吉利德科學 (GILD) 2002 Q1 法說會逐字稿

There is a company slide presentation. For those of you who would like to view the slide presentation, you may access the presentation by going to the home page on our web side, at W.W.W..try farm.com, and double clicking on the message at the lower left hand corner of the page, which says view the slide show for triangle pharmaceuticals, first quarter 2002 financial results. Although you will control the scrolling of the slide from your own terminal, we will identify the page numbers as we proceed through the presentation. Joining me today are our executive vice president, and we'll now go to page 2 of the slide presentation. After some brief introductory remarks by me, we'll have a financial update i first were Robert Amundsen, our chief financial officer, Dr. Franck Rousseau, our chief medical officer will then give us a clinical program update, followed by regulatory update from Ms. Anne McKay, our executive vice president of regulatory affairs. I will he then conclude the formal part of the conference call by a review of our near term objectives an then we'll throw it open to question and answers. As I stated in our press release, which went out on Tuesday, we're obviously pleased that during the quarter, we were able to once again reduce our operating expenses while continuing to make significant progress on our drug candidates. We are now on page 3. Most importantly, we remain on target for a fall F.D.A. submission for buyers Coviracil in the second half of this year. Since our last call, Shire pharmaceuticals announced that it, Blacksmith Kline and Emery, had reached agreement on the material terms of the settlement for their patent dispute involving 3T.C. and that Shire and Emery had reached agreement on material terms with respect to the patent dispute regarding covirus sew. Finalization of such a settlement will mark an important event for triangle in that it will remove patent uncertainties and additional future costs of potential litigation. We're very pleased that the parties have been able to resolve their disputes and look forward to the finalization of this agreement in the near term. Finally, since our last earnings call, the board of directors has decided to retain an executive recruiter to consider external candidates for the position of C.E.O. This search is on going, but is in the early stages and we'll keep you apprised of any developments in that regard. I will now turn over the microphone to bob Amundsen, who will review our first quarter results.

Thank you, Chris. On page 4, you will find a summarized profit and loss statement for the first quarter of 2002. Total operating expenses of $13.5 million for the first quarter were $12.2 million less than the same quarter last year. A 47% reduction quarter over quarter. Development costs were reduced by 45%, quarter on quarter, and other costs, which were primarily SG&A were reduced by 60%. This was the fifth straight quarter in which our operating expenses have been reduced. Of the $9.9 million reduction in development costs, compared to the same quarter last year, approximately half of the reduction came from reduced manufacturing costs. Approximately 40% from reduced clinical and development consulting costs, and the rest from payroll and related other costs. At this point the restructure, which we initiated last year, have been fully implemented with a resulting cost savingsest in our recent operating results. The operating costs for the quarter were largely offset as you can see on the slide, by a $10 million payment made to triangle during the first quarter on a key man life insurance policy. On page 5, we have a summarized analysis of the company's cash flow for the first quarter. The company's net loss, if you exclude the effect of the 10 municipal dollars key man life insurance payment, was $11.8 million. The other significant use of cash during the quarter came from a $10 million reduction of working capital, which in turn resulted from several large payments, which came due in the first quarter, and for the most part, those related to development expenses accrued in previous quarters. This use of working capital was almost exactly offset by the receipt of the key man life insurance payment noted before. Excluding the effect of the key man life insurance payment on the first quarter's results, we expect our cash usage to be significantly lower in the second quarter as compared to the first quarter.

I'll now turn it over to Anne McKay, of V.P. regulatory affairs who will give you an update on our regulatory activities.

Okay. We are now on slide 6. We do have a -- the N.B.A. for F.D.C. is scheduled for the fall of this year. We have a preN.B.A. meeting scheduled with F.D.A. in July. We also had with regard to the European submission, we had meetings with three different governments in the last few weeks that went very positively, and we plan to file with Abbott, who will be doing the filing in Europe the second half of this year for FTC for HIV. I'll now turn it over to Franck Rousseau.

We have five slides summarizing key studies ongoing, recruiting or completed recruitments in just the patient trials and then also on with the hepatitis B. First, or F.T.C. and H.I.V., as Anne mentioned, we're on target and on schedule. We studied 301 TOF ANfor our N.B.A. submissions Q-3 of this year. The other studies, the law studies on the slide, the trial conducted, in collaboration with the A.N.R.S. in France, in this is a phase 3 trial. The trial is complete and we expect to have the result in the fall of this year and the N.R.C. meeting next year. We have two collaborative studies with the clinical trial group in the U.S., study funded by N.H.I. money. It will look at the accumulation of F.T.C. of Calatram start is actually exploring the new (inaudible) the extent really once a day, and Caletra once a day regimen following success with the D.D.I., T.C.C., and F.D.A. regimine (inaudible) Last we have two ongoing pediatric studies, both one in the U.S., one in the U.S. plus rest of the world in order to preserve our package for the safety of F.T.C. in Germany. With regard to D.A.P.D., (Inaudible) We currently -- the page number 8 on the web cast, we're, as we announced, we are implementing a (Inaudible) program. We are happy to have completed implement of in Van Gogh program, the F.D.D.150. We also have two studies scheduled to initiate this quarter and those studies will bring critical data for the role of the E.B.D. in salvage population or in salvage, meaning patients or infected with H.I.V. as limited to no therapy option available. no particular option available. Finally e we have finalized a study protocol with the I.M.R.S. where we will explore a population of patient with multiple line of therapy, but I'm not totally salvaged, more in line with tragedy, adopted by 10 known anticipate initiation of that study in the Q-3 of this year. Now, we'll switch gears and move to the H.B.V. clinical trial program on slide number 9. As you can see, our first study, D.101 will be published next month in of the patients have unprotected viable load. 61% of the patient using the antigen and only 60% of resistance one year. Our pivotal trial B.301 is completing enrollment as of today with 220 over 240 patients targeted, and we're optimistic that we will close enrollment as planned before the end of June. The study B.204, has been -- this is our first combination trial that we have (inaudible) In the U.S. and we expect opening within the rest of the world. And the last study for F.F.T.C. combination is the study B.201, which is for we can resolve this administrative clearance, we will enroll and everything is ready to go.

On the next slide, page 10, we have the clinical trial summary for L.S.M.O.U., first we have open a U.S. I. and D. for the drug, we have completed those ranging studies 102. We're actively implementing a new program, the study B.203 randomized phase 3 trial of dose of Claritinis a proven dose in Canada and we're soon expecting approval in the other countries where the study is from and as I mentioned earlier, phase 204 is enrolling in the U.S. and Europe this man.

That completes the review of the study. Now I -- there is one slide of data that I would like to comment for you. These are the results, interim results that we're obtaining in our study F.L.U.102 where we have three groups of patients, four patient in the 10-milligram, 10 in the 50 and 10 in the 100 milligrams received drugs for 28 days. This is represented by the black bar, the green bar at the bottom of the picture, the left corner, and the curve represents the amount of time to six months after distinction of the drug. As you can see from the top dose, we don't have the data yet at six months but we have it at five months. There are several factors -- varying in these slides. First, we see a very rapid and profound (inaudible) while the patient is taking the medication ranging from 2.5 log to 3.5 log, just for relogging the 1,000 for reduction. But really, more interesting, and actually unique in our experience in antviral drugs, we have a very potent post antviral effect where a patient, for instance, at the 100 milligrams, would still have 1,000 fold reduction five months after stopping the drug and just receiving it for 28 days. This is absolutely remarkable and we're very excited about it.

We wanted to share that with you. I will now give the microphone back to Mr. Chris Ralles .

Thanks. We're now on the final slide, page 12. This is a summary of our near term objectives, many of which we've actually reviewed during the course of the discussion this morning. Most -- first and most importantlily are the U.S. and regulatory submissions for covirus cell H.I.V., scheduled in the fall, in the U.S. of this year, and the second half of this year, or sometime in the second half of this year, per Europe and also to prepare for commercial launch of this product in in 2003, however, we want to complete enrollment in the broad based studies during his presentation. And finally come to complete settlement of the patent issues relating to Coviracil for H.I.V. Hopefully we will be be able to make continued progress on these near-term objectives in accordance with our operating plan. I'll now turn it over to Jesse, so that we can start the Q. and A. portion of this call.

Thank you. If you have a question at this time, please press the 1 key on your touch tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.

Hello?

Jesse, we're not getting Matt's question.

Once again, if you have a question, please press the 1 key. Our next question is from Simon Houseof Mcquarry.

Good morning, Chris. How are you?

I'm fine. Simon, how are you doing.

Fine, thanks. I have two questions, the first relates to Dr. Russo's comments on L.S.M.A.U. If the individuals who have a -- still had a fast and forward reduction in the hepatitis B. virus after five months, given that, could one draw a line and say that this compound could be a cure for hepatitis B.?

Well, we certainly would like to get these kind of results in our clinical trial, but at this stage, it's very speculative. We're certainly hopeful that this will be a major improvement to help in the disease. Now whether it is a cure, it certainly is not at this point. The 1,000 fold reduction is not a cure. There is still a virus there and there's no guarantee that the virus would not come back with more followup, so we have not reached that stage. However, it is very different from any other drug, we work with, including F.D.C., which is very good, but when you stop, within the very variable period of time, determined within four months, the vast majority of the people, the virus coming right back to where it was before they started treatment, and that's true for all the other drugs, for L.T.D., et cetera, so this is really unique of post effect that we are intent to capitalize in the way that we will deliver the drug.

Okay. That's great. Just one more quick question. With Coviracil, does the company have any guidance to the shareholders with respect to the size of the market should the compound be approved next year by the F.D.A.? So the question is really what sort of sales would you view from that compound should it be approved?

Well, not at this time, Simon. A lot of that guidance would be dependent on variables that, quite frankly, won't become more apparent until you get closer to commercialization, so as we draw closer to commercialization, we will be providing customary guidance, but not this morning.

All right. That's great. Thank you very much. Okay.

David Bouchefrom Onterberg Tullivan. One question to chair nie, I must have business missed did you say the FTC301B. study has enrolled the last patient?

No, we're 220 out of 240 target.

Okay. And when do you expect that to complete?

Well, we certainly are optimistic that we will complete that before the end of June, which was our target date.

Okay. And quick question on Carburn, could you give us a little bit further guidance on what you expect in the way of Carburnfor this year?

David, as you know, we had previously given a target Carburnor what we're calling cash usage this year of $61 million. We're still holding to that target. We believe that the burn rate exclusive of this one time payment that we received on a life insurance will be reduced in the second quarter, probably the subsequent quarters. The only variable there that we'll have to watch closely for is the commercialization costs as we get to the end of the year. We've done our best to project those, but if those or other costs change that would materially impact the 61 million, we would certainly announce that, but currently we're hold to go that target.

Okay. Thank you.

Once again, if you have a question, please press the 1 key. This concludes the question and answer session. Mr. Raw he is, I would now like to turn the program over to you.

Thank you, Jesse. Well, again, thanks for everyone joining us today. As you can tell, we have a number of near term objectives. We're very excited about the completion of the regulatory submission, and submission later this year in both the U.S. and Europe, and the ultimate commercialization of our first product, so thank you again for joining us. And he good morning.