Earnings Labs

Jazz Pharmaceuticals plc (JAZZ)

Q1 2010 Earnings Call· Wed, May 5, 2010

$202.00

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Transcript

Operator

Operator

Good day ladies and gentlemen, and welcome to the first quarter 2010 Jazz Pharmaceuticals, Inc. earnings conference call. My name is Dominic, and I will be your Operator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. (Operator instructions) As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to, Ms. Kate Falberg, Senior Vice President and Chief Financial Officer. Please proceed, ma’am.

Kate Falberg

Management

Thank you, Dominic, and good afternoon everyone. Welcome to our first quarter 2010 conference call. I am pleased to kick off today’s call and introduce the participants. With me today are Bruce Cozadd, Chairman and CEO, and Bob Myers, President. After I provide the details of our results, Bob will share updates on our commercial activities in the first quarter and discuss our expectations for the rest of the year. Bruce will then wrap up with comments regarding the state of our business overall and will review our financial guidance for 2010. Following our prepared comments, we will open up the call for questions. As a reminder, remarks that we may make today on this call about future expectations, plans and prospects for Jazz Pharmaceuticals constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to Jazz Pharmaceuticals' financial performance and growth potential, including 2010 financial guidance; the potential impact of Xyrem price increases and the sufficiency of Jazz Pharmaceuticals cash resources; statements related to Jazz Pharmaceuticals' JZP-6 product candidate, including future clinical and regulatory matters and the potential approval and commercialization of JZP-6; and statements related to the future product development and growth, including statements related to establishing a new supplier for sodium oxybate and future developments of new dosage forms of sodium oxybate. Any statements we may make today on this call that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Jazz Pharmaceuticals' actual results to differ significantly from those projected, including, without limitation, those risks and uncertainties detailed in Jazz Pharmaceuticals' filings with the Securities and Exchange Commission, including under the heading "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and…

Bob Myers

President

Thank you, Kate. Good afternoon everyone, and thank you for joining our call today. Today, I'm happy to report that our sales and marketing team delivered another quarter of strong performance in the first quarter of 2010. In the quarter, our team achieved combined net sales of Xyrem and Luvox CR of $34.3 million. Xyrem net sales in the first quarter were $28.7 million, which represent an increase of 62% compared to net sales of $17.7 million in the first quarter of 2009. In the first quarter of 2010, our Xyrem revenue bottles shipped to patients increased by 5% compared to the first quarter of 2009. Our Xyrem revenue bottles shipped in the first quarter of 2010 decreased compared to the fourth quarter of 2009. This trend is consistent with our experience in the first quarter of 2009 when we also saw a quarter-to-quarter sequential decline in Xyrem volume shipments. In 2009, we delivered growth in Xyrem revenue bottles of 10% compared to 2008. In 2010, we expect to see continued Xyrem volume growth at a single-digit rate compared to 2009. Effective May 1, we've taken a price increase for Xyrem of approximately 15%. As we come through the impact of a price increase on patients, it's important to remember that the vast majority of our Xyrem patients have fixed monthly co-pays. These patients should not see any impact to their monthly co-pay from price increase. Approximately 80% of our Xyrem patients have monthly out-of-pocket costs of $50 or less. In recognition that the price increase may impact out-of-pocket costs to a small number of Xyrem patients who have co-insurance or who are cash-pay patients, we are clearly updating and enhancing our Xyrem coupon program to increase the financial support provided to Xyrem patients through this program. With our improved…

Bruce Cozadd

Chairman

Thanks, Bob, and good afternoon everyone. The first quarter has provided Jazz Pharmaceuticals with a solid base from which to deliver a great year of progress, again extraordinary commitment and dedication of our employees to deliver solid performance in our commercial business, continued progress in our clinical and regulatory activities, advancement toward a successful commercial launch of JZP-6 in 2011, and quick action on engaging a new supplier for sodium oxybate, as Bob discussed. Turning to the development side of our business, we continue to be very excited about the opportunity represented by JZB-6 and the potential benefit to fibromyalgia patients, if it's approved by the FDA. As we previously reported, the FDA has fired our NDA for JZP-6 with a PDUFA date of October 11, 2010 to complete its review based on standard 10 months review under the Prescription Drug User Fee Act. FDA has told us to expect an advisory committee meeting for JZP-6, and as we said before, we believe this will happen in August or September of this year; though no date has been published by FDA. Data from our two Phase III pivotal trials of JZP-6 in fibromyalgia are being presented by investigators at the relevant scientific conferences this year, including recently at the American Association of Neurology and at the upcoming Associated Professional Sleep Societies or APSS, and European League Against Rheumatism or EULAR meetings in June. Our development team is also making significant progress on our programs to develop oral tablet forms of sodium oxybate and we are currently enrolling patients for a clinical study. We believe that, if successful, this would be an important advance for patient convenience and compliance. As you may recall, we initially issued 2010 financial guidance in January, and increased it during our last earnings call in March.…

Operator

Operator

(Operator instructions) Your first question comes from the line of Corey Davis of Jefferies. Please proceed. Oren Lizark – Jefferies & Company: Hi, guys. This is actually Oren Lizark [ph] for Corey. Few questions. I am just curious if you had any thoughts on an explanation for this apparent seasonality in Q1 on volume declines in bottles of Xyrem shipped? And assuming that’s holidays, we get a nice big pop going forward, is it just the 15 or some partial utilization of the price increase just taken that accounts for your rated guidance for the year? I know there is a lot of moving parts, but can you give us a sense of how much of that 15% you think is realistically capturable? Thanks. That’s it for now.

Bob Myers

President

Hi, Oren, and this is Bob Myers. Let me try to answer your question here. The seasonality that we saw – we have seen in prior years, as we mentioned in 2009, the first quarter was down compared to the fourth quarter of 2008. The nice thing for us is that Xyrem sales continued to grow nicely, and not surprisingly managed care is starting to pay attention to us. And we did see more managed care firms putting prior authorizations starting with the plan year of 2010. Those prior authorizations are not preventing patients from getting the therapy, either new patients or refill patients. It did mean that we did see some delays in patients getting approval for therapy. And that did – we have seen it historically, we did see that again this year. So it’s – again, it’s not something that was unexpected and we have seen this seasonality trend in the past driven primarily by the increased amounts of prior authorizations. Again, not alluding to patients not getting a therapy but having a week or two delay in getting their prescription. Oren Lizark – Jefferies & Company: And I guess the other question if I am still on here is just with regards to the raised guidance. Is that just a function of the price increase rather than some other evidence of higher volume demand?

Bob Myers

President

What the price increase, I think, was your question, and how much of that – what’s going to be a net. The majority of that is going to flow into a net impact on our sales. It does – there is an increase in our gross to net as you might imagine, especially with this enhancement to our patient coupon program, the Xyrem coupon program that we are putting in place, which I think is an important program for patients. But the majority of that will be flowing through to our net sales line. Oren Lizark – Jefferies & Company: Thanks.

Bob Myers

President

Thank you.

Operator

Operator

(Operator instructions) Your next question comes from the line of Andrew Finkelstein with Leerink Swann. Please proceed. Andrew Finkelstein – Leerink Swann: Good evening, it Andrew on for Gary. Just a couple of quick questions, if you could talk on the Xyrem tablets, about how you think about potential abuse issues, and maybe some historical perspective from the original development of Xyrem, how the FDA looked into concerns? And then on Luvox if you could update us on the status with the patent litigation.

Bruce Cozadd

Chairman

So Andrew, on the Xyrem tablets in terms of abuse issues, I think it’s important to rev our starting point, which is moving from a liquid. We don’t see that there would be any increased abuse potential from the oral tablets. As you know from our prior discussions, our rationale for developing this very much goes to – of being a dosage form that we believe patients would actually find more convenient. We are doing this specifically in response to an abuse issue but rather something that we think would be better for patients. Janne Wissel is also here, who is our Chief Regulatory Officer. Janne, I don’t know if you want to comment on what happened with the original approval of the original [ph] form of Xyrem, which I’ll remind all of you, happened before we had registered the product.

Janne Wissel

Analyst · Andrew Finkelstein with Leerink Swann

Yes, when the FDA looked at the abuse potential for Xyrem itself they found that the abuse potential was fairly low. And that’s why it is a Schedule III controlled substance as opposed to Schedule II where the opioids lie. So that’s a non-narcotic product. And the abuse potential in our demonstrated REM program as well as our published post-marketing data is very, very low.

Bob Myers

President

And Andrew, the second question with regard to the Luvox CR ANDA litigation, this is Bob again. We are very early with our partner Elan in terms of that ANDA litigation, as you know we had a 30-month stay and we are still in the process of that. So there is really no update there on the ANDA litigation. Andrew Finkelstein – Leerink Swann: Okay, thank you very much.

Operator

Operator

Your next question comes from the line of Ann Trimble with Barclays Capital. Please proceed. Ann Trimble – Barclays Capital: Hi, it’s Ann on for Rich Silver. Could you review your expectations for the FDA advisory panel on JZP-6, including potential concerns of the FDA? How you think the FDA really evaluate the risk benefit profile of JZP-6, in light of the fact that it will more widely used in viron [ph]. Thanks.

Bruce Cozadd

Chairman

Ann, so why don’t we have Janne address that question as well.

Janne Wissel

Analyst · Ann Trimble with Barclays Capital

Well, because of the JZP-6 has a REM that was submitted with our application that it includes elements to assure safe use. On this regard, we know that we will have an advisory committee. We don’t know what specific questions there will be at that advisory committee, but we do know that the risk management program will be discussed because it’s required under the new law; so that where we stand on the risk benefit. I think that what the FDA is doing now is evaluating the risk benefit of the total application, and we’ve submitted to them a very robust package, which will allow them to make that assessment. And we hope that they are tracking on a timely manner to give us an action in October. Ann Trimble – Barclays Capital: Great. And then any update on the R&D portfolio review?

Bruce Cozadd

Chairman

No, Ann. We have said that we are looking at our other R&D programs, JZP-7, JZP-8 and JZP-4 that as we went through this year we would evaluate those programs, again, both in terms of their attractiveness as investment opportunities and in light of our ability to invest funds in additional development programs. And that we would be back to you this year. We are not there as yet, but we will be soon. Ann Trimble – Barclays Capital: Great. Thanks, very much.

Operator

Operator

We have a follow-up question from the line of Corey Davis of Jefferies. Please proceed. Oren Lizark – Jefferies & Company: Thanks, it’s Oren again. Just with regard to the supplier change, I know we had discussed in the past how the transition could take a couple of different forms as we gets close to it. I am just wondering, and you said your gross margins wouldn’t be affected which is great. I am just curious, do you think you will potential have to build up significant inventory ahead of such a transition which may impact your cash flow significantly.

Bruce Cozadd

Chairman

Yes, Oren, this is Bruce. I would say that certainly building up some inventory gives us the most flexibility, and would be preferred given the relatively low cost of goods relative to net sales for Xyrem. I don’t think an inventory buildup is actually a substantial use of cash for us. So I don’t think that that’s a major variable in our cash used this year. Oren Lizark – Jefferies & Company: That’s a good point. I guess, that’s a benefit of a high growth margin. Also just curious, I know you don’t want to tell us much about your oral tablet development for competitive reasons. But are you able to give us any idea about the design of the study – maybe how much R&D is being allocated on your guidance to that development program.

Bruce Cozadd

Chairman

So you correctly guessed we don’t really want to say too much about it. We are flagging it as a meaningful piece of our R&D budget this year. So this is something we are investing real dollars in. We were actually pleased today to be able to narrow our R&D expense guidance range for you a little bit to give you a better sense for that. But it is one of the major components of that and we are not saying a lot about the exact work we are doing, but our goal is to push forward a couple different variations of oral tablet forms of sodium oxybate and to get those to market as soon as we can. Oren Lizark – Jefferies & Company: Thank you. Allow me one more. I would actually just love to double check. I think you’ve spoken in the past a lot about it, I could be mistaken. Is the REM that was submitted for JZP-6 different in any material way from the existing REMs program for Xyrem?

Janne Wissel

Analyst · Corey Davis of Jefferies

s : Oren Lizark – Jefferies & Company: :

Operator

Operator

If there are no future questions, I will turn the call back over to Ms. Falberg.

Kate Falberg

Management

: