for only a partial quarter. For reference, we have provided the prior year's full quarter results for each of the former Azur products in a footnote in the financial tables accompanying our press release. We were very pleased with the strong Xyrem sales of $73 million in the first quarter of 2012. Year-over-year volume growth of 10% was in line with our expectation for high single- to low double-digit growth this year.

For the past few years, we have seen a sequential decrease in volumes from Q4 to Q1 that we've attributed to the impact of changes in patients' insurance plans and new deductibles. This year, we were pleased to see only a slight volume drop from the fourth quarter of 2011 to the first quarter of 2012. We attribute this to improved efforts through our pharmacy to address any changes in patients' insurance plans and to ensure timely shipments to patients. Our psychiatry products, which include LUVOX CR, FazaClo LD, and FazaClo HD, reached approximately $18 million in sales. LUVOX CR sales were up 34% year-over-year, while the FazaClo products were relatively flat overall. As a reminder, the lower dosage strengths of FazaClo are subject to potential generic competition as soon as July of this year as a result of a settlement with Teva.

First quarter 2012 Prialt sales of $9.5 million included $4.6 million due to our product supply agreement with Eisai for Europe, where Prialt is sold in about 10 countries. We think that this shipment to Eisai is likely to satisfy their needs for at least the balance of this year. Sales of the women's health and other products were $6.7 million compared to $8.6 million in the first quarter last year, as growth of Elestrin was offset by declines in other products. The overall gross margin for the quarter was 90%, which was impacted by $2 million of non-cash expense due to purchase accounting inventory fair value step-up. There is an additional $7 million of this non-cash expense to be reflected over the next several quarters as the inventory is sold.

R&D and SG&A combined for the quarter were $51 million, which reflects the combination with Azur, including an additional 170 employees. It also includes $6 million of transaction-related expenses, most of which are related to the Azur merger, and $3 million of stock-based compensation expenses, both of which are added back to adjusted net income. We also recorded a provision for income taxes of $5.5 million, which reflects our mid-teens estimated 2012 effective tax rate. Turning to the bottom line, we're very pleased to report GAAP net income of $28 million or $0.48 per diluted share for the first quarter of 2012. Compared to $22 million or $0.48 per diluted share for the first quarter of 2011. Adjusted net income for the quarter was $53 million or $0.91 per share, an increase of 54% over the prior year.

Our press release issued earlier today has further results and a full reconciliation of GAAP and non-GAAP financial measures. We ended the quarter with $244 million in cash and investments and no debt. During the quarter, we used $25 million in cash to pay withholding tax assets related to certain exercises of employee stock options in connection with the Azur merger. This net exercise transaction was priced at $48.60 per share and resulted in about 500,000 fewer shares outstanding. We're updating guidance today based on our current business, not yet reflecting the impact of our potential acquisition of EUSA Pharma. The increase in sales guidance of $20 million-$35 million reflects the anticipated strong performance of Xyrem. We've also narrowed the guidance range significantly as we are further along in the year and the commercial integration with Azur is complete.

The increase in operating expense guidance of $15 million-$20 million reflects increased investments we plan to make in support of Xyrem and Prialt, increases in hiring across the company to support current and planned growth, higher charitable contributions to a narcolepsy specific organization, or higher stock-based compensation expense due to the increase in our stock price this year. On the bottom line, we've increased our guidance for adjusted net income by $15 million, resulting in a $0.25 increase in adjusted EPS to a new range of $4.25-$4.40 before including the expected accretive impact of the EUSA transaction.

On a GAAP basis, we expect net income in the range of $165 million-$177 million or $2.75-$2.95 per diluted share. These are very exciting times for Jazz as we execute on our strategy to grow our existing product portfolio while leveraging our expertise and financial strength to add additional marketed or close to approval products. We believe we can continue to create shareholder value as we pursue our mission of improving patients' lives. Thank you for joining us on the call today. I'll now ask the operator to open the line for your questions. Operator?

Operator

Ladies and gentlemen, if you would like to ask a question, please press star one. If your question has been answered or you would like to withdraw your question, press star two. Please press star one now to begin. Your first question comes from the line of David Amsellem with Piper Jaffray. Please proceed.

David Amsellem
Managing Director and Senior Research Analyst, Piper Jaffray

Thanks. Just a couple. First on the Xyrem patient growth. Do you think that a lot of the patient growth is a function of finding these new doctors who are new to the product, or are you still getting traction from existing prescribers, who are just using the drug in more patients? How should we think about that?

Russ Cox
Chief Commercial Officer, Jazz Pharmaceuticals

Hey, David, this is Russ. I think you should think about it as a combination, but I think what you'll notice from the additional patient growth is that we've mentioned that approximately 10% of the new physicians are actually enrolled and about, you know, 50 of those have actually engaged in some type of prescription, so that's a part of it. I think a bigger part of it is that we're seeing more and more growth from what I would say, less high-tiered physicians. We're doing a better job with those who didn't have as much experience with Xyrem historically. Then in addition, our compliance and persistency programs continued to keep patients on longer. It's a combination of these.

David Amsellem
Managing Director and Senior Research Analyst, Piper Jaffray

Okay, that's helpful. Another question on Xyrem. How should we think about the gross-to-net spread on the product as 2012 progresses? In other words, should the spread narrow in the second quarter and the rest of the year as it did last year, or will you have a higher spread going forward due to the higher price point?

Kate Falberg
CFO, Jazz Pharmaceuticals

This is Kate . As is typical, the gross-to-net spread was a little bit wider in the first quarter. We would expect, just like in prior years, that to narrow a little bit, although we're not talking about big differences quarter to quarter and, you know, we remain in the low double digits.

David Amsellem
Managing Director and Senior Research Analyst, Piper Jaffray

Okay, that's helpful. Then one last one, if I may, on Prialt. Can you give us a little color on what kind of traction you're getting in the field and maybe quantify how many new starts you're getting on the product now that you've taken it over? Maybe as just a follow-up to that, when you think you'll complete the changes to the distribution model that you're contemplating? Thanks.

Russ Cox
Chief Commercial Officer, Jazz Pharmaceuticals

Yeah. David, I think we're still very much in the early stage as it relates to implementation programs with Prialt. Keep in mind, the additional heads that we just put against Prialt actually are functional in their new territories as of, you know, one month of the first quarter. So we didn't expect to see anything from that. We also have data that would tell us that it takes about six months from the time that somebody starts on Prialt to actually having some meaningful impact in the field. So it's still very early stage in terms of when we'd expect to see some return there. We're doing the analysis currently on what is the appropriate timing for looking at changes in distribution. We'll talk about that more later.

David Amsellem
Managing Director and Senior Research Analyst, Piper Jaffray

Okay. Thank you.

Operator

Your next question comes from the line of Corey Davis with Jefferies. Please proceed.

Corey Davis
Managing Director and Senior Equity Analyst, Jefferies

Thank you. Maybe I'll stick with Prialt. Curious that you mentioned possibility of new data. Any elaboration there? Is this something that you need is more for promotion to the doctors using it, or is it more for justifying the price to payers? Is it something about the correct dosing of Prialt or is it more on the efficacy of the drug that needs further clarification?

Jeff Tobias
Head of R&D and Chief Medical Officer, Jazz Pharmaceuticals

Yeah. This is Jeff. It's really some of a number of different areas. There are, you know, remaining questions regarding dosing, and I think that additional clarity in that area could potentially have an impact on the ability to increase the use of the product. But other things that we're looking at are potential patient selection issues as well as the role of how Prialt fits in with the other intrathecal therapies at this time. There are a number of different areas that we think we could have impacted.

Corey Davis
Managing Director and Senior Equity Analyst, Jefferies

Are these trials that would take months or years to complete in the, like, single digit millions or tens of millions?

Jeff Tobias
Head of R&D and Chief Medical Officer, Jazz Pharmaceuticals

They're really a range of options that we're looking at. Some of the questions can be answered by even retrospective chart reviews, and it could range up to a randomized trial. Really it covers the gamut.

Corey Davis
Managing Director and Senior Equity Analyst, Jefferies

Okay.

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Corey, this is Bruce. You know, one thing I'd remind you of is the number of patients on intrathecal pump therapy is limited. You know, most trials in this area you would expect to not be particularly large, not from a patient perspective.

Corey Davis
Managing Director and Senior Equity Analyst, Jefferies

All right.

Jeff Tobias
Head of R&D and Chief Medical Officer, Jazz Pharmaceuticals

Well, that's correct. It really, you know, some of these questions that we're not necessarily looking at pivotal type trials.

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Corey, I would just add that from a payer perspective, we don't feel we need additional data to convince payers at this point.

Corey Davis
Managing Director and Senior Equity Analyst, Jefferies

Okay. Wanted to ask about how you felt coming out of the Markman hearing and how important overall you feel the outcome there is to the success of your case. Do you have any idea when the judge might offer his ruling on those claim constructions?

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Nice multi-part question there, Corey. I would say in general, we're not doing a detailed commentary around progress in the litigation. We're still at a fairly early stage in litigation that involves a number of patents, a number of claims, a number of terms. We don't know when the judge will rule. You know, typically measured in weeks to months, but don't know whether that will apply in this case. You know, this was one step along the way in litigation surrounding intellectual property.

Of course, overall, you know, we think this is a pretty unique situation involving both legal and regulatory matters. We've got you know, proprietary and well-honed distribution system that's been in place for almost 10 years that we think does a very nice job of protecting both public safety as well as safety of patients using the product. You know, we certainly think that's serving everyone well. When it comes to litigation, we're gonna be very aggressive in defending our rights.

Corey Davis
Managing Director and Senior Equity Analyst, Jefferies

Okay, thanks. I was corrected by my associate. I should have asked when the judge would offer her opinion. That's all I had. Thanks.

Operator

Your next question comes from the line of Gene Mack with Mizuho. Please proceed.

Gene Mack
Executive Director and Biotechnology Analyst, Mizuho

Hi, Bruce. I wonder if I could just follow up on Corey's point there. Let's assume worst case scenario. The judge sort of interpreted everything in favor of the challenger in this case. Would the FDA still need to rule? Or in other words, the FDA would still then need to rule on its view regarding a duplicate distribution network or duplicate central pharmacy, in essence, in another REMS program. Does that sound reasonable?

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Yeah. Again, I won't do detailed commentary, Gene, other than to say you're correctly pointing out that there are a couple separate processes here. One is potential outcome of litigation, the other is regulatory pathway. Those, you know, in some cases are related, but they're not one and the same.

Gene Mack
Executive Director and Biotechnology Analyst, Mizuho

All right. The patents really wouldn't have any bearing on how the FDA viewed the creation of another central pharmacy?

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

I would say they're separate processes.

Gene Mack
Executive Director and Biotechnology Analyst, Mizuho

Okay. Also just on Prialt. Before you mentioned that the intrathecal pump market itself was slightly limited. I'm wondering, do you see a potential of maybe growing the implantable pump market at all, or are we kind of at steady state with the 70,000 that are sort of deployed right now?

Jeff Tobias
Head of R&D and Chief Medical Officer, Jazz Pharmaceuticals

No, we don't see tremendous growth there. You see models that have it growing anywhere from 1%- 3% per year.

Gene Mack
Executive Director and Biotechnology Analyst, Mizuho

Okay. Thanks. That's all I have.

Operator

Your next question comes from the line of Difei Yang with Auriga. Please proceed.

Difei Yang
Senior Equity Analyst, Auriga

Thanks for taking my questions. First of all, congratulations for a great quarter. A couple questions. The first one is related to Prialt. There's $4.6 million sales. Related to Eisai for sale in Europe. Could you comment a little bit more? Moving forward, are we expecting this kind of revenue to be a repeatable event?

Russ Cox
Chief Commercial Officer, Jazz Pharmaceuticals

Yes, we're expecting it to be a repeatable event in being that, you know, once they've exhausted their supply, we'll expect that they'll reorder, and we'll supply more. Our expectation is that this shipment, for which we have reported revenues, should satisfy their demand for this year. We're not expecting additional revenues from this source until next year.

Difei Yang
Senior Equity Analyst, Auriga

Oh, thank you. My second question is on Xyrem. After the price increase, what is the current price on Xyrem right now?

Russ Cox
Chief Commercial Officer, Jazz Pharmaceuticals

The current price on Xyrem is approximately $30,000-$55,000 depending on what your dose is. I would also say that our current bottle price is $1,635 per bottle.

Difei Yang
Senior Equity Analyst, Auriga

Okay. Yeah. Thank you.

Operator

Your next question comes from the line of Bill Tanner with Lazard Capital Markets. Please proceed.

Bill Tanner
Managing Director and BioPharma Analyst, Lazard Capital Markets

Thanks for taking the questions. I got a few maybe Russ for you. Number one, could you tell us how many physicians are currently prescribing Xyrem for?

Russ Cox
Chief Commercial Officer, Jazz Pharmaceuticals

Yeah. We have a current call universe of about 4,000 that we just characterized. Previously that was about 3,000. If you really look at unique users, you can get anywhere from about 3,000 to about 3,200, and the majority of the volume comes from about 750 physicians. That represents about 70% of the total.

Bill Tanner
Managing Director and BioPharma Analyst, Lazard Capital Markets

Okay. Just, you know, thinking about if you've gone to 1,000 new physicians, you've got 100 that have enrolled and 50 have actually started treating patients with Xyrem, what's a reasonable hit rate or conversion rate you think out of that 1,000? I mean, is this something that, you know, you've got 100 out of 1,000 that's kind of it, or do you think you'll build on that 100 out of those 1,000 over time?

Russ Cox
Chief Commercial Officer, Jazz Pharmaceuticals

I would expect it to build, but what I would say is that it's a very long process. Historically, we've seen that from the first time you call on a physician to the first time they actually start prescribing takes you about six months, even with somebody who's fairly receptive. I will say that we're having some good success, though, in getting physicians who have used the product 3x, 4x, 5 x to now use it significantly more. Our real goal with those folks is not for them to use it once or twice, it's for them to use it 4x or 5 x and then become a more meaningful user.

Bill Tanner
Managing Director and BioPharma Analyst, Lazard Capital Markets

That was gonna be my question. Is it just a matter that the physicians are dipping their toe in the water and treating a few patients and seeing how well they do before expanding it?

Russ Cox
Chief Commercial Officer, Jazz Pharmaceuticals

Just getting rolling. Typically, after they've used it 4x or 5 x, they have at least that one patient that's dramatic, and then they get it. Our goal is to continue to push them to getting to four or five.

Bill Tanner
Managing Director and BioPharma Analyst, Lazard Capital Markets

Do you have a sense out of that 1,000 physicians, how many narcoleptics are under their care in aggregate? Or do you probably have a sense, but don't care to share it with us?

Russ Cox
Chief Commercial Officer, Jazz Pharmaceuticals

Yeah. It's a big range, so I'm not sure it's gonna help you much. You're gonna see some that it's a handful, and you're gonna see some that are probably more like, you know, 8-10.

Bill Tanner
Managing Director and BioPharma Analyst, Lazard Capital Markets

Okay. I guess the last one is, I think Bruce mentioned something about APSS, the presence there. I'm wondering if you could, you know, sort of generally characterize what activities Jazz would be undertaking there and how that would be different maybe from what the company's done at APSS in years past.

Jeff Tobias
Head of R&D and Chief Medical Officer, Jazz Pharmaceuticals

Jeff. In addition to the commercial booth and having a pretty robust medical affairs presence, we have a number of our MSLs there, as well as some of our medical affairs physicians. We're also supporting a symposium, a CME symposium, that's gonna be on narcolepsy. There's some really good speakers set up for that, but of course, we have nothing to do with that.

Bill Tanner
Managing Director and BioPharma Analyst, Lazard Capital Markets

Okay.

Russ Cox
Chief Commercial Officer, Jazz Pharmaceuticals

I think the point is we've got both a significant commercial and medical presence for the first time in several years.

Bill Tanner
Managing Director and BioPharma Analyst, Lazard Capital Markets

Maybe just a question, Bruce, and I don't know if you really wanna answer it or not, but, I mean, should we think that the company is sort of done this year in terms of acquisitions or in licensings with the Azur closing and with EUSA or perhaps not?

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Probably not a good question for me to answer, Bill. I'll say what I said post Azur and pre the EUSA announcement, which is, we feel our business is in good shape. I think you can see that from our current period results and from our guidance for the year, even before a transaction. Obviously, we're very excited about the EUSA transaction and think that's additive on a number of different dimensions. Coming out of that transaction, we'll again be in a position where I think the company's in strong shape to continue to execute on a top line and bottom line growth strategy. We'd be open to looking at additional transactions if they're a good fit with our strategy, affordable, good return. We certainly aren't in need of doing something. It would be, you know, only if we see a really great opportunity.

Bill Tanner
Managing Director and BioPharma Analyst, Lazard Capital Markets

Yep. Okay. Thank you very much.

Operator

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

Michael Schmidt
Senior Biotech Analyst and Managing Director, Leerink Swann

Hi. Thanks for taking my question. I have a question on Erwinaze, as we are trying to better forecast that product. Now that it has been on the market in U.S. for one quarter commercially, one full quarter. What's the average number of doses that you see per patient, you know, versus the compassionate use program under which the product was available previously? I think the dose per patient, you know, was very widespread between three and 48 doses. Do you see use during maintenance regimen as well, or mainly in induction therapy? Thanks.

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Yeah. Michael, this is Bruce. I'm gonna cut Russ off before he jumps in to answer this question. Just say, you know, at this point, we've announced a pending transaction. We're expecting it to close next month. We certainly gave some information, including some financial highlights and some projections to give people a sense for the transaction, but I don't think we're gonna start dissecting, you know, results to date to that degree yet.

Michael Schmidt
Senior Biotech Analyst and Managing Director, Leerink Swann

Okay.

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

You know, I think we'll have more to say at closing and going forward, but let's wait till we put the two companies together.

Michael Schmidt
Senior Biotech Analyst and Managing Director, Leerink Swann

Sure. Thanks. On Xyrem, I was just wondering, with the generic Provigil now on the market, do you see any impact on prescriber behavior or maybe, you know, payer scrutiny and reimbursement issues?

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

No, we haven't seen any such changes. I will remind you that most Xyrem patients are actually on a combination of both the stimulant and on Xyrem.

Michael Schmidt
Senior Biotech Analyst and Managing Director, Leerink Swann

Right.

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

We don't see it as a direct competitor.

Michael Schmidt
Senior Biotech Analyst and Managing Director, Leerink Swann

Okay, great. Thanks a lot. That's all I have.

Operator

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

Douglas Tsao
Senior Analyst, Barclays

Hi. Good morning or good afternoon. Just first on Prialt. I might have missed it, but are you considering studies to refresh or update the label for the product? I know in certain instances, the drug is trialed not using an intrathecal pain pump, and I was just wondering if you were interested in perhaps pursuing those types of applications or, you know, getting approval for that use in that setting.

Jeff Tobias
Head of R&D and Chief Medical Officer, Jazz Pharmaceuticals

You know, those are areas that we're looking at. As we look at how we wanna proceed with how additional studies, those are certainly two areas that are on the radar.

Douglas Tsao
Senior Analyst, Barclays

On Xyrem and obviously the ongoing IP litigation, I was just curious, is there IP or patents that you have access to that are not to protect the franchise, that are not in the Orange Book?

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Yes.

Douglas Tsao
Senior Analyst, Barclays

Okay, great. Thank you very much.

Operator

Your next question is a follow-up from the line of Gene Mack. Please proceed.

Gene Mack
Executive Director and Biotechnology Analyst, Mizuho

Hi. Sorry if I missed this earlier. With respect to EUSA and the integration and, I guess, your guidance there, did I miss when you would expect to be able to give us some an idea of how it's gonna impact, I guess, second, third, and fourth quarters? Or is it going to be some part of the second quarter, given that you're expecting to close in June? Can you just clarify that for me? I guess I missed it earlier.

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Yeah. Gene, I don't think you missed it. You know, what we said on today's call is that we continue to expect to close the deal next month. What we said on our announcement call was that our combined results for 2012 would depend in part on when we actually do close the deal. One of the slides we made available, including on our website in conjunction with that announcement, was our expected results for the EUSA business as separate from the Jazz business for the full year of 2012. How much of that gets rolled through our results will depend on the timing of the close.

Gene Mack
Executive Director and Biotechnology Analyst, Mizuho

Okay. Okay, great. Thanks for that clarification. Appreciate it.

Operator

Your next question comes from the line of John Boris with Citi. Please proceed.

John Boris
Senior Managing Director, Citi

Thanks for taking the question. I apologize if this was asked. I just got on the call late. First, can you maybe characterize your thoughts around the Markman hearing, how that actually progressed and then, how you're thinking about different scenarios and/or outcomes, going forward here during the 30 months ahead?

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

John, that was asked earlier in the call. Corey Davis can give you a full debrief at the end of the call. I'll say to put the joking aside. In general, we're not doing detailed commentary on the Markman. It's one step in complex litigation that could well go on for quite some time. Lots of patents, lots of claims, lots of terms at issue, and an overall situation that encompasses not only ongoing litigation, but a regulatory pathway and other considerations. You know, not probably worth time doing a complete deep dive into the Markman, and something that we're not gonna comment on given the ongoing litigation.

John Boris
Senior Managing Director, Citi

Okay. Follow-up, if I may. Just on the asparaginase asset, some would argue that, you know, the bears would argue that the 10%-15% hypersensitivity reaction sometimes occurs after patients have taken quite a few doses, and it might be even potentially a lot smaller than that 10%-15% mark. Can you maybe just provide some context that when you did due diligence around the asset, what gives you confidence that you're gonna be able to grow volume with the asset going forward?

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Yeah, this is Bruce. Let me just jump in at a top level and say that we did significant diligence, but in this case, we also were relying on a lot of historical good information, whether that was compassionate use prior to FDA approval or in fact actual results for a number of months post-approval. You know, we're not just projecting based on no real information. I think we've got good information to do that. You know, you're pointing out correctly that there's a pretty broad range of potential use per patient, depending on a number of factors, including when that hypersensitivity is evident and treatment with Erwinaze begins, but also depending on characteristics of that patient and their treatment.

John Boris
Senior Managing Director, Citi

Thanks, and congrats on the results.

Bruce Cozadd
Chairman and CEO, Jazz Pharmaceuticals

Thanks.

Operator

As a reminder, ladies and gentlemen, if you would like to ask a question, please press star one. At this time, there are no further questions appearing in queue.

Ami Knoefler
Head of Investor Relations and Corporate Communications, Jazz Pharmaceuticals

Great. Thank you for joining our call today. We also want to remind you that we'll be attending two upcoming conferences, the Jefferies conference in New York, and we'll also be participating in the APSS SLEEP Meeting in Boston next month. We look forward to seeing those of you who will be attending these events. Thank you and have a good evening.

Operator

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

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