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Pharmacyclics, Inc. (NASDAQ:PCYC)

Q1 2014 Earnings Conference Call

May 2, 2014 8:30 AM ET

Executives

Rainer Erdtmann – SVP, IR

Robert Duggan – Chairman and CEO

Manmeet Soni – CFO

Matt Outten – VP, Commercial Operations

Jesse McGreivy – Chief Medical Officer

Maria Fardis – Chief of Oncology Operations & Alliances

Analysts

Michael King – JMP Securities LLC

Joel Sendek – Stifel, Nicolaus & Company

Brian Skorney – Robert W. Baird

Katherine Xu – William Blair

Ian Somaiya – Nomura Securities Co. Ltd.

Navdeep Singh – Goldman Sachs

Robyn Karnauskas – Deutsche Bank

Jason Kantor – Crédit Suisse AG

Matthew Andrews – Wells Fargo Securities, LLC

Operator

Good day ladies and gentlemen and welcome to the Pharmacyclics’ First Quarter 2014 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instruction will be given at that time. (Operator Instructions). As a reminder, this conference call is being recorded.

I’ll now introduce your host for today’s conference Mr. Ramses Erdtmann, Senior Vice President of Investor Relations. You may begin.

Rainer Erdtmann

Thank you very much, Ashley. Welcome to the Pharmacyclics’ 2014 First Quarter Earnings Conference Call. With me on the call is our entire executive team. We will hear prepared remarks by our CEO, Bob Duggan; our CFO Manmeet Soni; and our Vice President of Commercial Operation, Matthew Outten; our CMO, Dr. Jesse McGreivy and Chief of Oncology Operations & Alliances Dr. Maria Fardis.

Before we begin, let me remind you that, this non-confidential presentation contains forward-looking statements about the business prospects of Pharmacyclics, including expectations regarding Pharmacyclics’ financial performance, commercial products and potential future products in different areas of therapeutic research and development. Results may differ materially depending on the progress of Pharmacyclics’ product programs, actions of regulatory authorities, availability of capital, future actions in the pharmaceutical market and developments by competitors and those factors detailed in Pharmacyclics’ filings with the SEC, such as the 10-Q, the 10-K and 8-K reports.

I would now like to turn the call over to our CEO, Bob Duggan.

Robert Duggan

Thank you, Ramses. These are really productive times at Pharmacyclics. Today, we are reporting our first full quarter as a commercial organization with $56.2 million of IMBRUVICA net sales, well over 10,000 barrels of IMBRUVICA have shipped since our approval in November. We are clearly positively impacting many lives with the IMBRUVICA and as you will learn during our call today, we have initiated large-scale clinical trials and partnership with the Janssen that will yield a host for regulatory filing over the next one to four years. Potentially leading to numerous additional indications for patients treated either with IMBRUVICA as a single agent or in combination with standards of care.

IMBRUVICA’s profile and performance leads us to feel our molecule has a potential to transform the treatment of B-cell malignancies. The uptick in mantle cell in the past five month and most recently CLL over the past few months speaks to a significant unmet medical need. Together in partnership with Janssen, we are working on the clinical development and commercial expansion of IMBRUVICA with a combined 700 highly valued team members. I couldn’t be more proud of our combined teams. We so softly brought IMBRUVICA to the U.S. market in these past months.

In January, we learned about the interim results of our Phase III CLL study resonate and it’s especially positive results in progression-free survival and overall survival. In February, we’ve received an accelerated approval for IMBRUVICA and CLL patients with one prior therapy and most recently in April, we filed four resonate data package with the FDA. Along with our European filing last year, well-orchestrated by our partner Janssen, we are looking towards a robust world-wide registration of IMBRUVICA over the next 12 months and beyond.

We define a success of IMBRUVICA and the success of our company by the degree we help patients to achieve a true benefit from therapy. At Pharmacyclics, we are highly progressed on patients benefiting from therapy and achieving long-term positive effects while on our therapy. We look at the speed of efficacy, duration and tolerability of therapy in relation to the side effects profile as well as in relation to other available therapies.

As you look at the marketplace and compare the various existing and new therapies, you can ask yourself as we do, what are the benefits of each therapy is proving and for length of time? What is the discontinuation rate for each of these compounds? You will learn at ASCO for the first time comparative, randomized results between IMBRUVICA and a standard-of-care and CLL. You will also see an additional presentation addressing three year follow-up data in CLL patients with four prior therapies demonstrating the impressive safety and efficacy of IMBRUVICA through time.

Over the past months, there have been questions as to the bloody of different sales reporting data bases and also questions about that accuracy of the information these services provide. Estimates from the reporting companies or projections and may or may not be accurate making revisions often necessary as we have seen in this past quarter. We will not comment on third party reported number and trends. We respectfully request that you address to your questions to these reporting companies. The most reliable report of IMBRUVICA sales will be what we report on a quarterly basis.

You’ll here today a summary of our financials followed by a review of our commercial expansion, a clinical update in particular on our single and combination strategy and we will provide a general overview of our regulatory timelines for the indications that we are pursuing today.

I will now turn the call over to Manmeet Soni, our CFO. Manmeet?

Manmeet Soni

Thank you, Bob. Good morning, everyone and thank you all for joining us today. Pharmacyclics had an excellent start in 2014. We received our second FDA approval for CLL giving us $16 million of milestone revenue during the first quarter of 2014. Additionally, we completed our first full quarter of product revenues for MCL and six weeks for CLL.

We also closed the first quarter of 2014 in a strong financial position with $609 million in cash, cash equivalents and marketable securities as compared to $636 million as of December 2013. Consistent with the last quarter guidance, we continue to expect to end the year 2014 with cash, cash equivalents and marketable securities in access of $600 million. Earlier today, we reported non-GAAP net income of $31.3 million or $0.40 of income per diluted share for the first quarter of 2014, as compared to non-GAAP net loss of $28.3 million or $0.40 of loss per diluted shares for the first quarter of 2013.

Our first full quarter of IMBRUVICA’s net product revenue was $56.2 million. We recognize revenue from the IMBRUVICA’s product sales once titled and risk of loss transfers to our customers. Our gross product revenue for the quarter was approximately $64.8 million, our adjustments for charge packs the dates, results and discounts were approximately $8.6 million. This calculates a gross to net adjustment of approximately 13.3% for the first quarter of 2014, resulting in net product revenues of $56.2 million.

During our full quarter call, we highlighted that, approximately $3.6 million of our fourth quarter 2013 revenue was ready to inventory in the distribution channel as of December 31, 2013. Though our net product revenue increased to $56.2 million in the first quarter of 2014, our inventory in the distribution channel has only increased by 3.8 million to approximately 7.4 million at the end of the first quarter.

Accordingly, the actual product demand during the quarter was approximately $52.4 million. We currently estimate that, based on the current information, our net product revenue for IMBRUVICA in the second quarter will be 80 million plus or minus 5%. The percentage increase in net product revenue from the fourth quarter of the prior year for the first quarter of the current year was primarily due to approval of the second indication during the middle of the quarter. This growth rate may not at this time be indicative of the future quarterly growth rates.

We predict nominal growth rates until we benefit from another label. Until this occurs and until we better understand and can predict the patient duration and mix, we are using the second quarter estimates as a calculation for our 2014 full year guidance of net product revenues. We currently anticipate based on the current information that our net product revenue for the full year will be $295 million plus or minus 5%. We’ll update you during our quarterly calls as we learn and further understand the patient dynamics.

During the first quarter of 2014, we shipped approximately 4,000 bottles of 90-count capsules and approximately 2,900 bottles of 120-count capsules. As of today, since the launch of IMBRUVICA, Pharmacyclics has shipped more than 10,000 bottles to patients in need. Let’s now review our cost and expenses for the quarter ended March 2014.

Our non-GAAP cost and expenses which exclude stock-based compensation were $88.2 million for the first quarter of 2014, as compared to $32.2 million for the first quarter of 2013. This represents a $56 million increase. This increase was primarily due to the expansion of our commercial activities for IMBRUVICA after FDA approval for CLL and MCL patient and the expansion of our development program for IMBRUVICA and collaboration with Janssen.

For the first quarter of 2014, our 40% share of direct IMBRUVICA, R&D expenses and 50% share of our direct IMBRUVICA SG&A expenses amounted to $24.4 million and $18.1 million respectively totaling to 42.5 million. Pharmacyclics recognizes 100% of product revenue and cost of goods sold in the United States.

In the first quarter of 2014, we recorded net product revenues of $56.2 million and cost of goods sold of $6.1 million, which resulted in a net amount of 50 million. We split these amounts with our partners Janssen on a 50-50 basis and therefore we recorded a cost of collaboration expense of 25 million in our P&L.

To-date a total of $134.3 million in excess amounts have been recorded as a reduction in cost and expenses. During the quarter ended March 31, 2014 we recorded no additional use of excess amounts as we did not reached the 50 million annual expense gap in the quarter. Our share of direct IMBRUVICA R&D and SG&A expenses under the collaboration added up to $42.5 million and expenses offset by our share of profits amounted to $25 million, resulting in 17.5 million of net qualified expenses towards the annual $50 million expense gap.

As of March 31, 2014 we had additional $65.7 million in excess amounts with the current growth and revenue expenses, we anticipate to use minimal if any of excess amounts during the second quarter of 2014. We ended with 6.1 million of cost of goods sold for the first quarter of 2014, which is approximately 11% net product revenue, as compared to 26% for the fourth quarter of 2013. We expect this percentage to improve over time and normalize in the high single-digit range.

Our R&D expenses for the first quarter of 2014 were $24.4 million as compared to $34.2 million in the fourth quarter of 2013. This reduction is primarily due to timing of certain clinical and development activities. This result is not indicative of future quarters as we anticipate the cost of new trials can increase in the upcoming quarters. We also anticipate our SG&A expense under the collaboration to increase to support revenue growth in the future quarters. I would now like to turn the call over to Matt Outten, our VP of Commercial Operations. Matt.

Matt Outten

Thank you, Manmeet. Quarter one seem busy and successful for our commercial teams. Our 62 sales representatives, 19 market access team mates and JBI’s full time equivalent sales representatives have been outing the field educating healthcare professionals on the unique, efficacious and well tolerated benefits of IMBRUVICA.

Our sales representatives have contacted to the majority of the core U.S. MCL trading physicians and during this quarter have now focused on the CLL specialist as well. Our national account executives have seen all of the large national and regional commercial payers who are covering IMBRUVICA in both CLL and MCL for patients who have received one prior therapy.

Today, doctors are embracing the oral, once daily, single agent chemo-3 profile that IMBRUVICA offers patients. We have seen prescription uptick, broad awareness and use within the academic and community centers. As expected some community doctors require further education of the benefits that a targeted oral therapy offers. In November, after first approval for MCL, we saw IMBRUVICA being prescribed for these patients. We have since seen these gradually increase to healthier patients. Shifting gears, our access programs continue to set the standard for true, patient-friendly outreach.

Our YOU&i sell program which is basically free medicines for up to 60 days for eligible patients experiencing insurance coverage delays has been utilized by only a few patients due to fast and broad coverage by government and commercial payers. Our YOU&i Instant Savings program, which limits commercial patients out-of-pocket cost to $25 regardless of income level has been used by many patients. This program provides easy access and it’s quite popular. Along with our charitable donations to third party efficacy foundations, we are working to ensure that our patients in need gain access to IMBRUVICA independent of their financial status. We’ve made great progress this quarter with our commercial launch.

We continue to refine and adjust our marketing and sales strategies and tactics as we continue to gain market share and learn from our daily sales experiences. Today, we have taken over the lead and relapsed refractory MCL as reported by patient claims data and are working hard to become the leader in CLL as well.

I will now turn the call over to our CMO Dr. Jesse McGreivy. Jesse.

Jesse McGreivy

Thank you, Matt. As many of you know the strength of IMBRUVICA as a single agent is well documented. We believe the clinical success of Dr. John Bird and Dr. Michal Wong studies both resulting in the received of an FDA approval, it’s just the beginning for this molecule. If you look at what Dr. Susan have presented this past ASH 2013 regarding the durability of IMBRUVICA, 69.7% of relapse refractory responding patients with the median of four prior therapies were benefiting progression to 3 and a median of 23 months of follow up.

In the same presentation, you also get to see how IMBRUVICA performs for treatment naive patients 95.8% of these patients were benefiting a live and progression-free from single-agent IMBRUVICA at a median of 28 months of follow up. We do believe however that, there are patients who benefit from using IMBRUVICA in combination with other anti-cancer therapies. IMBRUVICA’s tolerability profile makes it a great candidate to undertake this type of approach, that’s why about half of our studies today look at combination regimens with IMBRUVICA. Histologies in which combinations are currently being studied include CLL, SLL, MCL, SL, MZL, DLBCL and multiple myeloma.

In addition, we are also looking at combinations with noble agents and clinical development, and as their clinical data matures, we will be evaluating these combinations in clinical trials. Most importantly, as announced on April 7th, we submitted our Phase III data to the FDA in support of we receiving a full approval for a CLL label. We hope to have the updated label by year end. The data generated by resonate is historical achievement in the relapsed/refractory CLL setting.

It’s really the first time when I said, the overall survival has been demonstrated against an approved active competitor. This benefit in overall survival was observed at the interim analysis in January despite the fact that ofatumumab treated patients were allowed to cause over to IMBRUVICA after-disease progression had been confirmed as of August 2013. This truly speaks to the efficacy and safety of IMBRUVICA and the strength of the data.

RESONATE is a 391 patient Phase III study that was conducted at more than 70 clinical sites in 10 countries. We are already excited to have the opportunity to share this data with you in oral presentation at upcoming ASCO meeting in this first week of June. Also at ASCO, we will provide an update from our single agent CLL/SLL long-term expansion study PCYC-1103 with three years of follow-up. We will also have three other poster presentations at this year’s ASCO, one of them reports data on the combination of IMBRUVICA and ofatumumab from our 71 patient Phase I/II study. Here you will see the impact of adding an anti CD-20 human antibody to IMBRUVICA in patients with relapsed/refractory CLL and SLL. We examined impact of various sequential dosing strategies versus the CD-20 antibody.

We would like to provide a top level update on the multiple myeloma PCYC-1111 study. Cohort 4 was recently expanded as we crossed a pre-specified boundary of response in the initial 18 patients enrolled in this cohort. Cohort 4 which evaluates the ibrutinib 840 daily in combination with dexamethasone has been expanded to enroll a total of 43 multiple myeloma patients. Cohorts 1 to 3 did not meet the pre-specified boundary of response and thus were not expanded. We will continue to develop IMBRUVICA in multiple myeloma in combination with other agents.

Lastly, we are excited to announce that last month we have dosed our first patient in a Phase I Rheumatoid Arthritis trail with our BTK inhibitor for autoimmune indications and should have preliminary data from this trial by Q1 2015.

I will turn the call over to Maria who’ll give you an update on our combination studies and clinical time line.

Maria Fardis

Thank you Jesse. My clinical development team delivered another three months of very highly-productive activities this last quarter. I would like to share some of these highlights with you today. As described in the press release, we currently have 43 active and ongoing clinical trials in eight diseases including 11 Phase III trials. Once fully enrolled these study enrolled represent over 7,500 patients participating in the clinical development of IMBRUVICA.

Truly an outstanding number with six off these 43 studies started to enroll during the first quarter of 2014. We are exploring the potential of IMBRUVICA as a single agent in 21 studies and as a backbone to combination therapies for our most of the B-cell malignancies and an additional 22 studies. Our clinical program is broad, both in terms of the number of diseases and investigating using IMBRUVICA as one of the nature of therapy in terms of using IMBRUVICA as a single agent as well as combinations. I will touch upon some of them during this morning’s call and to provide a general overview.

In treatment naïve CLL, two large Phase III investigator sponsored studies are being conducted in order to evaluate a potential of IMBRUVICA in combinations with peer analog and – The alliance that is led by Dr. – at the Ohio State University is designed to be evaluating the effect of IMBRUVICA alone versus IMBRUVICA plus rituximab versus bendamustine rituximab in 523 elderly treatment naïve CLL patient.

The [audio gap] study, which is designed to now investigation of the combination of IMBRUVICA rituximab versus SCR in young treatment naïve CLL patients was also initiated in the past quarter. IMBRUVICA is now being studied in a Phase III trial led by the German study group in untreated intermediate high or risk patients with CLL comparing mono-therapy IMBRUVICA to placebo or no therapy and this study is called CLL trial. In the previously treated space Dr. – at M.D. Anderson is currently enrolling a 208 patient study investigating the impact of adding rituximab to IMBRUVICA in the CLL patients.

Also in the relapsed/refractory CLL, IMBRUVICA plus REVLIMID is being studied at the National Cancer Institute by developed 40 patient CLL study. Multiple company sponsored trials allow investigation of the combination of IMBRUVICA plus CR in diseases such as CLL and CLL/SLL. These trials are global registration of Phase III studies. IMBRUVICA is being studied in combination with rituximab and REVLIMID and another NCI sponsored study in treatment naïve follicular lymphoma patients who are Phase II to Phase IV of the disease at the time of diagnosis. In addition, the combination of IMBRUVICA and REVLIMID is being investigated at Ohio State University in marginal zone lymphoma, follicular lymphoma and diffused large B-cell lymphoma.

Let me now turn to the data that we will generate in our studies. Over the next eight months in 2014, we will provide a number of clinical updates to the Start program. So far, we have a label in one of these three breakthrough therapies that IMBRUVICA has received which is MCL. We continue our work towards the second and the third label in Mission 17 PCLL and Waldenstrom. We are continuing our discussions in Waldenstrom with the agency to determine the funding requirement based on the Phase II data that we haven’t had to-date.

In the meantime, we will start a Phase III study in patients with Waldenstrom by third quarter 2014 as we will offer access to IMBRUVICA and to the patients in Waldenstrom as well as it would expectedly generate data in the randomized trial for full approval. In addition, in the second half of this year, we are going to report the Phase II data of IMBRUVICA from a four dosing cohort of the relapsed/refractory multiple myeloma patients. Also in 2014, we expect a regulatory update from European community based on CLL and MCL filing that took place in October 2013. This was a start of a very broad worldwide regulatory filing initiative organized by collaboration partner Janssen to establish IMBRUVICA in all major markets.

In 2015, a rapid progress in developing IMBRUVICA is expected to continue as we plan to have data available from treatment naïve CLL patients from our study PCYC-1115. PCYC-1115 is a study in with single agent IMBRUVICA as compared to Chlorambucil for elderly treatment naïve CLL patients. We planned pursue submission of this data to support a full label in front line CLL in 2015. It is our goal to achieve a label for each of the major B-cell malignancies in relapsed/refractory and treatment naïve patients in the near future. In the United States, we expect one new indication or label update every year for the next five years.

I will now turn the call over to Bob.

Robert Duggan

Operator, we would like to open the floor to Q&A please.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). Our first question comes from Mike King of JMP Securities. Your line is open.

Michael King – JMP Securities LLC

Good morning guys. Thanks for taking my question. Can you hear me okay?

Robert Duggan

Yes.

Michael King – JMP Securities LLC

Congrats on the full quarter. I have a number of questions and just coming off if I am taking too much time. But I just wonder if you could talk about a couple of things in the quarter in terms of utilization, do you have any longitudinal data that would indicate if you have some kind of sense of the patient turnover in the quarter?

Matt Outten

Yeah. Hey, this is Matthew Outten. So, we do have those numbers and do track, but we don’t feel on a public call that it would be a good idea to release those. But we do of course have those and I apologize that I won’t answer you directly sorry, Mike.

Michael King – JMP Securities LLC

That’s okay. And then a related question is, I know you don’t promote to off label I just wonder you did mentioned utilization in front line, just wondering if you can give us any sense of utilization there and whether there is off label and anything else like Waldenstrom or whatever?

Robert Duggan

Mike, it was deferred that to a much later point in time. It is not our priority to be discussing off label the news of the molecule at this early day.

Michael King – JMP Securities LLC

Okay. And then just in terms of the cadence of the readout of the ongoing trials, if I interpret your PR correctly, it looks like perhaps RESONATE 17 would be the next trial readout but I am curious if you can give us perhaps some broad perspective on when we could see readouts and things like HELIOS, BRILLIANCE and the ALLIANCE study?

Maria Fardis

Thank you Mike. This is Maria. I appreciate the question. Yes, RESONATE 17 will be read this year. It will process the primary endpoint during the 2014 and we expect to have the data and the results by late this year. Some of our remaining studies that you referred to such as CLL-3001 are event-driven trials and so their actual timing of interim analysis or final analysis will depend on how the event will come through, very of them are in fact time-based analysis. So, we will provide you an update as we get closer in terms of the number of events and be a more confident about the timing of when we can conduct these analysis.

Michael King – JMP Securities LLC

Okay. I appreciate that. Just a follow up on the just RESONATE 17, is it possible to read out to there could be by ASCO?

Maria Fardis

The readout will not be by ASCO given that the study is still ongoing and it’s hasn’t reached the time for primary endpoint analysis. But you are referring to ASH, it’s possible.

Michael King – JMP Securities LLC

ASH. Okay. I’ll get back in queue. Thanks.

Maria Fardis

Sure.

Robert Duggan

You’re welcome.

Operator

Thank you. Our next question comes from Joel Sendek of Stifel. Your line is open.

Joel Sendek – Stifel, Nicolaus & Company

Hey. Good morning. Thanks a lot. My question as to do with the guidance. It’s – if we work out the numbers for the quarter, it suggest flat sales in the third quarter and fourth quarter. I know you said it’s and you’re suggesting that in anticipation of a label enhancement driving the sales up. But I’m wondering why you can’t do better than that or maybe you just being conservative with your guidance as especially as you penetrate the community doctors more? Thanks.

Robert Duggan

You answered the question, Joe. We’re being conservative.

Joel Sendek – Stifel, Nicolaus & Company

Okay. That’s fair enough. But could you give that way than the other way.

Robert Duggan

Exactly.

Joel Sendek – Stifel, Nicolaus & Company

Can you comment a little bit on the slip between MCL and CLL and help us with how we should model it in the future. Should we expect more CLL overtime because it’s more an even split than I would have had expected at this point in time?

Robert Duggan

Well, those numbers will play out overtime and we like you are watch it very carefully and very interested in it. But I think as we come through Q2, we’ll have a full quarter of each and a little maturity in each and it will be much more reflective. So, we’ll be happy providing you some color at that time.

Joel Sendek – Stifel, Nicolaus & Company

Okay. Thanks.

Robert Duggan

CLL is a larger indication and overtime now we’ll manifest this all, but we continue to see growth in MCL. So, we’re pleased with progress in both histologies.

Joel Sendek – Stifel, Nicolaus & Company

Okay. And one last final thing, you expect the inventory piece is to build overtime. What do you expect for example $7.4 million in inventory this quarter be drawn down or do you think that that number will discontinued to increase over the next couple quarters?

Manmeet Soni

This is Manmeet. I think it will continue to increase while we’re growing our revenues because for stocking purposes, because all our distributors will normally stock for weak or so for their elementary so I would say yes that will continue to increase as we grow.

Joel Sendek – Stifel, Nicolaus & Company

Okay. Thank you.

Operator

Thank you. Our next question comes from Brian Skorney with Robert W. Baird. Your line is open.

Brian Skorney – Robert W. Baird

Hey. Good morning guys. Thanks for taking the questions and congrats on really nice quarter. And then I guess I just want to follow up a little more on Joe’s question on the guidance. I understand that you’re been conservative but I mean it almost comes off hard to even achieve the number that you’re giving us coming out of the second quarter I mean almost implied it is your new patient starts. And then I hear that you’re been conservative Bob, but I mean is this even realist? I mean, is there actually a risk but there would be no new patients start or where there any equilibrium between initiations and dropouts?

Robert Duggan

Well, I share your sentiments, Brian. We have an obligation to make sure that anything unforeseen is somewhat taken into account. So, that’s a bit of an actually more on and the numbers that we project here take into account the unknown which hopefully will never occur. But we’ve given numbers that we are we’re pleased with the alternatives is just to give no forecast whatsoever.

So, we’re one month into our quarter. We’re pleased with our progress and we’ll have a further update as the quarter comes to an end. This business launching products is variable as many factors that drive it. This is our first launch. This is our only product. So, we’re sensitive to any privatization. I would just say that these are numbers we’re very comfortable with and that should provide you with the bottom end of range and you are free to assess any upper range. We just caution to say nobody knows, and we’ll do our best to continue our momentum and we’re pleased with our progress.

Brian Skorney – Robert W. Baird

Okay. And then just let me think about the stress that you’re seen right now. Do you guys have any feel for how much penetration into the relapse/refractory CLL population you’re seeing right now? I mean, just any sort of broad struck and do you think these are all locations better relapsing with CLL right now or its 50% I mean just kind of a very general guidance there would be helpful.

Matt Outten

Yes. So it’s an interesting question. I mean, patients progress overtime. And so, I think that, there were some patients when we first launch to have been waiting and then as then the therapies that they’re on either stop working or they get a side effect or tolerability issue. I think that’s been a good opportunity for that patient position to consider IMBRUVICA.

So, I guess my short answer will be no. I don’t think it has stopped. I think there are still lots of patients. If you look at some of that patient data, I think you see those trends. I think I mentioned in my remarks that, we had gained the believe in terms of the second line MCL and I think that’s pretty good considering how long we’ve been out and with CLL will be tracking that as well and we’re seeing good growth in that area also. So, no, I don’t think we’re 50% but I’ll be hesitant to give you an actual number. It’s a little early for that.

Brian Skorney – Robert W. Baird

Great. And just real quickly, can you remind us what threshold was for cohort expansion in the myeloma study?

Robert Duggan

Yes. That’s a great question Brian. We haven’t actually released that yet. We’ll hopefully we having that in an update when we serve a data at a Congress down the road. So, now that we’ve extended the cohort, we’re encouraged by the data we saw in Cohort 4. If we continue to see that signal in the full expansion of 43 patients than that will be an encouraging and reaffirming. The signal we’re seeing here in 18 patients in Cohort 4 with dexamethasone.

Brian Skorney – Robert W. Baird

Great. Thanks guys.

Robert Duggan

You’re welcome.

Operator

Thank you. Our next question comes from Katherine Xu of William Blair. Your line is open.

Katherine Xu – William Blair

Yes. Hi good morning. I have a question of the – side from the PCYC-1125 that basically study we don’t received data this year, which is front line.

Maria Fardis

Hi, Katherine. Thank you for question. It’s unlikely that we will be able to release that data. We have started enrollment of that program just this first quarter and for follicular responses it may take some kind to mature. We are definitely watching that study very closely and we are very much on track in terms of enrollment. But whether we’re going be able to provide a meaningful data this year is not entirely clear to at enrollment.

Katherine Xu – William Blair

And what is the Phase III plan there after you see your data from the Phase II and then you would tolerate the Phase III, is that how it is?

Robert Duggan

Yes. So in terms of the follicular the overall clinical program is quite broad. We have multiple trials and multiple clinical settings evaluating either single agent or combination therapies. And in the relapsed double refractory population we’re doing the similar trial leads to our partners Janssen. That’s in patients who have at least two products and that’s ongoing and enrolling. In relapse setting more broadly, we have a combination trail within the – plus or minus ibrutinib. It’s a Phase III trial that’s been initiated and that trial is enrolling as well.

Then in the front line setting we’re putting together our first clinical data of CD-20 antibody with ibrutinib. There is two dose schedules for that regimen, one starts with the ibrutinib and then follow after a month you start you had in the CD-20 with ibrutinib and the other is commented administration. So, that will provide comparative data. There is really big historical data in front line follicular to see how we’re doing compared to other available therapies. We’ll obviously be doing biomarkers and other work to determine if we can look at patient and regimen, but we’re very hopeful of that will that study will show good results.

Katherine Xu – William Blair

And the follow up on the on your HVAC inhibitor and other combination potential combinations from there?

Robert Duggan

Yes. We are evaluating combinations with our HVAC inhibitor. We have been looking at new formulation. The CDPA clinical development plan for HVAC inhibitor and other interest would be combinations with ibrutinib.

Katherine Xu – William Blair

So for the study design for Janssen is pretty much for Phase III is just pretty much IMBRUVICA versus placebo event?

Maria Fardis

Rituximab is actually a standard of care.

Robert Duggan

So, that’s a good question. The trial design is slightly different than you know what we had three arm in the. The arm study is not the largest it’s one of the largest longer-term studies conducted to-date and we have 63 patients of data which is a very robust data set, looking at single agent of rituximab in longer-term.

For the Phase III, we chose for treatment arm to Rituxan in combination with ibrutinib as compare in the control Rituxan alone so, that trial will give us combination data and then three arm trial will give us single agent data. And thus at the end of this development program we will have different data sets to inform for different physicians whether for a patient that maybe appropriate for single-agent therapy as oppose to combination therapy.

Katherine Xu – William Blair

Great. And then on the Multiple Myeloma side don’t mind, I guess you know looking at the desk physicians patients or in patients you’re doing ibrutinib combination – overcoming businesses and then I guess the rational for combination is kind of similar in that way?

Robert Duggan

Yeah. That’s exactly right. Based on this initial signal, it does appear that, that’s in addition of dexamethasone make helps synergize and improve the activity of ibrutinib in myeloma. This is early data with 18 patients, but that’s clearly what the trial as it laid out shows to-date and there are a number of other examples in the myeloma space where single agent therapies don’t show responses unless they are added with dexamethasone. So, we are hoping this is retailing that story and by expanding this cohort we will be able to affirm that data, and we are also looking at combinations with carfilzomib and even potential in other spaces.

Katherine Xu – William Blair

Thank you.

Operator

Thank you. Our next question comes from Ian Somaiya of Nomura Securities. Your line is open.

Ian Somaiya – Nomura Securities Co. Ltd.

Thanks and congratulations on the solid results. Want to explore your guidance a little bit more and maybe based on a survey that we published recently, I want to get to the first half would you can share with us, what portion of your target physicians have at this point described IMBRUVICA? And then whether there is, whether you’re going through what might be an initial sort of paint up demand phase in terms of patients? And then third, if you can give us a sense for how much second and first lines usage you’re seeing for the physicians who responded our survey at point or wanted to use that drug immediately in those settings?

Matt Outten

Yeah. So, this is Matt again. There were couple of question in there. In terms of penetration, I’d have to sort of reiterate my previous statement, we track those numbers and have then. But on a public call, we are not going to release sort of how well we have done in terms of penetration. I guess I would say, we have very robust targeting lists, we have very larger field forces in play between both Pharmacyclics and JBI and we are very much on top of and focused on getting to the you know all of the prescribes getting typically the large prescribes within the academic and community settings.

Ian Somaiya – Nomura Securities Co. Ltd.

And just with the other questions related to paint-up demand and whether you are seeing usage across the second line?

Matt Outten

Yeah. I mean, so, we are obviously what indicated in one prior therapy, so I would say we are seeing use in CLL and MCL according to our indication. As far as front line I would repeat Bob statement from earlier as well that, that’s not our focus. We will be able to probably give more color on that later in the year.

Ian Somaiya – Nomura Securities Co. Ltd.

Right. And there obviously been some confusion caused by the prescription services, but if you look at the revised prescription data by IMS as well as Symphony, there is monthly data not the weekly data but the monthly data, it would have assume prescriptions stay relatively flat for the remainder of the year. We are already at the low end of your guidance 2014 guidance.

And if we think about the impacts that presentation of the Phase 2 data would have at the ASCO and the subsequent usage one of the things that even at the higher end of the guidance would be quite conservative and at least that’s our service can play. But just again, kind of I understand the comments made earlier that you believe that the guidance is conservative but a just larger question is what’s motivating you to give guidance at all at this point and to give guidance which really does seem to down play what’s likely to happen this year?

Matt Outten

A couple of items there in. You do have accessed the IMS and Symphony data. It’s updated once a month, so that should be able to allow you to comfortably update your forecast. It’s unusual. I guess in retail sales certain companies produced numbers on a monthly basis as well. So, you need to visit the industry at the end of each week, at the end of the each month, you will have to look into a window here that many other businesses don’t enjoy. So, in that background we provided a baseline and you can adjust the number weekly and monthly as you see it make sense.

On the MCL, I believe we have penetrated about 30%. We have about 30% share with the leading molecule prescribed in that histology for good reason and it’s really just too early to discuss the CLL label for just last six weeks of the quarter. Also, I think when you take our comments as a base line and you have got IMS, Symphony numbers you view every Friday you can see exactly what’s happened. They’re not too far off there.

So, I think there is plenty color to our each of you as a good analyst to come up with the correct a number. We just basically are not paid for speaking our next out unlike yourselves, you can get all start awards for speaking the next out being right. We get rewarded at where if we don’t overstate and then under deliver. So, that’s the context in which we have made some forecast and we thought we would rather give you a bottom-line rather than nothing in that we’ve done.

Ian Somaiya – Nomura Securities Co. Ltd.

And that’s fair and I think we all really appreciate that. If I can ask one follow-up on the multiple myeloma side. And again, I think it’s an exciting development. It’s filing leasing threshold, was there changes that at all of your development strategy going forward. Do you see this as a potential combination agent with dex alone? I think we all understand and appreciate the safety profile of the drug if you are finally seeing the efficacy that’s required in that setting just curious if that’s now development strategy that you could pursue into in the locker setting?

And then does it also open up an opportunity to explore combination beyond just the one we are exploring with inhibitor?

Matt Outten

Yeah. It’s a good question. And yes, I do think it’s expanded the way that we see of the development in that what we are looking at in the future it is combination strategies. The 1111 trial both lower dose single agent and at single agent although there were some activity did not have the level of activity we would want to take into larger development programs. But in combination, in these first 18 patients, we saw certainly in that activity to meet the thresholds and expands. So, this is just that dexamethasone may potentially ibrutinib and hence we are looking at how we can integrate and if we should integrate dexamethasone into future combination as it done with many other agents in myeloma.

So, whether it’s in AMiD or – inhibitor those are frequently given in combination with dexamethasone. So, we are looking how we should we be integrate dex into our program and other combinations strategies will still help potentially ibrutinib.

Ian Somaiya – Nomura Securities Co. Ltd.

Okay. Thank you very much and congratulations once again.

Robert Duggan

Ian, you are welcome. Thank you.

Operator

Thank you. our next question comes from Cory Kasimov of JP Morgan. Your line is open.

Unidentified Analyst

Hi. This is actually Whitney on for Cory this morning. I guess first question I know it’s early in the launch, but can you comment on around dropout rates that you are seeing in the CLL and is that kind of in line with your expectations or is any unexpected churn in terms of patients on drug?

Robert Duggan

There is no unusual churn to be expected. You do start with the conservative in group of community doctors that will provide with you a seek patient more or so than say average then you work your way up to better and healthier patients. So, we are energized by the process and obviously the momentum shows that, even those sicker patients are doing better than they otherwise would have been doing. So, all is well that regards.

Unidentified Analyst

Got it. And then can you give us any more color in terms of the patient mix by payer just as you kind of think about gross to net moving forward?

Robert Duggan

Manmeet?

Manmeet Soni

Yeah. So, currently I think our current mix of business is doing much 50% each for Medicare and the commercial patients and on the gross to net currently as you saw, we were in approximately 13% for the first quarter. We expect from quarter on quarter variability, but we should be in the range of 10% to 15% depending upon the payer of mix in this time. And our gross unit just over higher in the first quarter because of our share of Medicate deviations.

Unidentified Analyst

Got it. Thanks for taking the questions.

Operator

Thank you. Our next question comes from Navdeep Singh of Goldman Sachs. Your line is open.

Navdeep Singh – Goldman Sachs

Hey. Good morning and thanks for taking my questions. Just a couple of follow-ups on the guidance questions that you’ve been getting. You know you’ve indicated your guidance for IMBRUVICA is of $295 million for 2014 and you’ve also indicated that conservative. I am wondering what your thoughts are on the Q2 guidance of $80 million, do you believe that’s conservative as well?

Robert Duggan

Yes.

Navdeep Singh – Goldman Sachs

Okay that’s very helpful. And then I guess another follow up on the guidance. Do you assume the guidance that you are giving out it assumes the worst case scenario?

Robert Duggan

Yes.

Navdeep Singh – Goldman Sachs

Okay. And then, can you compare how the launch has done compared to the launch?

Robert Duggan

Better.

Navdeep Singh – Goldman Sachs

Okay. I’ll move back in the queue. Thanks a lot Bob.

Robert Duggan

You’re welcome.

Operator

Thank you. Our next question comes from Robyn Karnauskas of Deutsche Bank. Your line is open.

Robyn Karnauskas – Deutsche Bank

Great. Congratulations guys and I think given guidance is great and very helpful and singling is very exciting. I am just going to ask one question. So, on the next part of your franchise, so for the DTK and RA, can you give us some color or update on sizing and what kind of data we could see in the press release or whether just be top-line and how you are thinking about bringing in other molecules that that now might go collaborative or work with DTK? Thanks.

Maria Fardis

Thank you Rob and that’s a great question. And we order nothing is steady which is fairly standard in terms of early program it’s a combination of single ascending by multiple ascending dose. And off-course patients’ safety is our top priority. So in terms of how the cohorts are sacked, they are fairly linearly stacked which is why we thought we would have points of data that we expected around first quarter 2015.

So we are proceeding to our single ascending dose program and multiple ascending is however later this year assuming no surprises. This is our current plan. We are very much on target and we would expect that it will start around then multiple ascending fairly quickly. In terms of what other combinations I think that was your second part of your question, it really would depend on the profile of the compound in terms of safety, dose, efficacy and otherwise. So, it may be a little early for us to be able to say what combinations would be beneficial but absolutely that will be something would set or estimates the access of the data.

Robyn Karnauskas – Deutsche Bank

Thank you. And the times what your long needs would you press release the entire data set or just a top line and for medical needs?

Maria Fardis

I think it would depend on the nature of the data and it would be trend on the significance of it. We would have to make it a single but we actually have the data in hand. Again so, may be a little premature to this side not knowing what the data would look like.

Robyn Karnauskas – Deutsche Bank

Okay. Thank you.

Operator

Thank you. Our next question comes from Jason Kantor of Credit Suisse. Your line is open.

Jason Kantor – Crédit Suisse AG

Hello and thanks for taking the question and congratulations as well on a good quarter. A lot of my questions have been answered. I guess two things the myeloma data, should we be thinking ASK or is there some other meaning before ASK when we might get take a look at that data? And then a commercial question, I mean you said that there is some education then it’s be done in the community. I guess I’d be very interested to hear what if any kind of push back you might be getting from folks to our people – are there people on the side lines? Why are they on the side lines? Do you expect the data at ASCO to change that in anyway?

Robert Duggan

Jason, you really miss out in a sequential basis, we have a lot of feed on the street. We got a lot of education to do. I guess it’s appropriate to consider in the community hospital they know a lot less about IMBRUVICA than do those in the academic centers. But, we are really pleased with the uptick in community centers. There are regions where multiple doctors are dosing significantly. It will take a little time to really sweep the street clean. It’s a process that will occur over Q2, Q3 and Q4. But I would say this uptick is going quite well and those that are on therapy by survey feedback are more impressed than they thought they would be.

So that’s what I can tell you. So, the good news is the IMBRUVICA drug is really carrying its weight and we are encouraged by the response that the physicians are achieving with the product, and I think anytime you can be at a medium like ASCO and have overall survival to discuss with and you’ll see the level to the degree to which we are able to discuss that is pretty robust. Certainly, it’s going to buoy the crowd.

So, I would look for ASCO be good ASCO force and then over the next several months, you’d see the impact of that in the prescribed numbers and patients on board.

Jason Kantor – Crédit Suisse AG

And then in terms of the Myeloma data is that a dash or sometime before?

Maria Fardis

Hi, Jason. I can address that. We are planning on having that data ready for ASH as of now.

Jason Kantor – Crédit Suisse AG

Thank you.

Maria Fardis

Sure.

Operator

Thank you. Our next question comes from Mathew Andrews from Wells Fargo Securities. Your line is open.

Matthew Andrews – Wells Fargo Securities, LLC

Thank you. Good morning question for Jesse, following up on Jason’s question. So, how important do you believe Resonate data would be at ASCO in terms of brilliant script this year? Market research suggests that there is some conservative analysts still want to see a significant OS and PFS for broadly prescribing approval in CLL? And just one for Manmeet, you affirm that, you indicated parts would be high single-digits going forward? Thank you.

Jesse McGreivy

What was that last part of the question Mathew?

Matthew Andrews – Wells Fargo Securities, LLC

Yeah. Just on the COGS I thought Manmeet potentially would be a high single digits going forward. There was a bit of a step down from Q4, just wanted to know what we should think about going forward on cost to goods sold?

Robert Duggan

Manmeet will address the cost of goods sold first and we’ll turn it over to Jesse. Jesse, Manmeet will handle the cost of goods and then over to you.

Manmeet Soni

Hi, Matt. So for cost of goods sold, yeah, currently we are approximately at 11% as I mentioned in my script. We think that’s a little normalized to high single-digit. So, you should expect that to be lower than 10% in next two quarters.

Matthew Andrews – Wells Fargo Securities, LLC

Thanks.

Robert Duggan

And that’s inclusive of royalty payments.

Manmeet Soni

That’s right.

Matthew Andrews – Wells Fargo Securities, LLC

Okay.

Jesse McGreivy

Yeah. And in terms of the question about the data at ASCO. I mean, as on hematologists oncologists, I can tell you that the data is very compelling. CLL is a chronic disease. It’s a very difficult threshold to show an improvement and survival in the chronic disease. In fact, this first trial ever to so improved survival when you are looking at versus inactive competitor. And typically to show an improvement in survival at an interim analysis is even more difficult. You can certainly look at models on this and statistics, but you know with a number of events that you see at an interim to show this robust improvement and survival really speaks to the volume.

So I think this will have an impact and it is big data to hit the primary end point of PSS and LS really to speak to the effect of the drug and at some levels potentially paradigm shift and the field to what if you can inhibit in a critical part of treating patients with CLL. So, we are hopeful that will be the take home but time will tell, would you think the data is very rich and compelling.

Robert Duggan

And Mathew over 57 patients crossed over, that’s over 25% of on trial. We still hit the data you’ll see that P-value numbers will not manifest but they are spectacular. In additional, OS if that doesn’t move a dial then I don’t know what else you have to do to move it. This will be a first, but like you asked the question what difference does it make, we think a lot, but like see.

Matthew Andrews – Wells Fargo Securities, LLC

Great. Thank you.

Operator

Thank you. Our next question comes from Geoffrey Porges with Sanford C. Bernstein & Co. Your line is open.

Unidentified Analyst

Good morning. This is [inaudible] on for Jeff thank you very much for taking the question. I have a couple of questions. First of all, can you comment on what the average duration on the drug has been to-date and also what the average duration of the discontinuation has been? And also can you speak to any plans to formally include combination data for IMBRUVICA CD-20 and the IMBRUVICA label? Thank you.

Robert Duggan

Well, no on the first two. And CD-20’s we will be releasing data. Again, I think that will be very eye-popping. So, you’re all get at the same time as this announced, but we are we’re excited about. As Marie pointed out, half of our trails are in combination. So, we just felt it’s very important to take a claim as with the noble therapy what it really do standing on its own. That’s been spectacular. We only think the combination results will get better and you will see some of that in the reports that we provide at ASCO coming up.

On duration, just too early really to get into those numbers for multiple reasons but obviously something is working well because you can see the lift in business. It’s a fivefold increase in direct sales and in revenue from $10 million to well over $50 million. So, got be going pretty good.

Unidentified Analyst

Great, perfect. Thank you so much.

Robert Duggan

You’re welcome.

Operator

Thank you our next question comes from Mike King of JMP Securities. Your line is open.

Michael King – JMP Securities LLC

Thanks for taking the follow-up guys. A bigger picture question, I think we’ve discussed this entire calls, but one of the issues that crops up a lot. When I talked to investors about PCYC and IMBRUVICA does this suppose it better response rate that are seeing with ABT-199 and we know that Roche will have data in combination with ABT-199 plus. – at ASCO, so just again bigger picture question has to do with the topic of complete response and minimal residual disease in the future turns in CLL therapy and how you guys plan on responding to that.

Robert Duggan

Yes. Thanks Mike. This is a great question. So, ABT-199 does appear to be active based on their preliminary data they’ve start. We’re obviously going be looking at their combination data that will be presented. There is an interest of course always in combining novel agents and whether it’s ibrutinib in combination with BCL-2 inhibitor or PI 3-kynese inhibitor whatever the newer therapies that are coming out, we’re obviously looking at those sort of trails actively at this time. And I do think for a subset of patients, these MRV negative events are gone be important especially the young set patients in treatment naive setting that’s going be important outcomes for them.

For the vast majority of patients, the bulk of the patients being 70 or older whether or not a very deep response with the well tolerated therapy, three dose a day that’s prolonged over many years whether that’s any different than patients who has severe combination regimens to achieve MRD negative status. It’s not clear how that’s going to play out. But, I think from our perspective, we’re very excited about the activity of ibrutinib a single agent. It’s a very active drug in terms of response.

If you look at the O’Brien data published at ASH of 2013, the response rate are north of 80% in the aggregate in the CLL population by investigator response and these continuing to improve with and overtime with many patients. So, it’s really remarkable data and it’s very active drug in terms of response. So, I think this story will play out and we will get more combination data moving forward.

Michael King – JMP Securities LLC

Okay. And then just a complete tougher topic. Will the autoimmune – are you guys going to start referring to the autoimmune compound by either PCI designation or some kind of username at some point when one may start to hear that?

Maria Fardis

Thank you for that question, Mike. For your understanding user name usually granted around Phase II. So, as if now we don’t have to use name to refer to it. During that internal compound number which we haven’t released for this particular program and again as we referred before, we expect to be able to release may be preliminary data for around first quarter 2015. We will be able to release the compound number at that time.

Michael King – JMP Securities LLC

Well, you will have data before at the end of the year, is that correct? Is that what you’re seeing in your...

Maria Fardis

I expect that, yes. Our single ascending dose is expected to have we should have that data available to us for multiple ascending really that’s where you how potentially patients-enrolled and that’s where efficacy has seen. So, that’s why I’m referring to first quarter 2015.

Robert Duggan

Mike, this is Bob. Essentially to note, whenever that word come competitive molecules comes out that mentioned in drug name but all of these are in CD-20 combinations. So, there isn’t single launch at this time as is like as monotherapy single agent. So, you will see a substantial data release from that that indicates our ability to combine with CD-20. I think you will see, you will agree it’s outstanding. What we differentiate ourselves is the O’Brien data that comes out over a three year period of time is that equation that we suggest to everyone use efficacy, plus duration, plus tolerability.

Clearly we are doing quite well and we have a data coming for us with the CD-20 combination. But the numerator is powerful, but the denominator here of toxicity square is where the drugs is going make it or break it. So, overtime, we’ll wait and see how the other drugs that you mentioned do, but our data is known. So, we have stable data both numerator and denominator, single agent and in combination. When you put it all together, I think it makes a lot of sense to run the comparison and see where everybody comes out. But until they have three year data, both front line and in relapse refractory multiple dose patients it’s difficult to will it make the fair comparison.

Michael King – JMP Securities LLC

Yes. Here I would saying Bob, I just think that, what investors tell me is excite them is that proportion of CRs and not that IMBRUVICA response rates are an impressive. But that the proportion that is that are CRs is what people are focusing on.

Robert Duggan

Understood.

Michael King – JMP Securities LLC

Thank you.

Operator

Thank you. I’m not showing any further any further questions in queue. That does end the Q&A session. I like to turn the call back over to the CEO for any further remarks.

Robert Duggan

Thank you. Our progress of this breadth and the quality is never easily accomplished, that requires a team of dedicated people with focused attention and high purpose. We have such a team. We also have an excellent partner in Janssen Biotech that shares our philosophy. We together enjoy the process of introducing novel viable biotech therapies into the worldwide oncology healthcare market. Our next investor to update will occur on the 2nd of June at the tail end of the ASCO conference being held in Chicago. And we look forward to updating each of you at that time. Thank you very much for your time and attention. Have a good day.

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This concludes today’s program. You may all disconnect. Everyone have a great day.

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