Earnings Labs

Jazz Pharmaceuticals plc (JAZZ)

Q4 2012 Earnings Call· Tue, Feb 26, 2013

$201.42

-1.26%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+1.67%

1 Week

+4.05%

1 Month

-1.62%

vs S&P

-6.05%

Transcript

Operator

Operator

Welcome to the Jazz Pharmaceuticals' Year End 2012 Earnings Conference Call. Following an introduction from the company, we will open the call to questions. I will now turn your call over to Ami Knoefler, Executive Director of Investor Relations and Corporate Communications at Jazz Pharmaceuticals. Please proceed, ma'am.

Ami Knoefler

Analyst

Thank you for joining the Jazz Pharmaceuticals PLC Investor Conference Call. Earlier today, we reported our fourth quarter and year end 2012 financial results and provided 2013 financial guidance in the press release. The release is available in the News and Events section of the company's website. With me for today's call are Bruce Cozadd, Chairman and CEO; Kate Falberg, CFO; Russ Cox, Chief Commercial Officer; and Jeff Tobias, Head of R&D and Chief Medical Officer. I'm also pleased to welcome our new Vice President of Investor Relations, Cathy Latrell, [ph] who will be hosting future investor calls as I transition to a new role in Corporate Communications and Advocacy. Following some introductory remarks, we will the open your call for your questions. Please note that certain comments we make on this call constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to future events, future financial results, growth potential, financial guidance, pipeline opportunities, future regulatory and intellectual property matters and other statements relating to our plans, expectations and intentions. These forward-looking statements involve numerous risks and uncertainties that could cause our actual results to differ significantly from those projected, including risks and uncertainties associated with our ability to maintain and increase sales of Xyrem, the potential introduction of generic competition to Xyrem, potential change or increased regulatory restrictions on Xyrem, the challenges we face in developing and protecting our intellectual property, our need to obtain appropriate pricing and reimbursement for our products in an increasingly challenging environment, ongoing regulation and oversight by U.S. and non-U.S. regulatory authorities, our dependence on key customers and sole source provider -- suppliers, excuse me, the difficulty and uncertainty of pharmaceutical product development, clinical success and regulatory approval and our ability to identify and acquire…

Bruce C. Cozadd

Analyst · Louise Chen, Guggenheim

Thank you, Amy, and good afternoon, everyone. Thank you for joining us. 2012 was truly a transformational year for Jazz Pharmaceuticals. We completed 2 major transactions that broadened our product portfolio and enhanced the scale and capabilities of our company. We aligned our commercial operations with the portfolio and divested our non-core women's health business. We expanded our revenue base from continuing operations to $586 million, more than double our 2011 revenues, and importantly, we delivered a record adjusted net income of nearly $300 million, reflecting the significant top line growth and attractive margins of our business. 2013 is off to a strong start. We plan to continue the momentum in our business by growing our key products through continued solid execution in all of our business units and by making selective investments in new initiatives, which I'll talk about in a minute. We'll also continue our focus on corporate development with a goal of adding additional specialty products to our portfolio. Let me update you now on some of the initiatives related to the 3 products in our current portfolio that we believe have the highest growth potential, Xyrem, Erwinaze and Prialt, as well as our planned investment in R&D and corporate development to support our growth strategy. Kate will then review our results for 2012 and provide our financial guidance for 2013. Xyrem remains a key driver of our growth. In 2012, we achieved a record $379 million in revenues, reflecting an increase of 62%. We were pleased to achieve double-digit volume growth for the year, as the average number of active Xyrem patients in the fourth quarter grew to approximately 10,450 compared to 9,300 in the fourth quarter of 2011. This volume growth has come from improvements in compliance and persistence and increasingly, from new patient starts,…

Kathryn E. Falberg

Analyst · Greg Gilbert, Bank of America

Thanks, Bruce, and good afternoon, everyone. Beginning with the top line, total revenues for 2012 were $586 million, up $314 million or 115% from the prior year. Total revenues for the fourth quarter were $184 million, up $100 million or 120% from the year-ago period. These increases were due to revenues from products added to our portfolio from our 2 acquisitions, as well as continued strong growth of Xyrem. This year, we expect robust top line growth with total revenues in the range of $805 million to $835 billion, up 37% to 42% on an absolute basis and 20% to 25% on a pro forma basis. We are anticipating continued strong growth from both Xyrem and Erwinaze this year. Net sales of Xyrem were $379 million for the year and $114 million in the fourth quarter, up 62% and 58%, respectively. We were pleased to achieve 11% volume growth for the second year in a row, and we are very pleased with the 13% year-over-year volume growth in the fourth quarter. We do note that fourth quarter growth was positively impacted by having one additional shipping day compared to the fourth quarter of 2011. Our net sales guidance for Xyrem this year is a range of $530 million to $540 million and reflects our expectation of high-single to low-double-digit volume growth, as well as the 16% price increase implemented February 1. Turning to Erwinaze, worldwide net sales were $132 million for 2012 on a pro forma basis and $34 million in the fourth quarter. Remember that Erwinaze was approved by the FDA in November 2011, making year-over-year comparisons less meaningful. This year, we expect strong growth for Erwinaze, with net sales projected to be $155 million to $165 million worldwide. Under the terms of the EUSA deal, if Erwinaze achieve…

Operator

Operator

[Operator Instructions] Your first question comes from the line of Louise Chen, Guggenheim.

Louise Alesandra Chen - Guggenheim Securities, LLC, Research Division

Analyst · Louise Chen, Guggenheim

I have a few. First one is with respect to your bi-annual price increases. I know you get asked that a lot, but just curious. What gives you confidence that these can continue and where do you think you might start to get some resistance on these type of price increases annually? And then second question is on Xyrem with respect to settlement with Roxane or the other generics companies versus taking a calculated risk on the litigation front. How do you -- strongly do you feel about that? And then maybe last question is just on the prescriber base. As you go broader, where are you today and where could you go and what kind of upside could we see from that?

Bruce C. Cozadd

Analyst · Louise Chen, Guggenheim

So this is Bruce. Why don't I let Russ take the question about price increases. You asked it as -- as if it's a sure thing we'll increase prices twice a year. We haven't actually said what will do going forward, so I'll just clarify that. But I'll refer over to Russ your general question about price increases and maybe expansion of the prescriber base, and then I'll come back to take the middle part.

Russell J. Cox

Analyst · Louise Chen, Guggenheim

Sure. So in terms of -- if you look at how many of your colleagues have modeled the future going forward in terms of price increases, most of your colleagues has seen this sort of back off over time, so I don't think everybody is thinking that this is a fully sustainable approach for the next several years. I do think that what we spend all of our time thinking about is where do volume and price meet and really spent a lot of time looking at whether there is any impact on current volume as a result of price. From the patient perspective, we actually don't see the prices impacting the patient flow. In fact, we actually are more convinced that we've -- with the suite of services in place that actually address that issue in a very comprehensive way, and we're not seeing price being an issue at patient level. And so while we don't tend to tell you what we think we should do in the future with pricing and we monitor very carefully, we would also say that prior authorizations continue to increase at about almost a 50% rate. And beyond that, we don't see anything changing in the fair [ph] landscape. In terms of additional physicians, we've actually done a great job of targeting about another 1,000 physicians in our call universe that's driven by finding data that tells us where narcolepsy is being treated from a stimulant perspective, from refreshing new databases that we get from the sleep society, and then just ongoing prospecting, having a sales force now that is 100% focused on Xyrem. So we've gone from about a call universe of 3,000 to about 4,000, and that seems to be paying off.

Bruce C. Cozadd

Analyst · Louise Chen, Guggenheim

And your other part of the question, which was something about how we view potential for settlement versus proceeding through litigation, a little difficult for us to comment too specifically on that. We continue feel we've got substantial intellectual property protecting our Xyrem franchise, and we note that this is a complex area. We've certainly made our priorities clear, which is to continue to grow our presence in narcolepsy and help more narcolepsy patients, to continue to ensure the continued safe distribution of sodium oxybate for these patients through our restricted distribution system, which we believe does an excellent job in helping patients and protecting the public. But also the ultimately do what creates the most value for our stockholders, and that's how we'll continue to approach that balancing act that you described.

Operator

Operator

Your next question comes from the line of Greg Gilbert, Bank of America.

Gregory B. Gilbert - BofA Merrill Lynch, Research Division

Analyst · Greg Gilbert, Bank of America

I've got a few. First, I think, it's for Russ on Xyrem. Have there been any changes at the payor coverage in 2013 for Xyrem and can you at least comment whether the winds are shifting in that regard in any way? I'll ask them one at a time, if that's all right.

Russell J. Cox

Analyst · Greg Gilbert, Bank of America

Yes, sure, Greg. So we haven't seen overall change in reimbursement rate. We've typically said that it's around the 80% range, and we continue to see that to be very consistent. I did mention the fact that we are seeing an increase in prior authorizations. Now we've seen that for about 1.5 years now. It was one point in maybe the mid-30s are now approaching about 50% for authorization. And in terms of overall landscape change, we don't see anything meaningful that's actually happening today.

Gregory B. Gilbert - BofA Merrill Lynch, Research Division

Analyst · Greg Gilbert, Bank of America

Okay. And Kate, thanks for the new color on the tax rate longer-term, that's really helpful. Have you and the team decided to think about how much you spend in other line items in the P&L now that you have some better certainty that, that rate is lower than you had previously been projecting?

Kathryn E. Falberg

Analyst · Greg Gilbert, Bank of America

Well, so we gave a guidance for combined R&D and SG&A. And Bruce outlined, in his comments, a number of initiatives where we are making investments. We also announced 1 VD transaction today with Concert Pharmaceuticals. So the short answer is yes. We are continuing to think about the optimal mix of investing for the future versus delivering current earnings.

Gregory B. Gilbert - BofA Merrill Lynch, Research Division

Analyst · Greg Gilbert, Bank of America

And then lastly maybe, if I can have Bruce chime in. If you were to commit to significantly larger amount of R&D investment than you just laid for this year, so perhaps longer-term, philosophically, what would you like to be able to share with investors before committing to a much larger R&D spend than you've committed to for this year?

Bruce C. Cozadd

Analyst · Greg Gilbert, Bank of America

Yes. Well, Greg, I think, we're in the fortunate position of having really good top line and bottom line growth at the moment. Historically, I think, we've been underinvested in R&D in large part because of the company's limited ability to pursue that years ago. So at this point, I think, we can talk about meaningfully increasing our R&D investment without anyone being too nervous about that because frankly, even if we kept it the same, as a percentage of revenues, it's going up. Rather than committing to a defined R&D budget and saying, "What are we going to do with the dollars?" I think, our approach is much more, "Where are there great opportunities to invest R&D dollars?" Particularly, in things that would benefit our existing franchises or be great fits with our capabilities, and then look at how we best pursue those investments. So it's that project-driven decision much more than it is an overall, "Let's just commit a pool of dollars in R&D and then see what we do with it." It's a return on investment proven calculation.

Operator

Operator

Your next question comes from the line of David Amsellem, Piper Jaffray.

David Amsellem - Piper Jaffray Companies, Research Division

Analyst · David Amsellem, Piper Jaffray

Just a couple. So first on Xyrem. Just remind us what additional patent applications, if any, you have pending and maybe provide some detail on those if you can?

Bruce C. Cozadd

Analyst · David Amsellem, Piper Jaffray

So David, we haven't generally provided a detailed look at that. There has been one allowed, but not yet issued patent, and we've said we had a number of applications pending of different types that we certainly hope would issue in the months and years to come, but we haven't been more specific than that.

David Amsellem - Piper Jaffray Companies, Research Division

Analyst · David Amsellem, Piper Jaffray

Okay. And then second question is on Prialt. Maybe provide a little more color on the NAVIGATOR system and how would you characterize physician receptivity to that system and how it's -- you think it's impacted both usage or -- among doctors and also just the -- how it's resulted in any changes, if any, in the -- in reimbursement paradigms?

Bruce C. Cozadd

Analyst · David Amsellem, Piper Jaffray

Sure, David. I think the best way to think about the NAVIGATOR system at this point is, it's still very much early days. As you know, we launched last November and one of the things that we were very cautious about is, we wanted to make sure that we continue to sort of customized how about there that actually was reflective of what physicians wanted. As you remember, the single biggest objection that we've had from customers on Prialt is just having a better understanding of what the reimbursement landscape looks like. We think NAVIGATOR has done a really nice job of actually telling physicians and patients specifically, exactly, what that looks like. It takes a lot of the questions about risk away. Having said all that, when you launch something like this, you really have to put it out there, take a look and see what the physician response has been. I think we've gotten more of the difficult patients to date, and if you look at the overall uptake, we have about 50% enrollment from the total book of business. So I think we're on a very nice path. I think we're making little tweaks to make sure that we optimize the overall look from a patient-physician perspective so they know exactly what decisions they can make about patients that more based on the medication that's required as opposed to just reimbursement. And I think that as we continue to go down this road, we'll continue to put more and more emphasis on enrollment and put a little bit more rep resources behind making sure that, that happens. We wanted to go cautiously.

David Amsellem - Piper Jaffray Companies, Research Division

Analyst · David Amsellem, Piper Jaffray

Okay. And then one last question if I may sneak in one on the PEGylated asparaginase products. Just give us a sense of what the value proposition needs to be in order for it to be successful? And what you need to see in order to get this to market?

Bruce C. Cozadd

Analyst · David Amsellem, Piper Jaffray

Yes, David, I would say, at first principles, the PEGylation is really designed to provide less frequent dosing to patients. We're now at both an intramuscular injection and 3x a week dosing in the current formulation of Erwinaze in the U.S. and, obviously, there's potential to introduce a product that would be dosed once weekly or once every couple of weeks and provide the same type of benefits to patients. They also mentioned that if it's recombinantly produced that has some advantages, frankly, to us than managing a supply chain being more easily able to adapt to changes and demand potentially with some benefits in terms of the economics of product supply. So let's start with dosing patients as being the most obvious difference as we continue our clinical development it may be that we see other differences that could have importance, including potential hypersensitivity reactions to the Erwinia-derived asparaginase itself. But we'll need to see more data before we say more on that.

Operator

Operator

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

Douglas D. Tsao - Barclays Capital, Research Division

Analyst · Douglas Tsao of Barclays

Bruce, I was hoping you could perhaps talk a little bit about the agreement with Concert and what you think the new -- the lead compound, what potential clinical advantages would have over your -- over Xyrem as it exists today? And perhaps a little bit of -- some perspective because it's obviously early stage what -- how you see the potential development pathway?

Bruce C. Cozadd

Analyst · Douglas Tsao of Barclays

Yes, Doug, good question and let me turn that over to Jeff, our Head of R&D, to comment a little bit about sort of sodium oxybate and, while it's a great product, it's not perfect and does have some limitations and we're an early-stage program to look at an alternative molecule has, at least, potential to offer some advantages.

Jeffrey K. Tobias

Analyst · Douglas Tsao of Barclays

Right. So sodium oxybate as we now have a large number of very important therapeutic effects but it's also to some degree constrained by its pharmacokinetic, a very short half life. And so the newly rated [ph] technology has an opportunity to potentially impact that through changes in the metabolic profile. So that's one of the interesting parts about this program is to be able to assess whether or not we can really leverage that effective -- the duration and translate that into something that's clinically meaningful for patients. Development pathway. One of the nice things that we have, that we bring to Concert, this Concert also brings expertise to us is that we have a great deal of expertise here in this area in developing products for narcolepsy, et cetera. So we're going to utilize our expertise to make for efficient path forward acknowledging that this is a somewhat novel compound. So as we go through the development pathway, we're going to always keep in mind an efficient route forward.

Douglas D. Tsao - Barclays Capital, Research Division

Analyst · Douglas Tsao of Barclays

Okay. And also, just curious, perhaps a question for Russ on the dedicated sales force for Xyrem, I was just curious what advantages commercially or sort of exactly how is that having an impact in terms of driving volumes for the product? And also I wasn't sure if you mentioned it, if you gave guidance for what your expectations for volume growth were in 2013?

Russell J. Cox

Analyst · Douglas Tsao of Barclays

Yes, Doug. So if you characterize what the impact has been, it's been dramatic, and the reason I say that is because we were, at one point, spending about 70% of our time on Xyrem, and about 30% on LUVOX CR. And what that ultimately became is just a huge distraction in terms of downtime for our ability to really prospect. And so we've now really, with 100% focus on Xyrem only and really a restructuring to make sure that we have the right people, in the right places, the right account has led us to, what is now, for the first time ever, true growth in new patients. Whereas before a lot of our growth has truly been driven by changes in persistency and compliance. So we really think this dedicated and highly focused sales force who's now gone to the Atlanta Sleep School of Medicine and are being trained at a very, very high level and can go head-to-head with our narcolepsy experts, has really made a meaningful difference I would also say that we have projected high-single-digit, low-double-digit growth for the balance of the rest of the year.

Operator

Operator

Our next question comes from line of Ken Cacciatore, Cowen & Company.

Ken Cacciatore - Cowen and Company, LLC, Research Division

Analyst · Ken Cacciatore, Cowen & Company

I had a question. Bruce, you laid out that clearly the legal situation on Xyrem seems to be taking time or will continue to take time. I was just wondering, from a regulatory perspective, does the FDA take its cues from that kind of, I call it, legal delay? Or are they continuing to progress through and along the that line, have you been asked to negotiate with Roxane on a REMS and, if so asked, does that maybe started the creative process to finally resolving this in total?

Bruce C. Cozadd

Analyst · Ken Cacciatore, Cowen & Company

No, Ken, on the first part of your question, we don't know whether the FDA's process takes into account what's going on the legal side. I would say, not directly, but you'd have to ask FDA that question. On the second part of your question, have there been conversations between the parties specifically about the distribution system, I'm just going to have to decline to answer that question. That's not a change in response, that's been a pretty consistent response for us -- from us for a while and I expect it will continue to be the response from us. We're obviously involved in ongoing litigation between the 2 parties. So starting to go on record with any conversations that have or could start between the 2 parties that's going to put us in a really awkward position.

David Amsellem - Piper Jaffray Companies, Research Division

Analyst · Ken Cacciatore, Cowen & Company

Okay. Understood. I guess then on Business Development, just can you give us a sense in terms of anything, either near-term or size, are we seeing assets that we like or just continuing to be pragmatic as we go forward? Can you give characterization on the Business Development processes?

Bruce C. Cozadd

Analyst · Ken Cacciatore, Cowen & Company

We'll have Kate comment on that.

Kathryn E. Falberg

Analyst · Ken Cacciatore, Cowen & Company

Yes. So Ken, we continue to actively look. We think we're in the fortunate position where we don't have to do anything, but we'd like to. And we've got the financial capability to pull the trigger when the right thing comes along. But we'll continue to be disciplined, as always. I'd say that there continues to be a number of things that are interesting and the BD group is as active as always in terms of evaluating things.

Operator

Operator

Your next question comes from the line of Jonathan Eckard, Citi.

Jonathan Eckard - Citigroup Inc, Research Division

Analyst · Jonathan Eckard, Citi

If I ask you about the Concert agreement, it sounds like there's other analogues that are part of this kind of family. Does your agreement with them cover any of these other analogues? And also is there any expedited development test for an analogue that's already a controlled substance because it's the same kind of parent drug or is it basically considered a new chemical entity?

Bruce C. Cozadd

Analyst · Jonathan Eckard, Citi

The answer to the first part of your question is, yes, in terms of other analogues being included. The answer to the second part of the question, I'd have to say there are some advantages to working with a known compound with known properties in a particular disease and there's certainly some benefit to all the work that's been done in the past. But I think I have to stop short of saying there's a defined expedited clinical development or regulatory pathway because I would say that would be an overstatement.

Jonathan Eckard - Citigroup Inc, Research Division

Analyst · Jonathan Eckard, Citi

Okay, great. And then maybe a question for Kate. Remember, the previous discussion, you were kind of -- you're quite optimistic or eager to do more BD. And I know you just made some comments on it, but I think one of the things you said you wanted definitely do before 2013 was over, would this recent Concert agreement qualify for that or are you still eager?

Kathryn E. Falberg

Analyst · Jonathan Eckard, Citi

Well, let's ask my boss, if -- does this counts? No, all kidding aside. We did say, and have continued to say, we'd be disappointed if we didn't get another attractive specialty product into the portfolio this year. And so I'd say when we talk about that, we're really thinking things that are either already on the market or near the market. But I'd have to say this one is separate from that.

Operator

Operator

Your next question comes from the line of Gene Mack, Brean Capital.

Gene Mack - Brean Capital LLC, Research Division

Analyst · Gene Mack, Brean Capital

Question on Erwinaze and then on Prialt. First on Erwinaze. On the assay, is there any sense from you guys, at this point, based on what you know of how that might -- is there any possibility that it get worked into like a guideline for testing at some point after a certain number -- after a certain amount of data you've been able to compile with the assay? Would you be able to submit that? And then, the other question on Prialt's kind of similar. The outcome's -- or the outcome's database that you're planning, is there a hurdle rate there or a number of patients that you think you might be able to achieve, at some point, where you might be able to publish the data? Or what's the thinking in terms of an endpoint for both those types of things?

Bruce C. Cozadd

Analyst · Gene Mack, Brean Capital

Yes. So Gene, let's like Jeff take both the question on the asparaginase activity assay, as well as Prialt registry.

Jeffrey K. Tobias

Analyst · Gene Mack, Brean Capital

Right. So there's a great deal of interest in asparaginase activity assay as a way of measuring for silent hypersensitivity and we've had conversations with a number of people in this area, including the big cooperative groups, and they are looking into this as to whether -- and how actually to incorporate that into guidelines. So we expect more information on that, perhaps, even later this year. On the registry, the registry is designed so that we will have a constant flow, hopefully, of data that will be of interest for publication. So even as the registry is running, we will have interim analyses looking at a variety of what I think are some really interesting questions as the registry goes forward. So I would anticipate that.

Operator

Operator

Your next question comes from the line of Amy Fadia, UBS.

Ami Fadia - UBS Investment Bank, Research Division

Analyst · Amy Fadia, UBS

I've got a couple of questions. Firstly, on Erwinaze. Could you characterize where you expect the growth to come from, for the product, in 2013? And what I'm looking for is, is it just earlier detection of hypersensitivity or do you expect some usage in the adolescent population as well? And then just a connected question here on the assay. The assay that you talked about, was that launched specifically for ALL patients? And was specific to pediatric patients or a broader population? And then I've got 2 other questions.

Bruce C. Cozadd

Analyst · Amy Fadia, UBS

Okay, Amy, let me have Russ take the first part of the question on sources of Erwinaze growth in 2013.

Russell J. Cox

Analyst · Amy Fadia, UBS

We have to really look at 3 areas that we expect to see growth coming from Erwinaze in 2013. We're still making progress in existing pediatric protocols in terms of identifying hypersensitivity reactions and we've seen some good progress through the end of last year, and so we think that that's still an area for growth that we will continue to focus on in 2013. We also believe that the young adolescent, or AOA population, continues to represent some potential upside for the brand during 2013. And as you mentioned, we do believe that, with time, the opportunity for Xyrem hypersensitivity will be incorporated in the potential feature protocols and that, over time, that will outline value as well. So those are 3 areas that we're expecting 2013.

Bruce C. Cozadd

Analyst · Amy Fadia, UBS

And Jeff, maybe you could comment on the use of this assay and where's it directed?

Jeffrey K. Tobias

Analyst · Amy Fadia, UBS

Right. So the assay is really a generic asparaginase activity assay. So it measures the activity of Oncospar, of the Native E. coli, as well as Erwinaze. So it's really meant to be useful as kind of a therapeutic drug monitoring, as well as a way of looking at hypersensitivity and of interest of the recent publication that came out that showed when you do individualized therapy based on monitoring, you can see better outcomes. So this is really beginning to become, I think -- it's going to become standard of practice, if you ask me, going forward. But having the ability to have an assay like this allows people do those type of approach.

Ami Fadia - UBS Investment Bank, Research Division

Analyst · Amy Fadia, UBS

Okay, great. So the 2 other questions are really on the Xyrem franchise. One is the volume growth in the fourth quarter was close to 13% and that doesn't really change if I take out that one extra day. Why wouldn't that double-digit growth continue? Or do you expect to see a little bit of a slowdown because that's kind of what your guidance points to? And then just secondly, on the asset that was acquired today on the C-10323, do you have plans to develop it outside U.S. as well, because it even sounds like you got worldwide rights.

Bruce C. Cozadd

Analyst · Amy Fadia, UBS

So as it relates to Xyrem volume growth just a reminder that the third quarter was 8.7 and then fourth quarter was, in fact, 13. Having said all that, what I have shared with you is that, we've seen a change in terms of where the growth is coming from. It's not just compliance and persistency that's driving growth. We actually see new patient growth which we think does bode well for future volume. So hard to say whether we're going to see something different in terms of a current growth rate. We've seen high-single digit, low-double digits now for quite some time. The fourth quarter was obviously a very good quarter.

Unknown Executive

Analyst · Amy Fadia, UBS

And then on your question about the C-10323, that is a worldwide deal. As you know, Xyrem itself is not commercialized in all markets around the world but is certainly available in markets outside the U.S., including, through our partners, UCB in Europe and Valiant in Canada, so we do think there's an opportunity assuming development moves forward all the way through to the market to end up with a product that would be marketed broadly.

Operator

Operator

Your next question comes from the line of Michael Schmidt, Leerink Swann.

Michael W. Schmidt - Leerink Swann LLC, Research Division

Analyst · Michael Schmidt, Leerink Swann

I just have 2 quick ones. One on Prialt. I think in the past, you've been talking about potentially trying to modify the label of some ongoing work. Could you please update us on these activities? And then, secondly, on the Concert pharma product, what is the expected IP protection to look like on that product and given on the PK profile, are you envisioning this to be a product that could potentially eliminate the second deal [ph] that Xyrem currently has?

Bruce C. Cozadd

Analyst · Michael Schmidt, Leerink Swann

Let me have Jeff take the first part of the question on Prialt and label.

Jeffrey K. Tobias

Analyst · Michael Schmidt, Leerink Swann

Right. So currently, there aren't any specific activities going on to address the label although we're always looking at potentials to be able to use additional data both either to support changes in the data or to support the use of the product. So again, hopefully that answers your question.

Bruce C. Cozadd

Analyst · Michael Schmidt, Leerink Swann

And then on your question about the Concert technology and product candidate, certainly, this is novel work they're doing and we would absolutely expect significant IP protection around this program. Could it eliminate a second dose? I think, Jeff characterized this correctly when he talked about a different PK profile moving away from the current short half-life of sodium oxybate and some of the opportunities that might provide one of which worth exploring would be the potential for elimination of the middle of the night dosing for Xyrem. We don't know enough to say with confidence that, that's doable, but certainly, more possible with this approach than the existing indiscernible].

Operator

Operator

Your next question comes from the line of Bill Tanner, Lazard Capital Markets.

William Tanner - Lazard Capital Markets LLC, Research Division

Analyst · Bill Tanner, Lazard Capital Markets

And Bruce maybe these are for you or for Jeff, I'm just a little bit confused in terms of the development path forward to contemplated that bioequivalency testing would not be a viable path?

Bruce C. Cozadd

Analyst · Bill Tanner, Lazard Capital Markets

Yes, Bill, I would say, way too early for us to be talking in detail about clinical development and regulatory pathway forward. All we've said so far is we're going to do an IND later this year and start our efforts and -- to the extent we continue to move this forward, we'll obviously provide more color, but no answer to that question at present.

William Tanner - Lazard Capital Markets LLC, Research Division

Analyst · Bill Tanner, Lazard Capital Markets

Okay. And so I'm not that familiar with the compound. Jeff, would it characterized as like a prodrug or an analogue?

Jeffrey K. Tobias

Analyst · Bill Tanner, Lazard Capital Markets

No. It's actually -- maybe an analogue in that you're replacing some hydrogen atoms with deuterium atoms.

William Tanner - Lazard Capital Markets LLC, Research Division

Analyst · Bill Tanner, Lazard Capital Markets

Okay, Fair enough. And then just a question for Russ, just looking at my patient model, it looked like the patient adds in the fourth quarter, I guess, was a historic high. And if I think about the revenue run rate going forward and we do have a somewhat modest price increase baked in and beginning in the fourth quarter, it looks like you'd almost have to have a fairly significant deceleration of patient adds on a quarter-over-quarter basis in 2013 to hit that, and I know that you guys historically provided some very reasonable and beatable guidance at least at the outset, but how should we think about sort of the trajectory, going forward, if it -- I appreciate that it's hard to know with great clarity but assuming that the effort that you guys are making are not sort of at the end of their lifespan?

Bruce C. Cozadd

Analyst · Bill Tanner, Lazard Capital Markets

Bill, this is Bruce. I'll take that. Just to clarify and, if we didn't say it clearly before, let me say it clearly now. The guidance we provided for Xyrem revenues for this year is at its current price, which does reflect the February 1st price increase. On the other part of your question, I'm glad you're following us closely. I don't have your model up in front of me but, I think, your general comment about new patient starts is a good comment to make and you probably heard us in this call and maybe in the call before this one, emphasize more as the source of growth, new patient starts as opposed to -- in prior calls when I think we're much more focused on improvement and persistent and compliant. So does that mean we know exactly what's going to happen each quarter for the next 4, 8, 12 or 16 quarters? No. But we certainly think that the source of growth coming from the patient starts has the potential to be a more sustainable source of growth over the longer term.

William Tanner - Lazard Capital Markets LLC, Research Division

Analyst · Bill Tanner, Lazard Capital Markets

Fair enough. And then I had a -- I guess, one last question for Kate. Just as it does relate to the guidance thinking about the product specific guidance. I'm thinking about the product-specific guidance. So I guess practically speaking what's most important is Xyrem and Erwinaze. As we think about over the balance of the year and it may be a hard questions to answer is that, is the Erwinaze number, it's kind of tied, is that unlikely to be that conservative, you think, over the balance of the year? And if there's a delta, it's going to more from Xyrem potentially either from changes in price or changes in volume growth? Or do you guys feel pretty comfortable with that number, I mean, assuming that you're going to give a number that you think is definitely beatable, but I'm just trying to understand -- would you potentially see much upside to that? Apologize for [indiscernible] the question.

Kathryn E. Falberg

Analyst · Bill Tanner, Lazard Capital Markets

I'd characterize our guidance as reasonable and also recognize that it's early in the year so we're optimistic for strong growth for both Xyrem and Erwinaze, as we said, and I don't think I'd want to get into characterizing which one of them is -- which guidance was more conservative than the other. I think we tried to give reasonable guidance for overall revenues and for both of our lead products.

William Tanner - Lazard Capital Markets LLC, Research Division

Analyst · Bill Tanner, Lazard Capital Markets

And if I missed it, just on the Concert deal, was there an upfront payment that was made and is that in the R&D guidance?

Kathryn E. Falberg

Analyst · Bill Tanner, Lazard Capital Markets

So there will be a moderate-sized upfront payment. The amount was not disclosed, and our guidance does reflect the Concert deal.

Operator

Operator

Your next question comes from the line of David Morris, BMO.

Unknown Analyst

Analyst · David Morris, BMO

You and others have mentioned that you're in a good position for not needing a deal for the top line or the bottom line, but you'd still would like to do more deals, so can you talk a little bit about the "why" of that. So obviously, the ultimate "why" is to make more money, but if you could talk a little bit about the priorities for deals, is it to diversify the revenue or to keep sales force busy with -- in certain therapeutic categories, so what's your sweet spot for deals that you're looking at? And please don't say CNS, by the way.

Bruce C. Cozadd

Analyst · David Morris, BMO

Okay. I would say, David, that the primary driver for interest in additional business development here is that we think we have the opportunity to build on the success of the company right now in our area of expertise, which we think is commercializing the specialty products that require a more consultative stele, more medical education, reimbursement expertise. We think we can do that well and we're in the fortunate position of having both the infrastructure that we think we can absorb that, as well as the financial wherewithal to, in fact, go out and acquire assets like that. I -- and as we look at each new potential asset, we are really doing a return on investment analysis. We're looking at whether investing in that opportunity is attractive financially as well as strategically. That is different from saying, let's diversify our top line by going and buying different revenue streams. I certainly will point out that the 2 significant acquisition transactions that we did in 2012 did have the effects of diversifying our revenue stream, but I think about this more as us being on offense than defense. We're trying to go out and invest our capital in ways that make sense strategically and financially to create returns for our shareholders rather than saying, let's just change the profile of our revenue line by adding additional products.

Operator

Operator

You have no further questions at this time. I would now like to turn the call over to Ami Knoefler for closing remarks.

Ami Knoefler

Analyst

Thank you, Julie. In closing, a reminder that Jazz will be attending and presenting at 2 upcoming financial conferences in March, the Cowen & Company 33rd Annual Health Care Conference in Boston and the Barclays Global Health Care Conference in Miami. We hope to see many of you at one of these conferences. Thanks, again, for joining us today.

Operator

Operator

Thank you for joining in today's conference. This concludes the presentation. You may now disconnect. Good day.