Welcome to the Jazz Pharmaceuticals First Quarter 2015 Earnings Conference Call. Following an introduction from the company, we will open the call to questions. I'll now turn the call over to Kathee Littrell, Head of Investor Relations at Jazz Pharmaceuticals.
Thanks Ian and thank you all for joining our investor call. Today, we reported our first quarter financial results and reaffirmed our 2015 financial guidance in a press release. The release and the slide presentation accompanying this call are available on the news and events section of our website. With me for today's call are Bruce Cozadd; CEO, Matt Young; CFO, Russ Cox; COO, Jeff Tobias, our EVP of R&D Strategy, Karen Smith, our Global Head of R&D and Chief Medical Officer, and Mike Miller; Head of U.S. Commercial. 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, our 2015 goals, anticipated growth prospects for our products, planned commercial efforts and initiatives, anticipated regulatory matters, and events related to Xyrem and defibrotide. Our corporate development efforts, anticipated litigation-related events, and expected future activities and events related to planned clinical trials, including the timing of future events. 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, 2014, and our Form 10-Q for the quarter ended March 31, 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 the 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 and events section of our website. I'll now turn the call over to Bruce.
Thanks Kathee and good afternoon everyone. During the first quarter, we achieved revenues of $309 million, an increase of 25% compared to the first quarter of 2014, driven by strong sales of our key products, Xyrem, Erwinaze, and Defitelio. We realized adjusted net income of $125 million in the first quarter of 2015, reflecting the attractive margins in our business, GAAP net income for the quarter was $71 million. During the first quarter, we made progress toward our 2015 goals, with submission to FDA of the CMC module of the Defibrotide Rolling NDA and preparations for our planned initiation of three phase III JZP-110 studies this month. 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 with the addition of differentiated products that provide value to patients, are meaningful in size to Jazz and have the potential to create additional shareholder value. I'll now update you on our sleep and hematology/oncology therapeutic areas, 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 first quarter, demand for Xyrem remained strong and the average number of active Xyrem patients grew to approximately 12,375 from 11,400 in the same period of 2014. During the first quarter of 2015, we had bottle volume growth of 12% year-over-year.
As you'll remember, during the first quarter of 2014, we had bottle volume growth of 5% compared to the same period in the prior year due to delays in the timing of prescription fills and refills by SDS, our central pharmacy. We worked closely with SDS during the first quarter of 2015 and are pleased that the improved processes and increased staffing resulted in more timely prescription fills and refills. Payer reimbursement coverage and approval rates for Xyrem continue to be strong, despite a changing landscape in which specialty pharmaceuticals face increased utilization control methods, such as prior authorizations and reauthorizations. We're working closely with SDS and investing in services provided through our central pharmacy to help patients and providers navigate the increasingly complex and changing reimbursement environment. Now I'll briefly discuss a few of our Xyrem growth initiatives.
The Xyrem sales force is focused on the opportunity to increase Xyrem prescriptions written by new and current prescribers, with continued emphasis on increasing prescriptions by our low to mid-decile physicians. Another continuing growth initiative is aimed at increasing the diagnosed population of narcolepsy patients who may be candidates for Xyrem therapy. As part of our non-branded disease awareness strategy, we've added a new tool known as the Swiss Narcolepsy Scale to the morethantired.com narcolepsy website. The Swiss Narcolepsy Scale is highly specific and sensitive for the diagnosis of narcolepsy with cataplexy, and we believe that this tool may help patients in obtaining a more timely diagnosis of narcolepsy. Finally, we're looking forward to a strong presence at the SLEEP 2015 Annual Meeting in Seattle from June 6 to 10, 2015.
We're hosting a satellite symposium for healthcare professionals on June 8 titled Waking the Brain: An Update on the Neurobiology, Diagnosis, and Treatment of Narcolepsy. We also have 15 Jazz-sponsored abstracts that have been accepted for poster or oral presentation. I'll take a moment to highlight two of the abstracts that provide new information on Xyrem. To date, data on the effect of Xyrem on quality of life and on narcolepsy patients without cataplexy have been limited. At APSS, previously unpublished Xyrem data from randomized placebo-controlled trials will be presented, including data on quality-of-life effects in patients with narcolepsy on Xyrem, and data on efficacy in patients with excessive daytime sleepiness due to narcolepsy without cataplexy. 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 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 fourth quarter of 2015. The cases against the four other ANDA filers have been consolidated by the court, and fact discovery in those cases is scheduled to end late in the first quarter of 2016. As mentioned in our last call, in January 2015, two of the Xyrem ANDA applicants filed petitions with the USPTO'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 filed preliminary responses to these IPR petitions asking the PTAB to deny institution of the IPR petitions.
An additional IPR petition on one of the six patents covering our restricted distribution for Xyrem was filed in early April by an entity affiliated with a hedge fund. We expect to file a preliminary response to this IPR petition in the third quarter. We expect PTAB to rule on whether to accept the ANDA filers IPR petitions in the third quarter and on whether to accept the IPR petition filed by the hedge fund-affiliated entity in the fourth quarter. If review of one or more of the IPR petitions is instituted, a PTAB decision on validity would be expected approximately a year after institution of the applicable IPR proceeding.
We view the recent hedge fund IPR petition as an abuse of the PTO post-grant review system, and we understand that potential legislative changes to address such abuses and broader issues related to IPR proceedings are being evaluated by members of Congress. We can't predict whether there will be legislative changes that are helpful to us and other innovator companies or how the PTAB will ultimately respond to these types of petitions. However, because the hedge fund IPR petition challenges a patent that was already subject to an IPR petition by the ANDA filers, the later petition has not meaningfully changed our perspective on the IP protections for Xyrem. With respect to the Xyrem REMS, in late February, the FDA notified us of the approval of the REMS that we submitted in November, including provisions requiring distribution through a single pharmacy.
We expect to implement the final approved Xyrem REMS by late August and to submit ongoing assessments required under our REMS approval. Turning to our development program for JZP-110, we are preparing to initiate three phase III studies evaluating the safety and efficacy of JZP-110 this month. One in patients with excessive daytime sleepiness associated with narcolepsy, with a planned enrollment of approximately 240 patients. The other two in patients with excessive daytime sleepiness associated with obstructive sleep apnea, with a planned combined enrollment of approximately 640 patients. We also plan to initiate an open-label extension study to evaluate long-term safety. The clinical trial materials for the phase III studies have been manufactured, and we plan to make the materials available to sites shortly.
Finally, we announced today that clinical trials from the recently completed phase I study demonstrated that JZP-386 provided favorable deuterium-related effects, including higher serum concentrations and correspondingly increased PD effects at clinically relevant time points compared with Xyrem, with a safety profile that was similar to that observed with Xyrem. While the companies have determined that the deuterium-related effects observed in the phase I studies do not support advancing into a later-stage clinical trial of JZP-386 at this time, the results indicate that further evaluation of JZP-386 is warranted. Therefore, the companies intend to explore formulation options to enhance the positive effects observed in the studies to achieve an improved product profile for patients with narcolepsy.
We are committed to finding new therapeutic options for patients with narcolepsy, and JZP-386 is just one element of our R&D efforts that are focused on exploring and developing new options for narcolepsy patients that may provide clinically meaningful improvements compared to Xyrem. We're pursuing multiple potential approaches that include once-nightly dosing, as well as other areas where we have identified unmet need in narcolepsy patients. Our R&D activities include both mid and longer-term projects that are underway or in the planning stages. Now let me turn to the hematology oncology franchise. We're pleased with the continued growth of Erwinaze this quarter. We remain focused on our efforts to educate 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 chemotherapy regimens and of maintaining appropriate asparaginase levels.
We also continue to educate healthcare providers on the administration of Erwinaze through intravenous infusion. Now turning to an update on our study of Erwinaze in young adults or YA study. Our study was designed as a PK study to evaluate whether Erwinaze maintains adequate asparaginase activity levels in YA patients with ALL who developed hypersensitivity to E. coli-derived asparaginase. YA patients constitute approximately 20% of the ALL population in the U.S., representing an annual incidence of approximately 1,000 patients. In addition to the low incidence of ALL in YA patients, treatment centers are widely dispersed, with approximately 300 treatment centers across the U.S.. As such, many sites may only see one patient with hypersensitivity to E. coli asparaginase over the course of a year.
With these factors in mind, we've made the difficult decision to close this study and instead will focus our efforts on working with key oncology centers to support the treatment of the YA population. We will continue to build upon our investments in medical education and clinical investigations to better understand this patient population. The Defitelio launch in Europe continues to progress well. Our key focus in Europe is to establish solid pricing and reimbursement in order to maximize access for patients in need. We continue to engage in pricing and reimbursement submissions and discussions in the EU. We are continuing our efforts to provide disease awareness education on VOD, or veno-occlusive disease, for healthcare providers in Europe, and had a strong presence at the European Society for Blood and Marrow Transplantation meeting held in Istanbul in March.
We hosted two symposia, one for physicians and one for nurses, as well as other smaller events with approximately 900 total attendees. Now a brief U.S. regulatory update on defibrotide. We are pleased that we've completed remediation activities related to the existing defibrotide clinical data and are proceeding on schedule to complete the rolling NDA submission by mid-year. Defibrotide has Fast Track designation in the U.S., and we look forward to working with FDA to gain regulatory approval as quickly as possible. We've also begun pre-launch activities in the U.S. and are continuing our disease awareness program that includes a website, progressivevod.com, and other resources designed to educate healthcare professionals on the unpredictability, signs of progression, and potentially life-threatening consequences of VOD, as well as the need for timely diagnosis.
We're also pleased that we have observed an increase in the number of U.S. sites participating in the treatment IND for defibrotide. Our defibrotide development team continues to work with FDA on clinical trial design for the evaluation of defibrotide in patients with earlier VOD, which is VOD before it has progressed to multi-organ failure, and in prevention of VOD in high-risk patients. We plan to provide an update on our development plans during the second half of 2015. Finally, as mentioned in our earnings press release, we're excited that Dr. Karen Smith recently joined us as our Global Head of R&D and our CMO. Karen was most recently the Senior Vice President of Global Medical Affairs and Therapeutic Area Head of Dermatology for Allergan. Karen brings significant global R&D experience, and we look forward to her contributions as part of our executive leadership team.
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 first quarter as we saw adjusted EPS attributable to Jazz increase by 25% year-over-year. We expect continued strong top-line growth for 2015, driven by growth in sales of Xyrem, Erwinaze and Defitelio. We are reaffirming our total revenue guidance at a range of $1.31 billion-$1.37 billion and our adjusted EPS guidance at a range of $9.45-$9.75 per diluted share. Net sales of Xyrem for the quarter were $213 million, up 33% from $160 million in the first quarter last year.
I will remind you that our volume growth in the first quarter of 2014 was impacted by multiple factors that slowed the fill and refill timing from our central pharmacy. We are maintaining our guidance for Xyrem net product sales in a range of $950 million-$970 million and continue to expect high single-digit bottle volume growth in 2015. Turning to Erwinaze, first quarter worldwide net sales were $50 million, up 7% from the same period in 2014. We are maintaining our guidance for Erwinaze net product sales in the range of $200 million-$215 million for 2015. For Defitelio, first quarter worldwide net sales were $17 million, up 15% compared to pro forma net product sales of $15 million in the first quarter of 2014.
We are maintaining our previous defibrotide net sales guidance in a range of $73 million-$83 million. With respect to Erwinaze and Defitelio net sales, we've reiterated our guidance for 2015 despite continuing FX headwinds as our overall volume growth for these products has exceeded our expectations across Europe in the first quarter. Negative foreign currency impact to our top line during the first quarter of 2015 was approximately $2 million, primarily due to the continued strengthening of the U.S. dollar against the euro. I'll remind you that a bottom line impact is minimal as we incur European expenses and have otherwise largely mitigated our net exposure. In the first quarter, Prialt net sales were $7 million compared to $4 million for the same period in 2014.
The first quarter of 2015 includes sales to our European distributor of approximately $0.6 million, while the first quarter of 2014 had lower sales, primarily due to the timing of shipments to the exclusive wholesale distributor and central pharmacy for Prialt in late 2013. Turning to operating expenses, adjusted SG&A expenses for the first quarter of 2015 were $95 million compared to $78 million in the first quarter of 2014, or roughly 31% of total revenues for both periods, consistent with our pattern of higher SG&A expenses during the first quarter.
The dollar increase in adjusted SG&A expenses was primarily due to higher headcount and expenses resulting from the expansion of our business, including the Gentium acquisition and European Defitelio launch, an increase in marketing and promotional expenses, and an increase in professional services expenses such as litigation costs. Adjusted R&D expenses for the first quarter were $24 million or 8% of total revenues, compared to $16 million or 6% of total revenues for the first quarter of 2014. The increase was primarily related to increased costs for the development of the company's product candidates and lifecycle management activities for our existing products, as well as expenses relating to the rolling NDA submission for defibrotide in the U.S.. While the expenses in SG&A and R&D can vary quarter to quarter, we expect to be within our guidance range for the full year.
I'll remind you that we do not provide quarterly guidance. Our 2015 guidance for adjusted SG&A remains a range of $355 million-$365 million, and adjusted R&D guidance remains a range of $95 million-$105 million. As of March 31, 2015, cash and cash equivalents increased to $783 million, primarily due to cash generated from the business. We also have an undrawn revolving credit facility with capacity of $425 million. During the first quarter, the main uses of cash were to fund capital expenditures and repurchase our ordinary shares. As of March 31, 2015, the outstanding principal balance of the company's long-term debt was approximately $1.5 billion. During the first quarter, we repurchased approximately 63,000 shares at an average cost of $165 per share, leaving us with $11 million remaining in our $200 million share repurchase program.
In closing, we are pleased with our strong start to 2015 and are reaffirming our guidance for 2015. We continue to focus on investing in the growth of our key commercial products, advancing our 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 Kathee to make a brief comment about our Q&A session.
Thank you Matt. We request that you continue to limit your questions to a maximum of one at a time and then feel free to just 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.
Thank you. Ladies and gentlemen, your question and answer session will now begin. To ask a question, please key star then one. To withdraw the question, it's star then two. It's star then one to begin. We have our first question for you. It's from the line of Louise Chen at Guggenheim. Please go ahead, Louise.
Hi, t hanks for taking my question. I'm curious what you think about the business outside the U.S.? We've received some questions on this. You know, how large is it today? Where do you expect it to be over the next three to five years? Is this an expansion opportunity for you? Thank you.
Yeah Louise, this is Bruce. Let me start and I can ask Russ to add on. You know, the European business has been growing. You know, clearly, we added a new product to the mix last year with the acquisition of Gentium and the launch of Defitelio in the EU. That's also been a terrific fit with our Erwinaze business. The combined revenues of those two products have already increased our European presence. We obviously think those are both growth assets. Top line growth is looking a little less impressive this year thanks to the FX headwinds, but the underlying volume growth has been nice. From those two products, we see additional growth. We've told you we're looking at expanding the use of Defitelio over time through clinical investigation in other areas.
Of course, we remain active on the corp dev side, and that would include the potential for Europe-only products as well as additional global products that we'd add to that business.
Thank you.
Yeah. The only thing I would add to that Bruce, is we've become very focused on the hematology oncology side of the business from an international perspective, and we're pleased with what we're seeing from that team so far. We continue to look at where else we can expand there.
Okay, t hank you.
Thank you. We have another question for you. This one's from the line of Marc Goodman at UBS. Please go ahead.
Yes. Just on that topic of Defitelio, can you give us a sense of just country by country, like, where are we? I know that the U.K. was relatively new. How are we doing there? You've been fighting in France for pricing. Can you give us an update there? And I guess, you know, Germany's been a good market. So just give us a sense of what's been going on and stuff. And just remind us, how much was the FX impact just specifically on Defitelio? Thanks.
Marc just quickly, it's Matt. On the FX impact, what we've said across Defitelio and Erwinaze in the EU for the first quarter was $2 million. You'll recall on our previous call, we said the general headwinds this year could be $10 million-$20 million across our European portfolio. We did see, you know, higher pressure there than originally anticipated, so I'd say the upper end of that range.
Yeah. Just to take you through the quick list, Australia, Germany, Norway, England, Netherlands, Scotland, Finland, Denmark, Sweden, Slovenia, Romania, Ireland and Wales are all in sort of that public and approved status. We have both France and Italy that are working through some issues as it relates to maximizing reimbursement. I think that in general, we're really pleased with a couple of countries that we've invested in, and I would say in the early stages of the launch, like Germany, that continues to show really good growth.
Okay, thank you for your question, Mark. We have another question. This one's from Douglas Tsao at Barclays. Please go ahead Douglas. You're in the call.
Hi, g ood afternoon, t hanks for taking the question. I guess my first question is turning to Erwinaze, with the decision to close out the YA study, you know, maybe you could provide a little bit more color in terms of how you're thinking or some of the tactics that you intend to deploy to improve penetration into that patient base? which I think, you know, obviously seems to represent a pretty good opportunity, perhaps not necessarily just in patient numbers, but certainly in the volume of drug that you could potentially sell into.
Yeah. Doug, let me start that and then I'll turn it over to Mike. You know, I would say in general, we have been seeing growth in use of the drug in that patient population over time. You know, I gave the incidence number earlier. It's obviously a smaller number of patients than pediatric but since the dosing of the drug is related to the size of the patient, you know, and if you look at the amount of drug consumed by a smaller number of patients, it does make a meaningful impact on our business. Mike maybe you can comment a little bit more about what we're seeing.
Yea, t hanks Bruce. Just, you know, the YA has been and will continue to be an area of growth for us with Erwinaze. The medical literature and the guidelines certainly support its use. Our guidance with Erwinaze remains unchanged and includes the YA opportunity.
Okay, thank you. We have another question for you. This one's from the line of Michael Faerm at Wells Fargo. Please go ahead Michael.
Hi, t hanks for taking the question. My question's around JZP-386. Could you provide any color on some of the other options you alluded to, specifically where in development might any of them be? Is there anything that's near to being in the clinic? Is there still a chance that anything that you're developing now could get to market ahead of the expiration of the 2020 patents? Thank you.
Yeah Mike. You know, we're not gonna comment real specifically on where we are, but don't assume we haven't already done clinical work on some of the things we're looking at. In terms of timeframe, we do think programs we're working on, you know, do have the potential to come to market. That's making a number of assumptions between here and there, but during a relevant period for us, which is a period when we have Xyrem on the market, pre-competition.
Could you just clarify when you say a relevant timeframe?
Well, I don't think a given patent is the only relevant piece of timeframe here. It's really, you know, when we might see competition, generic competition or otherwise, and that's how we're thinking about it.
Thank you.
Thank you Michael. We have another question for you. This one is from Corey Davis at Canaccord. Please go ahead.
Thanks. I wanted to ask about JZP-110 and what you can do and what you are doing in the trial design to hopefully maximize the outcome in the phase III to be able to differentiate it in the clinical trials from generic Provigil? And I guess by the time you launch, what will be generic Nuvigil? At what point do you expect to conduct what the FDA and DEA will need to see in order to hopefully give you the best scheduling status possible? Lastly, it's still the same question, is how quickly can you enroll, and what's the soonest we would see data from these three different phase III on JZP-110?
Okay Corey, that was quite the one-part question there. On enrollment, I'd say we've talked about this program being largely a 2015 and 2016 program with a target of submitting an NDA in 2017. We haven't specifically talked about when we release data yet. On scheduling and the DEA, you know, certainly we made some assumptions when we were bringing the product in about, you know, different possibilities for scheduling and how that would impact the value of the asset we were buying. You know, let's just say the price we paid, you know, would offer us attractive returns given the assumptions we made. That left us with some work to do on the abuse liability side.
Of course, we won't know the final answer on that until we get ultimate scheduling from the DEA, which is still a couple of years away. Not a lot more to say about that right now. Maybe I'll turn it over to Russ to talk a little bit about what we think the market looks like when JZP-110 launches and how we're thinking about data we're collecting in our trial.
Yeah. Thanks Bruce. I would comment just based on Investigator meetings and the feedback that we're getting, we do think this could recruit very, very quickly around OSA, specifically. Historically, narcolepsy takes longer based on our experience, but we're really encouraged by the feedback that we've had from investigators so far. We do believe when we launch JZP-110, it'll be in a fully genericized market. The differentiation that we're focused on is primarily in efficacy and the treatment effect that we see from JZP-110 over Provigil and Nuvigil. We're also very encouraged by what we think we would see from a safety profile there. Having said that, we're looking at quality of life. We're looking at a number of different things that we will be able to build into a protocol that we think will be meaningful at launch.
I would just say Corey, although the trials that have been done have not been head-to-head, they've been done in a very similar fashion with very similar endpoints to those used in the modafinil and armodafinil trials.
Great, t hanks for all that.
Thank you. May I have another question for you? This one's from the line of David Amsellem from Piper Sandler. Please go ahead.
Thanks. This is a Xyrem question and I may have missed this earlier, but you cited the 12% bottle volume growth, but realized that there was an easier year-on-year comp because of the issues in the first quarter of 2014. If we hypothetically assume that first quarter of 2014 was normalized, can you say what that bottle volume growth for this quarter would have looked like? Thanks.
Yes, this is Mike. I think if we were to normalize that growth, I think we would look at probably 7%-8% bottle volume growth year-over-year.
David recall, we've talked about high single-digit volume growth as our expectation for 2015.
Thank you.
Thank you David. We have another question for you. This one's from Gary Nachman at Goldman Sachs. Please go ahead, Gary.
Hi, good afternoon. Also on Xyrem. Bruce, any update on what's going on with the shared REMS discussions with the generic companies? Can a generic actually be approved before that's finalized once you have the final REMS in place? I think you said by late August. Maybe just run through those different scenarios that you think could happen. Thanks.
Yeah, Gary. So single shared system conversations continue, although we've said we obviously can't provide specific updates on that. You know those conversations started back in January of last year, January 2014. You know, obviously at that time, we had a deemed REMS, not a final REMS. As of the end of February this year, we do have a final REMS, which I think at least provides a starting point. You know, the August date I gave is for us to finish implementing the Xyrem REMS, so the REMS that was approved for us to distribute our product. Can't comment specifically on timing of getting to resolution on a single shared system or a waiver, which are the two options available to FDA. You know, could FDA give an approval before a final REMS?
I think, you know, an appropriate REMS that protects the safety of patients and the public is an important part of distributing sodium oxybate. I think, you know, certainly before launch, you've got to have a system that accomplishes that.
Okay, t hank you.
Okay, thank you for your question. We have another question. This is from Annabel Samimy from Stifel. Please go ahead.
Hi, t hanks for taking my question. Just again on JZP-386. The way you released the data, it seemed that it was, you know, favorable deuterium-related effects corresponding to the effects in Xyrem. What is it that made you decide that it can't move forward at this time? I guess I'm a little confused about that. What criteria do you need to feel comfortable beginning to disclose the other next-gen Xyrem products? Is it data-driven or is it generic competitor-driven? Thanks.
I'm not sure we're gonna give much more information on JZP-386 specifically other than to say, you know, we have a view of what we'd like to see in a candidate to take into late-stage clinical trial, and we didn't get there with JZP-386 in its current formulation, so we've got some more work to do there. Karen, do you wanna add something on that?
Thanks Bruce. Hi it's Karen. Just to add to that, we did have predetermined criteria that we were seeking to meet before we actually felt comfortable moving immediately to later stage trials. That predetermined criteria is really related to standard criteria that you would expect to see in a PK study, so area under the curve and those sorts of measurements that we were looking for.
On not being more disclosing on the other efforts, I would say we don't particularly view it as helpful to our company or our shareholders for us to be giving people a lot of specificity on what we might be doing. You know, at this point, we think the best thing for us is to be relatively quiet.
Okay, thanks.
Thank you. We have another question for you. This one's from the line of Gregg Gilbert at Deutsche Bank. Please go ahead, Greg.
Thank you. Bruce, is it fair to say that you're as confident as ever about the durability of the current Xyrem product, given what you know now about regulatory, legal, and other variables? Thanks.
Complicated question, Greg. Obviously pulling together a lot of pieces, but, you know, we continue to feel, you know, that we've got a great and growing franchise, that we're continuing to invest in on the commercial side. We're continuing to invest in, with clinical work, as you're seeing with, our pediatric narcolepsy trial. We obviously have other development programs we're continuing to invest in, you know, and, our goal is, with all our programs is help more patients and provide a nice return to our shareholders in doing that. You know, all of that, I think you should take to indicate that we're confident we've got a business not just for the short term, based on all the factors you described, each of which we've obviously been very conscious of in all of our planning and execution over a number of years.
Thanks.
Thank you. We have another question for you. It's from Jessica Fye at JP Morgan. Please go ahead, Jessica.
Hey, thanks for the question. Can you remind us of your priorities for business development? I guess, specifically, should we think of Jazz as more focused on acquisitions that would add long-term durability, but maybe dilutive in the near term? If so, would you look at development stage assets outside of your current therapeutic verticals? I guess what I'm trying to figure out is how important is near-term accretion and the certainty of more immediate cash flows versus potentially longer term, more durable assets.
Jessica, let me break that question down into two parts. I'll take the accretion, non-accretion piece, and then maybe Matt can get back to sort of the criteria we're using in those deals. Near-term accretion is not important to us. That said, we have done accretive deals. We like accretive deals. I hope we'll do more accretive deals. But, you know, short-term cash flow is good for this company. Where we find additional assets that would bring us even more near-term cash flow and accretion all the way down to the per share level, great. All for it. But you've also seen us do deals that certainly are not near-term accretive.
You know, by definition, anything we do on the R&D side, including the JZP-110 deal, is clearly an investment we're making that we believe has great long-term returns, but doesn't start out as accretive. Matt, you wanna talk a little bit about the criteria we use?
Sure. Jessica I think they continue to be the same criteria, which really, again, start with great therapeutic benefit for patients, and then go to really attractive margins, which include targeted sales forces, again, reasonable R&D investment that we believe is appropriate from a risk-reward perspective, good cost of goods without high royalty burdens, and importantly, good longevity. Not just near-term cash flow, but growable long-term cash flow. We would look, I think, at development assets outside of just our core therapeutic areas to answer one of your other specific questions, but really starts again with the medical importance for patients and it isn't sort of. The accretion follows as opposed to leads how we would think about those types of product opportunities.
Got it, t hanks.
Thank you. We have another question for you. This one's from the line of Irina Koffler at Cantor Fitzgerald.
Thanks for taking the question. I wanted to push a little bit on the SG&A guidance. I mean, first quarter seemed pretty high, and you're looking at legal expense in the back half of the year, whether it's the IPR process or the trial. Are you sure that $355-$365 is doable, is the first question. The second question is, can you comment on any recent Xyrem price increases? Thanks.
Yeah. I'll take the second part first Irina, and say we took a Xyrem price increase, which we disclosed last quarter as 9%, in February and have not taken another price increase. Matt, you wanna handle SG&A?
Sure, yeah. Again, we feel confident in our numbers for SG&A for the year. We're making a number of investments across the business again related to the regulatory submission with defibrotide, our continued launch of Defitelio in Europe, launch prep for defibrotide in the U.S., as well as a number of initiatives. Our first quarter SG&A are typically higher as a percentage of sales based on what we normally see from a revenue perspective in a Q4 to Q1 trend. Again, we're around 31% last year, despite coming in at a much lower number annualized in terms of percentage of sales. I would feel very confident in our SG&A expenses as we've modeled them for the year at this point.
Okay. Just one quick follow-up. Can you remind us about the divestiture of some of your assets and when we should expect that to happen and any other expectations around that? Thanks.
Sure. We completed the previously stated divestiture of our general medicines business unit in Europe on March 20. We indicated it we thought it would happen by mid-year, and so it did happen shortly after our last call. The net proceeds from that, I think we have stated, it's $33 million with the purchase price adjustments that are balance sheet related. That is complete but for the ongoing related support agreements until we have fully transitioned the business to the buyer in that case, which has allowed us to again take management time and focus it on what we believe are longer term value drivers of greater priority to the business.
Thank you.
Yeah. Before we take the next question, while I've got Matt talking and we're talking about Europe, I just wanna go back. Matt gave an answer on FX a little while ago, but I think wasn't necessarily going back to the comparison that we show in our press release of first quarter to first quarter, which obviously takes into account a longer period and movement in euro-dollar ratio. Matt, maybe you could give a little more info on that.
Sure. Just going back to that question on FX briefly. If you looked at year-over-year and the relative state of the dollar euro in the first quarter of 2014 to today, the impact across Defitelio and Erwinaze together was on the order of magnitude of $6 million-$8 million in terms of the year-over-year impact, you know, roughly $4 million-$5 million of that being with respect to defibrotide or Defitelio. You know, again, the bigger number of the $10 million-$20 million which I stated was sort of the expected impact on an overall aggregate basis relative to our guidance relative to 2014 performance.
Thanks.
Thank you. We have another question for you. This one's from the line of Jason Gerberry at Leerink Partners. Please go ahead, Jason.
Hi, g ood evening, t hanks for taking my question. Bruce, just curious, you know, we get asked the question a lot about, you know, why hasn't Jazz done a diversification deal yet? I'm just kinda curious to what extent pending Xyrem litigation has played a role at all, either in terms of lenders being, you know, open to, I guess, lending to you at favorable terms or perhaps other companies, how they view your equity, if you were to use stock in a more transformative deal. Just kinda curious if you can comment on if, you know, Xyrem litigation plays a role at all in that in terms of your discussions. Thanks.
Yeah. Jason, the short answer is no. We think we've got great access to capital. Of course, you've watched us do a number of deals historically, at least post the Azur deal which required use of equity that in general have not used equity. You know, in terms of the comment that we haven't done a diversifying deal, of course, we have done a number of deals that I think are short-term or long-term diversifying. I think that was certainly true of the EU SA deal. I think that was true of JZP-110. I think that was true of the Gentium deal. I'm confident we'll do other deals.
The pattern of the deals we've done is we've been able to do bigger deals over time as well, and we certainly feel like we have the opportunity to do a deal that's larger than the deals we've done historically. I don't think it's a question of not doing deals and now doing deals, and I certainly don't think a driving factor in anything you've seen has been Xyrem litigation related.
Great, t hank you.
Okay, thank you for your question. We have another question for you. It's from the line of Liav Abraham from Citi. Please go ahead.
Good afternoon. Just wanted to follow up on a couple of previous questions on M&A. I'd be interested in your thoughts on asset pricing in the current environment, particularly the orphan drug space, which I know you guys have an interest in. I'm just wondering if you're seeing interesting assets out there at reasonable prices in the current environment. Thank you.
Sure, t hanks Liav. There absolutely is an aggressive and ambitious M&A market today. We have seen, in some cases, assets that we would think are a good and appropriate fit for Jazz that we've been watching for some time trade at valuations that we couldn't support. Conversely, we do see a lot of attractive opportunities out there. Again, we're not just looking at the subset of opportunities in the public domain, and we continue to be very active in evaluating and pursuing a number of opportunities we believe can be attractive and offer good returns for our shareholders. It is aggressive and competitive but we do believe we can still do transactions in this environment.
Great, t hanks.
Thank you. We have another question for you. This one's to the line of David Maris at BMO. Please go ahead, David.
Good afternoon. I'm curious, do you have any pending or issued Xyrem IP that's not been included in the Orange Book that you believe may be listable?
Yes.
Thank you.
Thank you. We have a question from Douglas Tsao again at Barclays. Please, go ahead.
Hi, t hanks for taking the follow-up. Just in terms of the SG&A spend, we saw a pretty significant step up. Was that purely related to litigation?
No Doug, it's a number of factors. Obviously, the business is growing year-over-year, and we did not have Gentium, you recall, for the full quarter of 2014 in the first quarter. We've grown the business, you know, both there as we've extended the commercial launch over time as we've secured reimbursement in countries. That's been sort of a steadily climbing expense. It's really, again, probably best to look at it on a percentage of sales basis, which is the same in both of those quarters.
Should we think about that as sort of a current run rate?
You know, you can look at our annual guidance and $355-$365 is the number.
Bruce, I have one quick follow-up for you. How many games for the Warriors?
Well, they lost one, which was a little disappointing, but we still like them out here.
Operator, we'll take one more call after this.
Okay thank you. We have this question. It's from, Kenneth Cacciatore from Cowen & Co. Please go ahead, Ken.
Thanks. As Bruce, you use, as you typically do, pretty interesting language, and you said here a relevant timeframe when you were talking about other lifecycle management programs that you would want to have them introduced for Xyrem, not necessarily patent-related. I guess you know what that relevant timeframe is. Is it something that you care to share with us? Are we moving or progressing to a point where that could be brought to the forefront or we could be made aware of what that relevant timeframe is? Thanks.
Yeah. Ken, I guess my point is that obviously we make a judgment based on everything we know at any point in time. If we had been on a call a year or two or three ago, and people had asked us you know what else we were working on and when it might launch, I think people would have asked us what do you think could launch by a year, that let's just say would have been sooner than the one that was asked about earlier in this call.
You know, my point is not to get anchored off one magic date in one piece of this whole puzzle, but to really be thinking about how everything fits together and what our best judgment is about you know the durability of the current asset as we think about optimizing value with other assets, too. It could be that optimizing value is getting something else on the market ASAP. It might be that optimizing value over the long term is getting something to market a little closer to when there might be some kind of a change. You know, our job is to use all the information we have on what we're doing and make the best call to optimize value, and that's what we're trying to do.
My answer wasn't intended to be too cryptic other than to say I wouldn't always anchor off any one date in your thinking.
Thank you.
Okay. Thank you very much. Now I'll turn the call back over to Kathee for closing remarks.
Thank you Ian. Thank you again for joining us today. We are planning to attend both the UBS and the Goldman Sachs conferences and look forward to seeing many of you there. This will end our call, t hank you.
Thank you. Ladies and gentlemen, that concludes your conference. You may now disconnect. Thank you for joining, en joy the rest of your day.