United Therapeutics Corp (UTHR) 2002 Q1 法說會逐字稿

Good morning and welcome ladies and gentlemen to the United Therapeutics first quarter 2002 financial results. At this time I would like to inform you that this conference is being recorded for rebroadcast and that all participants are in a listen-only mode. The rebroadcast for this call will be available approximately one hour after the conclusion of this call. To access this rebroadcast you may dial 1-800-428-6051 with the pass code ID number of 241913. At the request of the company we will open this conference up for questions and answers after the presentation. I will now turn the conference over to Martine Rothblatt. Please go ahead.

Thank you very much. Our statements today concerning United Therapeutics may include forward looking statements. Such statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward looking statements. The risks and uncertainties are described in the United Therapeutics Annual Report on form 10-K for the year ended December 31, 2001. It's quarterly reports and form 10-Q in the prospectus and form S-3 filed in June, 2001.

With that out of the way, I'd like to thank everybody for joining our call and wish everyone a good morning. We are pleased to report our first quarter financial results today but we've had our third consecutive quarter of a drop in our net loss for the quarter ended March 31, 2002. And the reason why we've been able to largely reduce the loss is that with the termination of our Beraprost program and the enrollment in our Remodulin program our clinical R&D class has been able to be reduced, so we're pleased to report that aspect of our financial reports.

Also, we are very excited that the revenues for the first quarter were able to remain steady as compared to the previous quarter with $1.4 million. And sales and marketing expenses did decline because we've been able to reduce the marketing costs associated with our Arginine product line. In addition to some of those financial highlights, we're also pleased to announce that as of now we've received advanced purchase orders from our U.S. distributors for Remodulin, selected distributors for Remodulin for approximately $9 million worth of Remodulin infusion pumps and supplies pending of course, FDA approval. And these orders reflect the estimates of the amount of Remodulin that the distributors will initially require to provide for existing and new patients in the United States after FDA approval..

We do expect that commercially-labeled Remodulin will be available to the distributors at the time of FDA approval, so we're feeling that the Company is in a very good financial position as we move into the second quarter with approximately $160 million in cash and reserves, as well as the operating results just reported and the financial purchase order backlog. With that summary of our press release which we issued, I'd like to invite people to join the call with me, Dr. Roger Jeffs, who is our President and Chief Operating Officer as well as Fred Hadeed, who is our Chief Financial Officer. So RCI operator, if you could, please open the line to questions. And you may feel free to direct your question to Dr. Jeffs, to Mr. Hadeed or myself. Thank you.

Our question and answer session will begin now. If you're using a speakerphone, please pick up the handset before pressing any numbers. Should you have a question, please press one followed by four on your push-button phone. If you would like to withdraw your question press one followed by three. Your question will be taken in the order it is received. Please stand by for your first question. Our first question comes from Steve . Please state your affiliation followed by your question.

Yeah, hi. It's Steve Saba with Kilton Capital Management. I'm a little unclear on what's that about the shipments of drug. Is drug being shipped now or is it being readied for shipment? I'm a little unclear on that. And if you could, just maybe clear that up.

Sure, Steve, I'm happy to clear that up. The drug of course, is not being shipped now because we are waiting for FDA approval which hopefully should come before the end of this quarter. We're targeting some time in June time frame. However, the drug is being readied to be shipped including printing of package inserts and boxes and labeling of the drug. And of course, we've had a substantial amount of the drug instability for quite some time, so we're all ready to be shipped And our distribution partners are doing the most responsible thing in terms of insuring that they have a continuing commercial drug supply to begin to allow them to continue to serve the patients on Remodulin as soon as the clinical trial material is used up. So the actual commercial shipments we would hope, subject to FDA approval to commence in June.

Great. Thanks.

Thank you. Just a reminder, ladies and gentlemen, if you do have a question please press one followed by four on your push button phone. Our next question comes from . Please state your affiliation followed by your question.

Good morning. My affiliation is Jalaa Equities. Martine, could you speak or maybe Fred speak to your estimates on assuming we get an approval mid-year and a launch soon after that do we have an estimate on 02's revenue from Remodulin and also an ending year cash number?

Good morning, Tom. This is Fred. As you know, we currently do not have any revenue guidance that we've published and do not expect to be publishing any revenue guidance until we've had at least a couple of quarters of revenues out there in the field. At that point we'll feel that we have you know -- will have a very good chance of you know, viewing what the uptake patterns are will be able to give you a meaningful guidance at that point. So for the time being, we're not giving any revenue guidance.

OK. Thank you.

Thank you. Our next question comes from Barry . Please state your affiliation followed by your question.

Management -- I wonder if you could, elaborate on your conversion studies and the results.

I'd like to -- Barry, thank you for the question -- and I'd like to refer that question to Dr. Jeffs, who you know is in addition to being President and Chief Operating Officer also is comprehensively in charge of the clinical development activity. Dr. Jeffs.

Well thank you Martine. To date we've transferred slightly less than 20 patients from to Remodulin and open later fashion. This place the dosage is slightly higher to 110 milligrams to kilograms of . The transition is normally open label study has taken between three and five days and all of the transitions have gone successfully by that I mean that it has been managed post transition from to Remodulin so that's something that we're very pleased about. And the data from that will be published very shortly.

Where do you hope to publish this -- the data?

It's been submitted to General American Oncology Cardiology. I believe and it should be coming out over the summer month.

Thank Barry, thank Roger.

Once again just to remind you ladies and gentlemen if you do have a question you may press one followed by four on your push button phone at this time.

Alrighty well we'd like to thank everybody for their participation in the conference call and again we're very please to be able to report a first quarter 2002 loss from operations of just about seven million reduced five million, I'm sorry five million, reduced from previously and as well to report a order backlog on the order of around nine million looking forward into the second quarter. I would like to thank everybody for getting up early to participate in the call and wish you all a great weekend. Thank you.

Thank you. Ladies and Gentleman rebroadcast of this call will be available approximately one hour from now. To access this rebroadcast you may dial 1-800-428-6051 with pass code ID number of 24913. That concludes our conference for today thank you all for participating, have a nice day. All parties may disconnet now.