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Jazz Pharmaceuticals, Inc. (NASDAQ:JAZZ)

Q2 2012 Earnings Call

August 7, 2012 4:30 pm ET

Executives

Ami Knoefler – Executive Director, Investor Relations and Corporate Communications

Bruce C. Cozadd – Chairman and Chief Executive Officer

Kathryn E. Falberg – Executive Vice President and Chief Financial Officer

Russell J. Cox – Executive Vice President and Chief Commercial Officer

Jeffrey K. Tobias – Executive Vice President, Research and Development and Chief Medical Officer

Analysts

Douglas D. Tsao – Barclays Capital, Inc.

David Amsellem – Piper Jaffray

Chris Holterhoff – Oppenheimer & Co. Inc.

Michael Faerm – Credit Suisse Securities

William Tanner – Lazard Capital Markets

Michael W. Schmidt – Leerink Swann LLC

Operator

Good afternoon, ladies and gentlemen, and welcome to the Jazz Pharmaceuticals Second Quarter 2012 Conference Call. Following an introduction from the company, we will open the call to questions.

I will now to turn the call over to Ms. Ami Knoefler, Head of Investor Relations and Corporate Communications at Jazz Pharmaceuticals. Ma’am you may proceed.

Ami Knoefler

Welcome to the Jazz Pharmaceuticals second 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 on 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 the related per share amount.

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. Also joining us is William Craumer, our new Director of Investor Relations. Following some prepared comments, we'll open the call for your questions.

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 the future events, future financial results, growth potential, financial guidance, plans, expectations and intentions and pipeline programs.

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 business combination transaction and related integration effort as well as related to our business, including our ability to maintain and increase sales of Xyrem and other products, our need to obtain appropriate pricing and reimbursement for our products in an increasingly challenging environment and the difficulty and uncertainty of pharmaceutical product development and the uncertainty of clinical success and regulatory approval.

These and other risks related to our business are detailed in our SEC filings including under the heading Risk Factors in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, as updated by our current report on Form 8-K filed on June 4, 2012 and July 9, 2012 respectively. Our SEC filings and reports are also 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.

We also use non-GAAP financial measures of adjusted net income and adjusted per diluted share on this call. We believe that the non-GAAP the 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. Our press release issued earlier today provides a full reconciliation of GAAP and non-GAAP financial measures and includes tables that break out the non-GAAP adjustments by line item to arrive at an adjusted income statement.

Please note that we expect to file shortly the Form 10-Q for the second quarter on behalf of Jazz Pharmaceuticals plc. Following some brief introductory remarks, we will open our call to questions.

Now I will hand the call over to Bruce.

Bruce C. Cozadd

Thank you, Ami. Good afternoon, everyone, and thanks for joining us. We are a little over halfway through the year, and I am pleased to report that we’ve made very real progress executing on our strategy and growing our business. Not only have we closed two significant transactions and expanded our operations and management capabilities, we’ve also broadened our portfolio and made important investments in key products, extended our geographical footprint into Europe, and structured our commercial organization for efficiency and scalability all while continuing to drive top and bottom line growth.

Our second quarter financial performance was extremely strong with record revenues of $130 million in the second quarter, more than double last year's second quarter revenues. GAAP net income of $27 million and adjusted net income of $66 million, a 72% increase over the second quarter of last year.

While this growth was partially driven by the expanded portfolio from our recent acquisitions, Xyrem was the major driver, posting 11% year-over-year second quarter volume growth. The average number of active patients during the quarter increased significantly to 9,850 from 8,700 from the prior year’s second quarter. We think this strong performance is the result of our ongoing programs to improve compliance and persistency and the focused efforts of our Xyrem-dedicated sales force, which has now been in place for a full quarter.

We think there is further room to improve on compliance and persistency measures and we’ve recently been obtain that data at a physician level, which will allow our reps to share with physicians how their patients are doing relative to the overall treated population. Looking ahead, we are now projecting the Xyrem volume growth for the year will be in the low double digits, and we are raising our guidance for Xyrem sales.

We have recently begun to increase efforts to improve the awareness and diagnosis of narcolepsy via medical education. In early June at the annual meeting of the Associated Professionals of Sleep Society or APSS, held in Boston, a standing room only crowd of over 400 health care practitioners attended a physician education symposium on narcolepsy. Jazz was the sole sponsor of this (inaudible) event, the first such event at the APSS meeting in over four years.

We also issued results of the narcolepsy awareness survey known as Awaken, which highlights the low understanding of narcolepsy among the U.S. public as well as in the medical community. These findings suggest that meaningful opportunities exist to help improve the diagnosis and treatment of this serious disease.

We have supported additional independent research, further characterizing the disease and its burden. One such effort includes new data to be presented by Dr. Maurice Ohayon from Stanford, at the upcoming American Neurological Association or ANA, meeting in Boston in early October. Dr. Ohayon's analysis has elucidated for the first time some of the very serious comorbidities associated with narcolepsy, again reinforcing the need for effective diagnosis and treatment.

Let me turn now to Erwinaze, the most recent addition to our specialty product portfolio. As a reminder, Erwinaze was approved by the FDA late last year for the treatment of acute lymphoblastic leukemia in patients who are hypersensitive to E-coli derived asparagins. We are pleased to report the second quarter worldwide Erwinaze sales matched with our first quarter level of $33 million and we have increased our original reported forecast range for the full year from $115 million to $125 million to a range of $125 million to $129 million.

Note that as the acquisition closed on June 12, only $6 million of Erwinaze sales were included in our second quarter results. A significant majority of Erwinaze sales are in the U.S., where we now have 20 sales representatives and a team of oncology focused medical science liaisons that support the product. The market is highly concentrated with roughly 50% of sales coming from fewer than 30 institutions, including the major oncology centers in the U.S., such as Children's Hospital of Orange County, MD Anderson Cancer Center and Dana Farber Cancer Institute.

Erwinaze had strong payer support at both the state and commercial level, and to our knowledge no patient has been denied treatment due to lack of reimbursement. Since approval, approximately 13 hospitals had purchased Erwinaze, suggesting additional growth can be achieved within the currently accepted treatment protocols. We intend to invest in additional medical education, scientific affairs. A particular focus to these initiatives will be to help the medical community and oncology nurses in particular better recognize and detect hypersensitivity to E-coli derived asparagins.

With meetings hosted by the Association of Pediatric Hematology Oncology Nurses, or APHON, and the American Society of Hematology, planned for later this year, we have several opportunities to increase the promotional and medical affairs presence for Erwinaze and provide information about its appropriate dosing and administration.

Going forward, we anticipate seeing increased utilization of asparaginase-based regimens among the adolescent and young adult populations, reflecting current practice trends and efforts by the National Cancer Institute and National Comprehensive Cancer Network. Over time the adolescent and adult population could be an opportunity for expanded use of Erwinaze.

I will now turn to Prialt, the only non-opioid, intrathecally-administered drug approved for severe refractory chronic pain. Prialt sales for the second quarter increased by 12% compared to the year ago second quarter in line with our expectations. This year we have been investing in and executing on three core initiatives. Expanding and training the sales force, increasing medical education and clinical affairs, and optimizing distribution and support services.

As you will recall we added ten sales consultants earlier this year bringing our total to 30 and we’ve since implemented an expanded training program. This group is off to a good start with expansion of current and addition of new accounts that help drive Prialt growth over time.

We recently implemented a nationwide speaker program and separately we are beginning to provide medical education with several programs planned this fall to improve the medical community's overall understanding of intrathecal therapies available for pain management. We are also increasing our medical affairs focus including building a larger medical affairs staff to support Prialt and pursuing related activities to help improve utilization of Prialt by insuring understanding of its benefits when appropriately dosed.

Finally, we are designing a customized, centralized distribution system that we expect to begin implementing through a phased launch starting late this year. We continue to believe that more patients could benefit from Prialt, and we remain committed to increasing awareness of and access to Prialt therapy.

I would also like to make a few comments regarding our development pipeline. We are working to obtain U.S. regulatory approval for IV administration of Erwinaze, and we plan to initiate enrollment in the U.S. registration trial this fall with the intent of improving patient comfort and compliance.

In the U.S., Erwinaze was administered to patients three times per week via intra muscular injections. Outside the U.S. Erwinaze is often administered intravenously. We anticipate that IV administration will provide significant benefits to patients, their families, and nurse providers.

Asparec, a pegylated recombinant erwinia derived asparaginase, is currently being evaluated in a Phase I dose escalation trial in Europe. We are also continuing the development of Leukotac, an anti-CD25 monoclonal antibody intended for the treatment of steroid refractory acute graft versus host disease. Leukotac is currently being evaluated in a Phase III study for which we anticipate results in mid to late 2014.

Finally I want to acknowledge the outstanding efforts of all of our employees including our new colleagues from EUSA Pharma. Integration efforts are proceeding well with the U.S. commercial operations of EUSA now incorporated into a new Erwinaze business unit under Russ Cox's leadership, and the international business of EUSA remaining under Brian Morton's leadership.

The Azur and EUSA transactions this year have not only brought us great product and product candidates, but also great people who together are committed to achieving our mission to improve patients' lives.

Let me now turn the call over to Kate.

Kathryn E. Falberg

Thanks Chris, and good afternoon everyone. Total net sales for the second quarter were $128 million, which includes the partial month of revenue for our EUSA products dating from the transaction closing on June 12. On a pro forma basis net sales for the quarter would have been $165 million as noted in the footnote in our press release issued today.

Our updated full year guidance for net sales in a range of $600 million to $610 million reflects expected growth from this pro forma run rate. Net sales of Xyrem were $89 million in the second quarter, a little more than half of our total pro forma net sales. Our revised full year guidance for Xyrem reflects a price increase that we implemented Friday coupled with our expectation for low double digit volume growth this year.

As an orphan drug that addresses a serious medical condition, Xyrem continues to have excellent reimbursement coverage, and we remain committed to ensuring that appropriate patients have access to Xyrem therapy. Last month we modified our coupon program so that we now cover patients' out of pocket costs that exceeds $35 per month.

Another example of our commitment to patients is a partnership launched with the Patient Advocate Foundation. It will help ensure that all narcolepsy patients not only those on Xyrem, have access to the case management services related to their insurance coverage and benefits via a toll-free narcolepsy care line. That sales of our psychiatry products were approximately $20 million for the quarter, up 18% year-over-year on a pro forma basis driven by a 44% increase in Luvox CR sales. While the FazaClo products were relatively flat in total, the proportion of sales from the higher dosage strength continued to grow, and now reflect over a third of total FazaClo sales.

We continue to expect near term generic competition to both FazaClo LD and Luvox CR under existing settlement agreement. Net sales of Prialt were $5.6 million, up 12% year-over-year on a pro forma basis, driven by higher volumes. We were pleased to see an uptick in the growth rate as compared to the 8% U.S. volume growth rate posted in the first quarter.

As a reminder, first quarter 2012 Prialt sales included $4.6 million of sales to Eisai for the EU market. Net sales of other products were $7.9 million for the quarter. This group now includes women's health and other products resulting from both the Azur and EUSA Pharma acquisitions. On a pro forma basis this group declined from the prior years largely due to declines in sales of the unpromoted brands partially offset by strong continued growth of Elestrin.

Gross margin for the quarter was 88%, which was impacted by $4 million of non-cash expense due to the purchase accounting inventory fair value step-up. Excluding this expense gross margin would have been 91%. That we’ll continue to be some of this non-cash expense over the coming quarters as the inventory is sold. For the full year, we expect gross margin to be in the mid 80% on a GAAP basis and about 90% on a non-GAAP basis.

SG&A and R&D combined for the quarter were $63 million. This amount includes $11 million of transaction and integration expenses, which are primarily comprised of professional service fees related to the use of transaction and $5 million of share based compensation expense. Excluding these items combined SG&A and R&D expenses increased by $5 million compared to the first quarter of this year, with about half of that increase being due to inclusion of a few weeks of expenses from EUSA. As a percent of sales, adjusted combined SG&A and R&D expenses were 37% in the quarter. Consistent with 39% in the first quarter and 35% in the second quarter a year ago.

For the year, we are updating our guidance for SG&A and R&D combined to a range of $260 million to $270 million, which includes expected transaction and integration expenses of $22 million to $24 million, as well as share based compensation expenses. As a percent of sales, adjusted for these items, SG&A and R&D combined are expected to be in a range of 34% to 37% for the full year.

Turning to the balance sheet and keeping with our strategy to deliver attractive shareholder returns while maintaining a lower risk profile, at quarter end we had $155 million in cash and investments and debt of $475 million, which is less than two times trailing adjusted EBITDA.

In closing, we are very pleased with our performance for the quarter and year-to-date. We are increasing our guidance today to reflect our expectation for continued solid execution and strong growth. As noted in our press release, we now expect GAAP EPS in the range of $2.34 to $2.57 for the year, and adjusted EPS in the range of $4.70 to $4.85. Thank you for joining us on the call today.

I’ll now ask the operator to open the line for your questions. Operator?

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) And our first question comes from the line of Douglas Tsao of Barclays. You may proceed.

Douglas D. Tsao – Barclays Capital, Inc.

Hi, good afternoon. Bruce, I was just hoping to get an update on the commercialization of Prialt. Obviously now you had the product for about half a year, and just curious in terms of what you have learned about the product in sort of what you see as the challenges and the opportunities today versus when you first acquired the product.

Bruce C. Cozadd

Sure, Doug, I’ll make some opening comments and then maybe I will turn it over to Russ to add his perspective. The first thing I will remind you is that we see Prialt as a long-term growth asset for us, worthy of investment in the near term to generate growth over time. And we are confident that growth can come because as we have looked at our physicians who have good experience using the product in their patients, they are getting good results, and we are seeing use in, as I have mentioned on prior calls, up to 25% of the intrathecal chronic pain patients as compared to the overall market share in pumps or something like 3%. So we think that it is worthy of investment to improve understanding how to properly use this product, and to make sure our distribution system takes reimbursement concerns away from the doctors. The doctors can focus on choosing the appropriate therapy for them.

Russell J. Cox

Yeah Doug this is Russ and I will just comment that, consistent with what Bruce said, we have not learned anything different than what we thought prior to going forward with the Azur acquisition. We did our market research on Prialt. We do think it reminds us a lot of Xyrem. A lot of the issues that we are dealing with today are misunderstanding of how to titrate and how to best use Prialt. We are starting to make some good progress in education there. We also think that there is a distribution issue that needs to be resolved, and as that happens, we think that will also help us over time. So we are continuing to focus on the two things that we thought were an issue going in, we are starting to see some progress there, and the new sales force that we have in place on Prialt is starting to make it.

Douglas Tsao – Barclays Capital

Okay, great. And then just another question in terms of the increasing guidance for Erwinaze sales, what has changed your expectations or what is different in terms of your assumptions today versus when first acquired EUSA?

Bruce C. Cozadd

Doug, I don’t think there’s any significant change, it’s just that we have had another quarter of performance to evaluate. We’ve now had a chance to put the team together with the rest of our business, align our expectations for the rest of the year, and because of that I think we – at this point, are giving guidance. We are confident in I think going into the deal, obviously, we were leaving room for the potential for some disruption during the integration process. And I just have to say I think the integration process is going very smoothly.

Douglas Tsao – Barclays Capital

Okay, great. Thank you very much. I will hop out of the queue for now.

Operator

Our next question comes from the line of David Amsellem with Piper Jaffray. You may proceed.

David Amsellem – Piper Jaffray

Thanks. Just a couple. So regarding Xyrem, and I know you get asked this a lot, but given the latest pricing action, I thought I’d ask it again. What’s the extent to which you think you can continue to take aggressive price increases? What do you think the managed care landscape will be like assuming you continue to engage in the same kind of pricing actions as we have seen in the past?

Bruce C. Cozadd

So David as you know, we generally don’t comment specifically on future pricing, but I would say you heard some of our comments about the research we are doing on the burden of this illness and the importance of treating narcolepsy well, and we think the therapy remains an important part of narcolepsy treatment and adds substantial value to the health care system. As we said, we had fewer than 10,000 patients on therapy in the second quarter, so this is a highly focused orphan population with a very debilitating condition and for which we have a therapy that we believe is very beneficial and unique.

David Amsellem – Piper Jaffray

And then regarding patients on Xyrem, this is a longer-term question, maybe tough to answer. But what’s an appropriate way to think about the peak number of patients on Xyrem. Maybe another way of asking is as of now, what’s your estimate of the number of U.S. narcolepsy patients that you think are appropriate for the drug?

Bruce C. Cozadd

Yeah, I will start that question, and then I’m going to hand that over to Jeff Tobias. Our estimate of the number of narcolepsy patients, and this is not unique to Jazz Pharmaceuticals, obviously we are going from a data collected by other groups, continues to be in the 125,000 or 150,000 up to 200,000 patients, but we also know that it is only a minority of those patients that are currently diagnosed and receiving a treatment for the condition, and that number is estimated to be about 50,000.

In terms of who is appropriate for Xyrem therapy, I will say that my lay understanding before we go to Jeff’s medical view is that this is a very serious condition. It’s not as though there is mild narcolepsy and serious narcolepsy. If you have narcolepsy, you have a disease that very much changes your life and Xyrem is seen as an important and first line therapy.

Jeffrey K. Tobias

Right. And so I think as Bruce pointed out, it is very interesting that the epidemiology of the disease, although numbers have been bounced around for some time, it is not necessarily well characterized. And in fact some of the data that we are beginning to generate might suggest even larger numbers of patients with narcolepsy. That being said, there certainly will be a subset of those patients that once they are identified and diagnosed and referred to the proper treating physician, that is somebody who may be comfortable with the use of Xyrem, a good proportion of those will be started out with either adding on to a – in most case as a stimulant or for example, cataplexy is their predominant symptom maybe going straight on to Xyrem. So that kind of background of uncertainty, we estimate about a third of those patients may be appropriate for Xyrem use based on either the severity of the disease, their refractoriness to other treatments, or certainly the cataplexy component, which Xyrem is the only approved treatment to lookout.

David Amsellem – Piper Jaffray

Okay. Thanks. That’s helpful. Just very quickly, on Erwinaze, just remind us how many total institutions you are currently calling on?

Bruce C. Cozadd

The majority of the Erwinaze volume is coming from about 28 accounts and there is an additional 128 accounts that exist.

David Amsellem – Piper Jaffray

Okay. Thanks.

Operator

Our next question comes from the line of Chris Holterhoff with Oppenheimer. You may proceed.

Chris Holterhoff – Oppenheimer & Co. Inc.

Hi, thanks, guys. Just a question on Xyrem first. Of the thousand or so additional target physicians you identified last year, do you have a sense of how many prescribed the drug to-date? Just trying to get a sense of if a lot of the new patient growth is coming from these docs or if you think you are getting uptake from existing prescribers of the drug?

Bruce C. Cozadd

Yes, I think it is a combination of both. I think of those additional thousand that we are calling on, we have closing in on a hundred now that are ultimately involved with [FDF] and are potentially new customers who are prescribing. We also have a segment of physicians who are not necessarily large prescribers, who were sort of dabbling in that one, two or three patients that are now getting in the four or five patient range, which appears to be a sort of a threshold to use more Xyrem. So we are seeing a combination of new physicians as well as the existing population that we're calling on being more correct.

Chris Holterhoff – Oppenheimer & Co. Inc.

Okay, that’s helpful thanks. And then in your prepared remarks you made a comment about thinking you can increase the compliance with Xyrem. I am just wondering if you can kind of elaborate on that and maybe tell us, remind us where you are now and realistically where you think compliance can go?

Russell J. Cox

Yes, our current compliance and consistency rates are consistent with specialty pharmaceutical. But there are certain areas where we are starting to see some improvement, particularly in the area of disenrollment we are making some progress, and clearly given the fact that we can now give physician level compliance and consistency data we saw certain physicians who were outliers and we now on a case to case basis we are actually dealing with those, and I think that will change over time.

Chris Holterhoff – Oppenheimer & Co. Inc.

Okay, thanks and maybe just one last one. The EUSA transaction is closed and you guys, some more time with the product and so I just wondering if you had a better sense of the average number of doses that you are seeing per patient.

Bruce C. Cozadd

Yeah so unchanged, we have historically data is anywhere from as well as on average of 42 as high as an average of 50 plus, but nothing has changed in terms of our (inaudible).

Chris Holterhoff – Oppenheimer & Co. Inc.

Okay, thanks a lot.

Operator

Next question comes from the line of Michael Faerm with Credit Suisse. You may proceed.

Michael Faerm – Credit Suisse Securities

Hi, good afternoon thanks for taking the question. A question on Xyrem, what was the prescription growth year-over-year in 2Q?

Bruce C. Cozadd

The volume growth was 11% I remember what we report as revenues are shipments directly from central pharmacy to patient. So that is an accurate – prescription volumes are identical means.

Michael Faerm – Credit Suisse Securities

I got follow-up, just regarding the relationship between patient and prescription growth, the last couple of – first quarter and second quarter, the prescription volume growth was just a tad below patient growth. I’m just wondering why that is that’s a turnaround from what it was last year, just wondering how to think about that.

Bruce C. Cozadd

Mike, I think that maybe bit of false precision. We reported sort of an average active patients number during the quarter. That number obviously literally varies by day. Volume does include dose per patient, but honestly the average dose per patient has been relatively constant.

Michael Faerm – Credit Suisse Securities

Just one other question regarding progress on the warning letter, is there any update there since the last update that you provided?

Bruce C. Cozadd

Yeah, I don’t think there is any significant uptake we got the last update we gave was a substantive one. It shows that we had finished our response to the May 2012 483, and that we were substantially complete with all of our efforts to in response of the warning letter of last year, both from a compliance standpoint. We clearly have been doing these things both to make sure ongoing event reporting system is robust as well as to make sure we had gone back and fully investigated any lapses that had happened historically both from a compliance and safety perspective. That information has all been provided to FDA, but for the things that will go in our periodic safety update report in September, and as you know we did last month have a phone call with FDA to wrap up the investigation we have done and with some of the older data.

So we really feel like it has been an active couple of months. Particularly May, June, July for really getting to the point where we can put this behind us. We obviously can’t do that without officially closing that out with FDA, and we respect that could still take some time. And then we also appreciate that ultimately the important thing here is to maintain great systems operating reliably over a long period of time. So in that sense it is never over, but we hope we’re back on a solid footing.

Michael Faerm – Credit Suisse Securities

Thank you.

Operator

Our next question comes from the line of Bill Tanner with Lazard Capital Markets. You may proceed.

William Tanner – Lazard Capital Markets

Thanks for taking the question. Congratulations on a solid quarter. Russ, just a question for you back on the – I was looking at the transcript from last quarter, I think that it was mentioned that there were 1,000 physicians that had been identified and about 10% had enrolled in the Xyrem success program with about 50% of them actually prescribing. So it sounds like maybe a similar number of physicians enrolled, but do you have any rough – and I appreciate the fact that it’s only a quarter removed, but any commentary as to accelerating prescribing by these physicians?

Russell J. Cox

Yeah, so of that new 100, we had mentioned 50, now we’re more heading more toward 75 and beyond. It definitely is progressing.

William Tanner – Lazard Capital Markets

Okay.

Russell J. Cox

It was that new 10% as compared to…

William Tanner – Lazard Capital Markets

And then just as it relates to the size of the sales force, is 80 the appropriate number? I mean is this because obviously if you get to a fairly big revenue number if the pricing keeps going up and you make some reasonable penetration. Is that kind of the – just trying to gauge the leverageability of the Xyrem dedicated sales force?

Russell J. Cox

We think 80 is the right number and I would characterize it is important to have the right 80. I think we’ve got the right 80 and that is making a big difference. I think where you are seeing additional resources on Xyrem is in the area of patient services and our ability to make sure that those patients who are in fact potentially able to get into the system are actually being prescribed Xyrem and being able to start on therapy. So we’re layering on some additional services and that’s where some additional (inaudible) are being applied to Xyrem.

William Tanner – Lazard Capital Markets

Okay. And then Bruce, just a couple of questions on the July CP. I’m curious as to the expectation potentially for the company to get a response from the FDA?

Bruce C. Cozadd

So our most recent citizen petition was filed after the new legislation that shortened the CP response time to 150 days. I don’t have any insight beyond that. That’s when we are supposed to get a response, and we look forward to hearing of that late this year.

William Tanner – Lazard Capital Markets

And then I think in the last two K’s the company has disclosed that you have been in the process of converting the risk map to a REMS. I guess that’s still in process. And then what are the implications for whatever RoxSan has submitted in terms of their ANDA as it relates to a REMS program, whatever Jazz may do or the FDA may request Jazz do in terms of modifying the risk map?

Bruce C. Cozadd

Well, for a full discussion of that you would probably want to see our citizen petition and pay attention to our litigation, but from a high level of point of view, the risk map of Xyrem and a number of other pre-SEDAR risk management programs are considered de-REMS, so it is REMS. We pointed out it needs to be approved in the new format or one of the number of instances where that process is not yet complete, but I don't think that has any particular bearing on the situation for RoxSan or questions around the RoxSan and situation really – fairly should whether they in fact filed a complete, workable, appropriate REMS to enable FDA evaluate whether they in fact are safe for distributing the drug in the same way that we are.

William Tanner – Lazard Capital Markets

Okay. And then maybe just one last question, I know that – I guess lot of people are looking daily or frequently for the Markman ruling, I suspect you guys have not a lot of visibility as to when it is going to come, but what will be expectation in terms of after it comes that – if there is a court date set, it would be set.

Bruce C. Cozadd

Yes, I don't have any particular insight into that, Bill. There are a number of things going on in the litigation that would come before court date and in general those have been pulling back in time not forward in time. I don't have any particular insight on whether Markman ruling would come, we recently we got a ruling in our prior matter. But I don’t know that you can use that to extrapolate to.

William Tanner – Lazard Capital Markets

Okay, great. Thank you.

Operator

(Operator Instructions) Our next question comes from the line of Michael Schmidt with Leerink Swann. You may proceed.

Michael W. Schmidt – Leerink Swann LLC

Hi, thanks for taking my questions, and congrats on a great quarter. Erwinaze, the hypersensitivity rate appears to be a great variable in determining product uptake and practice. I was wondering how is hypersensitivity currently determined and how – you had talked about maybe introducing a new way of doing that and I was just wondering if you could elaborate a little bit on that.

Bruce C. Cozadd

Yeah, why don’t I have Jeff take that question?

Jeffrey K. Tobias

Well, it’s a very good question, because there isn’t really a uniform method of diagnosing hypersensitivity across institutions. It is a clinical diagnosis. It takes somebody evaluating the patient really at the bedside and determining whether or not they have a certain severity in hypersensitivity ranging from just redness all the way up to anaphylaxis. So it’s a clinical diagnosis, and one of the things that we can do is to help educate nurses and other practitioners about the recognition of this types of hypersensitivity. To some sense these are not noted and they go untreated then that way. I believe for your second half of your question, Mike relates to other forms of immunological reaction that could impact the efficacy of the E-coli asparaginase, it's commonly referred to as silent inactivation, where people develop antibodies. We don’t necessarily have a clinical manifestation of hypersensitivity, but they have an immunological reaction that can clear and neutralize the asparaginase, and we think that that may have – data suggest that may have a negative impact on the treatment of these patients. This is another area that we will be looking at as we move forward with…

Michael W. Schmidt – Leerink Swann LLC

And what would you think a sensitivity rate might be with a different diagnostic potentially.

Jeffrey K. Tobias

If you are looking at the clinical hypersensitivity reaction, in the literature it is all over the place. It can range from a few percent to 60% or more. We are generally looking at reactions at about 15% to 18% of the patients who were exposed to an E-coli asparaginase. Whether or not that percentage of patients who have that immunological reaction, that's not well deployed.

Michael W. Schmidt – Leerink Swann LLC

Okay. And then the – I guess you have the pegylated version of the enzyme in early trials. Is that something that could be positioned for first line therapies?

Jeffrey K. Tobias

Well, we’re focusing now on the Erwinia placement in treatment and that is as a second line to the E-coli. Certainly as we go forward with the molecule will be looking at other potential indications, and whether or not it has a role as first line or second line.

Michael W. Schmidt – Leerink Swann LLC

Okay, great. Thank you.

Operator

There are no further questions at this time. I would now like to turn the call back over to the speakers for any closing remarks.

Ami Knoefler

Thank you for joining our call today. Please not that Jazz Pharmaceuticals will be presenting at the Morgan Stanley global healthcare conference in New York City in September. We will also be participating in several medical conferences this fall, including APHON and ANA. We may see you at one of these events. Thanks for joining us everyone and thank you operator.

Operator

Ladies and gentlemen, that concludes today conference. Thank you so much for your participation, you may now disconnect.

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