英賽德 (INCY) 2004 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

  • Good morning ladies and gentlemen and welcome to the Incyte third quarter financial results conference call. At this time all participants have been placed on a listen-only mode and the floor will be open for your questions following the presentation. It is now my pleasure to introduce our host, Ms. Pam Murphy, VP of Investor Relations and Corporate Communication. Ms. Murphy, you may begin.

  • - VP of Investor Relations and Corporate Communications

  • Good morning and thank you for joining us. With me today are Paul Friedman, Incyte's President and Chief Executive Officer; and Dave Hastings, Incyte's Executive Vice President and Chief Financial Officer. Rich Levy, our Senior Vice President of Drug Development, is also here and will be available to answer questions during the Q. and A. Paul will begin with a review of our drug discovery development program, followed by Dave's discussion of Incyte's third quarter financial results and our most recently financing. We will then open the call up for questions.

  • Before beginning, I would like to remind you that the prepared statements that management will be making during this conference call are statements made in response to questions will contain predictions, estimates and other forward-looking statements that are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those that are described in our SEC filings. These statement include anticipated plans, timelines, cost and outcomes related to our drug discovery and clinical development programs, and our expectations as to financial items, such as cash, revenues, expenses and the repurchase of existing debt. We encourage you to review our latest 10-Q, filed June 30, 2004, and our recent press release issued today. I will now turn the call over to Paul.

  • - President and CEO

  • Good morning. We made substantial progress in our drug discovery and development activities since our last call. I will start by telling you where we stand with Reverset. Earlier this week we reported positive findings at the ICAAC meeting in Washington. Dr. Rob Murphy presented data on the 10 treatment experienced patients who were in the fourth arm of our phase IIa trial. He had previously discussed this same cohort of patients in July at the International AIDS Conference, at which time he showed data demonstrating that Reverset was effective in these treatment experience patients when the drug was added to a failing combination regimen. Among the eight patients who received 200 milligrams of Reverset once a day for 10 days the mean reduction in viral load among the treatment experience patients was 0.8 log copies/mL. And 7 of the 8 treatment experienced patients had a clinically significant viral load response. 4 of them achieved viral loads of less than 400 copies/mL, and this was after only 10 days of dosing. At ICAAC, Dr. Murphy expanded our description of these patients to describe for the first time that those patients receiving and failing 3TC, or Epivir, and/or patients receiving and failing tenofovir, that is Viread, responded to 10 days of treatment with Reverset. Additionally patients with 3 or more TAMs, that's thymidine analog mutations, also responded to this same treatment.

  • No new resistance mutations developed during the dosing interval, the ten-day trial, and Reverset was again very well tolerated in all the patients. Based on our review of the data, the results from this fourth cohort of patients met our expectations and I'm confident that given Reverset's potent antiviral effects, its potential to cover virus mutations associated with other approved NRTIs its good tolerability, and its once a day dose mean that it has -- Reverset has the potential to be an important new treatment for HIV patients. We continue to enroll in study 203. This is the phase IIb trial in which we are evaluating 180 treatment experienced patients equally randomized to receive 50, 100, or 200 milligrams of Reverset or placebo once a day as part of their heart regimen. These patients are failing their current regimen when they come into the study. Our goal is to conduct an interim analysis by year end. That remains on track, and we expect to provide a detailed -- a top line description of that analysis in February on our fourth quarter year end conference call. But because this phase IIb trial is blinded for 6 months we will not be in a position to describe the results in a scientific meeting until the middle of 2005. And we hope to do that at the International AIDS Society meeting which takes place in Rio de Janeiro in July of 2005. Assuming the phase IIb study is positive, our plan is still to initiate the phase III trials in mid 2005, probably the late summer.

  • Now our next most advanced program deals with small molecule oral CCR2 antagonists. These antagonists are interesting new class of drugs with a potential to treat a variety of chronic inflammatory conditions including rheumatoid arthritis, multiple sclerosis, and atherosclerosis, to name three. In September, we completed a phase I single and multiple dose study in healthy volunteers with our lead compound, Incyte 3284. During the multiple dose portion of the study, we also conducted a delayed type hypersensitivity, or DTH test, which has the potential to serve as pharmacological proof of principal. The results from the phase I remain blinded, but based on a primarily analysis of the safety and the pharmacokinetics of Incyte 3284, we are moving forward with our plans for phase II and we expect to begin a one-month phase IIa study, most likely a safety study in rheumatoid arthritis and possibly an additional study in one other indication in the first and second quarters of next year. The wide range of indications in which CCR2 antagonists could have therapeutic utility do make it important that we partner the program. We've initiated early stage discussions with potential partners, and we've seen a great deal of interest in the program. As we have a strong cash position and the ability to advance the program on our own into phase II, I don't want to predict when we will ultimately partner this program or what the scope of that potential collaboration might be. I am confident we will secure a strong partner at the appropriate time.

  • Now I will move on to describe our most advanced oncology program. It's based on inhibition of the enzyme Sheddase. Our orally bioavailable Sheddase inhibitor compounds block a critical step in the signaling pathways of the epidermal growth factor receptor family. This family has received a great deal of attention given the clinical success of Perceptin, arrisa, Erbitux, and now tarceba [ph]. The epidermal growth factor receptor pathways are recognized as critical to the growth of a variety of solid tumors, such as breast, colorectal, and non small cell lung cancers. Our lead candidate, Incyte 7839, has completed IND enabling preclinical testing, including one month toxicology studies, and we remain on track to file the IND late this year and begin phase I clinical trials in early 2005.

  • In addition to these more advanced programs we are also making excellent progress in a number of earlier programs in the areas of HIV, diabetes, cancer, and in inflammation. And while we have selected a compound for preclinical development in HIV, until we have the one month toxicology studies completed and for competitive reasons, we've decided not to announce the target at this time. Now, in closing, I believe we remain in a very strong position to make continued progress through the rest of this year and in 2005 as we complete our phase IIb Reverset study and select a final dose for the pivotal phase III trials; initiating the phase IIa studies for our lead CCR2 antagonist; filing the IND and initiating phase I for our oral Sheddase inhibitor; and advancing our other internal discovery programs into formal preclinical testing. With that I will turn the call over to Dave Hastings, our CFO.

  • - EVP and CFO

  • Thanks Paul, and good morning. Before discussing our financial results for the quarter, I would like to highlight 2 significant events that recently occurred to strengthen our balance sheet. During the third quarter, we repurchased 38.4 million of our 5.5 percent convertible subordinated notes, and this past Monday, we announced the public offering of 9 million shares of common stock at 9.75 per share, resulting in an estimated net proceed of approximately 84 million. By repurchasing a portion of our 5.5 percent notes and upon the completion of our common stock offering, we have strengthened the Company's balance sheet while investing in our emerging discovery and development pipeline. You can expect that we will continue to repurchase our 5.5 percent notes as we focus on reducing our overall debt balance.

  • Now for our financial results and guidance. Our ending cash balance at September 30, 2004, was approximately 413 million, which reflects the net proceeds of 242 million from our 3.5 percent convertible subordinated note offering. Our net use of cash of approximately 85 million year-to-date, plus our repurchase of approximately 38 million of our 5.5 percent convertible subordinated notes. As a result of our focus on effective cash management, we are reducing our cash burn guidance from a range of 130 to 140 million, to a range of 120 to 130 million for 2004. As a reminder, cash and its use is the key metric by which we measure our financial performance. It's important to note that our cash guidance does not include any cash that may be used for additional repurchases of our 5.5 percent convertible subordinated notes, or for any possible end license or purchase of products in clinical development.

  • Revenues for the quarter were 3.4 million and were 15.2 million for the nine months ended September 30, 2004. Given the amount of revenue recorded thus far in 2004, we are raising our revenue guidance to a range of 15 to 17 million for the year, from a range of 12 to 14 million stated in our second quarter call. The net loss for the quarter was 26 million, or 35 cents per share, and 127.3 million, or $1.74 cents per share for the nine months ended September 30, 2004. Included in our net loss for the nine months ended September 30, 2004, were restructuring and related charges of 42.5 million, primarily recorded in connection with our closure of our facilities in Palo Alto. As you recall, our guidance for total restructuring charges for the year was up to 47 million. At this point that guidance remains unchanged. Also included in our net loss for the three and nine months ended September 30, 2004, are charges of 2.5 million and $5.2 million, respectively, recorded as a result of write-downs related to reduced market valuations and strategic investments that Incyte holds in other companies. These charges are included in interest and other income expense net.

  • Our R&D expense was 18.6 million for the quarter and 70.3 million for the nine months ended September 30, 2004. As a reminder, the first quarter of 2004 includes expenses for the Palo Alto operations, as the closure of those facilities was not effective until April 2. We still expect our overall R&D expense for the year to range from 91 to 95 million. This is unchanged from our previous guidance. Our selling, general, and administrative expenses were 5.2 million for the quarter and 17 million for the nine months ended September 30, 2004. We still expect selling, general, and administrative expense to range between 21 and 23 million for the year. Again, this is unchanged from our previous guidance. In terms of other income expense, our interest income was 2.1 million in the third quarter, and 5.7 million for the nine months ended September 30, 2004. We expect our interest income to range between 7 and 8 million for the year. This is unchanged from our guidance given our Q2 call. Our interest expense was 4.6 million for the quarter and 13 million for the nine months ended September 30, 2004. We expect total interest expense to amount to approximately $18 million this year. This is also unchanged from our guidance given our Q2 call. Both interest income and expense could fluctuate depending on what additional actions we take in connection with the 5.5 percent convertible subordinated notes. In addition, our other income expense guidance does not include any potential adjustments related to our strategic investments in other companies which may occur during the year.

  • I would like to conclude my remarks by saying that our financial results this year have exceeded our expectations during a challenging but successful transition year. And I believe we are well-positioned to advance our drug discovery and development programs and continue to improve our capital structure by reducing our overall debt load. With that, I will now turn the call back to Paul.

  • - President and CEO

  • Thanks, Dave. Operator, I would appreciate it if you could now open the call for Q&A.

  • Operator

  • [Operator Instructions]. David Witzke, SunTrust Robinson Humphrey.

  • - Analyst

  • Thanks for taking my call. First, regarding Reverset phase IIb topline results you will present on your call in February. What specific info such as viral load will you be able to share at that point?

  • - President and CEO

  • I won't be in a position to give you quantitative information at that point because the study is still blinded. I will give you a hypothetical statement that I could give if things turn out this way. I could make a statement such as, we've done the interim analysis. We are pleased with the extent of viral load lowering across multiple genotypes and the durability so far that we've seen. We are pleased with the safety and tolerability of the drug , and we are feeling very good about moving ahead as planned into phase III. Something like that is as much as I probably could say.

  • - Analyst

  • Can you say given the enrollment in the phase IIb right now you're still on track for a mid-'05 phase III trial to initiate?

  • - President and CEO

  • Yes. Toward the latter part of the summer of '05; we are still on track for that. We are still on track for doing the interim analysis by year end. Our goal had been to have the study fully enrolled by year end. I think that's a stretch. It may spill into the early part of next year, but that will not in any way effect either what we are able to say on the February call, the timing of the scientific presentation in the middle of the year, nor we believe the start of the phase III trial.

  • - Analyst

  • And a couple on CCR2 if I can, any comments on safety or adverse events? I assume it's clean since you stated you are going forward?

  • - President and CEO

  • Well, the study is blinded but even blinded we are gratified by the lack of, by the really excellent tolerability that we -- we believe -- that we're seeing there and that will be -- that will be even clearer when we unblind the trial. The one thing that I think I can say is that even blinded looking at the electrocardiographic studies that we've done that we see no hint of any QT prolongation, which is a concern in molecules of this class so that's particularly reassuring.

  • - Analyst

  • And on the drug properties, anything on PKPD at this point in the first trial, first phase I, still looking at twice a day dosing?

  • - President and CEO

  • Well, the PK actually looks pretty good, but again, it's blinded. But even saying that, the PK -- the half lives that we are seeing are actually greater than we had predicted from the animal data and from the invitro human microsomal drug metabolism kinds of studies, so the drug could be given either once or twice a day, we believe.

  • - Analyst

  • You do have a final formulation. Any stability issues?

  • - President and CEO

  • So, we -- there are no formulation impediments to going into phase II. But I would say like with any compound at this relatively early stage there are aspects that you continue to optimize as the compound progresses through development. Now this includes our current formulation. The current formulation for 3284 is quite sufficient for phase II, but it won't be our commercial formulation. And we have efforts well under way to develop the formulation appropriate for large scale development and commercialization.

  • - Analyst

  • And lastly, I believe you had not done the long-term animal tox required to do more than a thirty-day phase II trial? Can you give status of the long-term tox studies and when you think you can really get deep into phase II studies?

  • - President and CEO

  • They are about to begin, the three and six-month tox studies. And what that means, you are right, that the first studies we will be doing are one month studies. And that -- the timing for the beginning of the three-month studies will be in the second half of 2005. It is a little bit confining because the diseases that we are most interested in treating are chronic inflammatory diseases, obviously, and for most of these indications, to really be sure you see your maximal efficacy in these kind of studies, you need to go beyond one month. It doesn't mean you can't see efficacy in one month studies, and we certainly hope to, but it -- until we finish these three and six-month two species animal toxicology studies, we are limited to thirty-day studies.

  • - Analyst

  • That's helpful. Thank you.

  • Operator

  • Annabel Samimy, UBS Warburg.

  • - Analyst

  • Hi. It's Annabel, that was close, though. Thanks for taking my call. A couple quick questions. On the CCR2 program, exactly how far do you plan on taking this until you feel like you need to partner it? And what kind of leeway does the offering give you?

  • - President and CEO

  • The new offering obviously gives us even more flexibility than we had before.

  • - Analyst

  • But did you intend to use for that giving you that flexibility and move forward?

  • - President and CEO

  • Excuse me?

  • - Analyst

  • Do you intend to use the offering at all to give you more flexibility to -- for those options, or was it really pretty much for debt repayment?

  • - President and CEO

  • Well, I would let Dave answer that. I think we are going -- I think we are going to use the money in ways that make the most sense at this time, which it probably is a combination of the two. But, Dave, you want to expand on that?

  • - EVP and CFO

  • Yeah, Annabel, I think as we said in the past, our corporate finance strategy is different than our corporate partnership strategy and clearly this was focused to continue our restructuring of the balance sheet. And really that offering was aimed to adequately fund our pipeline but also decrease the leverage of the Company.

  • - Analyst

  • Do you have intentions of repurchasing back all the '07 notes before the end of the year? Why would you only do it in [technical difficulties], really?

  • - EVP and CFO

  • Yeah, I don't want to give specific guidance as to the amount or timing of our buybacks but as we said, as I've said today you can expect we will continue to reduce our overall debt levels. As you can see, we already accomplished some of that in the third quarter.

  • - Analyst

  • Okay, but I'm just a little curious. You didn't really change your interest expense guidance for the year but you are buying back debt. So.

  • - EVP and CFO

  • Yeah, the two events, the financing and the buybacks does impact interest expense and income, but they happen relatively late in the year so my guidance is still approximate at this point and really doesn't need to be changed. It will impact the 2005 results more than '04.

  • - Analyst

  • The guidance, the 120 to 130 in cash use, it seems like you pretty much only raised revenue guidance by a certain amount but the cash use was significantly lower. Was that pretty much from the third quarter savings, cash use -- less cash use in the third quarter or is there something I'm missing here? Because rest of [technical difficulties] items really was unchanged.

  • - EVP and CFO

  • I think our savings -- it would be fair to say it's generally across the board, but also reflects a really efficient shut down of our information business. Where we've used much less cash than we anticipated. We've actually generated more revenue than we thought we would. I think just as importantly, Annabel, it's important to note that the cost savings isn't as a result of any delays here in Wilmington. It really is more reflective of efficiencies.

  • - Analyst

  • Okay, great. And then one question on Reverset. The formulation that you're using to address the fasting requirements, at what stage do you think you are going to be able to figure out the final formulation for Reverset?

  • - President and CEO

  • Okay. So we are, we are in the midst of doing a number of clinical pharmacology studies. We have one formulation where we have enteric-coated beadlets in a capsule, where we will see whether that mitigates against the food effect to the extent that you would be able to take the drug with food in the stomach. As I've said many times before, I personally do not have high hopes for that, but it's possible it will work. Therefore I believe that the formulation that we have, a newer, better enteric-coated tablet where we are also doing some clinpharm studies will probably be our final formulation and that would require taking the drug sometime before breakfast or possibly before you go to bed at night. Again I would say that because it's a once a day drug, I don't think this is a terribly limiting situation. And we could get lucky with the beadlets, I just personally am not banking on it.

  • - Analyst

  • Okay. So there's no reason to believe that formulation issues could delay the phase III at all?

  • - President and CEO

  • No, not at all.

  • - Analyst

  • Great. Thank you.

  • - President and CEO

  • Now, the other thing you asked that I didn't answer, just to complete the answer on CCR2 and when we would partner it, the -- we have and continue to have very interesting discussions with a number of companies. The initial effort to engage people and speak to them has been, has been very fruitful and companies have expressed a great deal of interest in the program. But the potential financial aspects of a program of this size are enormous and we are not about to license the program prematurely at firms that are not a real win for us. And having said that, and having looked at the money that we now have in the bank, we can without batting an eye take the compound all the way through phase IIa if we wish to, and we could even take it through at least one phase IIb study, if we felt that that was -- that that made the most sense. So what we intended to do is to continue to talk to the current companies, talk to anyone else who wants to talk to us, and make it clear to them that we are not going to give away this asset. And for that reason I can't tell you at this point exactly when we will have it partnered. It could happen before we start IIa. It could happen in the midst of IIa. It could happen at the end of IIa. Those would be -- that would be the time spectrum in which I think a deal would be consummated.

  • - Analyst

  • Okay. Great. Thank you.

  • Operator

  • Thomas Wei, Piper Jaffray.

  • - Analyst

  • Thanks very much. I wanted to just ask on the nighttime dosing of Reverset. Where are you in doing the studies to allow that, and in the current phase IIb trial, is everybody taking it in the morning?

  • - President and CEO

  • I am going to let Rich Levy, our head of development who is more involved with the studies answer that question, Tom.

  • - SVP of Drug Development

  • Hi, Tom. So, the current study we are dosing in the morning before breakfast, but the ongoing pharmacokinetic studies with the new formulations that Paul mentioned in the response to a previous question, we're looking at dosing both on an empty stomach directly with a meal and several hours after that meal. And the data from those studies will help us determine whether we can also dose at bedtime to have the greater flexibility, and we should have those results by the end of the year, make the decision as to which formulation is going into the phase III program, which will be our commercial formulation. And know whether or not we will be able to dose at night in the design of our phase III study.

  • - Analyst

  • And when might we hear a little more about the preclinical HIV compound?

  • - President and CEO

  • I think it would probably be -- it's possible we could have something to say at the next call. It might -- or by the end of the first quarter.

  • - Analyst

  • And I apologize if this has been asked on a previous call, but do you know if Reverset has activity against the Hepatitis B polymerase, and if so do you know how it compares to 3TC and FTC on issues like potency and YMDD selection?

  • - President and CEO

  • Can you ask that again, Tom?

  • - Analyst

  • I was asking about Reverset activity against the Hepatitis B polymerase, and how that would compare to 3TC on potency and YMDD selection?

  • - President and CEO

  • Rich, you want to answer that?

  • - SVP of Drug Development

  • Thomas, I don't know the specific details of those assays. What I do know is that an evaluation that was done actually before I came to this company was that while this was somewhat active against Hepatitis B, it would not have any clinical utility, because it was not as active as other drugs that were already in the market against Hepatitis B. So we believe the clinical utility in Reverset is limited to HIV.

  • - Analyst

  • All right. Thanks very much.

  • Operator

  • Thank you. Alex Hittle, A.G. Edwards.

  • - Analyst

  • Thank you. Good morning.

  • - President and CEO

  • Good morning.

  • - Analyst

  • A couple questions here. One is -- I was under the impression that the 80 patient look in that you have would really be the gating factor for initiating phase III trials. Is that still the case, or are you going to need to see the unblinded data before you can proceed into phase III?

  • - President and CEO

  • Well, we have to plan for phase III. And the -- but you have to have -- you have to present the data of the study at an end of phase IIb meeting to the FDA. So the 80 patient study is internal gating. It's going to tell us the interim analysis what we think the entire study will show. And will allow us, I think, with a high degree of confidence to decide what the likely dose is going to be, whether we are going to tweak study designs for phase III that we are currently describing internally, and that we have a go for phase III. But you certainly have to take the data, and right now it's sixteen-week unblinded data, to the FDA for end of phase II meetings before the FDA will grant you permission to move into your pivotal trials. So, Rich, do you want to expand on that?

  • - SVP of Drug Development

  • Only to say that the -- and that's the interim analysis that will be done before the end of the year is a snapshot in time analysis. So it's not just [technical difficulties] data. Because patients have been enrolling in this study since June, we already have patients that are well out into the study. We will be looking at all of the data that exists at the time we do this analysis. So we will have data beyond four weeks and therefore as Paul was saying, we do believe that it will give us a pretty accurate picture of what the final data will look like.

  • - Analyst

  • That's very helpful. The second question relates to burn. I believe you've indicated that the burn for running Delaware runs about 80 million, and then the clinical development costs come over and above that. I'm wondering if that's still the case, or in terms of the reduced guidance, have you trimmed down what the -- the sort of Delaware run rate is?

  • - EVP and CFO

  • Yeah, the $80 million cash burn at Wilmington is all in, Alex. That includes discovery, development and G&A for the Company. As I previously mentioned really the reduction of our cash burn -- there are savings across the board, but primarily results from the efficiency of the shut down of the information business in California.

  • - Analyst

  • What I'm obviously sort of sneaking at here is a sense of what the run rate is going into next year. Is that a useful baseline run rate for you folks going into next year? Obviously, with some wiggle room there on the clinical development side.

  • - EVP and CFO

  • A couple things. The 2005 financial guidance we will give in our next call, our Q4 call after we finish our budget, I think in broad strokes what I can say is that we certainly wouldn't burn more cash next year than our current guidance, but there are sensitivities as you say, Alex, in the development spend and other factors, and I look forward to updating everybody in the Q4 call.

  • - Analyst

  • Okay. And finally, if I can jump to the internal HIV program, that's something that you folks have sort of hinted at, but also not indicated that you had a formal, full on program going in. Can you discuss a little more kind of how that fell out of your research side?

  • - President and CEO

  • Well, we do, we do -- as any company that's in drug discovery, what you do, if they do right -- if they do it the way I think is right, when you have a program that you've designated at a major program, you put significant resources including significant personnel on the program to drive toward a compound that you feel comfortable taking into preclinical -- possibly intention of taking it into man [ph]. But you have little pot boilers going on at any time where you have small numbers of people working on potential new major programs that we have scientifically discussed and feel have potential. And sometimes you get -- sometimes you get no where on those programs. I'd say that happens probably more often than not. Sometimes you get compounds that look like reasonable leads that then require a large chemistry effort to get an ideal molecule. And then every once in awhile, you get lucky and with a relatively small effort the actual compound pops out. And we got lucky on this particular program.

  • - Analyst

  • Interesting. Okay. Thank you.

  • Operator

  • Eun Yang, Wells Fargo.

  • - Analyst

  • Thanks. Dave -- a question to Dave, your guidance for the year that you are using cash between 120 to $130 million, that excludes the restructuring charges of the $47 million, right?

  • - EVP and CFO

  • No, that's all in.

  • - Analyst

  • Oh, that's all in.

  • - EVP and CFO

  • Yeah.

  • - Analyst

  • Okay. And on R&D part [ph], the closing the Palo Alto facility, is it all recorded in the second quarter or some of them is in the third quarter?

  • - EVP and CFO

  • We had to -- as we indicated in the past, we had to run the operations for the first quarter. So the cash impact of that is included in Q1. The primary cash outlie -- outlay for the restructuring charge is in Q2.

  • - Analyst

  • Okay. So in the third quarter, the R&D expense is primarily driven from your development programs?

  • - EVP and CFO

  • Discovery and development that's absolutely correct.

  • - Analyst

  • And one question to Paul. Paul, you mentioned that in terms of a partnership with the CCR2 programs and you are weighing various options, and I think in the past, you have mentioned that given the amount of interest that you received from potential partners, you could do partnership by end of this year or by end of first quarter. And so from this call -- today's call, should we assume that the partnership will more likely come after the phase II studies?

  • - President and CEO

  • I wouldn't assume that. But I think it's unlikely it will happen before the end of the year. I think there's a chance we could have something before the end of the first quarter, but you may turn out to be right, that we will be well into phase II before we get a deal done. These things take time and I'll be honest about this, I've done these deals from the big pharma side, not from this side before, and they take, they are protracted back and forths in negotiations, and it takes longer than I think I naively anticipated it was going to take. I remain very optimistic that we will partner the program with a desirable partner at good terms, but there's no urgency to rush into something that is not a real win for us.

  • - Analyst

  • Okay. But you are moving into phase II on your own while you are having the discussion with the partner and you said that phase II initiation may occur in the first half of next year?

  • - President and CEO

  • Yeah, we are definitely going to do that and I would think any potential partner wouldn't want us to sit on it. They'd want us to -- it will create value in the program. And it will also not allow it to fall behind from a competitive standpoint. So we certainly intend to go ahead and do these studies.

  • - Analyst

  • Okay. Thanks.

  • Operator

  • Bonnie Feldman, CCL Partners.

  • - Analyst

  • Thanks for taking my call. Just a few housekeeping questions. In the enrollment of the 180 patients in the phase IIb, when exactly should we expect that to be completed again? And for the interim analysis of the 80 patients with the primary end point being effacy 16 weeks, it's not clear to me how many of these 80 patients are four weeks versus more? If you could clarify that. Thank you.

  • - President and CEO

  • Well, I will start and I will have Rich expand. We are on track to look -- the way -- what we said is that when 80 -- at least 80 patients have been on the drug for at least one month, we will take a snapshot of those 80 or Taren [ph] said maybe it'd be 82, 83 patients. What you have there is, for example, patient one enrolls on day one. Patient 80 enrolls on day 90. And we take a snapshot one month after day 90. Patient one is out to 16 weeks at that point. So you are going to have a spectrum of people from one month out to 16 weeks at that point. And that will I think -- that will be very helpful in predicting the outcome of the entire study, selecting the dose, looking at tolerability, those kinds of things. As I said to an earlier question, from what I can see right now, I think the -- completing the recruiting of the study will move into the early part of 2005. But it will -- we don't belief at this point it will affect the time lines for a meeting with the FDA nor for starting the phase III studies. Rich, you want to add anything to that?

  • - SVP of Drug Development

  • As I said, we enrolled our first patient in June. But the bulk of the patients have been in this interim analysis were enrolled between the beginning of August and the middle of October. So that will give you a sense of where the spectrum of patients would be. It's going to be the last patient in came in the middle of October for that interim analysis. We are more than 50 percent enrolled and it's difficult to predict exactly when the study will be fully enrolled. It's a lot easier for me to tell you what the enrollment has been in the past than for me to be very precise about the timing in the future. As we said, our original goal was the end of December. We think the going to be a little bit later than that, but probably not too much, but I can't predict better than that.

  • - Analyst

  • Thanks.

  • Operator

  • At this time there appears to be no further questions. I would like to turn the floor back over to management for any closing remarks.

  • - President and CEO

  • Okay. This is Paul Friedman again. I want to thank you for your time this morning and we certainly appreciate your continuing interest in Incyte. I look forward to keeping you updated on our programs in particular on that interim analysis on study 203 for Reverset, on our unblinded CCR2 phase I results and plans for phase II. And on further progress with our novel Sheddase inhibitor. With that I will say good morning and thanks again for dialing into our conference call.

  • Operator

  • Thank you, and thank you, callers. This does conclude today's conference. You may disconnect your lines at this time and have a wonderful day.