Earnings Labs

Jazz Pharmaceuticals plc (JAZZ)

Q2 2008 Earnings Call· Fri, Aug 8, 2008

$201.26

-1.33%

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the second quarter 2008 Jazz Pharmaceuticals, Inc. earnings conference call. My name is Amanda and I will be your coordinator for today. At this time, all participants are in listen-only mode and we will be facilitating a question-and-answer session towards the end of this conference. (Operator Instructions) As a reminder, this conference is being recorded for replay purposes. I would now like to turn the presentation over to your host for today's call, Mr. Matthew Fust, Chief Financial Officer. Please proceed, sir.

Matthew Fust

Management

Thanks and welcome to our second quarter financial results conference call. With me here today are Dr. Sam Saks, our CEO, and Bob Meyers, our President. Following some prepared remarks, we will open the call up to Q&A. Our second quarter financial results press release was issued earlier this afternoon and is also available at our website. And I'll remind you that remarks we may make on this call about future expectations, plans or the prospects for Jazz Pharmaceuticals constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and our actual results may differ. I'll ask Bob to begin today's call with an update on our commercial activities.

Bob Meyers

Management

Good afternoon, everyone, and thank you for joining us today. The first half of this year has been transforming for our Company. We've successfully launched Luvox CR. At the same time, we are continuing the strong growth trajectory for Xyrem. I'll begin today with update on our progress for the launch of Luvox CR. Our sales representatives and our marketing activities are focused on highlighting the key features of Luvox CR. Most importantly, its proven efficacy in treating both obsessive compulsive disorder, or OCD, and social anxiety disorder, or SAD, two chronic and debilitating anxiety disorders, as well as Luvox CR's once daily dosing and its favorable tolerability profile, the weight neutral profile and a low incidence of sexual adverse events in our clinical trials. Luvox CR'S tolerability profile is particularly important in light of recently published updates to the practice guidelines for OCD, which recommend increasing doses to levels that might not be tolerated with other therapies. As we review IMS prescription data, it is important to remember that it's still early in the Luvox CR launch. Overall, looking at the [dilutive] quantity of weekly IMS prescription data currently available, we're currently tracking somewhat lower than our expectations. According to NPA weekly data from IMS, from the time that our sales force started promotion in mid April through the week ended July 25th, which is the most recent weekly data that is available, approximately 8,600 prescriptions have been written for Luvox CR. In July, the number of Luvox CR prescriptions reported by IMS grew significantly by approximately 50% compared to June. Not surprisingly, the majority of these prescriptions are new prescriptions for Luvox CR. In recent weeks, we're starting to see an increasing level of refill prescriptions. As we evaluate the success factors of the launch of Luvox CR,…

Dr. Sam Saks

Management

Thanks, Bob. I'll begin the development updates today with an update on our JZP-6 clinical development program for fibromyalgia. As you'll recall, we are running two pivotal Phase III clinical programs together with an open label safety and efficacy continuation study for those patients who have completed one of the Phase III trials. On June 2nd, we announced the completion of enrollment for the first Phase III trial with a total of 550 patients in 65 clinical sites in the U.S. We expect the last patient to complete the end-of-life portion of the trial in September and we will then move as quickly as possible to complete and lock the study database and begin analyses of the results. We anticipate providing top line results from this second Phase III trial during the fourth quarter of 2008. Our second JZP-6 Phase III trial, which is being conducted at clinical sites in the U.S. and Europe, is more than 50% enrolled and we're on track to submit an NDA by the end of 2009 subject to the positive results from both of these studies. The primary endpoint for both of these studies is the change from baseline and pain based on the Pain Visual Analog Scale, which the FDA and the European Medicines Agency have indicated is the appropriate primary endpoint in this disorder and which was an endpoint in our Phase II trial. In our Phase II trial, the reduction in pain was statistically significant when compared to placebo. Presentation and publication of data regarding the use of sodium oxybate for the treatment of fibromyalgia are continuing as we move through the year. In June, two abstracts were presented at EULAR, which is the European League Against Rheumatism, meeting in Paris. One abstract focused on disordered sleep and described the abnormal…

Matthew Fust

Management

All right. Thank you, Sam. So, we're pleased to report another quarter of strong sales growth. Our total revenues for the quarter ended June 30th, 2008 were $15.5 million, led by growth in Xyrem sales to $12.4 million for the quarter. Because this is the first quarter in which we are recognizing sales revenue from Luvox CR, I'll remind you that we're currently applying a sell-through revenue recognition method for Luvox CR, which means that we recognize sales revenue based upon prescription data. Our GAAP net sales during the second quarter, measured using this sell-through approach, were approximately $0.7 million. During the second quarter, we shipped approximately $0.2 million of Luvox CR to wholesalers, which brought our total wholesaler shipments for the first half of 2008 to approximately $3.2 million. For the second quarter of 2008, our reported gross margin on net sales was approximately 81%. Excluding Luvox CR, gross margin on net sales of Xyrem and Antizol would have been approximately 88% for the second quarter. Cost of product sales in the second quarter includes approximately $0.1 million which relates to the net sales of Luvox CR, which we recognized during the quarter, along with approximately $1 million in manufacturing period costs, also related to Luvox CR, for which there is no corresponding net sales revenue. And that results in a lower reported gross margin. Research and development expenses for the second quarter of 2008 were $21.9 million compared to $17.4 million for the second quarter of last year. The higher research and development expenses during the second quarter of 2008 primarily reflect the expanded Phase III clinical activities for JZP-6. As we mentioned during our investor day presentation in March, we intend to limit our net R&D expenses during 2008 to the range of $60 million to $70…

Operator

Operator

(Operator Instructions) Your first question comes from the line of Rich Silver with Lehman Brothers. Please proceed, sir.

Rich Silver - Lehman Brothers

Analyst

Good afternoon. At what point will you provide updated guidance on Luvox CR? I mean, I think obviously, we know it's early. We appreciate all the detail that you provided in terms of the managed care receptivity, the physician receptivity. But again, just trying to get a sense of when you might be in a position to provide that kind of revised guidance.

Matthew Fust

Management

Hi, Rich. It's Matt. Thanks for the question. We're not able today to provide you with a specific date or timeline for that guidance. On our end, we're obviously watching the weekly prescription trends along with the other data of the sort that Bob outlined for you. But our sense is that we had expected that we would see an inflection point, kind of growth in sales in prescriptions, and we want to monitor sales progress over the course of the next several weeks at minimum before we're in a position to provide more detail or specificity on guidance for the full year.

Rich Silver - Lehman Brothers

Analyst

I mean, everything on the anecdotal front makes it sound like you're pleased with the launch, yet by sort of hesitating with this issue of the inflection point, that's where it sounds like its more cautionary. I mean, seriously, why don't you just, I mean, do we need to actually wait for another conference call?

Matthew Fust

Management

We believe that we just don't have enough data in hand today to predict with confidence the sales that we'll see for the full year. We would not necessarily wait all the way until our next quarterly earnings call. In fact, at the point where we reach the conclusion either that we can confirm the guidance that was previously provided or that we need to change that guidance, we would expect to be back to you.

Rich Silver - Lehman Brothers

Analyst

Okay, thanks.

Operator

Operator

Your next question comes from the line of Marc Goodman with Credit Suisse. Please proceed.

Marc Goodman - Credit Suisse

Analyst · Credit Suisse. Please proceed.

Yes, what is the cost per script that I should be using for my script model for Luvox CR?

Bob Meyers

Management

Were you asking about cost of goods, Marc? This is Bob Meyers.

Marc Goodman - Credit Suisse

Analyst · Credit Suisse. Please proceed.

No, no. The price per prescription, the average selling price, because you have these coupons and things going on, so I'm just wondering, like, how it all nets out. I mean, obviously the WAC is, like, 97 and change I think it was.

Bob Meyers

Management

Yes. The important thing to remember there is that for patients who are taking -- the starting dose for Luvox CR is obviously 100 mg and patients can titrate in 50 mg increments. And what we're seeing is that patients are titrating above 150 mg into the higher doses, which means that they are taking multiple pills once per day. So, the value or price of a prescription is not 30 times $3.25 but actually 60 times $3.25 once you get to 200 mg or higher. So, that's the first point is consider that when you think about your model. As I mentioned in my comments, we are handing out these discount cards that are only being used on a very small percentage of the prescriptions, which we had expected. So, that discount is a pretty small fraction once you realize the percent of prescriptions that are used net and the amount of the dollar discount.

Dr. Sam Saks

Management

One thing we can say from our clinical trials, Marc, is that, to back up Bob's point about the blended rate between one and two pills a day, is that the average dose that patients wound up on in our randomized, controlled clinical trials was north of 200 mg, which would necessitate two pills a day. Obviously early in launch, everybody starts with one since that's the initial titration dose. But we would expect as the market matures that you're going to get a blended rate of between one and two pills per day.

Operator

Operator

(Operator Instructions) Your next question comes from the line of Corey Davis with Natixis. Please proceed. Oren Livnat – Natixis: Hi. This is actually Oren for Corey. I have a couple of questions. First, just following on that last one, your overall gross margin I think is closer to 81% but you stated excluding Luvox CR it's about 88%. Can you just remind us what impact the coupon is having, if any, on the Luvox CR gross margin or what we should use for the sort of long term gross margin assumptions for that product?

Matthew Fust

Management

Hi, Oren. This is Matt. The discounts that result from the prescription discount card will actually be reflected in the gross sales to net sales adjustment. So, in some ways, they're a little invisible to you in terms of our external reporting since we will report net sales of the product. We continue to believe, although it's still early in the manufacturing process as well as in the launch that the gross margin for Luvox CR will be approximately 80% on net sales, which is after taking impact of those prescription discounts into effect. Oren Livnat – Natixis: Okay, thank you. Another question unrelated is to JZP-6 Phase III. There's been a lot of talk and we've probably been trumpeting it as much as anybody, but FDA's changing landscape in terms of statistical analyses, particularly with chronic pain studies, and an issue that's gotten a lot of attention is the imputation of missing data. I'm curious if you can speak at all to what methodology you did or maybe if you can't, what you didn't do or aren't doing in the JZP-6 space there?

Dr. Sam Saks

Management

Well, I would say that we are very fortunate here because we've had two very recent approvals, one in the middle of '07 and one within months. So, there's a very recent FDA view, so we're not having to figure out based on what happened five or 10 years ago. We're looking at what happened in the last 12 months. So, there's that aspect of it. So, in terms of how those companies treated the endpoints and particularly missing data and other statistical issues, we're very well informed about that. And then secondarily, we've had our own direct interactions with the FDA as well as the European authorities on these issues and we believe that we have a statistical analysis plan that has a high probability of being successful given that others have gone down the path very recently and we've had our own detailed discussions. Oren Livnat – Natixis: Thank you so much.

Operator

Operator

Your next question comes from the line of [Phillip Perram] with Bridge Partners. Please proceed.

Phillip Perram - Bridge Partners

Analyst

Matthew Fust

Management

Hi, Phillip. It's Matt Fust. We were obviously very pleased to have support both from KKR as well as a number of our other participants in our pre-IPO financing of our series A and B rounds, take part in the registered direct offering that we completed in July. So, that has continued to be a very productive relationship for us. Obviously, without having more visibility in terms of the Company's financing needs going forward, I can't speculate about future participation from KKR or other investors.

Phillip Perram - Bridge Partners

Analyst

Okay, thank you very much.

Operator

Operator

Ladies and gentlemen, this concludes the question-and-answer session for today's conference. I'll now turn it back to Mr. Fust for closing remarks. Please proceed.

Matthew Fust

Management

Great. Thank you and thanks for your participation in today's call. We look forward to keeping you updated on our development and commercial progress. This fall, we'll be making Company presentations at the UBS Global Life Sciences Conference, which is being held in New York, September 22nd to 25th, at the Natixis Bleichroeder Hidden Gems Conference in New York on October 13th, and at the Credit Suisse Healthcare Conference being held in Phoenix on November 12th to 14th. We look forward to seeing you there and I hope you have a great afternoon.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Have a good day.