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Incyte Corporation (NASDAQ:INCY)

Q1 2009 Earnings Call

May 07, 2009 8:30 AM ET

Executives

Pamela Murphy - Vice President of Investor Relations

Paul A. Friedman, M.D. - President and Chief Executive Officer

David C. Hastings - Executive Vice President and Chief Financial Officer

Richard S. Levy M.D. - Executive Vice President and Chief Drug Development and Medical Officer

Analysts

Mona Ashaya - JPMorgan

Thomas Wei - Piper Jaffray

Thomas Russo - Robert W. Baird & Company

Arlinda Lee - FTN Equity Capital

Eric Schmidt - Cowen and Company

Lisa Bayko - JMP Securities

Operator

Greetings, ladies and gentlemen, and welcome to the Incyte Corporation First Quarter 2009 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow formal presentation. (Operator Instructions). As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Ms. Pamela Murphy, Vice President of Investor Relations and Communications. Thank you, Miss Murphy. You may begin.

Pamela Murphy

Good morning and thank you all for joining us. On the call today are Paul Freidman, Incyte's President and Chief Executive Officer; Dave Hastings, Executive Vice President and Chief Financial Officer; and Rich Levy, Executive Vice President and Chief Drug Development and Medical Officer.

Paul will start with a brief review of our lead program and Dave will follow with a quick summary of our first quarter financial results. We'll then open up the call for Q&A.

Before beginning, we'd like to remind you that some of the statements made during the call today, including statements regarding our plans and expectations for our drug development program, timing of our clinical trials and the potential efficacy of our compound as well as our expected financial results and financial guidance are forward-looking statements. These statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially including those described in our Form 10-K for the year ended December 31, 2008 and from time to time in our SEC documents. Paul?

Paul A. Friedman, M.D.

Good morning everyone. We've had a productive first quarter and looking forward to a number of important events over the next few months. These include the initiation of our Phase III registration trials for INCB18424 in patients with myelofibrosis.

Final results from the three month Phase IIb trial of topical 18424 in psoriasis, the dosing of the first patient in a six month Phase II trial for INCB28050 in rheumatoid arthritis and the final results from our three months Phase IIb trial with INCB13739 in type 2 diabetes.

With respect to these pending events for 18424 for treatment of myelofibrosis, as we've stated before, we have resubmitted the SPA and expect to hear back from the FDA soon. If the FDA agrees with our submission, we remain in a position to start our pivotal Phase III in the first half of the year. We have over 70 sites set up to participate in this trial and coincidently about the same number for the European registration trial. We anticipate that the European trial will also begin within the next month or so.

We continue to believe it will take about six months to enroll each of these studies. For 424 in polycythemia vera and essential thrombocythemia, later this year at ASH, we expect to present data from our ongoing Phase II trial. This study is fully enrolled and we're encouraged by the results we've thus far seen both in terms of safety and efficacy.

Regarding the Phase IIb study using topical 424 in psoriases; we look forward to having results late this summer. For 28050, our oral JAK inhibitor for inflammation, we started screening subjects this week for a six month Phase II trial in Rheumatoid arthritis patients. Dosing should begin in the last week of this month and we expect to have results of the trial in the first half of 2010.

With respect to Incyte 13739, we have just heard back from ADA that the abstract which you'll remember was submitted back in March based on the interim analysis that we did was accepted for this year's late breaking clinical therapeutics poster session at ADA on June 7th in New Orleans. All patients have now completed the trial and we expect to have the final data in early June in time for ADA.

Now turning to our partnering efforts for the JAK oncology program. It remains our intent to keep North American rights, but as we've said before we would consider an ex-U.S. alliance if the deal terms were attractive. The strong rest of the world partner could certainly help us rapidly optimize the NPD opportunity for 424 as well as improve our financial position.

For the JAK Inflammation program, we could do a broad global licensing deal or there maybe opportunities in which we could retain certain indications and or sharing downstream economics.

So in completing my opening remarks, while we don't have a lot of new news to report to you today, we've had a productive quarter and set us up for a very eventful next few months.

So I'll turn the call over to Dave Hastings now, who will walk through a quick review of our first quarter financial results.

David C. Hastings

Thanks Paul and good morning everybody. I'll start my brief review this morning by discussing our cash position.

We ended the first quarter with 175.6 million in cash and investments and our cash use this quarter was 42.2 million. This performance is right on plan and our cash use guidance for the year remain unchanged in the range of 122 to 128 million. As always, this guidance excludes funds that could be received from any potential partners this year.

Another area I'd like to briefly discuss this morning is our operating expenses, particularly R&D costs. Our operating expenses for the quarter were in line with our expectations. R&D expense totaled 29.6 million which is lower than 2008's first quarter R&D expense and reflects our intent to focus on spending on programs that we feel have the greatest likelihood of creating near term value.

Finally, in terms of our overall capital structure, we understand and appreciate that our convertible note balance represents a significant financial overhang. They are various alternatives and strategies available to us to restructure or reduce the notes, and while it's not appropriate to openly discuss all our options and strategic plans, the steps we take to deal with the debt will be focused on maximizing shareholder value.

So with that, I'll now turn the call back over to Paul.

Paul A. Friedman, M.D.

Okay. Thanks Dave. Operator, we can now open up the call for questions.

Question-and-Answer Session

Operator

Thank you. We will now be conducting the question-and-answer session (Operator Instructions). Our first question comes from Mona Ashaya with JPMorgan. Please state your question.

Mona Ashaya - JPMorgan

Hi good morning. I'm here for Cory. A couple of questions. One on the acceptance of 13739 data for ADA. Is it safe to assume that you wouldn't have pushed this if you weren't excited about the findings from the interim analysis?

Paul Friedman, M.D.

I think that is a safe assumption. But that interim analysis was done on about 35% of the patients who ultimately enrolled in the study. So I think it would be prudent to not make assumptions until we get the final data set very early in June.

Mona Ashaya - JPMorgan

Okay. And then my second question is, so it sounds like in the SPA, the second iteration is ramping up and I wonder if you could speak to how much the trial design might have changed to what you had originally envisioned. Is it similar to what you had spoken about earlier?

Paul Friedman, M.D.

Well, I don't want to get into that until we get agreement from the FDA.

Mona Ashaya - JPMorgan

Okay.

Paul Friedman, M.D.

I think if they agree with our resubmitted SPA we'll able to start pivotal and I think at that point in time we will provide you with a very clear description of what we're doing. Suffice it to say we are still anticipating completing the study and filing the NDA in late 2010 or early 2011.

Mona Ashaya - JPMorgan

Okay.

Paul Friedman, M.D.

But I just think it's not prudent to be talking about things that the FDA is reviewing. I'd rather wait until we get the feedback from them.

Mona Ashaya - JPMorgan

Okay. Fair enough. And then my last question is, you've spoken about potentially partnering your early stage oncology assets. And I wonder if you could just provide an update and maybe speak about how much of a priority that is at this point?

Paul Friedman, M.D.

You mean c-MET and sheddase?

Mona Ashaya - JPMorgan

Yes.

Paul Friedman, M.D.

Yes. Well, I think for c-MET if we could find an appropriate partner that... we think we have the best molecule of the c-MET inhibitors. There has been a fair amount of interest and it is a reasonably high priority for us. But if you think about the other things that we talked about partnering and our balance sheet issues, it doesn't move the needle as a pre-clinical entity in a way that an inflam deal or an MPD deal could do because such programs are significantly farther along.

With respect to sheddase, I think until we finish the study that we're currently doing in combination with Herceptin in metastatic breast cancer, I think that program will be... I think it will be hard to get the value that it would have, should that study end up positive as the early results suggest it could. So, those were the two early programs. So we have the IDO program, we've not attempted to partner at this point in time.

Mona Ashaya - JPMorgan

Okay. Thank you.

Operator

Our next question comes from Thomas Wei with Piper Jaffray. Please state your question.

Thomas Wei - Piper Jaffray

Hi, thanks for taking my question. First one is just on the partnership stuff. So, in the prepared comments you focused on the partnership for JAK II in the hematologic indication. You didn't mention the inflam partnership progress. Should we assume that if on the oncology side where you've gotten the most interest in where things have moved along the fastest?

Paul Friedman, M.D.

I did. Actually I did. Let me read it again. I said for the JAK inflammation program we could do a broad global licensing deal or there may be opportunities in which we could retain certain indications and or share downstream economics. There is a lot of interest in that program.

Thomas Wei - Piper Jaffray

Okay. And have you encountered any issues there in terms of splitting out the JAK by indications? Have partners raised it all that as an issue?

Paul Friedman, M.D.

I think that's kind of difficult for me to get into at this point in time. I mean the fact that you ask it, I think because the molecules are different that we're going forward with. I think we've minimized that issue but I don't think I can comment any further on that at this point in time.

Thomas Wei - Piper Jaffray

And just scanning through the OpCo (ph) abstracts, the presentation that that Rubin Mace is making, is that based on a cohort of your patients?

Paul Friedman, M.D.

Rich, you want to answer that?

Richard Levy M.D.

It's based on a combination of two data sets, all from Mayo. One are the base line patients that were enrolled ... based line data on the patients were enrolled involved in our study and then there is the second group of patients that were not enrolled in our study, they also have data.

There is no data in that abstract or in the presentation on the results of treatment with 424 in terms of improvement in six minute lock test. We'll most likely present that data assuming we get an abstract accepted at ASH for December.

Thomas Wei - Piper Jaffray

So, it is no data at the European Hematology Conference on what this other co-primary endpoint might be?

Richard Levy M.D.

We decided that we've been presenting quite a bit on this program and that it was better to wait until ASH to do update a year later. So we will talk once we define exactly what the agreement with the FDA is about the endpoints as well as the data that we have, that suggest that those endpoints would be easily achievable. But not in a scientific presentation in the first half of this year.

Thomas Wei - Piper Jaffray

Okay. And then just lastly on the PVET trial. You had shared with us some insights into the early patients who have been going enrolled during the last call. Do the data now that the trial's fully enrolled still about consistent with those early findings?

Richard Levy M.D.

Yes, they do.

Thomas Wei - Piper Jaffray

Okay, great. Thanks.

Operator

Our next question comes from Tom Russo with Robert W. Baird & Company. Please state your question.

Thomas Russo - Robert W. Baird & Company

Good morning. I was just wondering, after you got the interim results for 739, did you at that time reach back out to some for the partners you talked to in the past or did they reach back to you at that time.

Paul Friedman, M.D.

So what we decided, remember because... I think mainly because a lot of Exubera trials never got done, we were able to enroll the study significantly faster than we had anticipated. So when we looked at where we were with respect to the final data versus the interim analysis, we were close enough to having the final data that we saw that was going to be essentially not a good use of our business development time to go out and reengage everybody with data.

We're in the process of reengaging and we've never disengaged with some people. But we thought we would wait for the final data because it was only like seven more weeks that you had to wait. So, that's kind of where we are. We started to wait until early June before getting back to people.

Thomas Russo - Robert W. Baird & Company

It sounds like you'll have all that data before the ADA meeting. I guess is the logical place to begin those partnership talks again and would we see all that data at that time? Or we just going to see the interim data?

Paul Friedman, M.D.

You'll see the data from the study. I mean, that's the idea. We used the interim data to write the abstract, but we should have all the data from the study collated and ready for the ADA presentation by early June.

Thomas Russo - Robert W. Baird & Company

Okay. And then with 424 in Europe, is the only thing left before starting to get the SPA in U.S. agree to, so that the two trials will look the same or is there anything else that has to happen in Europe before you could start?

Richard Levy M.D.

There is nothing else that needs to happen in Europe other than that the INPD's are still pending approval in some countries and have been approved in others. So that's completely independent of the FDA review.

Thomas Russo - Robert W. Baird & Company

Okay. And then real quick for Dave, the pattern of R&D, there was a comment in the press release over the remainder of the year. So, just how lumpy should that look or will it look more flat and lumpy the rest of this year?

David Hastings

It should look pretty flat this year, Tom.

Thomas Russo - Robert W. Baird & Company

Okay. Thanks very much.

Operator

Thank you. (Operator Instructions). Our next question comes from Arlinda Lee with FTN Equity Capital. Please state your question

Arlinda Lee - FTN Equity Capital

Hi, this is Alinda sitting in for Josh Schimmer. The question is the thing is to how to value converter likely close to as low as they will ever get. Have you attempted to repurchase any of the notes on favorable terms, and if not, why not?

Paul Friedman, M.D.

Yeah, I appreciate the question. I think as I mentioned in my script I don't want to disadvantage us in terms of getting into details about our strategies around the convertible notes. I just want to assure you that any actions we take would obviously we want to focus on maximizing shareholder values. So I don't really want to give you a play by play there on that particular set of strategies.

Arlinda Lee - FTN Equity Capital

Okay. Thank you.

Operator

Our next question comes from Eric Schmidt with Cowen and Company. Please state your question.

Eric Schmidt - Cowen and Company

Thanks for taking my question. I'm a little less familiar with potential FDA responses to SPAs and I guess I'm wondering if you could kind of outline what the potential outcomes are when you hear back from the FDA later this month. Is it black and white either except all changes or just reject your amendment or is there potential for some middle ground and if so, how do you move forward under any of those scenarios?

Richard Levy M.D.

So, in practice there is middle ground because the FDA doesn't really want to be in a position where for a minor, minor tweak to a sentence or something like that their going to reject an FDA and say you need to fix this sentence and start again. So that's an extreme example of course.

So, whereas, they have the legal right to simply say yes or no and then give the comments as to what needs to be changed and then ask for another submission if it's closed but the practices that they'll usually meet with the company either right before the deadline or come back at the time of the deadline and ask for a couple of extra days to try to work out the extra details and give an approval.

So it's not completely black or white. If you're far off, so you're obviously not going to get just a quick meeting to fix everything up. Since we've been through this process once with them already including having meetings in response to the first SPA, we're pretty optimistic that we either get approval or be in a position where these small changes can be quickly made and not have to resubmit.

Eric Schmidt - Cowen and Company

So, it' possible that we might not hear anything in mid May but rather a couple weeks later if you still ironing out some minor details?

Richard Levy M.D.

It's possible but my feeling is, I'm pretty optimistic that we will be able to talk to you in the second half of May.

Eric Schmidt - Cowen and Company

And then a question on 424 in the topical version in psoriasis. Could you just talk a little bit about what type of profile you think is today attractive in terms of efficacy for a topical agent?

Richard Levy M.D.

So first of all topical agent has to be pretty safe. I mean that's clear. In terms of efficacy, if you look at the vitamin-D and vitamin-A analogs, the typical primary endpoint for approval now for topical is an investigator's assessment clear or almost clear and generally with those products you get responses in the 20% range. In fact, there was drug approved within the last year that I think had about 23% clear or almost clear. So, I think that's about the minimum that you need to see and obviously you'd like to have advantages over what's out there.

Eric Schmidt - Cowen and Company

Thanks a lot.

Operator

Our next question comes from Lisa Bayko with JMP Securities. Please state your question.

Lisa Bayko - JMP Securities

Hi, good morning. Thanks for taking the question. Can you just maybe review with us how you're going to communicate the design of the Phase III once you achieve an SPA. Would that just be informal or will you put out a press release? What should we expect?

Paul Friedman, M.D.

Well, we're still thinking about the most optimal way to do that. And both of the possibility that you mentioned are being considered what we haven't finalized how we're going do it yet.

Lisa Bayko - JMP Securities

Okay. And just in the off-chance (ph) that you're sort of far away from FDA in terms of what they want to see in a trial. Are you committed to an SPA or if you can't reach an agreement would you just go ahead regardless?

Paul Friedman, M.D.

We very much like to have the SPA. We are not wedded to it.

Lisa Bayko - JMP Securities

Okay, fair enough. And then.... I think that's actually the majority of my questions. Thanks.

Paul Friedman, M.D.

Thank you.

Operator

Our next question comes from Thomas Wei with Piper Jaffray. Please state your question.

Thomas Wei - Piper Jaffray

Thanks for taking the follow-up. I just wanted to go back to, Dave, a comment that you had made a little bit earlier about R&D being flat for the remainder of the year. I guess with the burn being some $40 million in the first quarter, can you just help us reconcile that against the cash burn guidance for the year and the R&D spend being flat from the first quarter. How do we actually get to the cash burn then?

David Hastings

Yeah, you have a little bit of a reverse hockey stick in our burn. So Q1 is seasonally the highest quarter for our burn. We pay our interest and our notes and plus we pay a lot of our working capital down in Q1.

Thomas Wei - Piper Jaffray

Okay. So it's all in the cash flow statement, interest and working capital and a one-time payment on all the interest due on the...

David Hastings

We make two payments a year.

Thomas Wei - Piper Jaffray

Two payments a year. Okay, great. Thanks.

David Hastings

Sure.

Operator

Thank you. Ladies and gentlemen, there are no further questions at this time. I will now turn the conference back to management for closing comments.

Paul Friedman, M.D.

Thank you all for joining us this morning. As I said I think we are making good progress in the clinical programs. Clearly, our top priorities is to begin the registration trials in myelofibrosis and to improve our financial position by partnering one or more than one of our programs. I look forward to keeping you informed of our progress over the next few months. And with that, let's end the call.

Operator

Thank you. Ladies and gentlemen, this concludes today's teleconference. You may disconnect your lines at this time. Thank you all for your participation.

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