Jazz Pharmaceuticals plc (JAZZ) Q2 2015 Earnings Report, Transcript and Summary

Welcome to the Jazz Pharmaceuticals Plc Second Quarter 2015 Earnings Conference Call. Following an introduction from the company, we will open the call to questions. I will now turn the call over to Kathee Littrell, Head of Investor Relations at Jazz Pharmaceuticals.

Thank you, Whitley. And thank you all for joining us on our investor call. Today we reported our second quarter financial results and reaffirmed our prior 2015 financial guidance in a press release. The release and the slide presentation accompanying this call are available in the News & Events section of our website. With me for today's call are, Bruce Cozadd, Chairman of the Board and our Chief Executive Officer; Matt Young, our Chief Financial Officer; Russ Cox, our Chief Operating Officer; Mike Miller, our Head of U.S. Commercial; and Karen Smith, our Global Head of R&D and Chief Medical Officer. Following some remarks, we'll open the call for your questions. I'd like to remind you that some of the statements we will make on this call relate to future events and future performance rather than historical facts and are forward-looking statements. Examples of forward-looking statements include statements related to our 2015 financial guidance and goals, investment in our products and R&D pipeline, our corporate development efforts, growth in our product sales and the potential launch of defibrotide in the U.S., our commercial efforts and initiatives, litigation and intellectual property-related events, regulatory matters related to Xyrem and defibrotide, events related to our clinical trials and the timing of such events and activities. These forward-looking statements involve numerous risks and uncertainties that could cause actual events, performance and results to differ materially. These risks and uncertainties are identified and described in today's press release, the slide presentation accompanying this call and under Risk Factors in our Form 10-Q for the quarter ended March 31, 2015 and our Form 10-Q for the quarter ended June 30, 2015 that we expect to file shortly. We undertake no duty or obligation to update any forward-looking statements we make today. On this call, we will discuss several non-GAAP financial measures, including historical and expected 2015 adjusted net income attributable to Jazz Pharmaceuticals and related per share measures and historical and expected 2015 adjusted SG&A and R&D expenses. 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 reported GAAP measures. Reconciliations of GAAP to non-GAAP financial measures discussed on this call are included in today's press release and the slide presentation accompanying this call. Both are posted in the News & Events section of our website. I'll now turn the call over to Bruce.

Good afternoon, everyone, and thank you for joining us. During the second quarter, we achieved revenues of $334 million, an increase of 15% compared to the second quarter of 2014, driven by strong sales of Xyrem. We realized adjusted net income of $152 million in the second quarter, reflecting the attractive margins in our business. GAAP net income for the quarter was $88 million. We have made significant progress on the R&D front. We're very pleased to announce today that we completed the submission of the defibrotide rolling NDA last week. We have also begin enrollment in JZP-110 Phase 3 trials evaluating excessive daytime sleepiness in narcolepsy or obstructive sleep apnea. We continue to invest in our key growth products and our R&D pipeline. In addition, we remain focused on our corporate development efforts as we evaluate potential transactions to further enhance and diversify our portfolio. I'll now update you on our sleep and hematology and oncology therapeutic areas, including information on key commercial, legal, regulatory and clinical development activity during the quarter, after which Matt will review our financial results for the quarter and provide comments on our guidance. I'll start my comments with our sleep therapeutic area and our lead product, Xyrem. In the second quarter, demand for Xyrem remained strong and the average number of active Xyrem patients grew to approximately 12,475 from 11,750 in the same period of 2014. During the second quarter, we had bottle volume growth of 7% compared to the same quarter last year and we remain on track for high-single digit volume growth this year. I'll briefly discuss our key Xyrem growth initiatives that align with our goals of broadening the market opportunity by increasing penetration within the currently diagnosed narcolepsy population and expanding the overall number of diagnosed narcolepsy patients in the U.S. One new initiative employs a more targeted or predictive approach to engaging with our physician call universe, which we believe will increase the efficiency of our sales force. Through extensive claims resources collected over the years, we have identified key characteristics that correlate with the highest diagnosing physicians and use these criteria, such as overall volume of sleep patients, patient mix and complexity of diagnoses, among others, to identify a group of physicians for our salesforce to target. We believe this initiative and predictive approach can further drive Xyrem penetration in the currently diagnosed narcolepsy population, similar to the success we've had in increasing prescriptions with the low to mid-decile prescribing physicians. Our second growth initiative is aimed at expanding the diagnosed population of narcolepsy patients who may be candidates for Xyrem therapy. By increasing our emphasis on the diagnosis and treatment of cataplexy through the use of the Swiss Narcolepsy Scale. While the prevalence of narcolepsy with cataplexy represents approximately 70% of the narcolepsy population, we are aware that cataplexy is often undiagnosed or misdiagnosed. The Swiss Narcolepsy Scale was incorporated into the morethantired.com website last fall and there have been over 60,000 completions of this scale. Importantly, approximately 14,000 of the individuals who completed the Swiss Narcolepsy Scale had scores less than zero, which are highly specific and sensitive for the diagnosis of narcolepsy with cataplexy. The tool is available to physician offices through our salesforce and we are also integrating the SNS into our broader medical education programs, as we believe this can provide increased awareness and diagnosis of narcolepsy patients with cataplexy, where Xyrem is the only FDA-approved medication. Finally, as part of our broader disease awareness and education efforts, we hosted a very well attended National Satellite Symposium during the second quarter titled, Practical Considerations in the Clinical Understanding of Excessive Daytime Sleepiness and/or Cataplexy in Narcolepsy, with more than 800 healthcare practitioners in attendance. Following the strong response to these educational efforts, we plan to conduct another satellite broadcast during the second half of the year. Turning to a brief legal and intellectual property update on Xyrem. Patent litigation continues in the District Court of New Jersey. No trial dates have been set in any of the cases, although we anticipate the trial of a portion of the case against the first filer, Roxane, could occur as early as the first quarter of 2016. The expert discovery phase of this case is now scheduled to complete in November, with a status conference scheduled to follow. Finally, we have received additional Paragraph IV certifications by Wockhardt Bio AG and Lupin, Inc. We have recently initiated litigation against Wockhardt and are evaluating initiation of litigation against Lupin. As mentioned in our last call, in January two of the Xyrem ANDA applicants filed petitions with the PTO's Patent Trial and Appeal Board, or PTAB, for inter partes review, or IPR, of six patents covering our restricted distribution system for Xyrem. We recently received decisions from PTAB to institute review under these IPR petitions and the parties will now present their evidence and arguments on the prior art in the petitions. We expect the final decision from PTAB on the validity of the patents in approximately 12 months. The final decisions will be appealable to the U.S. Court of Appeals for the Federal Circuit. As previously disclosed, an additional IPR petition on one of the six patents covering our restricted distribution system for Xyrem was filed in early April by an entity affiliated with a hedge fund. We filed our preliminary response to this IPR petition in the third quarter and expect PTAB to rule on whether to accept this petition in the fourth quarter. If review is instituted, the PTAB decision on validity would be expected approximately a year after that. With respect to the Xyrem REMS, we are on track to implement the final approved Xyrem REMS and begin the submission of ongoing assessments later this month. The REMS includes new forms and requires one-time reenrollment of all prescribers and patients. Our goal is to provide uninterrupted pharmacy service to our patients and providers. To do this, we've prepared the field salesforce and our specialty certified central pharmacy in an effort to provide a smooth transition to the new Xyrem REMS. We are also educating Xyrem prescribers on the new Xyrem REMS program enrollment and process as a component of our upcoming satellite broadcast. Now turning to our development program for JZP-110. We're excited to have advanced this unique wake promoting product candidate into Phase 3 studies. During the second quarter, we began enrollment of the three Phase 3 studies evaluating the safety and efficacy of JZP-110 in the treatment of excessive daytime sleepiness in narcolepsy or obstructive sleep apnea. We also began enrollment in the long-term safety study. We anticipate that the studies will finish enrollment during the second half of 2016. Now on to the hematology/oncology franchise. Our efforts with Erwinaze remain focused on educating healthcare providers on the importance of identifying hypersensitivity reactions to E. coli-derived asparaginase in acute lymphoblastic leukemia, or ALL, in both pediatric and adult oncology centers using asparaginase therapy in their treatment regimens and on the importance of maintaining appropriate asparaginase levels for optimal outcomes. Although we believe that we are well penetrated in the pediatric ALL population, we believe that the adolescent and young adult population with ALL provides us with a further growth opportunity, as more adult oncology centers have begun using the pediatric-inspired asparaginase protocols in their ALL patients. Now to Defitelio. The European launch of Defitelio has progressed well and we're pleased with our success in obtaining a narrow pricing range for Defitelio in the EU of approximately €426 per vial. We've made good progress on driving centralized Defitelio pricing and reimbursement since launch. While we have experienced some pressure on net sales from foreign exchange and reduced use of Defitelio in the prevention of VOD, we continue to see an opportunity to grow Defitelio by working with the healthcare systems to establish appropriate reimbursement mechanisms and providing them with the most appropriate information on outcomes for VOD patients treated with Defitelio. We also believe medical education around VOD pathophysiology and treatment, appropriate diagnosis and other attributes of Defitelio as well as expanding the base of experienced physicians will allow us to drive volume growth. Now a brief U.S. regulatory update on defibrotide. We completed our NDA submission on July 31. My sincere thanks to our entire submission team for their dedication to achieving this milestone. Defibrotide has Fast Track Designation in the U.S., and we have requested a Priority Review, which could reduce the timing for FDA review from 10 months to six months. We anticipate hearing from the FDA as to whether the NDA has been accepted for filing and whether we have received Priority Review by the end of September. In the meantime, we're focused on educating U.S. healthcare providers in the recognition and treatment of VOD through an unbranded disease awareness program. We've also begun preparing for a potential launch of defibrotide in the U.S., including a health outcome and reimbursement assessment and a field force sizing analysis that includes planning for a joint Erwinaze/defibrotide salesforce. Finally, our defibrotide development team continues to work with FDA on clinical trial design for the evaluation of defibrotide in prevention of VOD in high-risk patients or in earlier VOD before it has progressed to multi-organ failure. We expect to provide more details on clinical trial design during the second half of 2015. We are also evaluating potential development of defibrotide in other diseases. The first half of 2015 has been quite active. Year-to-date we refinanced our existing loans and credit revolver to add flexibility to the business on our capital structure, sold non-core assets to focus on our key therapeutic areas and delivered on key corporate objectives, including completion of the submission of the NDA for defibrotide and the initiation of the Phase 3 JZP-110 program, all while continuing to deliver continued growth in Xyrem sales and strong margins. We believe we are well positioned to execute on a wide range of business development transactions and look forward to further execution of our corporate growth strategy. Matt, let me now turn the call over to you.

Thanks, Bruce. And good afternoon, everyone. We are pleased with our strong performance in the second quarter, as we saw adjusted EPS attributable to Jazz increase by 19% year-over-year. We expect continued strong top-line growth for 2015, driven by growth in the sales of Xyrem and Erwinaze. We are reaffirming our total revenue guidance at a range of $1.31 billion to $1.37 billion and our adjusted EPS guidance at a range of $9.45 to $9.75 per diluted share. Net sales of Xyrem for the quarter were $248 million, up 30% from $191 million in the second quarter of last year. Although we observed bottle volume variability between quarters in 2014, during the first half of 2015 we've observed a higher level of consistency and predictability in our core Xyrem business. Our bottle volume growth for the first half of 2015 was 9.7% compared to 8.3% for the same period in 2014, so we're pleased with our growth and continue to expect high-single digit bottle volume growth in 2015. We are maintaining our guidance for Xyrem net product sales in a range of $950 million to $970 million. Turning to Erwinaze. Second quarter worldwide net sales were $46 million, down 4% compared to net product sales of $48 million in the second quarter of 2014. Product demand increased slightly compared to the second quarter of 2014. The key factors that negatively impacted Erwinaze net sales in the second quarter of 2015 were, one, increased chargebacks and rebates resulting from increased utilization of 340B and Medicaid programs and switching distributors near the end of the second quarter. Foreign exchange negatively impacted Erwinaze net sales by approximately $2 million and $4 million for the three months and six months ended June 30, 2015 compared to the same periods in 2014, respectively. We are maintaining our guidance for Erwinaze net product sales in the range of $200 million to $215 million for 2015. For Defitelio/defibrotide second quarter worldwide net sales were $15 million, down 25% compared to net product sales of $20 million in the second quarter of 2014. Net product sales in the second quarter of 2015 were impacted by foreign exchange headwinds that reduced Defitelio net product sales by approximately $4 million in the three months ended June 30, 2015 and our pro forma net products sales by approximately $7 million in the six months ended June 30, 2015 compared to the same periods in 2014, respectively. Other factors that impacted sales of Defitelio in the second quarter of 2015 were the discontinuation of the cost recovery program in July of 2014 and increased volume due to shipments to distributors during the second quarter of 2014 following launch of Defitelio. With this said, there can be variability quarter-to-quarter from products that treat rare disease and where volume is impacted by weight-based dosing. We are reaffirming our Defibrotide net sales guidance in a range of $73 million to $83 million, taking into account our anticipated volume growth during the second half of 2015. I'll remind you that the foreign currency impact to the bottom line is minimal as we incur European expenses and have otherwise largely mitigated our net exposure. In the second quarter, pre-op net sales were $7 million compared to $6 million for the same period in 2014. Turning to operating expenses. Adjusted SG&A expenses for the second quarter of 2015 were $88 million or 27% of total revenues compared to $82 million or 28% of total revenues in the same period in 2014. I'll remind you that the first quarter and second quarter adjusted SG&A spend as a percentage of revenues has been a fairly consistent pattern. The dollar increase year-over-year in adjusted SG&A expenses was primarily due to higher head count and other expenses related to the expansion of our business. Adjusted R&D expenses for the second quarter were $24 million or 7% of total revenues compared to $17 million or 6% of total revenues for the same period in 2014. The increase was primarily due to increased costs for the development of our product candidates and lifecycle management activities for our existing products, as well as expenses related to the rolling NDA submission for Defibrotide in the U.S. Our 2015 guidance for adjusted SG&A remains a range of $355 million to $365 million and adjusted R&D guidance remains a range of $95 million to $105 million. During the first half of 2015, cash and cash equivalents increased to $922 million primarily due to cash generated from the business. We refinanced our credit facilities in June 2015, which added flexibility to our capital structure. In the refinancing, we reduced the term loan facility from approximately $900 million to $750 million, increased our borrowing capacity under the revolving credit facility from $425 million to $750 million and reduced our expected cash interest expense by approximately $5 million to $6 million in 2015. We lowered the interest rate, including removing the LIBOR floor, extended the date the facilities mature to June 2020 and improved business flexibility by increasing total cash available for general corporate purposes. As of June 30, 2015 the principle balance of the company's outstanding indebtedness was approximately $1.5 billion. During the second quarter, we purchased approximately 8,000 shares at an average cost of roughly $169 per share leaving us with $9.7 million remaining in our $200 million share repurchase program. In closing, we are pleased with the first half of 2015 and are reaffirming our 2015 guidance. We continue to focus on investing in the growth of our key commercial products, advancing our development pipeline, working toward regulatory approval of defibrotide in the U.S. and pursuing acquisition opportunities to further grow and diversify our product portfolio and pipeline. Thank you for joining us on the call today. And I'll now ask Kathy to make a brief comment about our Q&A session.

Thanks, Matt. We request that you limit your questions to one at a time and then just feel free to jump back in or reenter the queue if you have further questions. With that said, I'll turn the call back to the operator to open the line for your questions.

Our first question comes from the line of Louise Chen with Guggenheim. Please proceed.

Hi. Thanks for taking my question. So, curious where you're seeing the best deals in business development. You noted this has been a focus for the company. Is it large or small deals, pipeline or commercial? And also, would you consider using equity for deals and, if so, under what scenarios? Thanks.

So, let me have Matt take that.

Hey, Louise. It's Matt.

Hi.

So we see good opportunities in several areas as it relates to corporate development. As we've talked about, we're willing to look at large transactions, including up to the size of our company. And as it relates to that, that we would in fact consider the use of equity and we would try to shape the capital structure related to the risk and growth profile accordingly. So, absolutely, we would consider equity. I'm going to refrain from commenting on specifically under which rocks we might find great corporate development opportunities, but I do think there's a range of good alternatives out there.

Great. Thank you.

Your next question comes from the line of Gary Nachman with Goldman Sachs. Please proceed. Gary J. Nachman - Goldman Sachs & Co.: Bruce, at a high level maybe you could give us thoughts on the PTABs decision to review all six Xyrem distribution patents. How do you feel about the generic challenges that were actually thrown out versus those that they're going to be reviewing? Thanks.

So, Gary, good question. Unfortunately, since we're involved in litigation here, I'm not going to say too much about the specifics. Unlike the CBM situation earlier this year, where I think we predicted or we didn't think it should get picked up, I think we were pretty neutral on whether PTAB would pick up these IPRs, and they did. I was actually pleased that they narrowed the scope of that challenge, as you indicated. I think that's helpful to us because those things won't be argued. And now both sides will have to make their arguments on the more narrow grounds that remain. But I can't comment on which we think are stronger or weaker. Gary J. Nachman - Goldman Sachs & Co.: Okay. Thank you.

Your next question comes from the line of Annabel Samimy with Stifel. Please proceed. Annabel E. Samimy - Stifel, Nicolaus & Co., Inc.: Hi. Thanks for taking my question. I had a question on defibrotide. You mentioned the $4 million FX impact. Can you maybe quantify the impact of the discontinued cost recovery program? And in terms of the dynamics in Europe, to what extent does the change in use from preventative prophylaxis to I guess earlier use in high-risk patients, at what point does that sort of shift over to just normalized use in the right populations? Thanks.

Sure. As it relates to the first part of that question – it's Matt. In the quarter, it was roughly $1 million related to the elimination of the cost recovery program and it's a little over $2 million for the year, given it was July so it was shut down partway through the third quarter. So with that, I'll turn it over to Russ as it relates to the second part of the question.

Yeah. Hey, Annabel. So, I'd just reiterate that we're still seeing double-digit growth in the high-teens in the EU for defibrotide. And as you mentioned, clearly we have the FX effect, we clearly have issues around initial shipments to distributors in the second quarter of 2014 also, so that was a little piece of it. And then you mentioned the fact that we we're no longer doing cost recovery. So that combined is comparison of the second quarter of 2014 to the results in 2015. In terms of how it's shifting, we clearly have seen some change in the way that physicians think about defibrotide. Now that it's at €426, they're treating more for severe VOD as opposed to prophylaxis. It doesn't mean prophylaxis is not happening. What I'm telling you is that you've seen more of a focus on severe VOD. When we've done market research with physicians, it creates an opportunity for us to explain that there is a opportunity to see more patients who have VOD and clearly the opportunity to then get to it earlier is something that we will be working over in time.

And I would say, Annabel – this is Bruce. We've seen in some of the earlier markets to start reducing prophylaxis use that we're starting to see overall volumes come back. So to your question of where are we in this evolution, it's a little bit market-by-market, but I sort of feel like a lot of that shift in many markets is now behind us. Annabel E. Samimy - Stifel, Nicolaus & Co., Inc.: Great. Thank you.

Your next question comes from the line of Gregg Gilbert with Deutsche Bank. Please proceed.

You hear me okay?

Yeah. We can, Gregg.

Great. Back to Xyrem. Bruce, do you make anything of the changes in ownership of the first to file application? That's part one. And part two, in terms of the mandatory settlement discussions that are part of the IPR process, how different is that as a process than, let's call it, the more typical litigation scenario where there are such things as well? Thanks.

Yeah, on the change of ownership of Roxane, that's come up I think in some of our prior calls that there were at least rumors that was going to happen. We've obviously seen that announcement although the change in ownership hasn't happened yet. We'll see what that means in terms of new owners' goals and objectives and how they want to handle this situation among others. But too early to tell. And then on settlement, I would say that, in our particular case, where we have 20 patents covering Xyrem which are involved in complex litigation, the IPR process is only one part of the whole picture. So I don't think commenting on settlement as part of IPR necessarily gets to the bigger question, which is, is there a business resolution of the outstanding issues that make sense and when?

Next question?

Your next question comes from the line of David Amsellem with Piper Jaffray. Please proceed. David A. Amsellem - Piper Jaffray & Co: Thanks. I have a question on JZP-110. So is it possible that we could see to- line data in the second half of 2016, or is that mainly a first half of 2017 event? And then can you walk us through other gating factors to the NDA filing beyond the trials you're running, what kind of toxicology work, non-human work that you have to do to get this in front of the FDA? Thanks.

Yeah, so, David, this is Bruce. Let me take the second half of that and then I'll turn it over to Karen to talk about potential timing of data availability. I would say we view our Phase 3 human clinical trials as critical path to our submission, which we've said is a 2017 targeted event. So, yes, there's other work we need to do, but I don't think we see any of that as time-limiting. Karen, do you want to talk about potential data availability?

Thanks, Bruce. We're tracking very well in terms of the clinical trials and enrollment. We do have patients enrolled across all of the three Phase 3s and also into the open-label extension study, so we are certainly on track to have data in 2016 and, as Bruce mentioned, that would be looking at an NDA submission in 2017.

Next question, operator?

Your next question comes from the line of Jessica Fye with JPMorgan. Please proceed.

Hey, guys. Thanks for taking my question. Maybe just going back to business development here. It seems like you guys are being pretty disciplined on valuation. But bigger picture in the sector, I think we're in what's been characterized as sort of an eat-or-be-eaten environment. And with your strong balance sheet, taking on some leverage could almost be viewed as almost a takeover defense. Does that enter into your thinking at all as it relates to sense of urgency to do a deal?

So, Jess, I would say the way we think about corporate development is about value creation. And, yes, we spend most of our time thinking about the buy side of that equation. But it really is about creating value. I do think we're staying disciplined, we stayed disciplined for years. That doesn't mean we don't get transactions done. And I would say we feel the same way in today's environment. We think, as Matt said, there are deals to be done, but I don't think this management team spends a lot of its time thinking about deals just to change the shape of the company based on what's going on with other people. We've got a good strategy, we think a good long-term sustainable growth strategy that we want to execute on, we think we've been executing on well. And we believe some additional transactions as we move forward would be consistent with that strategy we've been executing on.

Thanks.

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

Hi. Good afternoon. Maybe turning to Defitelio, if you could talk a little bit about – obviously you've dealt with some sort of near-term headwinds in the first half of the year. But you obviously reaffirmed guidance. So maybe an update in terms of where you see the growth coming from in the back half of the year. And more specifically along that, an update in terms of what markets you have gotten approval and where you're commercializing now. Thank you.

Yeah, Doug, I'll start that and have Russ chime in. Again, I think part of the growth in the second half of the year is really letting some of the growth we are seeing underneath the top line emerge. Over a number of quarters, we've seen that masked by changes in FX, which we're not seeing as much of now, not that I can predict the future. But also this effect we were talking about a little bit earlier in this call, where growth in some markets has been offset by declining prophylaxis use in other markets. And while you can't say growth continues forever, you can continue growing off a base. Prophylaxis use can only go away once. Once it's gone away, it doesn't go away again. And so I think as we reset to a more treatment-only or primarily treatment usage in some of these markets, we then will see growth from there. So I think we're already seeing growth, I think that growth will continue. I think what's the easier way to think about this is some of the headwinds going away as we move forward.

Yeah, Doug. And again, as you know, part of our initial strategy was to secure the appropriate pricing and reimbursement in the countries that we are approved. And I'm happy to walk you through all of them, if you want hear it. Having said that, I do think the growth opportunity that exists for us is now continuing to allow physicians to look for VOD. We've done some more recent market research that tells us that we still have an opportunity that exists there. And I think as they understand the value proposition better of defibrotide, I think that that creates a better opportunity for us to treat patients in the not too future. So, we have reaffirmed guidance because we believe that those things will happen with time.

And just as a couple of quick follow ups. So, Russ, along those lines, are there any key additional markets that you expect to come on-line or be major contributors that second half of the year? And then a follow up to Bruce. Do you expect the Warriors to repeat?

I'll let you take the first half, Russ.

Yeah, so I'm not waiting on any one country. There's a couple smaller ones that are coming on. Clearly we're working through some reimbursement issues with France and Italy. And so those are areas that we continue to see some additional work. I would also say that if I look at the team that we currently have in place working on this, they're very much focused on defibrotide and Erwinaze now, which I think allows us the ability to do a little bit more as well.

And the Warriors look good.

Your next question comes from the line of Ken Cacciatore with Cowen & Company. Please proceed. Ken C. Cacciatore - Cowen & Co. LLC: Thanks, guys. Just on the not collecting any more defibrotide in the U.S., this was to be able to expand it to more institutions, if I recall. So can you just give us an update on how many more institutions over the last maybe six months that are using the product now that you're giving it to them? And then also just on business development, just trying to understanding maybe what type of impediment Xyrem not being settled or resolved is. I would imagine your cost of debt is going to be significantly higher if the lenders can't get conviction on the duration. And also your currency maybe confined here because there's been no settlement and, therefore, lower than you'd like it to be. So just trying to understand the confluence of maybe more costly debt, a currency that's not high enough as you go approach these much more costly assets that are out there. Thank you.

Yeah, Ken, I'll take the second part of the question first. Of course, we just refinanced our debt and brought our rates down and extended maturities. So I don't feel like that's an accurate representation of where we are on the deal side right now. I think debt remains available and actively priced certainly by historical standards. That's true for us as well as other companies. And while Matt did talk earlier about our willingness to use equity for the right transaction, I wouldn't say it's our preference. If it unlocks a bigger transaction that's important to us, great. But as you know, we've been buyers of our stock thus far. So for the right transaction, I think we've got leverage capacity at good rates and some ability to use equity. On the first part of your question, I'll let Russ comment on what we've seen since we discontinued the cost recovery program. But I would say the focus is not just on the number of institutions that are using defibrotide, it's on which institutions are using defibrotide and really making sure the sites where we see the greatest number of transplants are up the learning curve in this area.

Yeah, to Bruce's point, it really is the quality of sites that we focus on for the most part. But also, the number of sites has increased very nicely. We're very pleased with the progress that we've made there. We're in the ballpark of 100 active sites that are ongoing and so it's a number that we feel has really come a long way over a very short period of time. And I think it's a testament to the fact that people are starting to understand the value of proposition defibrotide in the U.S. Ken C. Cacciatore - Cowen & Co. LLC: Thank you.

Your next question comes from the line of Marc Goodman with UBS. Please proceed.

Yeah, Russ, if we could just go back to Defitelio, you were talking about some of the countries. Where are we making most of the money right now? And is Germany the top country? And you have mentioned many quarters in a row about reimbursement issues with Italy and France. So does that mean we're not selling the product there at all, or is it minimal? Or just give us a sense of where the growth is coming from.

Sure, sure. Good question. So there are number of large countries. Germany and France are always on top of the list, and the reason being is I think Germany is very progressive in the way that they have approached the use of defibrotide in VOD and I think they're a good basis point for how we can look at a number of countries. One of the big differences between Germany and France is that, while in Germany it's central reimbursement, in France it's actually hospital-based reimbursement, so they're not centrally paid for. So while I would characterize the two as being very different just from a reimbursement perspective, I would also say that I'm pleased with the amount of use that we're seeing in France. And the amount of physician support that we have for defibrotide in France is very good, too. So those are probably the two biggest countries. And then you kind of look at the big five as being the majority of your support coming from.

The next question comes from the line of Jason Gerberry with Leerink Partners. Please proceed.

Hi. Good evening. Thanks for taking the question. Just curious, as you guys think about obviously Defitelio in Europe faces some challenges, how you typically are thinking about a U.S. launch curve for Defitelio, given that it would seem like the U.S. market is primed for fast adoption of the product. Thanks.

Yeah, so we're giving a lot of thought to how to launch defibrotide in the U.S. right now. So the key activities that we're mostly focused on are what's the right size of the sales force, what's the profile of the sales force, what's the right pricing, ultimately what is the learnings from the European campaign that we want to bring forward to the U.S.? So having said that, I always think of Erwinaze to some degree as being an example of something that we can do from taking something from a named patient basis to a commercial product. That doesn't say that we should expect the same adoption curve. But the way that we're thinking about it is commensurate with that. That we're going to have a fully dedicated and focused team to make sure that we can make that curve as steep as humanly possible. And we're getting pretty excited about it.

Yeah, and the other dynamic I'd mention here is, obviously we executed the start of the European launch two months after we completed the Gentium transaction in January 2014. And obviously we've had a little more time to get our arms around orchestrating a successful submission and launch in the U.S. So I echo everything Russ said, but I also just want to say we've given our teams – and that's a combined historical use, so historically Gentium and Jazz team a real chance to get their arms around what's going to make the most sense in this new market.

Great. Thank you.

Your next question comes from the line of David Maris with BMO Capital Markets. Please proceed.

Good afternoon. We're halfway through the year, you didn't narrow the EPS guidance. And so to get to the midpoint of the guidance, there'd need to be a step-up sequentially. So aside from the commentary on the other products that had growth and the continued growth in Xyrem, what are the swing factors of being on the higher end versus the lower end of this guidance? Is it on the spending side or is it just continued growth in Xyrem and people aren't expecting that or what should we be thinking about?

Yeah, David, there are a few factors there. Obviously Xyrem is the largest product is one swing factor. So as we go through the REMS implementation later this year, conduct some ongoing volume initiatives and have other factors that can move revenue one way or another, that would obviously have a meaningful impact. Similarly, with Erwinaze and Defitelio, any kind of substantial FX worsening or increases in volumes from the growth rates we're seeing or expecting could make a big difference given the profitability of all those franchises. But also as it relates to R&D, while as we've talked about our enrollment on JZP-110 is on track, if we have more rapid enrollment, that could accelerate some of the R&D spending. So we need to be cognizant of that. As it relates to SG&A, there are several items, including expenses related to ongoing litigation, business development activities, other things that can be swing factors in SG&A and can also be timing-related as it relates to certain commercial initiatives in terms of where our spend might hit annually. So, again, we continue to be pretty comfortable with the range for both SG&A and R&D as it relates to that. But there are a few things that are harder to predict in terms of timing or magnitude.

Yeah, David, I would just add that there are a couple of places where I think earlier spending would be a positive sign. If we are enrolling our clinical trials quickly on JZP-110, if we're feeling bullish about a positive defibrotide action and we're gearing up for a launch, those are times when I'd actually like to be spending the money this year.

And just as a follow up in a completely unrelated but I'll say related question. You mentioned a few times in today's call that there's a wide range of business development opportunities that you're looking at. Would you say when you say wide range, do you mean in size or do you mean in therapeutic category? I know there's a big temptation to say, well, yes, both. But if you can give us any sort of color on what you're thinking there.

Sure. Again, we've mentioned we would consider quite large transactions that would be more transformational for us and maybe come with significant revenue. We'd also look at development opportunities, though we've generally said we'd restrict that to within our current major therapeutic areas. So I would say, yes, it's going to be first and foremost related to our current franchises or relative adjacencies to that. So it certainly will be beyond that. I wouldn't say it's completely agnostic. I think we've talked many times about the criteria we use to judge the types of products we want to bring into the company. And as it relates to, again, size and character of asset, again, it could be large and have significant revenues associated with it or it could be a development-stage asset, in which case to be the upfront might be smaller and maybe some contingent payments as it relates to that. So it really is a broad gamut of possible opportunities, David.

Great. Thank you.

Okay. Operator, we'll take our one more question.

Last question comes from the line of Liav Abraham with Citi. Please proceed.

Good afternoon. Just a quick question on JZP-386. And I was wondering if you had any updates there. And you mentioned last quarter that the further development warranted kind of evaluation. Where are you with the evaluation? And can you update us on any timeline for the progression of this asset forward? Thanks.

Yeah, Liav. Good question. On this call, we don't have an update on that. We are continuing our work on sodium oxybate lifecycle management, including JZP-386. We're also continuing work on Erwinaze-related lifecycle management around JZP-416 or other possibilities. But I would say the primary focus of our R&D efforts over the last few months has been a couple of things we highlighted in today's call, the defibrotide submission, the JZP-110 clinical progress, and I think us spending a lot of time too thinking about where our opportunities to continue to grow JZP-110 and defibrotide may be beyond where we're aiming them initially. So when I put all that together, I'm feeling good about where we are both with respect to lifecycle management, but some of our newer and larger opportunities as well.

Should we read into that that you feel comfortable as well with the longevity of Xyrem?

Well, without giving you a date, yes. We feel comfortable with where we are with the product and our ongoing initiatives around it. You know we're in a pediatric trial we're doing as well. We continue to invest behind growing this brand because we believe that will have a good return for our shareholders over a meaningful period of time.

Okay. Thank you.

Okay. Go ahead, operator.

That concludes our Q&A. I'll now turn the call over to Kathee.

Okay, thank you. So thank you again for joining us today, and this now ends our call.

Thank you again for joining us today. You may disconnect. Have a great day.