Incyte Corporation's CEO Discusses Q1 2011 Results- Earnings Call Transcript

| About: Incyte Corporation (INCY)

Incyte Corporation (NASDAQ:INCY)

Q1 2011 Earnings Call

May 3, 2011 8:30 am ET

Executives

Pamela Murphy - VP, IR/Corporate Communications

Paul Friedman - President and CEO

Dave Hastings - EVP and CFO

Rich Levy - EVP, Chief Drug Development & Medical Officer

Analysts

Karen J - JPMorgan

Salveen Richter - Collins Stewart

Brian Abrahams - Wells Fargo Securities

Lea Beck - UBS

Eric Schmidt - Cowen & Company

Masha Chapman - Bank of America, Merrill Lynch

Ying Huang - Gleacher & Company

David Friedman - Morgan Stanley

Tom Russo - Robert W. Baird & Co.

Operator

Greetings, ladies and gentlemen, and welcome to the Incyte Corporation first quarter 2011 financial results conference call. A brief question-and-answer session will follow the formal presentation. (Operator instructions) As a reminder, this conference is being recorded.

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

Pamela Murphy

Thanks and good morning. On the call today, are Paul Friedman, Incyte’s President and Chief Executive Officer; David Hastings, Executive Vice President and Chief Financial Officer; Rich Levy, Executive Vice President, Chief Drug Development and Medical Officer; and Pat Andrews, Executive Vice President and Chief Commercial Officer.

Regrettably Paul is trapped in major traffic jam. So while he will be here with us on the call and part of Q&A, Rich will open up the call with a brief overview of our first quarter accomplishments, then Dave will follow with a discussion of quarters financial results and we’ll then open up the call for Q&A.

Before beginning we would 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 programs, including timing of our clinical trials, regulatory submissions, anticipated launch plans and the potential safety and efficacy of our compound as well as our expected financial results are forward-looking statements.

These forward-looking 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, 2010 and from time-to-time in our SEC documents. Rich?

Rich Levy

Good morning everyone. In the first quarter we focused on the preparation of the NDA for our most advanced development compound ruxolitinib for the treatment of myelofibrosis or MF for short. The NDA is based on the positive results for your quarter end December for COMFORT I, our first pivotal phase III trial.

Now that the positive data from COMFORT II, the second phase III pivotal trials are available, Novartis is moving forward with its regulatory submission to the EMEA in Europe. These data will also be included as an important supportive study in our NDA. As reported in mid-March COMFORT II achieved its primary endpoint of significantly reducing spleen size in patients with MF when compared to best available therapy.

These results complement what we saw in COMFORT I and here too the safety profile was consistent with previous studies. We now have a very comprehensive data set to present to the regulatory authorities evaluating ruxolitinib versus two relevant comparators placebo and best available therapy. I can confirm that we and Novartis are both on schedule to submit the NDA and MAA in June.

Since the FDA has given ruxolitinib fast track designation we think it is likely that the agency will grant the NDA a six month priority review. Because ruxolitinib is the first JAK inhibitor for MF we also think it is likely that the agency will schedule an advisory committee meeting and we’ve already started to prepare for this. If the FDA does complete it review within the six month timeframe and approves the products, we’d be prepared to launch it later this year.

As you saw in today’s press release, the results from COMFORT-I and COMFORT-II will be featured in consecutive Oral Presentations at ASCO on June 6th beginning at 09:30 in the morning Chicago time. On that evening, we plan to host an Investor Meeting with the two presenting officers, Dr. Verstovsek the lead investigator for COMFORT-I and Dr. [Bernuke], an investigator for COMFORT II will discuss their presentations. The Investor Event will be webcast.

Both studies will also be featured in the upcoming “Best of ASCO” which is an educational initiative that features representations of key data that were presented at the annual meeting. Abstracts selected for this program include research that ASCO considers relevant and significant to practicing oncologists.

The two studies have also been accepted for presentation at the 16th Congress of European Hematology Association or EHA, which will be held in London. The COMFORT-I abstract, which will be presented in a Presidential Symposium plenary session on June 11th and the COMFORT-II abstract, will be the subject of an oral presentation the following day on June 12th.

I think you will be very impressed with the level and breadth of this data that will be reported for new studies, not the least of which will be the demonstration of the benefit of JAK inhibition compared to placebo as well as the best-available therapy beyond the data on safety and reduction of spleen size, the substantial impact of ruxolitinib on reduction of symptoms that may impact the patients quality of life will also be described.

These aspects of the disease and in large spleen debilitating symptoms and inability to live life normally are the ones that place such a tremendous burden on the patient. Our market research indicates that ruxolitinib’s ability to address these negative outcomes should be very meaningful to both patients and physicians who treat them.

Moving beyond the COMFORT II studies, we also have a very well conceived plan for further development of ruxolitinib in MF as well as other myeloproliferative neoplasms and other malignancies.

With respect to MF, we recently initiated a joint global phase II trials in patients with low platelet counts, those starting between 50,000 and 100,000 and will soon initiate a second related phase to study in the same population of MF patients only in the U.S. Although we have successfully treated patient with platelet counts in this range during Phase II and III studies, these initial studies will assess dosing regimens in patients who have a low platelet count at entry.

Beyond MF there was a global Phase III trial called RESPONSE evaluating ruxolitinib in patients with Advanced Polycythemia Vera, which began in the fourth quarter of last year. We are conducting the trial in the U.S. while Novartis is conducting it outside of the U.S. Most of the U.S. sites are now active and Novartis continues to initiate sites in all of its territory.

In addition to the ongoing trials in MPNs, there are Phase I and Phase II trials with MD Anderson and the Children's Oncology group evaluating ruxolitinib in other leukemias and other hematological malignancies and solid tumors. A Phase II investigator response to study in patients with lymphoma is expected to initiate in the second half of the year as well we plan to initiate our own Phase II trial in patients with pancreatic cancer also in the second half.

For our second oral JAK 1 and JAK 2 inhibitor, we are just partnering with Lilly but all I can say to you is that the Phase 2b trial is progressing and Lilly expects to complete the enrollment by the second half of the year.

To finish up, I’ll give you brief updates on our earlier stage oncology compounds beginning with sheddase inhibitor INCB7839. We hope to complete the analysis of the tissue samples from the HER-2 positive breast cancer patients mid year. We plan to use these results to finalize interpretation of our phase II data and determine whether moving into phase III development is warranted.

Our endowment Indoleamine 2,3-dioxygenase one or IDO inhibitor INCB 24360 represents the novel cancer immunotherapeutic approach and is currently in a phase I trail in patients with solid tumors. The trial is progressing and it is expected to complete the dose escalation phase by the end of the year. Although this mechanism has potential application in a variety of tumor types, we will likely focus on melanoma and a variant cancer in our phase II clinical development program.

Our dose-ranging Phase I trial for our oral cMET Inhibitor INCB28060 in patients with solid tumors is ongoing. As you know Phase I trial is designed to find the maximum tolerated dose. And we are not there yet, so we will continue to study until we reach that dose level. This compound is part of our collaboration with Novartis and in the first quarter we earned a $15 million milestone payment based on achievement of this predefined milestone.

In addition, we are on track to file an IND for another oncology target mid-year and once the IND has been cleared by FDA, Paul and I will be in a better position to describe the program in further detail. I’ll now turn the call over to Dave.

Dave Hastings

Thanks, Rich and good morning everybody. I’ll start my brief overview this morning by discussing our cash position. We ended the first quarter was $384 million in cash and investments excluding $38 million in restricted cash held in escrow for interest payments through October 2012, on our 4.75% Convertible Senior Notes.

Our ending cash also doesn't include the $15 million milestone earned from Novartis for the cMET program. Cash used this quarter was $45 million excluding $4 million in proceeds from stock option exercises. Our cash used for the quarter was on plan and 2011 cash use guidance is unchanged at $185 million to $200 million. This guidance, as always excludes actual and potential milestones received from partners and proceeds from stock option exercises.

Because of the milestone we earned this quarter we are increasing our revenue guidance from $67 million to $82 million for 2011. Now moving to our operating expenses. These two were in line with our expectations and our guidance remains unchanged in both R&D and selling, general and administrative expense as we prepare for the potential launch of ruxolitinib.

In terms of hiring in the commercial area while we've had a core marketing team in place for sometime, this quarter we continue to build out and staffing a sales operation and training functions including our first regional business manager. Importantly, our medical affairs team is now almost fully staffed. So now with that overview, Paul I'll turn the call over to you.

Paul Friedman

Thank you, Dave. Operator, let's open the call for Q&A now please.

Operator

Thank you, sir. (Operator Instructions). Our first question today comes from the line of Karen J with JPMorgan. Please proceed with your question.

Karen J - JPMorgan

Good morning. This is Karen J for Cory Kasimov. I have two quick questions. One, on the commercial build out, could you update us on your plans for the next couple of quarters, as to whether or not they’ve changed and what has been Novartis’s role? Have they’ve been instrumental or helpful in that? And secondly if you could comment on importance or benefit of being first to market with the JAK inhibitor, that would be great?

Paul Friedman

So Pat Andrews should address that question.

Pat Andrews

Great, thanks Paul. So our plans are the same. We plan on hiring our regional managers in the second quarter and reps in the third quarter. We are on track for that. Our plans are in place and we are moving, and as Dave mentioned, we’ve actually already brought on board the first regional manager. And our head of sales has been on board since mid last year. So those plans are on track.

Novartis has the ex-US portion of this and we have the US piece. Of course we talk frequently, we have excellent communication between the two companies, but the US build out is ours. Where possible and appropriate, we align on global aspects. We previously said that the brand name that we are working on for example is a global brand name.

Now that may because it still needs to go through regulatory authorities, may not ultimately end up being the circumstance, but that’s the type of thing that we would plan on with the Novartis, because there are certain synergies associated with it.

And then being first to market is a very strong plus. It allows us to shape the market. It allows us to create the first impression of JAK inhibition in myelofibrosis patients. It of course gives us a window of time before our competitor comes in which is in the two to three year range, assuming some of the competitors do progress their studies. So there are tremendous advantages to it. It’s an excellent position to be in.

Operator

Thank you, our next question comes from the line of Salveen Richter with Collins Stewart. Please proceed with your question.

Salveen Richter - Collins Stewart

So at ASCO, we will see data from ruxolitinib and other MF drugs using varied definitions for anemia response. May be you could just give us some clarity in terms of your physician feedback. What are they most focused on here?

Paul Friedman

So I will start and then I will have Rich and perhaps Pat follow up. Obviously some people are focused on thrombocytopenia and but there is much less focus frankly on dealing with anemia because these physicians are used to doing that, obviously we had a drug that would cure the anemia along with all the other benefits, that would be an advantage.

But mainly interested in the ability to shrink the spleen by at least 10% is significant shrinkage of the spleen and the relief of these profoundly debilitating symptoms, obviously they are also with the interest in improving survival although that was not an outcome that was – that we expected in either study to yield statistical significance, although we’ve indicated that there are positive trends.

But I’ll turn it over to Rich and to Pat to see whether they want to add anything further.

Richard Levy

I have to make – to add, I mean I don’t hear from the physicians that they are particularly concerned about the sciatic profile of the drug in fact there are – the things that we hear is how remarkably well tolerated it is.

I mean, anemia is something that they’re very used to dealing with and not something there is a particular concern, of course they prefer drug that didn’t have any effects on anemia or cure to anemia. But that’s not a focus; and so they are focused on the safe and effective use of the drug. And I don’t know what you understand there.

Paul Friedman

So I would just add that many of these physicians have been treating their patients for a number of years and during that period of time may not been able to help them with the debilitating symptoms that they have. And the symptoms really do give and that patient core quality of life. There is a lot of them and whilst anyone of them maybe mild to moderate collectively they post quite a disease burden on the patient.

So the physicians, they are looking for something which has a good risk benefit profile and they are focusing on efficacy and they believe like oncologists, typically they are focusing more on efficacy and they try to manage this side effects and consequences that might occurred with taking a medication.

And that's how we have seen consistently in all of our research. We have interviewed probably close to now 1,000 physicians in the U.S. and in some other countries. And the overwhelming response is that if the improvement in the debilitating symptoms and the reduction in spleen or there any other consequences that might include thrombocytopenia or anemia are manageable.

Salveen Richter - Collins Stewart

Great. And just a follow up if I may, how many patients from COMFORT I remain on drug?

Paul Friedman

Rich, do you want to answer that?

Richard Levy

Yeah. I don't have that number at hand, but it's a vast majority. I mean there were some placebo patients who didn’t make it thru to the crossover; probably over 90% of the patients who originally randomized to ruxolitinib did and the dropout rate after the crossover, I don't have quantitative information on, but my understanding is that it’s minimal.

Salveen Richter - Collins Stewart

Great, thank you.

Operator

Thank you. Our next question comes from the line of Brian Abrahams with Wells Fargo. Please proceed with your question.

Brian Abrahams - Wells Fargo Securities

Hi, thanks for taking my question and congrats on the continued progress. I had a question on the SR formulation, you mentioned that you initiated a Phase II study and we saw that recently posted ClinicalTrials.gov.

I was just wondering if you could maybe talk a little about what the technology or approach here is with this formulation. What you have seen so far in clinical and pre-clinical studies.

And whether or not you think the Phase II would be a sufficient enough approaching study to potentially expand the label to the Phase II to once a day or over the new larger Phase III? And then I guess for Pat, from the commercial standpoint how much of an impact do you expect a once a day formulation to have this more targeted towards – is this targeted towards expanding the market potentially or more protected to help and protect against future competition? Thanks.

Paul Friedman

Yeah. So I’ll start and then I’ll pass the time again to Rich and to Pat. We already have shown with doses of 150 once a day IR that we get very good responses. We’re looking for a smoother profile, a lower peak and you know more extended AUC by using SR formulation.

We’ve seen in that animals in our early PK we’ve been able to demonstrate as well. But I don’t think we have – Rich may have something add to this, but we’ve just begun the studies, so we don’t have a whole lot of information yet from the Phase II trial.

Would that be fair Rich?

Richard Levy

Yeah. I think we only had our first patients receiving the drug for a few weeks now and so I just know that there are no problems so far and I don’t really know anything more than that. The studies that we are doing now would not be all you would need to get to market; that’s pretty clear. This is essentially dose escalation and expansion added dose.

What would you actually need to get it to market, if we decide that it has enough benefit over the IR in order to do that is not exactly clear; and when look at the data that we have from the COMFORT I study, you can see that wouldn’t require a whole lot of patients in order to be able to demonstrate effectiveness versus control, if that was to be required. It would be more of an issue as to how many patients would need to expose to that formulation for safety in order for regulatory authorities to be comfortable. But it shouldn't take too long, but this one study is not the only one.

Paul Friedman

Pat, do you have something to add?

Patricia Andrews

Yes, a couple of things. So a twice daily drug commercially in myelofibrosis is high and we would really be studying it more for competitive reasons to protect our share in case any competitor one day down the road did come in with a once a day product. By itself that's not enough to make a difference, but if someone came in with a comparable efficacy in once a day, it’s a slight plus.

There's also a generally greater compliance with the once a day rather than a twice a day. We don't expect it would have a huge difference in this particular therapeutic area, because actually the patients feel pretty good on drug and they actually feel a bit worse off drugs, so they are probably more inclined to have a high compliance rate in this area; nonetheless in general, compliance is higher with a once a day drug say maybe 10% to 15% higher.

So while that doesn't expand the market in the sense that the number of patients will remain the same. It might make there to be slightly more drug utilization just through compliance. So those would be the reasons why we would be – and of course with greater compliance comes generally greater efficacy, so – and that would benefit the patient population. So those would be the reasons why we would be looking at once a day dose.

Brian Abrahams - Wells Fargo Securities

Thanks, that’s very helpful. And then just a real quick follow-up; any differences in the areas of focus between the ASCO presentations and the EHA data presentations?

Paul Friedman

Rich would say not – not really...

Rich Levy

As of now, absolutely not. It may turn out that based on some questions we may get at that one presentation we might make some last minute modifications in order to be able to address those things more fully in light of later presentation. But you are asking whether you need to go to both. They are going to be fairly similar.

Brian Abrahams - Wells Fargo Securities

Okay. Thanks very much for the clarity.

Operator

Thank you. Our next question comes from the line of Matt Roden with UBS. Please proceed with your question.

Lea Beck - UBS

Hi, good morning. This [Lea Beck] for Matt Roden. If I could just sort shift gears for a second and talk about the RA program. Have you had any potential discussions with Lily or afterthoughts regarding the imbalance or shift that Pfizer has recent seen in their Phase III trials? And just as an aside or I guess a follow-on to that, do you think there is anything that you might see in a potential safety benefit being more of a JAK1/2 specific target rather than a pan JAK target? Thanks.

Paul Friedman

We are taking Pfizer at their word that in the one study that seems to have created all this excitement. There were four deaths in on-drug. I think two of those that’s occurred after patients were off-drug. One was respiratory that and one was acute heart failure which Pfizer was willing to tell us was not related to drug.

So, I am actually at a loss to understand what the issue is frankly. We have in hundreds now of MF patients, older patients sick with cardiovascular disease have not seen any increased incidents in patients on drug in congested heart failure or cardiac problems.

And so I don’t understand what the issue is frankly at this point unless you don’t take Pfizer at your word. And so I would ask Rich to expand on that if he can, but that’s my level of understanding of what’s happened in the last couple of weeks around their publication of their abstracts.

Rich Levy

So I mean abstracts are helpful. It is going to be a while both at the ULAR meetings and then again some of the data won’t come out until ACR to be able to see a little bit more in detail on these things. But just looking at it from what’s available, I mean number one, I think that there is a lot more exposure to drug than they are to controls over the long course here.

Two, that these are for the most parts patients who have comorbidities. It is quite well known for example that because of the inflammatory state that exists within rheumatoid arthritis as in other inflammatory states, there are more risks for cardiovascular disease than an age matched population.

I would also say that we find it encouraging that they have completed all of their phase III studies and they all showed positive efficacy results including within a very short timeframe, which is only six months showing a difference in – and the X-Ray changes indicating that it is a true [indicator] and we haven’t seen the smoking guns by any means that suggest that the safety profile is going to be a problem for them.

And with respect to our and Lilly’s drug, we haven’t seen any of the – we clearly have fewer patients exposed with that particular drug so far, but we haven’t seen heart disease, respiratory failure and any of those things.

And with respect with the JAK 1, 2 versus JAK 1, 2, 3 is going to make a difference here. I mean this is just theoretical. It’s possible, but we don’t have the data to really address that.

Lea Beck - UBS

Right, thank you.

Operator

Thank you. Our next question comes from line of Eric Schmidt with Cowen & Company. Please proceed with your question.

Eric Schmidt - Cowen & Company

Thanks for taking the call. Just a couple of minor questions remaining; is there any update on enrolment in the response study?

Paul Friedman

So enrolment in the response study is proceeding reasonably well and we still have a number of the most important sites meaning that the academic sites with their longer times to get everything through, not only their IRB’s but their oncology review committee and things like that; those always take more time and those are the sites that we expect to enroll with the largest number patients and that’s kind of where we are in the U.S.

With respect to Europe, Novartis has really only gotten started within the past months and so they have some other sites, but the majority are still not out. So its really going to take I think another quarter to have a good sense as to whether or not we have all the right sites to be able to complete this on time. Right now, it’s just a little bit behind.

Eric Schmidt - Cowen & Company

On time being by year-endish?

Paul Friedman

That's right.

Eric Schmidt - Cowen & Company

Okay. And then the $15 million milestone from the Novartis for the cMET Phase I, can you talk about what was accomplished in that trial and also this may be a bit of a net, but Dave why doesn’t the cash front guidance go down by 15 million, with that milestone in hand.

Dave Hastings

Yeah. Eric so, in terms of the cash burn guidance, we always give gross cash burn excluding milestone, so certainly on net basis our cash burn will be lower but on a growth basis, we have not changed the 185 to 200.

Eric Schmidt - Cowen & Company

And what was milestone for?

Dave Hastings

Well, unfortunately as you know, because of the confidentiality, we can't go into that detail. We can just say that it was a pre-defined milestone for progress in the clinic, we are happy with where the program is as is Novartis and we look forward to moving that program forward.

Operator

Thank you. Our next question comes from the line of Rachel McMinn with Bank of America, Merrill Lynch. Please proceed with your question.

Masha Chapman - Bank of America, Merrill Lynch

Good morning. This is [Masha Chapman] for Rachel. I have a question on ruxolitinib, how does the most recent pricing in the oncology effect [deal value] of ruxolitinib pricing and the second question is, will Novartis have expanded access in Europe?

Paul Friedman

So Rich is, is Novartis doing expanded access firmer in Europe?

Rich Levy

We know that they are doing something, but I don't have any details on exactly which countries are starting when, I think it is likely to start after they file which again should be in June. But I have not been privy to all the details because it doesn’t really involve us directly.

Masha Chapman - Bank of America, Merrill Lynch

Right. And, Pat would you like to comment on the, the question about pricing?

Pat Andrews

Sure. Yes, of course we continually monitor what’s happening in the oncology market place, you know all aspects including on price. So we are certainly aware of prices that have come out on drugs recently launched and we continually compare our thinking. With that we will also be fielding some substantial market research over the next few months to help us determine what that price will be and then we will actually set it launch.

Operator

Thank you. Our next question comes from the line of Ying Huang with Gleacher & Company. Please proceed with your question.

Ying Huang - Gleacher & Company

Hey, good morning guys, thanks for taking my question. I guess my first question is on Sustained Release (NYSE:SR) formulation here. Is there any reason to believe that based on what you have learnt from preclinical studies that this formulation may have some beneficiary effect on myelosuppression?

Paul Friedman

I don’t think we can say that. It's more meant for protecting us and having what we believe is the best once-a-day formulation that you could have in the event that we needed these are big competition and as Pat mentioned, if you could have a once-a-day, it has compliance advantages over twice a day. I would say from the pre-clinical data, there would be no way for us, whether there would be less myelosuppression. It's possible, but we have to see the demand.

Ying Huang - Gleacher & Company

Okay thanks. And then I will follow up on your filings here. So as I understand, you would probably take both data from COMFORT-I and COMFORT-II to talk to FDA in terms of the US filing and is this also the same case with Novartis filing in Europe and does that also take the data from COMFORT-I here?

Paul Friedman

Rich, that is what's going to happen, correct?

Rich Levy

Yes, first of all you always have to essentially give all the data that you have. It’s a question of how you emphasize the data. So for the US, COMFORT-I is our pivotal study and COMFORT-II is supportive and that also means that data from COMFORT-II can result in labeling claims, including what we think is very important being able to compare to best available therapy and beyond just being able to compare to placebo.

With respect to Europe, the symptom data for the most part comes from COMFORT-I which is the blinded trial and although that symptom data hasn't been presented yet in any kind of detailed way, that will also be very important to Novartis' product profile that they want to get across in Europe, so the two studies are complimentary.

Operator

Thank you. Our next question comes from the line of David Friedman with Morgan Stanley. Please proceed with your question.

David Friedman - Morgan Stanley

Can you discuss the dosing that you think will end up being the most successful in the low platelet study and for patients in COMFORT-I and/or COMFORT-II who have had low platelets, where do they tend to settle out in terms of dose?

Rich Levy

Yes, so what we've found is that 5 milligram BID can be a quite active dose, but it’s clearly not as effective as higher doses. 10 milligrams BID gets to be close to as effective as the higher doses and the patients that we treated before who come in with very low blood accounts and are I shouldn’t say very little – come in with lower end blood accounts and then end up being managed with on drug and they end up pretty much mostly around 10 milligram OAD, some at five and some at 15, not too many higher than that.

So I think that doses for the patients who come into these new studies with low blood accounts will probably end up on somewhat lower doses and we’ve studied in the Phase III trials. But once that we expect will give them much of the benefits, better patients with higher starting blood accounts, but we need to see the data of course.

David Friedman - Morgan Stanley

And just a quick follow-up, is there anything about the patients that gets thrombocythemia to suggest that they’re more sensitive to the drug; that they could get a similar benefit with a much lower dose or is it more about their own disease that as and the characteristics of their marrow that dictate the thrombocythemia?

Paul Friedman

So, I can’t give you absolute answer to that question, but it seems as if the most predominant thing is their disease state. The degree of thrombocythemia is that they already have before starting on a JAK inhibitor. So I don’t know that anyone is more or less sensitive to the drug per se; it’s just that you have less of above or before you start getting into accounts that you’re trying to avoid.

David Friedman - Morgan Stanley

Okay, thanks very much.

Operator

Thank you, ladies and gentlemen. We’re coming to the end of our time here today. Our last question comes from the line of Tom Russo with Robert W. Baird. Please proceed with your question.

Tom Russo - Robert W. Baird & Co.

Most of my questions have been asked, but just with ASCO coming up and I know your data is going to be in the slot-like quite a bit there. But can you talk about just any other awareness maybe Pat, may be if you address any other awareness programs that we should look for it or EHA or may be even any patient focused meetings that’ll be coming up? Thanks.

Pamela Murphy

This is Pam, Tom. There are no real formal patient meetings around either at the scientific forum. There’s a concentrated effort obviously at this point with media that’s not been there before and there’s a lot of interest from the media.

I think other than that there is an education session that ASCO had put in the agenda that Dr. Verstovsek will participate and I think we might be sponsoring some CME this year. We certainly will have a very large booth in [Albright] and which we should do this; it will have a lot of interesting stuff there and a medical information area.

Tom Russo - Robert W. Baird & Co.

Okay, thanks.

Pamela Murphy

Hey, thanks.

Operator

Thank you. Ladies and gentlemen, at this time, I’d like to turn the call back to management for any closing comments.

Paul Friedman

All right, this is Paul. We’re looking forward to being able to discuss our data at ASCO, its now only about a month away and then again at EHA and we’re – as we said in the beginning working diligently to get both regulatory documents in, in the June timeframe and we’re on track to do that.

So stay tuned and we’ll see everybody at ASCO, and thanks for listening this morning, and with that I’ll say goodbye.

Operator

Ladies and gentlemen, this concludes today’s teleconference. You may disconnect your lines at this time. And thank you for your participation.

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