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Incyte Corporation (NASDAQ:INCY)

Q3 2009 Earnings Call

November 5, 2009 8:30 am ET

Executives

Pamela Murphy – Vice President Investor Relations and Corporate Communications

Paul Friedman – President and Chief Executive Officer

Dave Hastings – Executive Vice President and Chief Financial Officer

Rich Levy – Executive Vice President Chief Drug Development and Medical Officer

Pat Andrews – Executive Vice President Chief Commercial Officer.

Analysts

Tom Russo – Robert W. Baird & Company

Eun Yang – Jefferies & Company

Cory Kasimov – JP Morgan, Chase & Company

Joshua Schimmer – Leerink Swann

Liisa Bayko – JMP Asset Management

Lucy Lu – Citigroup

Jeff Elliott – UBS

Operator

Welcome to the Incyte Corporation Third Quarter 2009 Financial Results. (Operator Instructions) It is now my pleasure to introduce your host, Ms. Pamela Murphy, Vice President of Investor Relations and Communication.

Pamela Murphy

On the call today are Paul Friedman, Incyte's President and Chief Executive Officer, Dave Hastings, Executive Vice President Chief Financial Officer, Rich Levy, Executive Vice President Chief Drug Development and Medical Officer, and Pat Andrews, Executive Vice President Chief Commercial Officer. To begin, Paul will provide a review of our lead programs and Dave will follow will a description of our recent financing and third quarter financial results, and 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 this call today including statements regarding our plans and expectations for our drug development program, including timing of our clinical trials, regulatory submissions, and the potential safety and efficacy of our compound, as well as expected financial results and guidance are forward-looking statements. These forward-looking statements are subject to a number of risk and uncertainties that may cause our actual results to differ materially, including those described in our Form 10-Q for the quarter ended September 30, 2009 from time to time in our SEC documents.

Paul Friedman

For our lead JAK1/JAK2 inhibitor Incyte 18424, we're currently enrolling patients in the two Phase III trials, COMFORT-I in the United States, Canada, and Australia, and COMFORT-II in Europe. Our objective remains to complete enrollment late this year or early next and this will keep us on track for filing the new drug application in late 2010 or early 2011. As the press release stated, we have three oral presentations at ASH this year.

Dr. Verstovsek from M.D. Anderson has two of these and will present results from the Phase II trial in patients with advanced polycythemiavera and essential thrombocythemia, as well as give an update on results from the ongoing Phase II trial in patients with myelofibrosis. Additionally Dr. Ravandi also from M.D. Anderson will be presenting results from an investigator sponsored IND for 18424 being used as monotherapy in patients with relapsed or refractory leukemia's.

M.D. Anderson was interested in testing 424 in these patients based on evidence that the JAK-STAT signaling pathway plays a key role in hematopoietic malignancies, and that trial began in May of 2008 and is still recruiting. Given that these treatment refractory patients tend to have very poor outcomes as well as the published data which indicate that JAKs may be centrally involved in this setting, we were supportive of M.D. Anderson's desire to evaluate 424 in leukemia's and look forward to seeing these early results presented at ASH.

Another new program for 424 that we expect to initiate next year evolved from a request from the Children's Oncology Group at the NCI to evaluate 424 in children with relapsed or refractory solid tumors, haematologic malignancies, and myeloproliferative diseases. Your interest came from evidence that JAK-STAT signaling is involved in a variety of cancers as well as recent publications documenting that a percentage of children with acute lymphoblastic leukemia, particularly those with poor prognosis, carry JAK mutations.

Therefore the Children's Oncology Group researchers believe JAK inhibitors may be effective treatments in high risk pediatric cancers. As is the case with most such first in-patient studies the primary objective of this trial will be to obtain dose limiting toxicity data and establish that 424 can be used in children. Obviously we'll be looking for any objective responses in their tumors as well. Based on the NCI's current timelines we expect to see results in the middle of 2011.

Now moving on to the topical formulation of 424, as you know in September we announced positive top line results from our first three month Phase 2b trial in psoriasis. We shared these results with a number of leading KOL's and dermatologist and were encouraged by their feedback. Both groups indicated that the mechanism and profile for topical 424 looked promising.

Particular importance to these physicians is 424's potential to provide a rapid onset of action, meaningful advantages in terms of safety, tolerability, and duration of dosing, and possible application on the face and other sensitive areas without the tolerability concerns that significantly limit or preclude the use of steroids or Vitamin D treatments on these areas. In addition these results have generated a good deal of interest from potential partners and we intend to initiate discussions with these companies to determine whether a partner for this program could make sense.

For our second oral JAK1/JAK2 inhibitor Incyte 28050, we continue to enroll rheumatoid arthritis patients into a six-month Phase II dose ranging trail that we began this past summer. This study involves 100 such patients who have had inadequate responses to their DEMARD treatment. We expect to have three-month results late in the first half of 2010 and six-month results in the second half, which would mean we could present these results at ACR next year.

In regard to our 11beta-HSD1 program, in October we presented results on the Phase 2b trial at the European Academy for the Study of Diabetes, the EASD annual meeting. These results were initially presented during a poster session at ADA annual meeting in June and demonstrated that 13739 significantly improved glycemic control and total cholesterol levels. The EASD oral presentation included a subgroup analysis of total and LDL cholesterol and triglycerides, as well as a description of body weight changes, all of which revealed further positive effects of 739 treatment.

As we said multiple times in the past, this program is not one we'll advance further on our own. We're pursuing partnership opportunities and I should add here that as we've also said before, in addition to partnership discussions for 739 we're an active and productive discussions for our JAK inhibitor programs.

And for those while it remains our intent to keep the U.S. rights to 424 for oncology, we believe a strong rest of the world partner could help us rapidly optimize the MPD opportunity, as well as improve our financial position. With the JAK inflammation program, we would consider a broad global licensing deal or we could opt to do a deal which we share in downstream economics.

With that, I'll turn the call over to Dave to run through our financial situation.

Dave Hastings

I'd like to start this morning by describing our recent financing, the changes to our fourth quarter financial guidance as a result of that financing, and then finish by highlighting a couple of areas in our third quarter financial results.

On September 30, we completed our dual tranche offering of $400 million of 4.75% convertible senior notes due in 2015, and I'll follow on equity offering of $20.7 million common shares. Our note offering resulted in net proceeds of $388 million while our equity offering resulted in net proceeds of over $132 million. We intent to use the proceeds from the note offering to reduce or otherwise retire our existing 2011 convertible notes, in fact we have retired a little over $212 million of these notes thus far.

In addition, as anticipated we placed $56 million of cash in an escrow account reserved for the first three years of interest payments on these new notes. We intend to use the proceeds from the equity offering for general corporate purposes including continuing our investments in our advancing pipeline, particularly our JAK inhibitor programs.

As a result of financing we have increased our interest expense guidance from $26 million to $33 million in 2009. The components of the increase are as follows, $5.3 million of non-cash amortization of debt discount on our new notes as a result of $148 million debt discount we recorded pursuant to provisions of the latest guidance on derivative accounting EITF 07-5. We will amortize that non-cash discount over the life of the notes. In addition, we expect $4.8 million of interest expense on the new notes in the fourth quarter.

Now these increases are partially offset by a $1.9 million reduction of interest expense as a result of the retirement of $212 million of our existing 2011 notes and a $1.2 million reduction in amortization of debt discount as a result of the retirement of $86 million of the existing 2011 senior notes.

Also because of the accounting guidance mentioned above until we get shareholder approval to increase a number of authorized shares of common stock, we will record a mark-to-market non-cash adjustment on the $148 million derivative liability that we recorded upon issuance of our new notes. Because this variable mark-to-market adjustment is tied to our share price, it could result in a significant non-cash gain or charge in the fourth quarter. A special meeting of stockholders is being held on November 24 to approve an increase in number of authorized shares.

In terms of our third quarter operating results, we ended the quarter with $395 million in unrestricted cash and marketable securities. So far we have used $103 million in cash in our cash used guidance of between $122 million and $128 million remains unchanged, although we do expect to be on the upper end of that range in 2009.

Our 2009 cash used and cash used guidance does not include amounts raised in our [dual-trance] offering, amounts used to retire our existing 2011 notes or the amount we placed in escrow for the three years of interest payments on those notes.

In terms of our third quarter and year's date net loss it is important to note it includes a non-cash charge of $5.4 million or $0.05 per share. This charge primarily relates to a portion of our deferred offering cost and debt discount on our existing 2011 notes that we retired at the end of the quarter. As a reminder, of the $212 million that we have retired so far, $186 million was completed in the third quarter and $26 million has been completed so far in the fourth quarter.

We're gratified that we successfully completed our recapitalization as we have strengthened our balance sheet and removed a significant financial overhang. This is critical to our ability to continue to advance our pipeline and enter into negotiations with potential partners.

With that, I'll turn the call back over to you, Paul.

Paul Friedman

Operator, let's just move ahead and open the call to questions, please.

Question-and-Answer Session

Operator

(Operator Instructions) Your first call comes from Tom Russo – Robert W. Baird.

Tom Russo – Robert W. Baird & Company

I'm guessing you probably won't want to set any explicit guidance on timing or partnership, but could you characterize just any of the ones that people focus most on, including the 4240 U.S. diabetes inflammation have meaningfully advanced in the last three months and which if any of those need additional clinical data or new information in order to get to something mutually satisfactory?

Paul Friedman

I would say they all have advanced substantially in the last few months or none of them do I at this point in time anticipate we need any further clinical data to consummate a partnership.

Tom Russo – Robert W. Baird & Company

Do the potential partners for 424 already have the data that you referred to for presentation at ASH? Have they had a chance to look at it?

Paul Friedman

I think in one form or another they've seen it, yes.

Tom Russo – Robert W. Baird & Company

In terms of the enrollment for 424, it sounds like everything is on track. Would you be able to put any percent to the enrollment status at this point?

Paul Friedman

No, I wouldn't do that but what I can tell you is that we have projection curves that keep us on track to enroll give or take a few weeks within the frame of what we anticipated and we're doing just fine in both studies.

Tom Russo – Robert W. Baird & Company

Switching real quick to a financial question, in terms of modeling how should we think about the timing or the pace for paying off the remainder of the old converts that are due in 2011? I know it might be lumpy, but it looks like you paid maybe $25 million in the last month or so and I'm just kind of trying to figure out if there is anything that you can say to help us think about that going forward.

Dave Hastings

Tom, I think we have a lot of optionality there. As you know, all the notes are callable but as we indicated in today's press release we have retired a fair amount and we will continue to do that. But I think you said it well, it is lumpy and difficult to predict. But again, we are focused on using the proceeds from the new note offering to continue to reduce that balance.

Operator

Your next question comes from Eun Yang – Jefferies & Company.

Eun Yang – Jefferies & Company

Paul, you mentioned that 424 you are looking for XUS partners particularly oncology. Does that imply that the oncology rights to utilize [inaudible] in the U.S. Is that only specific in myelofibrosis or it depends on the cancer types?

Paul Friedman

I think in general what we've tried to do with all potential partners is retain oncology rights for 424, not just for myelofibrosis. That seems to be going pretty well.

Eun Yang – Jefferies & Company

Then 424 the understanding that for psoriasis indication is a topical formulation, but is there any plan that you would actually try to 28050 for a topical formulation and then kind of a package of those two indications together and present it to potential partners?

Paul Friedman

Yes, that would be cleaner if it were possible to do. The issue is the structural differences between 050 and 424 lead to very different fluxes through the skin. 424 has a certain functional group which gives very good skin flux and 050 is a more polar compound and has less skin flux. So we were less optimistic that we could make an effective topical with 050, which is the reason we haven't done that.

Operator

Your next question comes from Cory Kasimov – JP Morgan, Chase & Company.

Cory Kasimov – JP Morgan, Chase & Company

First on PV/ET, just heading to ASH wondering if you could set expectations a little bit for the data we're going to see relative to the MF data you presented in the past, really here in terms of how we should be interpreting [M points] all the same or any key differences, and then also within that PV/ET arena, if you could discuss the market opportunity there. And then I have a follow-up on 050.

Paul Friedman

I'm going to let Rich answer the first part of the question. The second part of the question is we have presented in the past the prevalence of PV and ET relative to myelofibrosis as best you can estimate with the data that's out there and it's somewhere between five and seven times as many patients have PV and ET each than myelofibrosis.

I think that's a range that's not unreasonable to give you. About maybe 25% or so of each of those patient groups when they get farther advanced have the sane symptoms. It's very significant symptoms that myelofibrosis patients have. They have splenomegaly and the difference is they don't have fibrosis in their marrow and they have one or more of the blood cell counts elevated, in polycythemia it varies. The red count in essential thrombocythemia it's a platelet count.

So the group of patients that we're currently studying are the more advanced patients and exactly what we would have for endpoints in pivotal trials requires discussion with regulatory agencies, which we are planning. But let me turn it over to Rich to describe to you what you might be expected to see presented at ASH with respect to data from the ongoing Phase II study.

Rich Levy

As Paul said, there are some key differences between PV and ET and myelofibrosis in terms of what you would want to be accomplishing. So, remember in myelofibrosis often times the counts are low because the bone marrow is no longer working very well, whereas in PV and ET the problem is that the counts are high.

And it can be more than just the red cell that's high in PV you can have high platelets and high white count there too. In ET, you generally by definition don't have a high hemoglobin or hematocrit, but you'd have high platelets and you may have high white cell. So, one of the things you're going to be looking for is to bring those high counts down into the normal range.

The second thing is that you do have some patient's who have some significant splenomegaly in PV and ET, as these are advanced patients you will see data on that as well. But that's not the key finding as an important a component to improvement of the patient as you see in MS, where the spleens can be absolutely massive and really debilitative.

The third aspect is the symptoms themselves, and that is fairly similar to myelofibrosis in that patients do tend to have a lot of the same symptoms. One that's really key in psoriasis is pruritus or itching, and it can be –

Paul Friedman

In PV.

Rich Levy

What did I say?

Paul Friedman

Psoriasis.

Rich Levy

In PV, the itching which can be really severe, people can rate them 10 on a scale of 10, so just as we see improvements in pruritus or itching in MF patients, in PV that would be a key thing to look at. But also other symptoms as well that are overlapping. So, I think those are the key areas that you should be looking for when we present the data at ASH.

Cory Kasimov – JP Morgan, Chase & Company

Then the follow up on 050, regarding the ongoing Phase 2, are there still plans to conduct an early interim look at the data that you're going to keep proprietary to share with partners, and if so is it safe to assume that no new would be good news on that front?

Paul Friedman

Yes, there won't be any news and if we keep this study going, I would think that would be good news. And we are planning to do that sometime in the first quarter.

Operator

Your next question comes from Joshua Schimmer – Leerink Swann.

Joshua Schimmer – Leerink Swann

Do you expect the Phase 2 ASH data for PV and ET to be sufficient to begin regulatory discussions and do you feel that the path you went through for the MF SPA in any way facilitates those discussions for PV and ET?

Paul Friedman

Rich?

Rich Levy

Yes, I think the data are sufficient to have discussions with FDA. And as Paul said, we do plan on meeting with them probably sometime early next year. In terms of the endpoints, the endpoints I believe will be different than in MF just as I talked about it a few minutes ago in terms of the objectives. But I think we did learn a lot about how FDA thinks about these things, which are different than their typical cancer studies and the accommodations that we've reached through the FDA process can be applied to the thinking of how we would approach PV and ET.

Joshua Schimmer – Leerink Swann

And you'll be looking for an SPA in those syndications as well?

Rich Levy

It's possible, we haven't decided whether to go the SPA route on a secondary indication is that may not be as critical a decision as it was to get the drug to the market in the first place. The first meeting that we're requesting is not related to an SPA, it's kind of a pre-SPA stage to just have a first level of discussions and based on that we would decide whether or not the SPA makes sense or not.

Joshua Schimmer – Leerink Swann

Then can you give us a quick update on the status and timelines of the QT and carcinogenicity studies for 424 and 050?

Rich Levy

So the definitive QTC study has started. You get different doses and then you get a positive and a negative control each a week apart, and so we're into the dosing phase of that, but then the actual analysis of all the ECGs takes quite a bit of time. So, we don't expect to have results until sometime in the first quarter of next year.

With respect to the carcinogenicity studies, we are doing two studies, one is a transgenic mouse model and that study has begun and we will have results in time for the initial filing. The rat carcinogenicity study, which is a traditional two-year study, per agreement with regulatory authorities it's not required for initial approval. Those studies have also begun, but will not have data until after the registration files are in and likely approved.

Operator

Your next question comes from Liisa Bayko – JMP Securities.

Liisa Bayko – JMP Securities

I'm just wondering if you can give us a sense of what we might expect from the updated data from the Phase 2 trial at ASH. I know that you've been continuing patients on therapy and is there anything different that you've been observing as patients are on therapy longer?

Rich Levy

Patients continue to do well where the abstract is in and the presentation will be in line with what's in the abstract. In terms of the actual content of what topics we're going to cover in depth hasn't been fully decided yet. I mean it is Dr. Verstovsek's presentation and those are his decisions to make and we just haven't reached that point. But I think everything will be in line with the fact that patients are still continuing to do well on drug now some patients two and a half years out.

Our average exposure is now about a year and a half on drug, among the 150 or so patients that were enrolled in the study. Spleens continue to be smaller, symptoms continue to be getting better, and the drug continues to be well tolerated.

Liisa Bayko – JMP Securities

With patients on treatment longer, are you starting to see any signals that there's a change in the underlying disease?

Rich Levy

I'm going to leave that for the final presentations. I think there may very well be some positive interesting data that we're going to present, but I don't want to try to get into it now.

Liisa Bayko – JMP Securities

How many patients of the 150 that started in this trial, how many are still on treatment?

Rich Levy

I don't have the daily numbers, but the last I looked it was around 115.

Liisa Bayko – JMP Securities

If you could just discuss a little bit about the breast cancer trial, you're going to have data for that coming up, I mean how should we think about it and what other kind of data points are going to be presented at San Antonio and I will step back in the queue?

Paul Friedman

We're going to update people on the status of P95 positive patients where they're getting Herceptin plus 7839, the sheddase inhibitor. We have a handful more patients than we had the last time we presented. Some of those are out far enough that you can add them to the data list in trying to determine whether we're doing better with P95 positive patients than you would expect them to be doing with the Herceptin alone.

And there may be several others who are in the study, but who haven't been on drug long enough to be able to add their responses to the overall response rate. I think that's the kind of data we're going to see.

Operator

(Operator Instructions) Our next question comes from Lucy Lu – Citigroup.

Lucy Lu – Citigroup

Just a general question for you, on the partnerships for your inflammation program, diabetes, as well MF for Europe, they were one of the ways you were going to retire the debt and fix your balance sheet in 2009. Now that you have raised a lot of money and enough to retire the debt, I'm just wondering is that still a corporate priority for Incyte, and how has the fact that you've raised money changed the partnership priority?

Paul Friedman

Forming the partnerships is in and of itself a priority and I'll just enumerate the different programs, I think it will become clear why we believe that a strong partner, XUS, for myeloproliferative diseases with established sales force experienced getting reimbursement in Europe would allow for a stronger launch a stronger ability to get appropriate reimbursement and overall higher NPV.

So we've always had that aim whether or not that was going to be the pot of money that we primarily used to retire the debt depended on what else we did with respect to financing, but we've done these things in parallel.

With respect to inflammation, when you look at a company like us both the infrastructure we have and the amount of money that we can spend, and then you look at the opportunities that exist in parallel to be investigated in inflammation, Crohn's disease, ankylosing spondylitis, juvenile rheumatoid arthritis, the list gets pretty long.

And while RA is the most prominent one, there are quite a few others that optimally you'd like to be looking at in a quasi parallel fashion. We just can't do that by ourselves and we see that Pfizer, like the 10,000 pound gorilla, they can do that. And so to remain temporarily competitive, if we can find the right relationship with a partner we think that that would be a more ideal way to fly.

With respect to diabetes, we've always said that we are not going to take forward primary care indications like diabetes into pivotal trials and then to try to launch and so we've always said we were going to have a partner there as well. So there are I think very compelling reasons apart from just having money for retired debt, which have propelled us to aggressively seek partnerships and we continue to do that and those discussions are and have been very fruitful ones. And when we get there, we will announce it to the world.

Lucy Lu – Citigroup

Paul, I don't mean to push you just really trying to understand a little bit better. I think a lot of investors had been expecting one or two deals for inside this year because you guys have so many opportunities. I guess I'm just trying to understand a little bit better. What have been some of the gating factors?

Paul Friedman

Well, the year is not over yet and the fact that we've raised money I think has given us a significant amount of leverage in these negotiations that should be helpful in closing one or more deals. And there's really not much more I can tell you. I would think that investors would not want us to willy-nilly sign a deal so we could announce a deal if we thought that with a little bit more back and forth deals could be optimized and just the fact that it takes a while to get through contracts and committees.

Operator

Your next question comes from Jeff Elliott – UBS.

Jeff Elliott – UBS

Just a follow-up in terms of some of the programs that you had put on hold early in the year like c-MET and the IDO program, where do you have to get from a capital perspective to restart those or should we view those as inactive?

Paul Friedman

Well, I think we probably have capital now where if we choose to we could start either or both of those programs and we may choose to do that.

Jeff Elliott – UBS

But you're not at this point.

Paul Friedman

Well, we're doing work in one of the two.

Operator

There are no further questions. I'd like to hand the floor back over to management for any closing comments.

Paul Friedman

Thank you for your attention and your questions and I think that our ASH presentations are going to be very interesting ones. We hope that we'll have something to say on the partnership front in the very near future but, again, until those things are over they're not over and I appreciate your understanding on that part. And we look forward to speaking with you again soon. With that, we'll end the call.

Operator

This concludes today's teleconference. You may disconnect your lines at this time.

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