Jazz Pharmaceuticals PLC (JAZZ) 2010 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the First Quarter 2010 Jazz Pharmaceuticals Incorporated Earnings Conference Call. My name is Dominique 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.

Thank you, Dominique, 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 future product development and growth including statements related to establishing a new supplier for sodium oxybate and future development 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 Exchange Commission filings and reports, including in its annual report on Form 10-K for the fiscal year ended December 31, 2009 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on March 4, 2010.

Our first qua4ter 2010 financial results were reported in a press release issued earlier today. We plan to file our Form 10-Q for the three months ended March 31, 2010 with the SEC tomorrow. These documents will also be available on our corporate website.

Now, moving on to the results. Total product sales were $34.3 million in the first quarter, an increase of 61% over the first quarter of 2009, driven primarily by price increases taken on XYREM during 2009 and, to a lesser extent, increased XYREM and LUVOX CR sales volumes. Gross margin on product sales was 91.6%, compared to 90.9% in the first quarter of 2009. Total revenues were $35.2 million for the first quarter of 2010, compared to $22.1 million in the first quarter of 2009, representing an increase of 59%.

I would like to comment briefly on the impact of the recent healthcare reform legislation on our business. We estimate that approximately 12% to 15% of our combined sales are reimbursed under the Medicare and Medicaid programs and that the cost to us of the new required rebates will be approximately $1 million in 2010, which will be reflected as a reduction to our net sales. We have factored this impact into our sales guidance for 2010, and we are in the process of more fully analyzing the new legislation for any additional impacts on our business.

Total operating expenses were $27.9 million for the first quarter 2010, a decrease of 5% compared to the first quarter a year ago. R&D expenses of $6.2 million in the first quarter of 2010 were down 46% compared to the first quarter of 2009, due to the reduced level of clinical trial activities for our JZP-6.

R&D spending in the first quarter of 2010 was primarily focused on the prosecution of our new drug application for our JZP-6 product candidate, our ongoing long-term safety study for JZP-6, which we expect to complete mid-year 2010, and development work on oral tablet forms of sodium oxybate, the active pharmaceutical ingredient in both XYREM and JZP-6.

SG&A expenses were $16.8 million for the first quarter of 2010, an increase of 18% compared to the same period of 2009, as we are beginning to invest in preparations for a potential launch of JZP-6 in Fibromyalgia, if approved by the FDA. The increase in SG&A also reflects increases in compensation costs for employees including non-cash stock-based compensation.

Due to our substantial net operating loss carry-forwards, we had no provision for income taxes in the first quarter and do not expect any tax provision for 2010. Net income for the first quarter of 2010 was $1.5 million, or $0.04 per diluted share, which compares favorably to a loss of $13 million, or $0.45 per diluted share, in the first quarter of 2009.

Non-GAAP adjusted net income was $6.1 million, or $0.18 per diluted share, compared to a GAAP net loss of $9.9 million, or $0.34 per diluted share, in the first quarter of 2009. As a reminder, the non-GAAP adjusted figures back out amortization of intangibles, which is primarily related to the original acquisitions of XYREM and LUVOX CR, non-cash interest expense, which is related to debt issuance costs and the warrants issued in connection with our senior secured debt, stock-based compensation, and contract revenues, which are due to the amortization of milestones received from UCB in prior periods.

We encourage you to review the table reconciling our GAAP net income or loss and earnings per share to the related non-GAAP adjusted figures provided in our press release issued earlier today, which is available on our website at www.jazzpharmaceuticals.com under the Investors tab.

As of March 31, we had $19 million in unrestricted cash, which was up $3.4 million since the beginning of the year. In March, we made our first amortization payment of $3 million on our senior secured notes, and we paid $3 million to the US government for the USAO settlement liability.

Looking forward, we believe our existing cash balances, cash generated from operations, and funds available under our revolving bank line of credit will be sufficient to fund our operations and meet all of our obligations through March 31, 2011.

I'll now turn the call over to Bob Myers, our President, to provide you with updates on our commercial products XYREM and LUVOX CR.

Thank you, Kate. Good afternoon, everyone, and thank you for joining our call today. Today, I am 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 this price increase. Approximately 80% of our XYREM patients have monthly out-of-pocket costs of $50.00 or less.

In recognition that the price increase may impact out-of-pocket costs for the small number of XYREM patients who have co-insurance or who are cash-pay patients, we are currently updating and enhancing our XYREM coupon program to increase the financial support provided to the XYREM patients through this program. With our improved XYREM coupon program, approximately 97% of the XYREM patients will have a monthly out-of-pocket cost of $100 or less.

In addition, we are improving our patient assistance program to allow more patients to qualify under this program. As a reminder, under this program we ship XYREM bottles at no cost to patients, and this important program already provides approximately 8% of patients with XYREM therapy at no cost to patients.

I'm also pleased to report that our dedicated nursing program continues to have a positive impact on patients. As a reminder, our nursing program provides new patients on XYREM with nursing contact along with education and support during their initial weeks and months of XYREM therapy.

Our experience has shown that patients participating in this program are more likely to continue on XYREM therapy and receive the benefits of treating this debilitating condition. We are proud to provide this important service to patients at no cost.

These programs -- our XYREM coupon program, our patient assistance program, and our nursing program, represent just a portion of our Company's strong and continuing commitment to patient care. XYREM continues to be the only product approved by the FDA to treat both of the major symptoms suffered by patients with narcolepsy, excessive daytime sleepiness and cataplexy. XYREM is recommended as standard of care for the treatment of narcolepsy by the American Academy of Sleep Medicine.

Shifting now to LUVOX CR. In the first quarter of 2010, net sales of LUVOX CR were $5.5 million, representing 54% growth over the same period in 2009. We expect to continue to grow the number of LUVOX CR prescriptions by focusing our messaging on physicians who currently prescribe LUVOX CR.

Our objective is to move LUVOX CR up in the treatment paradigm so that LUVOX CR is the first drug prescribed for appropriate newly diagnosed patients, and the first drug chosen for appropriate patients when a physician believes that a change of medication is needed.

Now, as previously disclosed, our current supplier for sodium oxybate, the active pharmaceutical ingredient for XYREM and JZP-6, has announced their intention to close their manufacturing plant later this year and have notified us that they'll not be renewing our supply contract that expires at the end of 2011.

Accordingly, we've contracted with a new supplier, Siegfried USA, an established manufacturer of pharmaceutical compounds in the United States, to supply our sodium oxybate requirements in the future. We and our suppliers are working closely to obtain the necessary quota and approvals from the DEA and FDA to transfer supply operations from Lonza to Siegfried on an exbidited basis.

Under our agreement with Siegfried, we are allows to obtain a second supplier for sodium oxybate, and we're currently evaluating potential second suppliers. We do not expect any significant impact on our gross margins from this change in suppliers and we continue to expect gross margins in 2010 to exceed 90%.

Given our solid sales performance in the first quarter and as we now have more visibility on key drivers for the full year, I'm pleased to provide an update on our sales guidance for 2010. Today, we are increasing our guidance for 2010 net sales of XYREM from $124 million to $130 million to a revised range of $128 million to $132 million, which represents a year-over-year sales growth of 32% to 36%.

At this point, we remain comfortable with our previously issued guidance of 2010 LUVOX CR net sales to be within a range of $24 million to $28 million. As a result, we are increasing our guidance for total product sales in 2010 from a range of $148 million to $158 million to a range of $152 million to $160 million, resulting in year-over-year sales growth of 32% to 41%.

Finally, turning to JZP-6, our next potential major product launch. Our commercial team is working to ensure that we are prepared for a successful launch of JZP-6 for the treatment of Fibromyalgia, if approved by the FDA.

From market research that we have sponsored, we've heard consistently that physicians and patients still have significant unmet medical needs in their treatment of Fibromyalgia. Specifically, our market research has shown that close to half of treated patients with Fibromyalgia are not getting significant relief from symptoms of pain, fatigue, poor sleep quality, and a lack of functionality.

In addition to understanding patient needs, we're also assessing the perfect sales force size that we'll need to effectively reach physicians that are treating these patients with Fibromyalgia. As the year progresses, we'll be providing further updates on our pre-launch planning for JZP-6, a product that we believe, upon FDA approval, will be an important new therapy for Fibromyalgia patients and an important product for our Company's future growth.

I'll now turn the call over to Bruce Cozadd, our Chairman and CEO.

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. We've seen 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 JZP-6 and the potential benefit to Fibromyalgia patients if it's approved by the FDA. As we previously reported, the FDA has filed our NDA for JZP-6 with a PDUFA date of October 11, 2010 to complete its review based on a standard ten-month review under the Prescription Drug User Fee Act.

The FDA has told us to expect an advisory committee meeting for JZP-6. And as we've 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 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 ULAR, 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. Today, we are again increasing sales guidance, but also tightening the range of expense guidance to reflect the investments we plan to make this year in R&D and pre-launch planning for JZP-6.

As a result, we remain comfortable with our previously issued adjusted EPS guidance. As Bob discussed, our guidance for total sales in 2010 was revised to a range of $152 million to $160 million for year-over-year sales growth of 32% to 41%.

Our R&D efforts will be primarily focused on prosecuting the NDA for JZP-6 with the FDA, preparing for an advisory committee meeting, and developing new oral tablet forms of sodium oxybate. We are narrowing the range of R&D expenses for this year from $25 million to $35 million to $28 million to $35 million. We are also narrowing the range of SG&A expenses from a range of $65 million to $75 million to a range of $68 million to $75 million as we prepare for a potential launch of JZP-6 for Fibromyalgia in early 2011.

Our guidance for 2010 non-GAAP adjusted EPS continues to be a range of $0.80 to $0.95 per share and GAAP EPS is in the range of $0.26 to $0.41. As we mentioned previously, a reconciliation of our GAAP EPS to non-GAAP adjusted EPS guidance is provided in our press release issued earlier today.

I'd also like to point out our second press release of this afternoon. We're very pleased to welcome Rick Winningham to our Board of Directors. Rick has served as CEO of Theravance since 2001, and prior to that spent 15 years at BMS in various US and global management positions including President of Global Marketing.

This concludes our management team update. Thanks for your attention. And I'll now turn the call over to the operator to begin the Q&A portion of our call.

(Operator Instructions)

Your first question comes from the line of Corey Davis of Jefferies. Please proceed.

Hi, guys. This is actually Oren Livnat for Corey. A few questions. I was just curious if you had any thoughts on an explanation for this apparent seasonality in Q1 volume declines in bottles of XYREM shipped?

And assuming that's all it is and you get a nice big pop going forward, is it just the 15 -- or some partial realization of the price increase just taken that accounts for your raised guidance for the year? And I know there's 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.

Thanks, Oren. This is Bob Myers. Let me try to answer your question here. The seasonality that we saw, we have seen in prior years. As I mentioned, in 2009, the first quarter was down compared to the fourth quarter of 2008.

The nice thing for us is that XYREM's sales continue to grow nicely. And not surprisingly, managed care is starting to pay attention to us, and we did see more managed care firms put in prior authorizations starting with the plan year of 2010. Those prior authorizations are not preventing patients from getting 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 that historically; we did see that again this year.

So again, it's not something that was unexpected and we have seen the seasonality trend in the past, driven primarily by the increased amounts of prior authorizations. Again, not leading to patients not getting therapy, but having a week or two delay in getting their prescription.

I guess the other question, if I'm 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?

With the price increase -- I think was your question, and how much of that was going to be a net? The majority of that is going to flow into a net impact on our sales. 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 important program for patients. But, the majority of that will be flowing through to our net sales line.

Thanks.

Thank you.

(Operator Instructions)

Your next question comes from the line of Andrew Finkelstein with Leerink Swann. Please proceed.

Good evening. It's 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 at those potential concerns. And then on LUVOX, if you could update us on the status with the patent litigation.

Andrew, on the XYREM tablets, in terms of abuse issues, I think it's important to remember 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 being a dosage form that we believe patients would actually find more convenient. We're not 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 existing form of XYREM, which I'll remind all of you happened before we had rights to the product.

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's a Schedule III controlled substance, as opposed to a Schedule II where the opioids lie. So it's a non-narcotic product, and the abuse potential in our demonstrated REMS program as well as our published post-marketing data is very, very low.

And, Andrew, the second question with regard to the LUVOX CR ANDA litigation -- this is Bob again. We're very early with our partner, Elan, in terms of that ANDA litigation. As you know, we're in a 30-month stay and we're still in the process of that. So, there's really no update there on the ANDA litigation.

Okay. Thank you, very much.

Your next question comes from the line of Ann Trimble with Barclays Capital. Please proceed.

Hi, it's Ann in for Rick 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 will evaluate the risk/benefit profile of JZP-6 in light of the fact that it will be more widely used than XYREM? Thanks.

Ann, so why don't we have Janne address that question as well?

Well, because the JZP-6 has a REMS that was submitted with our application, that it includes elements to assure safe use (inaudible) 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's 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 have submitted to them a very robust package which will allow them to make that assessment. And we hope that they're tracking in a timely manner to give us an action in October.

Great. And then, any update on the R&D portfolio review?

No. So, Ann, we have said that when looking at our other R&D programs -- JZP-7, JZP-8, and JZP-4 that as we went through this year we'd 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're not there yet, but we will be soon.

Great. Thanks, very much.

We have a follow-up question from the line of Corey Davis of Jefferies. Please proceed.

Thanks. It's Oren, again. Just with regard to the supplier change -- I know we've discussed in the past how the transition could take a couple of different forms as we get closer to it. I'm just wondering, you said your gross margins wouldn't be affected, which is great. I'm just curious, do you think you will potentially have to build out significant inventory ahead of such a transition which may impact your cash flow significantly?

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 build-up is actually a substantial use of cash for us, so I don't think that that's a major variable in our cash use this year.

That's a good point. I guess that's the benefit of a high gross 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 of your guidance to that development program?

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 it 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're not saying a lot about the exact work we're doing, but our goal is to push forward a couple of different variations of oral tablet forms of sodium oxybate and to get those to market as soon as we can.

Thanks. If you'll allow me one more, I'd actually just love to double check. I think you've spoken in the past about it, but I could be mistaken. Is the REMS that was submitted for JZP-6 different in any material way from the existing REMS program for XYREM?

No, the REMS programs are very similar.

All right, thank you.

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

Thank you, Dominique, and thank you, everyone, for joining us today. We look forward to keeping you up-to-date on our progress in 2010 and to seeing you at the upcoming Jefferies Global Life Sciences Conference in New York on June 9. Good afternoon, everyone.

Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Have a wonderful day.