Jazz Pharmaceuticals plc (JAZZ) Q1 2016 Earnings Report, Transcript and Summary

Welcome to the Jazz Pharmaceuticals Plc First Quarter 2016 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, Carmen and thank you very much for joining us today on our investor call. Today, we reported our first quarter 2016 financial results and updated financial guidance in a press release. The release and the slide presentation accompanying this call are available in the Investors section of our website. With me for today's call are: Bruce Cozadd, Chairman of the Board and CEO; 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 2016 financial guidance and goals; our corporate development efforts, future product sales and volume; future litigation and intellectual property-related events; ongoing and future clinical trials and other product development activates; 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-K for the year ended December 31, 2015, and our Form 10-Q for the quarter ended March 31, 2016, which 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 2016 adjusted net income attributable to Jazz Pharmaceuticals and the related per share measures and historical and expected 2016 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 Investors section of our website. I'll now turn the call over to you, Bruce.

Thanks Kathee. Good afternoon, everyone, and thank you for joining us. The highlight of the first quarter of 2016 was our receipt of FDA approval of Defitelio on March 30 and our commercial launch in the U.S. in the days following approval. We delivered strong top and bottom line growth in the first quarter and remain well positioned to broaden our business through corporate development. Market conditions during the first quarter allowed us to accelerate share repurchases under our existing $300 million repurchase program while maintaining our strong balance sheet. We remain focused on achieving our 2016 goals which are generating increasing shareholder value while continuing to execute on our mission of improving patient's lives. I'll now update you on key commercial, legal and clinical development activities in the first quarter, highlight some upcoming key events that we expect in 2016 and then turn the call over to Matt to review our financial results for the quarter and provide 2016 financial guidance. I'll start my comments with our sleep therapeutic area and our lead product, Xyrem. During the first quarter of 2016, we observed sound underlying organic demand for Xyrem. In the first quarter, the average number of active Xyrem patients grew to approximately 12,775 from 12,375 in the same period of 2015. Xyrem bottle volume growth was 4% versus the prior year's strong first quarter. We have worked closely with SDS since the launch of the final Xyrem REMS in August of last year and are pleased that the improved processes and increased staffing at SDS minimized operational disruptions and resulted in a smooth transition through the payer churn that is common in our industry in the early part of the year. We continue to expect high-single digit volume growth for the full year. Turning to key Xyrem growth opportunities. Our sales representatives continue to actively educate healthcare providers on narcolepsy and the use of Xyrem, with a focus on physicians with high narcolepsy potential and low Xyrem utilization. We will host nationwide Satellite Symposia for healthcare providers during 2016, including our May program entitled Navigating Narcolepsy: A Case-Based Clinical Series. Our past years' Xyrem promotional symposia have been well attended with more than 1,500 attendees in 2015 and successful in generating new start patients for Xyrem. Our narcolepsy market expansion efforts include consumer facing Web-based disease education to increase the awareness and diagnosis of narcolepsy in the U.S., as well as physician directed disease education. We are also looking forward to another great APSS SLEEP Meeting for Xyrem. SLEEP 2016 will take place next month in Denver with five Xyrem related posters and one of oral presentation. Turning to a brief legal and intellectual property update on Xyrem. Patent litigation continues in the District Court in New Jersey. No trial dates have yet been set in any of the cases. We anticipate the trial of a portion of the case against the first filer, Roxane Laboratories, would not occur any earlier than the third quarter of 2016. We recently executed confidential settlement agreements with two of the seven ANDA filers, Wockhardt Bio AG and Ranbaxy. Under the settlement agreements, we granted Wockhardt and Ranbaxy licenses to manufacture, market and sell generic versions of Xyrem on or after December 31, 2025, or earlier depending on the occurrence of the certain events customary for settlement agreements with so called second filers. Activity on challenges to our patents with the U.S. Patent and Trademark Office, Patent Trial and Appeal Board, or PTAB, is continuing. In March PTAB instituted IPR proceedings on only three claims out of the 28 claims included in our '963 patent, a distribution system patent listed in the Orange Book. PTAB earlier instituted IPR proceedings on six other patents in this family. Hearing on those six patents was held last month and we expect a decision in late July. In April, PTAB instituted IPR proceedings on only a limited number of claims in our '306 patent, a patent with claims related to the safe use of Xyrem for patients receiving concomitant administration of divalproex sodium or valproate. There are two other pending IPR petitions on patents in this family and we expect PTAB to issue decisions on whether to institute these IPR proceedings in the third quarter. For additional detail, please see our Form 10-Q which we will file shortly. Now turning to our development program for JZP-110. The enrollment of patients in our Phase III safety and efficacy studies is ongoing, and we've recently broaden the inclusion criteria to capture more real world patients and to accelerate the enrollment rate. Our goal is to have preliminary efficacy results from our Phase III studies by the end of 2016 though this is dependent on our ability to drive increased enrollment rates. We are focused on doing what we can to accelerate and complete enrollment in all of our trials. Subject to the results of these Phase III trials, we anticipate submitting an NDA in the second half of 2017. We look forward to sharing the JZP-110 human abuse and liability results next month. The data were accepted for presentation at both the SLEEP 2016 Meeting and at the College on Problems of Drug Dependence Meeting in Palm Springs. Now on to the hematology/oncology franchise. We believe that Erwinaze has the potential to help more patients in the adolescent and young adult population with ALL and, in 2016 we continue to see additional first time orders from adult accounts for Erwinaze. With this said, I'll remind you that because of constrained manufacturing capacity, we have not been able to build sufficient inventory levels to absorb any supply disruptions. In the first quarter, we experienced product quality and other supply challenges and, as a result, we did not ship drug in the U.S. for a five-day period following a delay in product release. These challenges were ongoing and we anticipate that we may experience further disruptions in our ability to supply certain markets, including the U.S., in the current and future quarters. We are very focused on minimizing any supply disruptions and are working closely with the healthcare community and our distributors to prioritize available supply for use by patients who are currently undergoing or initiating treatment. Recently, the manufacturer has increased shift work to expand production capacity and longer-term efforts are focused on improving manufacturing processes and optimizing product yields to further increase capacity. Now, I'll turn to Defitelio. Our sales force was well prepared and began promotion of Defitelio in the U.S. immediately following FDA approval on March 30. We will be providing more specifics on sales performance for Defitelio with our second quarter results. However, we have observed hospitals both initially stocking and reordering the product. The sales force is focused on increasing the recognition and diagnosis of VOD and we are pleased with the level of interest from healthcare providers and institutions. Our reimbursement account managers are meeting with key hospital decision makers, such as pharmacy and therapeutics committee members, pharmacists, transplant specialists and payers to increase their understanding of the clinical value and the cost effectiveness of Defitelio, with a focus on educating these decision makers about the importance of rapid formulary approval to ensure patients have access immediately upon diagnosis. To-date we have not seen any issues with patients receiving access to Defitelio, although it is still very early in the launch. We have a commitment to providing medical education for healthcare providers and believe this is an important initiative in the Defitelio launch. During the February ASBMT Meeting in Hawaii, there were over 650 attendees of the Jazz sponsored CME symposium entitled, Solving the Problem of VOD in HSCT Patients: Case-Based Insight on Risk, Recognition and Treatment. We also presented Defitelio budget and cost effectiveness data at the AMCP Managed Care and Specialty Pharmacy Annual Meeting in April. Our work on the Defitelio prevention of VOD in high risk patients post-HSCT study has continued and we now anticipate the study start-up in the third quarter and first patient in by fourth quarter 2016. Our efforts in the EU remain focused on providing medical education on early identification of the warning signs of VOD, VOD pathophysiology, appropriate diagnosis and the importance of prompt treatment with Defitelio. During the remainder of 2016 we look forward to delivering on key financial, commercial and R&D goals that have the potential to drive significant value creation. We will continue to invest in our key products, Xyrem, Erwinaze and Defitelio, and our product candidate JZP-110, and to pursue focused development programs that have the potential to generate important new therapeutic options for patients. Finally, we remain enthusiastic about opportunities to further enhance and diversify our portfolio in 2016. Matt, let me now turn the call over to you.

Thanks Bruce, and good afternoon, everyone. We are pleased with our strong growth in the first quarter of 2016 compared to the same period in 2015, with increases in adjusted net income of 13% and adjusted EPS of 14%. Revenue in the quarter, compared to the same period in 2015, grew by 9%, driven primarily by higher sales of Xyrem partially offset by supply constraints on Erwinaze and lower sales of other products, including the divestiture of certain assets in the first quarter of 2015. We expect continued strong top and bottom line growth for 2016 and are maintaining our total revenue guidance in the range of $1.49 billion to $1.55 billion. Due to first quarter market conditions, we opted to accelerate our share repurchases which reduced our estimated weighted average shares outstanding for calculating EPS to approximately 62 million for 2016. As a result we are increasing our guidance for adjusted EPS, which is now expected to be in the range of $11.10 to $11.50 per diluted share compared to prior guidance of $10.90 to $11.30. Net sales of Xyrem for the quarter were $250 million, up 17% from $213 million in the first quarter of last year. We are maintaining our guidance for Xyrem net product sales in the range of $1.095 billion to $1.13 billion and continue to expect high-single digit volume growth during 2016. Turning to Erwinaze. First quarter worldwide net sales were $51 million, up 2% compared to net sales of $50 million in the first quarter of 2015. The increase in sales was partially offset by higher charged vaccine (14:27) rebates from increased utilization of 340B and Medicaid programs and continued supply challenges, which led to a brief period of supply outage in the first quarter. We are maintaining our guidance for Erwinaze net sales in the range of $200 million to $225 million for 2016. Defitelio first quarter worldwide net sales were $18 million, up 3% from $17 million in the first quarter of 2015. We began shipment of commercial products to U.S. institutions on April 4, 2016. The impacts of foreign currency exchange to Defitelio and Erwinaze net sales in 2016 is expected to decrease as compared to 2015. We are maintaining our guidance for Defitelio net sales for 2016 in the range of $100 million to $125 million, with approximately $20 million to $35 million in the U.S. and $80 million to $90 million in ex-US sales. Prialt net sales for the first quarter of 2016 decreased to $6 million compared to $7 million in the same period in 2015. Turning to operating expenses. Adjusted SG&A expenses for the first quarter of 2016 were $103 million or 31% of revenue compared to $95 million, also 31% of revenue, in the same period of 2015. The increase in adjusted SG&A was primarily due to higher head count and an increase in other expenses resulting from the expansion of Jazz's business including Defitelio launch expenses. As you recall, our adjusted SG&A expenses as a percentage of revenue historically are higher during the first quarter, consistent with our typical pattern of spend and the payer churn that can negatively impact Xyrem revenues. Adjusted R&D expenses for the first quarter of 2016 were $28 million or 8% of total revenues compared to $24 million or 8% of total revenues for 2015. The increase in R&D expenses was primarily due to higher cost of clinical studies and outside services for the development of our product candidate JZP-110 and line extensions for the company's existing products. Our 2016 guidance for adjusted SG&A expenses remains in the range of $390 million to $410 million and guidance for adjusted R&D expenses remains in the range of $115 million to $130 million. In the first quarter of 2016, the company spent $134 million to repurchase shares at an average cost of $123.77 per ordinary share, leaving us with approximately $125 million remaining under our $300 million share repurchase program. As of March 31, 2016, the outstanding principal balance of the company's long-term debt was $1.3 billion and cash, cash equivalents and investments were $981 million In March 2016, we reported a $150 million milestone owed to Sigma-Tau Pharmaceuticals which was triggered by the FDA approval of Defitelio on March 30, 2016. The milestone was capitalized as intangible asset and was paid in April of this year. In closing, we are pleased with our strong start to the year. We expect our positive momentum to continue into 2016 with the launch of Defitelio in the U.S. and through continued investments in our key marketed products, including the exploration of new indication and our clinical development pipeline. We believe the environment is favorable and are highly focused on corporate development transactions that allow us to bring meaningful products for patients and, as a result, have the potential to deliver long-term growth and returns to our shareholders. Thank you for joining us on the call today. I'll now ask Kathee to make a brief comment about our Q&A session.

Thank you, Matt. We request that you limit your questions to one question at a time and then feel free to reenter the queue if you have further questions and we'll get to as many people as possible that way. With that said, I'll turn the call back to the operator to open the lines for your questions.

Thank you. And our first question is from the line of David Amsellem with Piper Jaffray. Please go ahead. David A. Amsellem - Piper Jaffray & Co.: Thanks, I guess I'll get the biz dev/M&A question out of the way. So maybe the way I'll put is this, do you, in your discussions, in your conversations with potential targets, are you getting the sense that companies/targets have not adjusted to new market realities and I guess are overly price sensitive? Maybe talk to the extent to which there is price sensitivity and a disconnect between what an acquirer would be willing to pay and what targets would ask for? Thanks.

David, good question. I don't necessarily feel that people have not adjusted to new market realities. I often think that for a situation we're interested in whether that's marketed products, near market products or development programs, valuation expectations relate as much to the stage of that particular program or product and what's been accomplished there than just to changes in market valuations. As we've said a couple of times over the last couple of quarters, I think the move down in valuations relative to some of the peaks of last year was helpful to us but I would also say that timing of the transactions we do tends to be around key milestones and development, commercialization, regulatory or otherwise. And I don't feel that some reluctance to look at current market valuations is particularly important to us at this time. David A. Amsellem - Piper Jaffray & Co.: Thanks.

And our next question is from the line of Jessica Fye with JPMorgan. Please go ahead.

Hey, there and thanks for taking my question. I'm not sure if I missed this in the prepared remarks but you bought a lot of stock back in the quarter. Did you comment on whether or not you've bought back in the second quarter and how you're thinking about the remainder of that repurchase authorization?

Hey, Jessica, it's Matt. We did not comment on what we've done in the second quarter but we remain active under our repurchase program. We are pleased to be able to take advantage of stock prices in the first quarter to be more aggressive than we initially anticipated. And as noted we're able to reduce our share count by roughly 1 million shares this year in our guidance. We used much of our free cash flow in the first quarter on those repurchases. And again subject to alternative uses of cash and market conditions we'll continue to buy under our authorization. So we'll comment more as get to the end of the next quarter.

Great, thank you.

And our next question is from the line of Gregg Gilbert with Deutsche Bank. Please go ahead.

Good afternoon. Bruce, sometime has passed since the first to file generic Xyrem application has changed hands. So, I was hoping to catch you on a talkative mood today wondering if you feel confident that a reasonable compromise can be reached under this new setup condition where litigation stands, what we've learned in litigation so far. So, throw us a bone, if you would.

Oh, Gregg, I hate to disappoint you. I won't comment as to whether I'm in a talkative mood generally but on this topic probably not. Tough for us to comment specifically on any conversions that might be happening with any of the generic filers. I think it was significant that we reached settlement agreements with two of the second filers since last we spoke in the case of the first to file, Roxane. Yes, there was a change in ownership there during the last few months. There is a lot going on with respect to Xyrem. We referenced litigation. We referenced what's going on in the IPR side with PTAB. There are regulatory issues, and I can't specifically say what will make sense to both parties when. We have said for long time we've remained very confident that in the upcoming trial which does continue to get pushed out, we're ready to go to trial and we're confident in our position. Whether there is a different or better outcome than going to trial we'll wait and see but we're preparing that we're ready to do that.

So, I guess you're not going to settle – if you settle – for later than 2025, so we know that much now.

I think that's probably a sensible comment, Gregg of course.

Thank you. I'll get back in line.

And our next question is from Douglas Tsao with Barclays. Please go ahead.

Hi. Good afternoon. So just maybe following up, asking Gregg's question a different way. Bruce, maybe would you think of 2025 is a little bit of a line in the sand for you in terms of how you are thinking of that settlement and your position on terms of Xyrem IP? And then just also in terms of life cycle management, obviously for the first quarter – when you reported 4Q, you sort of indicated that you might be in position at some point this year to talk a little bit more about those ongoing efforts. Just curious, has there been incremental progress and is that feeling like a greater certainty to you at this point?

Doug, thanks for the questions. I'll point out I said December 31, 2025, so most of us look at that as 2026 as being the relevant way to think about it. What we would do with respect to other settlements we just can't comment but we thought resolving a couple of these with nearly a decade remaining before that date was a smart thing for us to do under the circumstances. On what else we're doing with sodium oxybate, you're right about my prior comments, we have said we could be in a position depending on how things play out to share more information later this year. I'd still say the same thing, but no specific update there.

Okay, great. Thank you very much.

And our next question is from the line of Annabel Samimy with Stifel. Please go ahead. Annabel Samimy - Stifel, Nicolaus & Co., Inc.: Hi, guys. Thanks for taking my question. I just wanted to go back to a comment you made with regard to enrolling real world patients in JZP-110. What exactly do you mean by real world patients and what's going on with the enrollment that you need to sort of enlarge it like that?

Good question. And all of our patients are real world patients, so I got to be careful on my terminology there. But we did slightly broaden the inclusion criteria. As you know, the more you restrict who gets into a trial, the more you can be criticized later that that doesn't line up well with the broader population that might use the trial – or I'm sorry, use the drug after approval. So, I think this is a good thing for us to do. We are interested in speed here. We're very excited about this drug. Based on what we saw in the Phase II data, we'll be sharing human abuse liability data next month in a couple of key meetings. We're excited to get to the answer here and start working on a regulatory filing. So anything we can do to speed that up, we'd like to do. Karen, do you want to add anything on what we're doing here?

Yes, it's not unusual to broaden the inclusion and exclusion criteria on a clinical study as you learn more about the molecule along the way. Certainly, this is done in conjunction with discussions with the FDA and they were supportive of broadening that criteria. And I think at the end of the day it's about bringing the product to market for those patients and so the quicker that we can enroll and complete these studies then that's a good thing for the patient. Annabel Samimy - Stifel, Nicolaus & Co., Inc.: Can you just describe what you broadened it to and from what it was broadened from?

So, we broadened a lot of the inclusion and exclusion criteria. So for example I'm looking at things like BMI or cardiovascular or concomitant medications. There are lots of areas where a patient would be excluded where in discussions with the FDA we agreed that those patients could actually be included in the trial. Annabel Samimy - Stifel, Nicolaus & Co., Inc.: Okay, great. Thank you.

And our next question is from the line of Louise Chen with Guggenheim. Please go ahead.

Hi. Thanks for taking my question here. So with respect to your settlement with Wockhardt and Ranbaxy, did they have to get their own approval to launch or will you supply them with product? And now that you've got potentially a longer runway for Xyrem into at least 2025, potentially, how should we think about the volume growth for your product? How much broader can you go in terms of prescribing base? How many doctors do you target today? And what's the potential universe for Xyrem? Thanks.

So Louise, I need to be a little careful on how much I say just because terms of the settlements are confidential. I think I said in my remarks to launch their generic versions of the product, so I'll just leave that there. Maybe I can ask Mike to comment on what we're seeing in the way of volume growth and possibilities for Xyrem in the prescriber base.

Sure, Bruce. The 4% volume growth that we saw in Q1 was compared to a strong first quarter last year. We feel very good about where we have given our guidance and we're excited about some of the initiatives that we're undertaking. Actually, this week, as a matter of fact, we're doing our Satellite Symposium. So we will continue to drive volume on Xyrem and the SDS Pharmacy is operating well. And to your question on the audience, it's about 4,000 physicians.

Right. But I was just curious how we think about volume growth longer term for Xyrem now that you have this potential longer runway. Is there any color you can provide there? Or maybe from users, potential patient users or maybe not just the doctor base.

Yeah, our overall view continues to be that narcolepsy is under recognized and under diagnosed. And we think with better education, both at the physician level but also potentially out to the patient level, helping people recognize this sleep disorder that often takes years to properly diagnose, we could in fact drive better treatment over time. So we certainly don't feel like our work is done on expanding use of the product.

Thanks.

And our next question is from the line of Jason Gerberry with Leerink Partners. Please go ahead.

Whoops, I was on mute. Hey, thanks for taking my question. Bruce, there were some comments maybe a year ago around some additional pending IP for Xyrem could be issued and kind of curious where that stands. Have we sort of gotten the last Orange Book listable patent put in the Orange Book, or is there possibility there's some additional IP in the works? Thanks.

Probably, I'm going to essentially no comment on that. We specifically were highlighting, and I think when people weren't focused on the fact that we could end up with multiple patents and multiple families with different expiration dates. And I won't say we'll never see additional IP around Xyrem but I think with the 20 issued patents in the three different patent families, we feel very confident in the IP protection around Xyrem.

Great. Thanks.

And our next question is from the line of Ken Cacciatore with Cowen & Company. Please go ahead. Ken Cacciatore - Cowen & Co. LLC: Thanks, guys. On the '306 patent, the valproate combination patent, you discussed that there's some remaining IPRs. Can you just discuss if it's similar arguments that are being made and in front of the same set of judges who've made that decision? Thank you.

So generally yes and yes would be the answers to the question, Ken. Ken Cacciatore - Cowen & Co. LLC: Great. Thank you

And our next question is from the line of Marc Goodman with UBS.

Yes. The Erwinaze supply issues, can you just tell us how much that impacted revenues in the quarter, and how you're thinking about that impact for the full year? And then can you also just was there – did you tell us the FX impact, maybe I missed it in the press release just FX on total sales? Thanks.

Thanks, Marc. We did not comment of the FX, so I'll get to that in a second. As it relates to Erwinaze, in the first quarter it was roughly $1 million in terms of impact to sales with respect to our temporary supply gap. The FX differential or impact for the first quarter would have been about $1.7 million across Defitelio and Erwinaze for the first quarter.

Thanks.

Yeah, and it probably goes without saying here for everyone on the call but our urgency in this company to solve this problem is not driven by financial impact. It's driven by the fact that this is the drug that these patients need, particularly these kids being treated with ALL. And so even though the financial impact many not be great, we are doing everything we can to make sure that patients don't go without this therapy. So part of the reason we're highlighting this is just to make people aware of it but you should know the internal effort here which really is our number one priority right now is just ensuring we don't in fact impact patient therapy.

And our next question is from the line of Liav Abraham with Citi. Please go ahead.

Good afternoon. Just a follow-up question on M&A. Bruce, can you just remind us of your willingness to enter into new therapeutic areas and whether you have the capabilities either from an R&D perspective or from a commercial perspective to do this? Thanks very much.

Liav, good question. We've historically said that while our focus is primarily around sleep, hem/onc and pain, which were the areas we're in now that we would contemplate going into an additional therapeutic category. We certainly think we have skills at this company that would be broadly applicable to other areas as well, the expertise we have that in fact we do use over our current different business units. The interesting part of your question as you referenced R&D in particular. And I think we would grant you that it's harder to parlay expertise in R&D broadly across therapeutic categories. And that's why historically we've said we probably wouldn't enter a new therapeutic area through an R&D program. We'd probably do it through commercial first and follow that market expertise by building additional R&D expertise. But we are open to entering another therapeutic area if we see both an attractive on-market or near-market opportunity that we do think is a fit with what we do well along with the opportunity to build out that therapeutic area over time through additional products and our R&D programs.

Great. Thanks very much.

And our next question is from the line of Irina Koffler with Mizuho. Please go ahead.

Hi. Thanks for taking the question. Just to go back to this the two settlements. So because you've settled with two parties, I'm guessing at some point, shared REMS discussions have come up and I was just – I know you probably don't want to comment on it but can you comment on whether the settlements included a shared REMS and also whether at least the contemplation of the shared REMS has now been expedited such that other settlements can come quicker because you might have a pathway with that now? Thanks.

Irina, good question. So the settlements are really around IP, not REMS. With respect to the REMS, we remain interested in moving forward as appropriate with shared system discussions. As we note in our SEC filings, it's not particularly clear the generics feel similarly about that, so no particular other update on that front for now.

And our next question is from – a follow-up from Gregg Gilbert with Deutsche Bank. Please go ahead.

Thank you. Couldn't help myself with this one question, guys. Matt, can you give us cash flow from ops in the quarter? And then Bruce or Mike, if Flamel begins their enrollment for its oxybate as planned later this year, would you expect to see the noticeable effect on volume growth at least temporarily for Xyrem?

I'll start, Gregg, with the cash flow question. So our adjusted net income of $141 million, again we repurchased shares at $134 million. And we had through a small IP related acquisition $9 million of expenditure there. The rest is effectively close to neutral on the balance sheet with another $2 million in CapEx. So increased cash and cash equivalents was $4 million but again the vast majority of that was cash spent on share repurchases.

And then on the question of whether someone else's clinical trial could impact our volume growth maybe I'll let Mike comment on that.

Sure. I believe Flamel studies about 300 patients. I don't think we even know the mix between EU and U.S. These would likely not be patients on Xyrem currently. So I do not think that they're going to impact our existing patient load or have a great deal of impact on our ability to grow the product.

Thanks.

And our next question is a follow up from Douglas Tsao with Barclays.

Hi. Good afternoon. Thanks for taking the follow-up. So just maybe one final clarification to your answer to Irina's question just in terms of the settlement, it is around the IP, so did that presume that the generics would still need to somehow get their own REMS put into place albeit shared or individual?

It does mean, Doug, that they would need to get a product approved. And getting a product approved involves having a distribution system, whether that's a shared system or a waived REMS.

But that does not necessarily – right, you still have your own intellectual property that's not necessarily patents, right, in terms of the patient database, et cetera, and that is not included in the settlement, correct?

We can't comment on that, Doug.

Okay. Thank you.

Thanks, Doug.

And we have a follow up from the line of Annabel Samimy with Stifel. Annabel Samimy - Stifel, Nicolaus & Co., Inc.: Hi, guys. Just really quickly. You gave us the FX impact on Defitelio and Erwinaze. Can you just tell us what the volume growth was for Defitelio in Europe this quarter, is it still on the same trajectory?

I can comment that Defitelio in general is on the same trajectory that what we've seen. We saw a little bit of a wider first quarter, but in general guidance is exactly the same and we're feeling confident about Defitelio in Europe. Annabel Samimy - Stifel, Nicolaus & Co., Inc.: Great. Thank you.

I'd just follow on to that that it's a product again, it's a small number of patients with different patients between pediatric and adult and weight-base those drugs so you get some inter-quarter variability as we've seen in the past with Erwinaze. So while you have a timing differential there that can perhaps look on a particular quarter-over-quarter comparison as less robust. I think we feel good about the business and how it's growing. Annabel Samimy - Stifel, Nicolaus & Co., Inc.: Thanks a lot.

And before we go to the next question in case Ken is already writing up his note based on my prior answers, I was just handed a note that we don't know that the PTAB panel for the '306 decision would necessarily be the same. We do think the arguments are similar but I said it would be the same; I don't know that. Sorry about that.

And our next question is from the line of David Buck with Northland Capital Markets. Please go ahead.

Yes. Thanks good afternoon. Just a quick one on the timing of the settlement, Bruce, is it fair to read that the timing of settlement with next filers being announced, that there was some additional certainty or confidence that yourselves got after the PTAB decisions or the other parties that led to that coming to a conclusion. And then just a quick one on Defitelio, you mentioned there has been no patient access issues, has there been any early reimbursement issues with the centers actually getting reimbursed for the drug? Thanks.

So, two sort of different questions there. Some of the back and forth around IPRs and PTAB over the last couple of months, I think has been interesting just because, if you look at it from the generics' point of view, where they want to use these proceedings obviously to potentially get rid of patents, the failure to pick up those patents for review or to pick up all claims in the patents I think from a practical standpoint just means there remains some uncertainty that will have to be dealt with through litigation, which I think is generally a positive development for us. On access, Mike, on Defitelio?

Sure. So Defitelio has been doing very well this month, we are not seeing any pushback yet on payer but it's early. The P&T committee meetings have gone well. Our health economic model works well in those settings. Payer discussions have been positive, but really it's early and it's a lot of education going on right now. But we're pleased.

Okay. And our last question is from the line of Ronny Gal with Bernstein. Please go ahead. Ronny Gal - Sanford C. Bernstein & Co. LLC: Good afternoon, and thank you for taking my questions. I have one about Xyrem access. First, we kind of noticed the cyclicality on the earnings, can you just help us understand how you guys think about a copay reimbursement in terms of patients being on coinsurance? Is this a rising trend, roughly how many of the patients you have in the commercial area actually have coinsurance that you are reimbursing? And last, just wondering how you're handling the Medicare population? I know you've got to use a foundation and not do it directly but given that you got the only drug in the category with Xyrem, how do you avoid the regulations that require you to have multiple drugs in the category reimbursed?

Yes, so the question varies a lot across products. The population of patients that get our different drugs varies considerably in terms of percentage of coverage that comes through commercial pay, government pay and otherwise. So the characteristics are different. Have we seen big changes in how coverage works, particularly commercial coverage with respect to Xyrem? I would say in general no. We have disclosed that under that coverage, we tend to see more prior authorization and reauthorization but that's different from saying the patient level impact of co-pay is changing meaningfully. In the case of Erwinaze, we certainly talked about the potential for more 340B use over time as a trend. In terms of the assistance we do provide, that varies depending on what set of patients we're dealing with. Your comment was how do we avoid regulations? We don't avoid regulations. We operate within regulations. And there is pretty clear guidance on how these things should work and we believe we follow that guidance. Ronny Gal - Sanford C. Bernstein & Co. LLC: Thank you.

Operator, this will be our last question.

Thank you. And our last question is from David Maris with Wells Fargo. Please go ahead.

All right. Well, thank you very much. Is there anything, Bruce, on the regulatory front that you're watching that we should be watching other than things that you've mentioned so far, and specifically around the REMS programs or anything else on the regulatory front that you're launching?

Well, we watch lots of things on the regulatory front all the time. We're particularly interested in things that affect our ability to rapidly develop drugs for small patient populations. Obviously, we operate in many markets around the world, when we can see more harmonization, that's a positive for us. I'm looking around the room here to see who wants to volunteer anything. The sort of demonstration project changes in Part D, I am not sure our position will be different from anyone else in our industry which is we think the proposals are not particularly well thought through in terms of ultimately what they'll do. In terms of providing healthcare to people, I think sometimes people get awfully focused on the cost of a therapy rather than are we providing good outcomes for patients across all the ways we can intervene with drugs being just one of those ways. So I think sometimes that debate is a little off track. You mentioned REMS in particular, David, I would say there's been a pendulum swing, maybe a couple of different ways over a long period of time about whether REMS are a good thing or a bad thing. And I think honestly there's a little bit of both. REMS are designed to help change the risk/benefit equation on a particular drug in favor of allowing effective use of that drug for the right patients. I would argue that's a good thing for the healthcare system. But there have been complaints that REMS can make certain things more difficult for generic competitors, including getting access to drug. And so, there's often in commentary you read either demonization of REMS, it's all bad or talk of REMS it's all good and I'd just like to remind people, they are real balanced. We're involved in multiple REMS across multiple of our products. So I think we have a pretty good feel for that. So I think people just need to take into account the totality of that situation. When used correctly, I think REMS really do benefit the healthcare system and patients.

Thank you.

And ladies and gentlemen, this concludes our Q&A session for today. I would now turn the call back over to Kathee Littrell for final remarks.

Thank you, Carmen. Thanks to each of you for joining us today on the call. We will be participating this quarter in the UBS Healthcare Conference this month and Goldman Sachs Healthcare Conference in June and we hope to see many of you at the conferences. This now ends our call.

And ladies and gentlemen, thank you for participating. You may all disconnect.