Halozyme Therapeutics, Inc.
Q3 2015 Earnings Call Transcript

Published: 10 Nov 2015

[Operator:]

Good afternoon and welcome to the Halozyme Therapeutics Third Quarter 2015 Financial Results Conference Call. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder this conference call is being recorded. It is now my pleasure to introduce your host, Jim Mazzola, Vice President of Investor Relations at Halozyme Therapeutics. Mr. Mazzola, you may begin your conference.

[Jim Mazzola:]

Great, thank you. And good afternoon everyone, welcome to Halozyme's third quarter 2015 financial results conference call. Following market close today we issued a news release with the summary of our results and posted a short slide presentation to accompany this call. You will find both on the investor page at halozyme.com. Leading our call today is Halozyme's President and Chief Executive Office, Dr. Helen Torley who will provide an overview and update on our business. Then Laurie Stelzer, our Chief Financial Officer will review financial results for the September quarter followed by a Q&A period. Also with us for today's call is Dr. Athena Countouriotis, our Chief Medical Officer. Before we begin, let me remind you that during this conference call, we will be making forward-looking statements. The company's actual results may differ materially from those expressed in or indicated by such forward-looking statements. For a description of risks, please refer to our quarterly and annual filings with the Securities and Exchange Commission. Now let me turn the call over to Helen.

[Helen Torley:]

Good afternoon everyone and thank you for joining us today. It's a pleasure to update you on our recent progress. As we do every quarter let me begin by summarizing our strategy. We make investment decisions and operate the business based on the value we're creating in two pillars. The first pillar is our oncology business with our investigational drug PEGPH20 at the core. PEGPH20 temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugar in the body that accumulates around certain tumors and constricts the tumor vasculature. Degrading hyaluronan or HA reduces tumor pressure, increasing the blood flow and thereby the access of cancer treatment into the tumor. We're currently studying PEGPH20 in pancreatic, non-small cell lung and gastric cancer patients. But see broader potential applicability for its use in multiple tumor types in combination with immuno-oncology agent, monoclonal antibodies and chemotherapy. To that end we've announced additional trials to study PEGPH20 in combination with the immune checkpoint inhibitor [indiscernible] in non-small cell, lung and gastric cancer patients. And also with halaven in first line HER2 negative metastatic breast cancer patients. This study will be in collaboration with our clinical partner Eisai. Our work in oncology is funded in part by the second pillar of our strategy which is centered on our licensing agreements with marquee partners including Roche, Baxalta, Pfizer, Janssen, and AbbVie. These partners co-formulate or co-administer their therapies with our ENHANZE technology platform which temporarily degrades HA under the skin to enable larger fluid volumes or molecules to be delivered with a subcutaneous injection or in a less frequent dosing schedule. Roche's Herceptin SC and MabThera SC are co-formulators with ENHANZE and delivered with a subcutaneous injection, while Baxalta's HYQVIA is co-administered with ENHANZE to reduce the frequency and number of injections required. Both ENHANZE and PEGPH20 are based on our proprietary rHuPH20 enzyme. Our revenue is driven by product sales, milestone payments and royalties from the second pillar. For the third quarter revenue increased 42% year-on-year to nearly $21 million with royalty revenue up $8.3 million, reflecting sales of partner products in April, May and June of 2015. Our royalties increased $2 million from the second quarter of this year and nearly 200% from the third quarter of last year. I’m very pleased with the progress we've made in both pillars since our last quarterly call. And with that brief overview let me now provide a more comprehensive update beginning on Slide 3 with progress in the oncology pillar. Our clinical evaluation of PEGPH20 is most advanced in pancreatic cancer, where I'm pleased to report we've made significant progress during the quarter towards our goal to complete our target enrolment in Stage 2 of Study 202 by the end of 2015 and to initiate Study 301 by the end of the first quarter of 2016. Study 202 is our ongoing Phase Two trial in metastatic pancreatic ductal adenocarcinoma patients. In an oral presentation at the American Society of Clinical Oncology annual meeting in May of this year we presented interim findings from 146 randomized patients indicating that in the high HA population receiving PEGPH20, ABRAXANE and gemcitabine there was a more than doubling of progression free survival, response rate and duration of response compared to patients receiving ABRAXANE and gemcitabine alone. These results including the potential risk profile are summarized on Slides 4 to 8. Since its interim update we've continued to enroll towards our target of an additional 114 patients in Stage 2 of Study 202. Interest in the study has remained strong and I'm pleased to report that we now have 104 patients enrolled. This progress keeps us on track to complete our target enrollment by the end of 2015. We've also [technical difficulty] has sustained decline in our screen failure rate with the result that a higher percentage of patients are being enrolled following screening since we modified the exclusion criteria over the summer based on the recommendation of our clinical advisor. As we work towards completing our target enrollment in Study 202 we also made substantial progress during the quarter preparing to start our Phase 3 study in previously untreated metastatic pancreatic cancer patients with high HA. An overview of the design is shown on Slide 9. Study 301 will be a 420 patient global, double blind, placebo controlled randomized trial with patients prospectively identified and included based on high levels of HA. With input from a [indiscernible] meeting with the FDA in March of 2015, and scientific advice from the European Medicines Agency in July of this year, we're proceeding with two primary endpoints, progression free survival and overall survival. We plan to conduct an interim analysis from the target number of progression free survival events is reached. Based on the interim analysis, the Data Monitoring Committee will have the option to recommend if we stop the study base and efficacy, continue it to the target enrollment of 420 patients, increase enrollment up to 570 patients for the final overall survival assessment or to stop the study for futility. If progression free survival is significant and both the overall survival and overall with benefit or supportive, these data may form the basis for marketing application in the U.S., and a conditional marketing authorization in Europe. I am pleased to share that we’re making good progress on our plans for an end of Q1 2015 start. Our progress to-date include selection of our contract research organization, as well as the U.S. and European principal investigators that mission of protocol through the FDA and the European Regulatory Authority and approval of our study design by central institutional review board in the United States. We’re also making good progress with our partner Vetana toward submission of our investigational device exemption to the FDA to support the study start, and to finalizing a commercial ready companion diagnostic test. Ventana is providing the expertise to develop this proprietary diagnostic which will be used to prospectively identify and select patients with high levels of HA. We look forward to sharing details of our approach and methodologies early in 2016. We anticipate a number of important milestones in our pancreatic cancer program as we close 2015 and we begin 2016, which are summarized on Slide 10. These include completing target patient enrollment and stage 2 of study 202 by the end of this year, and we are on track to achieve this. Next, expect to provide an update in early 2016 on the way Thromboembolic event in stage 2 of study 202. Following our 2014 clinical hold we and our data monitoring committee had continuous closely monitored these events. Our last update in May of 2015 at ASCO [ph] and so the revised protocol substantially reduced the TE event break. Our next update will build on the early data with a broader population of patients. We plan to provide additional data of our approach to prospectively identify the high HA population early in 2016. And finally, we intent to present mature progression free survival response rate and duration of response data from the completed Phase 2 study at an appropriate form in the second half of 2016. This was an event driven study with progress free survival as the primary endpoint. Recall we’ve maintained a blinded efficacy data set and it would be all go to un-blind this data set in 2016, after the appropriate number of events have occurred and prospectively analyze these data using the finalized companion diagnostic methodology. Turning now to an update on our non-small cell lung cancer program. Our preclinical model support the potential of PEGPH20 in a broad range of solid tumors, and we selected non-small cell lung cancer as the second primary tumor setting to explore. The time of study is designed to evaluate PEGPH20 in combination with docetaxel and local events in metastatis patients who did not respond adequately or lost the response to our platinum based regime. The initial Phase 1b portion is designed to evaluate and identify the dose and safety of PEGPH20 plus docetaxel. In animal models we’ve seen an increase in dose response as the dose of PEGPH20 escalates. These models support importance of our design to serially test several escalating doses to identify the maximum tolerated dose in combination with docetaxel. Since the update we provided on last quarter’s call, we’ve continued to make progress moving from first to our second dose escalation cohort. The trial design modifications and the addition of five new U.S. sites have allowed us to improve our screening rate from the last quarter. We also have the opportunity at world’s long congress to discuss the trial with our advisors and investigators who reaffirm their interest and the value of exploring those combination based on the data that conforms that not all patients will be suitable for, respond to or have a sustained response to the newer agents such as the PD1 and investigational PDL1 inhibitors. We expect this initial dose escalation phase will continue to move at a measured pace in part due to recent approvals and the number of PD1 and PDL1 trails in this space. Once we determine the maximum tolerated dose, we would expand with additional sites outside the U.S. and screen prospectively to enroll high HA patients. We’re closing monitoring progress in the study and are encouraged by the steps we’ve taken and the positive input we continue to receive about the potential value of the study and I look forward to providing a further update on our progress at our upcoming calls. In addition to continue our progress with the PRIMAL study we’re in a very good position to adapt to the changing landscape in the treatment of non-small cell lung cancer with our Phase Ib study of PEGPH20 and Keytruda or pembrolizumab. The standard of care in non-small cell lung cancer is shifting and we believe PEGPH20 has a role to play with a range of emerging treatment options. As we indicated last quarter, the PEGPH20 plus pembrolizumab trial will enroll higher to relapse-refractory Stage 3b and Stage 4 non-small cell lung cancer patients who’ve been treated with at least one platinum based regiment or with current locally advanced metastatic gastric adenocarcinoma patients who have failed at least one chemotherapy regiment. An overview of this trial design is shown on Slide 11. We were pleased to announce last week that got our first patient in this study. Initiation activities are continuing at a number of clinical site, ultimately we plan to enroll approximately 80 patients at approximately 25 clinical sites in the United States. This study will consist of a Phase 1b dose escalation portion designed to sequentially test several increasing doses of PEGPH20 to determine the maximum tolerated dose in combination with pembrolizumab. Once the max tolerated dose has been identified, we will expand to the dose expansion portion of the study with additional patients selected for high HA tumors and then a case of gastric cancer also based on PDL1 expression if a test is available. In this study, piroxicam a non-steroidal anti-inflammatory drug will be used prophetically to help reduce muscular-skeletal events. This is different from our ongoing studies in which dexamethasone is prophetically used and dexamethasone may still be used in the study if needed to further attenuate muscular-skeletal event. The final update on our oncology program is on our recently formed clinical collaboration with Eisai to evaluate HALAVEN or eribulin in combination PEGPH20 and first line HER2 negative high HA metastatic breast cancer patients. Since cementing the collaboration in July, we’re finalizing the protocol with Eisai and continue to estimate a steady start in Q1 of 2016. As a reminder, this will be a Phase Ib2 clinical trial to explore whether HALAVEN in combination with PEGPH20 can improve overall response rate as compared with HALAVEN alone. In our preclinical model we financial the addition of PEGPH20 to eribulin showed significantly higher tumor growth inhibition and overall tumor regression when compared to eribulin alone. Now let me move to the second pillar of our strategy, our ENHANZE platform. Our ENHANZE Technology platform can be used in combination with the variety of other drugs and is applicable across many therapeutic categories. The value proposition includes lifecycle management with the opportunity to prolong the exclusivity period for the combined product and the ability to reduce building frequency and duration by taking drugs from an IV to a subcutaneous formulation or allowing higher volumes to be infused at one time. ENHANZE business is anchored by collaborations that generate revenues today through milestone payments, product sales and royalties and have strong future potential as these relationships result in new co-formulated products. Slide 12 summarizes our recent progress. Today with ENHANZE from Roche's Herceptin SC and MabThera SC in Europe and Baxalta's HYQVIA in the U.S. and Europe. Roche indicated publicly by that Herceptin SC is available in more than 44 global market and its sales now account for more than 35% of the total Herceptin sales in Europe. MabThera SC is at an earlier stage of launching for the treatment of patients with common forms of non-Hodgkin's lymphoma. In Europe, Roche has announced that it filed MabThera SC for previously untreated chronic lymphocytic leukemia during the fourth quarter of 2014. Baxalta's HYQVIA which was launched in the U.S. in October of 2014 combined immunoglobulin fusion 10% with our rHuPH20 and is indicated for adults with primary immunodeficiency or PID. PID is a chronic condition and HYQVIA is the only once a month subcutaneous treatment for adult patients. The PID market is expected to reach $3 billion in for by 2020 with subcutaneous therapies representing more 50% of the market. Baxalta's in its third quarter call stated HYQVIA is experiencing strong uptick and a very favorable reception by patients and physicians with run rate site sales now exceeding $100 million. More than 60% of U.S. HYQVIA patients are converting from competitive therapies and approximately 25% are newly diagnosed patients. Baxalta is also pleased with momentum in select European markets including accelerating growth in the Netherlands and launches in additional market. And finally Baxalta said, it will soon initiate a Phase III study of HYQVIA in chronic inflammatory demyelinating polyneuropathy with the goal of gaining a new indication. During the quarter, we made new progress in our collaborations with Pfizer, Janssen and AbbVie. As we’ve recently announced, Pfizer has entered the clinic and started dosing patients with subcutaneous formulation of Rivipansel for vaso-occlusive crisis in patients with sickle cell disease and Janssen began dosing patients in a trial involving a subcutaneous formulation of the anti-CD38 antibody daratumumab in multiple myeloma patients. Finally, AbbVie recently announced their plan to work with Halozyme and HUMIRA under the collaboration agreement we formed in June of 2015. AbbVie’s goal is to identifying of ENHANZE and help to reduce the number of induction injections at higher doses and to help deliver additional performance benefits. The momentum we and our partners have with ENHANZE continues to generate interest from new potential partners, our team estimate that maybe more than 150 targets remaining that could be a match for ENHANZE which keeps us highly motivated to work with our current and potential partners to crease transformative therapy for patients, partners and peers. With that I'll now turn the call over to Laurie to discuss our financial results for the quarter in greater detail. Laurie?

[Laurie Stelzer:]

Thank you, Helen. I will begin on Slide 13 where you will see that revenue for the third quarter was $20.8 million compared to $14.6 million for the third quarter of 2014, driven primarily by the year-over-year increase in royalty revenue. Our revenue is primarily comprised of royalties, bulk sales of rHuPH20 for use in manufacturing collaboration products and Hylenex product sales. During the third quarter royalty revenue totaled $8.3 million, an increase of $1.9 million sequentially from last quarter and $5.4 million above the third quarter of last year. The increase came largely from higher sales of Roche's Herceptin SC during April to June. Bulk sales of rHUPH20 totaled $6.3 million, Hylenex product sales totaled $3.9 million and other collaboration revenue totaled $2.2 million. Turning to Slide 14 for a more detailed breakdown of our P&L, Research and Development expenses for the third quarter were $27.6 million compared to $19.9 million for the third quarter of 2014. We talked about this planned increase during last quarter's call which is primarily due to an increase in personnel and spend to support our growing clinical and manufacturing activity for PEGPH20. Selling, General and Administrative expenses were $10.2 million compared to $8.6 million for the third quarter of 2014. The increase was primarily due to personnel expenses including stock based compensation for the period. Overall our operating expenses increased by $10.4 million from the third quarter of 2014 which as we said last quarter was anticipated as we ramp investments in our expanded clinical program and put forward to manufacturing expenses. Our net loss for the quarter was $25.5 million or $0.19 per share compared to $20.3 million or $0.16 per share in the third quarter of 2014. Cash, cash equivalence and marketable security were a $123.7 million at September 30th compared to a $140.7 million at June 30th. Our financial results for the quarter keep us right on track with the 2015 guidance I provided last quarter. On Slide 15 you will see that we continue to expect net revenue to be in the range of a $110 million to $115 million, operating expenses to be in the range of a $160 million to $170 million. Net cash burned to be between $20 million and $30 million and our yearend cash balance to be between a $105 million and a $115 million. Since I joined Halozyme this summer we have conducted a thorough review of our strategic plan including the short and long term investments required to deliver the greatest return against that plan. This was a disciplined process that put us in a good position as we allocate resources going into 2016 and beyond. Our top priority are clear - to make the necessary investments that result in the approvals and commercialization of PEGPH20 and to support the opportunity we have to grow our ENHANZE business. With focus on these two pillars we intend to remain disciplined in our evaluation of new opportunities and prudent in our investment. With that let me turn the call back to Helen who will provide some closing comments.

[Helen Torley:]

Thank you, Laurie. I want to reiterate the strong progress we're making in both pillars of our strategy. We believe in any market environment our business model is an important differentiator and a driver of value for our investors. During the quarter we took significant steps forward in our pancreatic cancer program and continue to expand the exploration of PEGPH20 into a wider array of tumor and therapy types and at the same time with yet another quarter of important milestones for our ENHANZE pillar with two new products beginning Phase 1 trials and the recent announcement by AbbVie of their planned development in the roadmap for Humira. I remain very optimistic about our investment that we're making in both pillars to deliver even greater value for the future. And I’d like to close by thanking the growing Halozyme team for the continued hard work in advancing our program and supporting our partners. We're now ready to take your questions. Operator, could you please open the call for questions.

[Operator:]

Thank you. We will now be conducting a question and answer session, [Operator Instructions], our first question will come from Dr. Duncan with Piper Jaffray & Company.

[Charles Duncan:]

Helen, thanks for taking the question, congrats on a solid quarter of progress. So my first question is on PEGPH20 and moving into Phase 3, exciting to see that and hear about that. I kind of missed the adaptive design part, is that true that it’s an adaptive design and what is the number of patients in which you will take a look at that first stock cohort?

[Helen Torley:]

Charles, so it is a design that gives us multiple shots and goals to have efficacy and that’s really how we look at it. I’ll turn it over to Athena just to give a high level overview of the design and the number of patients and when we’ll do the interim analysis.

[Athena Countouriotis:]

So the total sample size is 420 patients with high HA, obviously metastatic pancreatic cancer and the two primary endpoints as you know are progression free survival and overall survival. And we do believe it is the unique design in pancreatic cancer because it does have multiple options and the options occur at that interim analysis. The first option as Helen mentioned in her prepared remarks is to show superiority in terms of progression free survival based on the final PFS analysis. At that time as we said previously if the magnitude of PFS is great enough as well as the overall toxicity profile and the interim overall survival that could lead to a potential marketing application. At the interim there is also the optionality to continue to the final overall survival analysis which is still in the 420 patients. There is a third option to increase the sample size to a total of 570 patients and further evaluate overall survival and the last option is obviously to stop the study through futility. So again it is unique in that it has obviously a targeted population with high HA but also essentially three options to show superiority within the same study.

[Charles Duncan:]

That sounds like a pretty cool design. Can you give us a sense of even a rough order of magnitude of the difference in PFS that you’d like to see to trigger that first or at that first analysis to trigger a superiority, rough order of magnitude that you’d like to see?

[Helen Torley:]

Charles that’s not our practice to go into detail on the statistical plans for our studies, all I can say is obviously we’ll be seeking to demonstrate a clinically meaningful benefit.

[Charles Duncan:]

And last question is on enrollment timelines. Can you give any color on that at this point?

[Helen Torley:]

We’re deep in the preparations for the study start, which we’re targeting for the end of the first quarter that includes contracting and gaining support from the sites that will be joining the study. So it would be premature to I think given an enrollment timeline at this point in time Charles. But obviously there is nothing other higher priority for what we’re working on at the moment and we’ve got a great team working very hard to get this started.

[Operator:]

Thank you. Our next question will come from Jonathan Eckard with Barclays Capital.

[Jonathan Eckard:]

Forgive me if this has been discussed before, but when it comes to the definition of high HA, I know that you’re going to go through that with regards to pancreatic cancer. But are you expecting that their definition could vary from cancer tumor type to tumor type? And I guess I am particularly interested the [indiscernible] combination where whether you need to have the same level HA versus the second type of combination in trials that you’re going on with PEGPH20?

[Helen Torley:]

It’s fair to say that this is something that we are most advanced in terms of our studying and in pancreatic cancer. As we’re entering into non-small cell lung cancer and breast cancer, we’re going to be using a similar approach, but what we don’t have defined at this point in time is if the top point level will be the same. The data that we’re going to be generating in the dose escalation parts of these studies as well as pathological samples that we have are going to be informing as we go along as to what we believe the top point should be. So in summary, it will be a similar approach and we’re going to learn a little bit more as we enroll patients in our study as to where we’re going to place the top point for high HA in those tumors.

[Jonathan Eckard:]

Maybe just the step up of some of the enhanced collaborations that you have, how do we look at where a program is being announced or being [indiscernible] about what transpired in the [indiscernible] lead up to that announcement. For example will that be in HUMIRA doing a collaboration in June and therefore it seems like there could have only been limited amount of maybe background work done in the combination of the two to four as data started to [indiscernible] that being in the product. So when we see a product or the new products that are coming, what could we assume that may or may not have been done in preparation for that selection process?

[Helen Torley:]

I think you may have been referring to certainly as we’ve seen recently with the Janssen collaboration but also as we mentioning HUMIRA, the time between finding these deals and the potential to enter the clinic as saw with Janssen is shorter than it was in prior collaborations. I think that is in part due to the fact that we from a manufacturing standpoint have more product ready and information ready for our potential collaboration partners. And I think that in terms of the work done for everybody I think it’s fair to say when we signed a collaboration we’ve done basic compatibility work and as we sign the collaboration we move into formulation work. But I think Janssen is good example of I think a company partnering with us very well to move rapidly from signing the agreement to being able to move into the first dosing of patients in just -- well certainly under a year.

[Operator:]

Thank you. Our next question will come from Jessica Fye with JP Morgan.

[Tim Ryan:]

This is Ryan on for Jess, appreciate you guys taking my question. I guess following on to that prior question regarding the AbbVie, HUMIRA collaboration. How should we think about those timelines, should we think about them progressing at a similar rate as some of the other ENHANZE collaboration?

[Helen Torley:]

Each company is going to progress at a different rate and obviously per the terms of the agreement we’re in a position of only being able to announce things that our partner companies have elected to advance. I think what HALAVEN has been able to do though is to build a wealth of information with regards to the products that have had successful regulatory path, we have products ready for them to begin their formulation work and we have a lot of information for regulatory authorities with regard to the CMNC [ph] section. So we have everything ready for them to begin their work, I am thinking about the pathways they are going to take for their regulatory approval as well as how they are going to formulate the new product. But we have to await our partner companies announcing anything.

[Tim Ryan:]

And second question if I may on PRIMAL. Can you help us think about when we might be able to see some data from that study and are there any expectations to plans to increase the number of site enrolling for that study?

[Helen Torley:]

I’ll reiterate the comments that made in my prepared remarks and maybe ask Athena to add a couple of comments to your second part of that question. We certainly have been pleased with the progress we’ve seen in the last quarter following our expansion of the number of centers and with the screening rate really increasing. Athena I think Ryan’s follow-up questions were, any estimate of timing to data and any time to further expand clinical site.

[Athena Countouriotis:]

Yes, Ryan as Helen mentioned in her prepared remarks, we actually had a very encouraging meeting at the World Lung Conference with investigators not only in the U.S. but outside the United States and based on that I do agree that docetaxel will continue to have a rolling on cancer and based on that, do plan on extending predominantly outside of the United States to multiple different countries. As we move pass the maximum tolerated dose into the randomized portion of the study.

[Operator:]

Our next question will come from Andrew Peters with UBS Investment Research.

[Andrew Peters:]

Thanks for taking the question and congrats on the progress. I just wanted to understand question -- a statement you said earlier that the screen failure rate is now lower and appropriate for you 202 study, just want to understand if you have any data on a blinded [indiscernible] basis, if that changed since ESTO [ph] and how that has impacted kind of the -- in other way what you're speaking about the Phase III? And then just secondly, the terms of the interim is going to be based on a look at PFS, but its decision is going to be based on whether or not the number -- whether or not the size of the trial will be needed to increase for overall survival. So just want to understand kind of based on your idea on the trial right now how you thinking about the number of OS events that you’re likely to see at the time of the interim and kind of how that impacts the analysis and plan going forward?

[Helen Torley:]

Thanks Andrew. I’ll take the first part of the question and I’ll turn the 301 questions over to Athena. With regards to the screen failure rate, we certainly have seen a consistent reductions since we changed the inclusion-exclusion criteria to allow patients in based on lab value who previously were excluded. Your question on event rate was that the thromboembolic event rate you were interested in on the blinded basis?

[Andrew Peters:]

Yes.

[Helen Torley:]

So we have the last update we provided was in May as you know, after what we showed that we’ve seen a reduction in the thromboembolic event rate. It's our intent to provide an update early in 2016 on the thromboembolic event rate. What we can say is our data monitoring committee continues to monitor the pace of this study including the TE events and as does now indicated there is any cause for as to be evaluating this. So we’re taking that as a good sign. Let me turn over to Athena to answer your questions on 301.

[Athena Countouriotis:]

So Andrew your understanding of the Phase III study is correct, obviously we’ll be evaluating progression free survival at the interim analysis and have two options in terms of overall survival, it's not our practice to share detailed statistical plans in terms of number of events we will see in terms of OS. But what I should reemphasize is that this is a design that we have discussed with both the FDA and DMA and are moving forward and obviously we’ve also had the opportunity to discuss if the PFS magnitude to benefit is great enough to further our dialogue in regards to whether that could lead to an application.

[Operator:]

Thank you. Dr. Torley there are no further questions at this time. I’ll now turn the floor back to you for closing comments.

[Helen Torley:]

Alright. Well thank you and thank you everyone for joining us today. Obviously we’re pleased with great progress in the last quarter and we look forward to speaking with you on our next call, have a good evening, thank you.