Ionis Pharmaceuticals, Inc.

Ionis Pharmaceuticals, Inc.

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Biotechnology

Ionis Pharmaceuticals, Inc. (IONS) Q3 2013 Earnings Call Transcript

Published at 2013-11-05 17:43:04
Executives
Stan Crooke - Chairman and Chief Executive Officer D. Wade Walke - Vice President, Corporate Communications and Investor Relations Beth Hougen - Chief Financial Officer B. Lynne Parshall - Chief Operating Officer
Analysts
Chad Messer - Needham & Company Jim Birchenough - BMO Capital Whitney Meredith - JPMorgan Andrew Goldsmith - Canaccord Stephen Willey - Stifel Navdeep Singh - Goldman Sachs
Operator
Welcome to the Isis Pharmaceuticals’ Third Quarter Financial Results Conference Call. Please note this event is being recorded. Leading the call today from Isis is Dr. Stan Crooke, Isis Chairman and CEO. Dr. Crooke, please begin. Stan Crooke - Chairman and Chief Executive Officer: Good morning everyone and thanks for joining us on today’s conference call to discuss our third quarter financial results. On this call first Beth will walk you through our financials and updated guidance, then Lynne will highlight some of our recent business successes and I’ll close the call by focusing on some of our upcoming events. Joining me on today’s call are Lynne Parshall, Chief Operating Officer; Beth Hougen, Chief Financial Officer; and Wade Walke, Vice President of Corporate Communications and Investor Relations. Now Wade if you read our forward-looking language and (completions)? D. Wade Walke - Vice President, Corporate Communications and Investor Relations: Thanks, Stan. A reminder to everyone that this webcast includes forward-looking statements regarding the financial outlook for Isis, Isis’ business and a therapeutic and commercial potential of Isis’ technology, and products, and development. Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs including the commercial potential of KYNAMRO is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs. Isis’ forward-looking statements also involve assumptions that they can never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Otherwise these forward-looking statements reflect the good faith judgment of its management; these statements are based only on facts and factors currently known by Isis. As a result you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis’ programs are described in additional detail in Isis’ Annual Report on Form 10-K for the year-ended December 31, 2012, and its most recent Quarterly Report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company. Now I’ll turn the call over to Beth to discuss our financial results for the second quarter of 2013. Beth Hougen - Chief Financial Officer: Thanks Wade. Good morning everyone and thank you for joining us. I am pleased to report that we continued our strong financial performance by ending the quarter with more than $670 million in cash which was due in large part to the $200 million we received from our partners so far this year. In addition our pro forma net operating loss for the year to-date at $23 million was significantly lower than our guidance would suggest. We achieved these financial results by effectively executing our business strategy and successfully advancing the drugs in our pipeline. These results illustrate that our business model is working by consistently generating cash and revenue and (indiscernible) in our pipeline in advance. As a result of our strong financial performance this year we will substantially exceed our cash guidance and significantly improve upon our pro forma NOL guidance. As such we are now projecting to end the year with more than $625 million in cash and a pro forma NOL in the mid $40 million range. Over the last couple of years we kept our pro forma NOL in the $60 million range while significantly expanding inventory in our pipeline. We are pleased that we have 10 drugs in Phase 2 and Phase 3 development, we are able to project the pro forma NOL for this year in the mid $40 million range, more than 30% reduction from our initial guidance. This substantial improvement in our already healthy cash balance was primarily due to the $200 million we received from partners so far this year. In the third quarter alone we received $100 million from our recent strategic collaboration with Biogen Idec. In addition to-date we received nearly $100 million from six of our partners associated with advances in eight different drugs, that we can consistently generate revenue from multiple partners and numerous drugs is a reflection of the success of our partnering strategy. This strategy and its successful execution is a key element of our ability to continue to remain financially strong while expanding and advancing our pipeline and continuing to improve our technology. The improvement in our NOL was also driven by the success of our partnership strategy from which we’ve earned more than $94 million in revenue primarily from milestone payments and the amortization of upfront fees so far this year. In our year end call in February we projected that our 2013 revenue would include $45 million from milestone payments as our partner drugs advance in development. We significantly exceeded our projections by earnings more than $70 million already this year. In the third quarter alone we earned $2 million from Biogen Idec for advancing ISIS-SMNRx and $9 million from GSK for advancing ISIS-TTRRx and ISIS-GSK3Rx. With numerous successful partnerships encompassing multiple drugs we still have several opportunities to earn additional milestone payments from our partners in the fourth quarter. Already in the fourth quarter we’ve earned a $10 million milestone payment from Biogen Idec for initiating the IND-enabling tox studies for ISIS- DMPKRx, our drug to treat patients with myotonic dystrophy Type 1. Another significant component of our revenue is the amortization of upfront fees from our collaboration. In our guidance we included $40 million from this component of our revenue. Here again we are on track to exceed our guidance. In October we began amortizing the $100 million upfront payment we received from Biogen Idec over the six years of the research collaboration which will provide us with new revenue of approximately $4 million in the fourth quarter and each quarter thereafter through the research term. As the drugs progress in development our expenses will continue to increase as they did in the third quarter. The increase this year and next will reflect the increasing number of drugs we have in Phase 2 and Phase 3 development including ISIS-TTRRx for which the Phase 3 program is progressing well and ISIS-APOCIIIRx than ISIS-SMNRx for which we plan to initiate Phase 3 program early next year. In addition our drug to treat type 2 diabetes recently began Phase 2 program. We project that our fourth quarter pro forma NOL will be similar to Q3 in other words in the low to mid $20 million range. We are projecting revenue in the mid $30 million range including revenue from the amortization of upfront fees of approximately $15 million which includes the new revenue from our Biogen Idec collaboration. In addition to the $10 million milestone we recently earned from Biogen Idec we still have several opportunities to earn additional milestone payments before year end. With the significant maturation of our pipeline we are projecting that our expenses will increase in the fourth quarter as we progress ISIS-APOCIIIRx and ISIS-SMNRx into Phase 3 development in advance to seven drugs we have in Phase 2 development. As a result of this substantial increase in our revenue offset in part by an increase in operating expenses we are projecting a significant improvement in our pro forma NOL to end the year with an NOL in the mid $40 million range. We are also projecting to end the year with more than $625 million in cash. In fact we think it’s likely that we will significantly exceed this projection. We’ve had an excellent year so far because of the effective execution of our business strategy and the success of the drugs in our pipeline we expect to continue our strong financial performance through the end of the year and into 2014. Now I’d like to turn the call over to Lynne. B. Lynne Parshall - Chief Operating Officer: Thanks, Beth. 2013 has been a year of substantial growth in maturation for ISIS. KYNAMRO approval started the year on a great note. And since then we’ve had a continuous stream of positive news from our pipeline and from our partnering activity including adding new partners and expanding existing partner relationships. We believe that our partnership infrastructure to provide the best support and ultimately best value for each drug in our pipeline. Our pipeline is matured significantly this year with multiple positive clinical data events showing that our drugs work in many diseases and many patient populations. These activities have added significant value to ISIS stand to our shareholders. Earlier this year we added Roche as a partner to help us develop our Huntington’s disease program which is a high priority program for us. Roche’s expertise and neurological disease has already provided us with significant value. We plan to select the development candidate to move into IND-enabling studies this year. Our pipeline is also matured this year. We now have a pipeline with numerous late stage clinical programs. For example our Phase 3 study with ISIS-TTRRx and patients with TTR amyloidosis is enrolling on schedule. We’ve already earned $22 million in payments from GSK associated with the advanced ISIS-TTRRx including $12 million related to the ongoing Phase 3 study. As this study progresses we are able to earn an additional $48 million in milestone payments from GSK prior to GSK licensing the drug. Our triglyceride-lowering drug ISIS-APOCIIIRx is ready to move into Phase 3 development early next year. This is a drug that we wholly own and one that we believe we can rapidly move towards to market in our first indication, patients with FCS. FCS’s severe and rare genetic condition characterized by extremely high levels of triglycerides. We plan to advance our drug to treat children and infants with spinal muscular atrophy ISIS-SMNRx into a Phase 3 program next year also. And OncoGenex and Teva planned to report data in the first half of next year from the Phase 3 study of OGX-011 in men with prostate cancer. These data, if positive, we’ll support OncoGenex’s regulatory filing for marketing approvals OGX-011. This year, we reported eight sets of positive clinical data including four sets of Phase 2 data on ISIS-APOCIIIRx at the upcoming AHA Meeting this month. We also initiated clinical trials in six drugs including advancing two drugs from a metabolic franchise to treat type 2 diabetes in the Phase 2 development. We also continue to add new drugs to pipeline. Taking together, these activities look like an unusually high number of positive events for a single year but when you consider that, our pipeline consist of 30 drugs, men moving into later stage development. This level of activity is consistent with the steady positive progress of our business and our pipeline. In the third quarter, we significantly expanded our alliance with Biogen Idec completing our fourth collaboration with them in less than two years. Fourth collaborations represented very significant investment by Biogen Idec and antisense technology from which we have the potential to earn milestone payments and licensing fees in excess of $4 billion plus double-digit royalties. Coupling our antisense technology to Biogen Idec’s internal and external network of disease expertise from basic science through complex clinical developments, we believe that we can build a large and valuable neurological disease franchise well beyond what we could do on our own. We already have a good start on this. Our drug to treat children with spinal muscular atrophy will enter Phase 3 development early next year. And we plan to begin clinical development on our myotonic dystrophy drug next year as well. And we also plan to add new drugs to treat neurological diseases to our pipeline. In addition, as Beth mentioned we received $200 million this year from our partners in upfront milestone and licensing payments. All of these accomplishments have added significant value to ISIS and increased our already strong financial position. We’re happy to share with you today that we’ve updated our 2013 guidance to reflect these successes. So, as you can see it’s been a very busy and productive 2013 thus far. We look forward to carrying this momentum through the end of this year and into next year as we continue to advance our pipeline. With that, I’ll turn the call back over to Stan. Stan Crooke - Chairman and Chief Executive Officer: Thanks, Lynne. I think you’ll agree the first three quarters of 2013 have been productive. And as we look at the – to the remainder of this year, we have a number of exciting events that we can still look forward to. So, later this month at the American Heart Association Scientific Sessions, we’ll provide additional detail on the Phase 2 program for ISIS-APOCIIIRx. In addition to ISIS-APOCIIIRx, data at the AHA we’ll also present results from the Phase 1 study of our LPA reducing drug ISIS-APOARx. This drug is particularly exciting because high levels of Lp(a) it represent another independent risk factor for cardiovascular disease. There are patients with normal LDL cholesterol but extremely high levels of Lp(a) who are with extreme cardiovascular risk. For these very sick patients there is nothing today they can significantly lower Lp(a) and improve the risk of cardiovascular events. We’re developing ISIS-APOCIII and ISIS-APOARx to treat patients with the severe and rare with the disorder. We’ve initiated Phase 2 studies on a glucagon receptor and PTB-1b inhibitor. Both the drugs were designed to treat patients with type 2 diabetes. We planned to initiate a Phase 2 program and include corticoid receptor drug also this year. And we look forward to giving you an update on these metabolic problems early in 2014. We also planned to complete report data from the ongoing ISIS-SMNRx studies by the end of this year or very early next year. When these stages are complete we plan to move rapidly towards initiation of registration directive studies for ISIS-SMNRx in the next year. So, finally and we find to expand our pipeline by adding at least two more exciting new drugs to our pipeline this year. With that I want to thank all of you for joining us today. And we’ll now open it up for Q&A. (indiscernible) if you can set us up for questions.
Operator
We will now begin the question-and-answer session. (Operator Instructions) And our first question comes from Chad Messer of Needham & Company. Please go ahead. Chad Messer - Needham & Company: Great. Congratulations on an another great quarter and thanks for taking my question. On APOCIIIRx at AHA you’re building this as a sort of a Phase 2 grand overview from all the data we’ve seen so far but it sounds like there will be some newer incremental data as well. I was wondering if you could comment further on what kinds of new data we might expect to see?
Stan Crooke
The new information will just be a continuation of the data in a very high triglyceride patient population primarily. So, we expect to summarize all of the Phase 2 information in sort of one place where you certainly can put it all together. Chad Messer - Needham & Company: All right. Great. And then I mean you’re going into not just one but actually two pivotal trials with APOCIII next year I mean presumably the FCS trials could that be shorter and report out of earlier eight. I was wondering if you can comment on as we progress this, how you think of the optionality that you have around this program with going into two pivotal trials one that may report out – as this progresses maybe you could just cover this a little bit more about how you sort of think and prioritize the options that you have for this program.
Stan Crooke
So, I think I understand the question and if I don’t understand exactly what you’re asking and maybe Lynne she could help or you can help me clarify. We are planning two Phase 3 endeavors, the first is FCS and second is the 880 and we do expect the FCS study to complete first. We think that, that initial FCS opportunity as a rare disease opportunity that will certainly support value pricing and the 880 opportunity is also a rare disease opportunity. That will again support very significant value pricing. We look at each –we look at these two indications as different in the nature of the marketing requirements and nature sales force and lot of other things. But obviously in the aggregate, they represent a very substantial opportunity for ISIS-APOCIIIRx. And we are continuing to control ISIS-APOCIIIRx ourselves and we’re looking at a whole range of opportunities in terms of – in which we are going to seek to maximize the value of APOCIIIRx while retaining commitment to our overall strategy which is to remain small and focused and focused on innovation. Lynne, you want to add or subject anything to that? B. Lynne Parshall: Yes. The only thing I would add is with the overall Phase 3 program that supports both of these drugs will of course be made up of multiple studies and we’ll work out the details of that with the FDA and European regulatory agencies we have in our Phase 2 meeting. But the two programs will be quite complementary of one another with as Stan mentioned the FCS program being smaller and shorter reflective of the indication. And so that being our initial indication followed by the 880.
Stan Crooke
I’m not sure Chad, whether we answered your question or not but… Chad Messer - Needham & Company: No, that does answer my question. Thank you, very much guys.
Stan Crooke
Thank you. You bet.
Operator
And the next question is from Jim Birchenough of BMO Capital. Please go ahead. Jim Birchenough - BMO Capital: Hi, guys. Congratulations on all the progress. Just on the Lp(a) program. Based on feedback you get from clinicians, what’s a meaningful reduction in Lp(a). And if you could talk about where these patients are seen right now, is this a big component of patients that are refurbished right now. And I’ve got a couple of follow-ups.
Stan Crooke
Sure. Again what we’ve learned over the last couple of years is that there is a very wide variation in levels of Lp(a). And the levels of Lp(a) vary primarily genetically so there is very little environmental influence on LPA levels. People who have generally greater, I think than 30 milligram per deciliter are considered at high LPA risk certainly 50 is a very significant risk. But we understand that there are patients who have LPA levels better as high as in the 100s. And these people have an LPA driven cardiovascular risk which is very, very substantial. It is that group of patients that we’ll focus on in the development of APOARx that is patients with a genetically driven extremely high Lp(a) level in their blood and obviously since our drugs that really lower Lp(a) with exception of KYNAMRO. There is a little information about how treatment what sort of treatment benefits and so on and the general belief of the experts that we talk to is any significant reduction of Lp(a) in these patients will bring cardiovascular benefit very similar to a significant reduction on LDL. With regard to the question about apheresis I don’t know Jim, I don’t think there are that many Lp(a) patients who a getting a apheresis I think the bulk of the people that are getting apheresis are really there for their LDL problems and occasionally triglycerides. But I think I’ll go back and talk to our experts and give a clear answer to that for you. Jim Birchenough - BMO Capital: And then at AHA Stan are we going to see Phase I data in patients with mildly elevated LPAs or the very high LPAs, I'm just trying to get a sense of the patients you’re studying the drug right now?
Stan Crooke
Yes we’ll see data in normal volunteers and as we’ve learned normal volunteers have extremely high range Lp(a)s. So, you’ll see data in patients who have low to moderate Lp(a)s in normal volunteers and you’ll see people who have some very, very high Lp(a)s. And then we’ll present that, the results of that study in a poster and we’re excited about the data. Jim Birchenough - BMO Capital: And just one other question just on Myotonic Dystrophy can you be more specific in terms of when that program will start and in the Phase I will there be any ability to look at efficacy or is it going to be purely safety?
Stan Crooke
Yes, I can’t answer that question today. Lynne, do you want to respond to that at all? B. Lynne Parshall: I actually I can’t answer today either. Jim Birchenough - BMO Capital: Okay that’s fine. Well thanks for taking the question.
Stan Crooke
Yes we are in the process of planning all this now. So, give us another couple of months okay. Jim Birchenough - BMO Capital: Okay. Thanks guys.
Stan Crooke
You bet.
Operator
The next question is from Cory Kasimov with JPMorgan. Please go ahead. Whitney Meredith - JPMorgan: Hi, this is actually Whitney on for Cory today. Can you hear me okay?
Beth Hougen
Yes we can hear you.
Stan Crooke
Yes. Whitney Meredith - JPMorgan: Great, great so going back to APOCIII I just wanted to follow up on the optionality. I know u guys had mentioned potential follow on compounds there. So, I was just wondering if there is any update on progress on those? And then also headed into the SMN data if you guys can just help us set expectations in terms of what data we’ll see initially and then kind of what you guys would view as a positive out come from that?
Stan Crooke
With regard to APOCIIIRx follow on yes we’re very excited about the follow on. And we do believe that the follow on is significantly more important and that will give us opportunities to address a wider range of patient populations and so on. So, we look at the APOCIII opportunity as a real franchise opportunity as far as with APOCIIIRx and then assuming we’re successful than the follow on expanding the opportunities even more. With regard to SMNRx what you’ll see is a continuation of the data from Phase 2 in the older children and these are those children that we’ve shown single dose data on and now you’ll have the opportunity to see the benefits of these children they get with dosing with repeat dosing with – then children have different amounts of dosing that they’ve gotten depending on the dose level of they would have gotten. But you’ll have the opportunity to evaluate, we will have the opportunity to evaluate the performance of the drug with regard to safety and tolerability as well as benefit as principally in the Hammersmith scores now with more doses. And we would think that any suggestion of improvement in these children will be a cause for real optimism about the drug. Whitney Meredith - JPMorgan: Got it. Thanks for taking the questions.
Operator
The next question is from Salveen Richter of Canaccord. Please go ahead. Andrew Goldsmith - Canaccord: Hi this is Andrew Goldsmith on the line for Salveen. I just, a question on APOCIII I was wondering if you could speak all about how you see the competitive landscape and particularly anything about DGAT1?
Stan Crooke
Well we think that these patients who have FCS are in desperate need. And they need every new agent that they can possibly get. As we understand DGAT1 its principle activity is likely to be and reducing expirations after meals in triglyceride levels. And based on the information from Phase II we think it’s the effects of the DGAT1 Inhibitors really quite modest on triglycerides compared to the enormous changes that we’re seeing with APOCIIIRx. So, we can easily imagine because the two drugs are really quite different that the drugs would be used in combination and we certainly believe that the kind of efficacy we’re seeing out of APOCIIIRx is unlikely to be matched by any drug in development that we know about. Andrew Goldsmith - Canaccord: Great thanks. And then just a follow up also on the SMN program, can you just remind us about the conversations that you’ve had with the FDA recently in particular with regard to the Phase III trial?
Stan Crooke
Well the conversations are still in progress and we will update you when the conversations with the FDA have reached at appropriate conclusion. Andrew Goldsmith - Canaccord: Okay, thanks so much.
Operator
The next question is from Stephen Willey of Stifel. Please go ahead. Stephen Willey - Stifel: Yes thanks for taking my question. I hop on the way so my apologies if this was already covered but just I guess any thoughts on the recent FDA panel favoring specifically I guess the FDA stance at the triglyceride risk I think patients at(500) was discussed in terms of the data set not necessarily being the best indicator of risk and does that now I guess change FDA’s thinking with respect to a particular cut off value I know you are 880 cut off reflects that thought process?
Stan Crooke
Well Steve I really can’t amplify on what I'm about to say and of course I'm not able to, I certainly won’t speak for the FDA. But what we are, that was important to us off of that conversation is that there are questions in some minds about the benefit of lowering triglycerides in patients who have triglycerides lower than 500 and lower. We actually think the way the evidence supports the benefit of lower triglycerides in that patient population. But we’ve always believed that outcome studies would be required for approval of any triglyceride lowering agent in those relatively lower risk patients. So, from our perspective the conversation didn’t change anything about our plans. Lynne, do you want to amplify on that? B. Lynne Parshall: Yes the other thing I would add is it was very interesting at the initiation of the panel discussions in Eric Colman’s introductions but he made very clear that in the over 500 patient population but well in the over 500 patient population where there were myriad of health problems including triglyceride or the endpoint but the – basically broad dyslipidemia, triglyceride is over 200 patient population that we’re being studied and considered by the panel at the meeting was a different question. And, so I – I think he went out of his way to say, we’re not – that this conclusion you know is not a conclusion on all triglyceride lowering drugs is the conclusion on this patient population.
Stan Crooke
Yes in short we felt very encouraged that the way we’ve been thinking about the development of APOCIIIRx seems to be supported. That is, we’re going to focus on patients with severe triglyceride on problems whose health problems are very clear and very clearly associated with triglyceride. And there is an outcome study would be required for those patients who have lower triglyceride on 500 whose primary issue is cardiovascular risk which is – and the benefit is finally have to be defined by our kind of studies. So, we really feel that – the plan that we’ve been talking with you folks about the last couple of years is very much on point. Stephen Willey - Stifel: Okay and just a quick question on STAT3, can you may be just provide a little bit of color on how much additional data we might be seeing and certainly the abstracts that occurring due out here in the next couple of days? And then may be just remind us the opting there over the magnitude of the milestone payment is response based is that correct?
Stan Crooke
Yes, those – Lynne you want to answer the – that. B. Lynne Parshall: So I don’t believe we’ll have new data at ASH where you might confirm or confirm that and we’re not under – in two different places. And the.
Stan Crooke
That’s right, Lynne. B. Lynne Parshall: And the – and the opt-in is based on the magnitude of responses you’re exactly right. Stephen Willey - Stifel: Okay. So do you know may be approximately as to when that opt-in decision might be reached? B. Lynne Parshall: Yes we – next year. Stephen Willey - Stifel: Okay. Well thank you.
Stan Crooke
I would add that we’re very pleased with the progress both in the – lymphoma studies and in the additional study that initiated by AstraZeneca and we think the partnership was going very well.
Operator
The next question is from Yaron Werber of Citi. Please go ahead.
Unidentified Analyst
Hi, this is actually (indiscernible) in for Yaron. Congratulations on the quarter and the progress. I wanted to ask you a couple of questions regarding your SMNRx, clinical trials I saw that you increased the dose in the infant study from 9 to 12 milligrams and I was wondering what specifically gave you confidence in that dose from your preclinical studies and if you stop that that dose would be the upper range of the dosing and what the evidence of that was?
Stan Crooke
We think it is the upper range and the – basis for the confidence really derived from the excellent safety and the evidence of that activity that we saw in the studies in the whole children.
Unidentified Analyst
Terrific, great. And in your Phase III study are you planning on incorporating a biomarker there from any of the recent biomarker studies?
Stan Crooke
Well we looking at a variety of measures of pharmacological activity and we are working with Biogen very hard on far more different measures that we’re going to use. But I think I’d rather leave it there for now because is still very much a work-in progress.
Unidentified Analyst
Terrific, thank you so much and congratulations again.
Stan Crooke
Okay.
Operator
The next question is from Navdeep Singh of Goldman Sachs. Please go ahead. Navdeep Singh - Goldman Sachs: Hey, thanks so much and thanks for taking my questions and a nice progress on the quarter. Not sure if you can provide this level of color, but I thought -- it worth a shot. Since the Phase II trial in that open-label study for SMNRx the size of the basic trial for SMNRx is open-label study do you have any sense on how the patient (inaudible) quarters are trending? Also any update on the 12 milligram dose can you remind us why the FDA allowed for you to increase the dose and the infants from 9 to 12 milligrams but not in children?
Stan Crooke
Well nice try, but no we’re not going to give you any information about what – what anecdotes we’re hearing. We remain along with our progress with Biogen extremely encouraged about SMNRx. And the – I think the logic for supporting a higher dose in infants is principally the severity of the disease these infants have and to obtain the need for the intravenous aggressively as possible prevent their very rapid deterioration in them. Navdeep Singh - Goldman Sachs: Okay. And then a quick follow-up, can you discuss the level of confidence you have in your TTR program, are you more concerned with efficacy or safety in this program and do you believe it’s higher chance of success in familial amyloid polyneuropathy subset or versus the cardiomyopathy subset?
Stan Crooke
Well we know that our drug is the lowers TTR profoundly. And the evidence is I think very clear that TTR levels determine the course of the disease. So, we’re very optimistic and as the GSK and that’s why we went straight to Phase III and that we have a drug that should work. And we are very encouraged with the enrollment that we’re seeing and obviously the study is blinded and we don’t have additional information other than to say that the performance of the trial sight is very good and all of the things that we’re hearing from the field speak to excellent tolerability at this stage. So, right now we just need to get the study enrolled and – see what the results look like. We think the polyneuropathy is better first indication for us to pursue and – and that’s the decision we made jointly with GSK and we think that’s a sensible decision. Navdeep Singh - Goldman Sachs: Okay, and final question on APOCIIIRx, any update on your commercial strategy, are you still planning to partnering for the 80, 80 population or do you think you can do that on your own? Thanks
Stan Crooke
Well what – I think is important for us to say is, just to repeat what we’ve said. That is, that we understand that APOCIIIRx is unique opportunity and we need to maximize the value of APOCIIIRx for our shareholders and we need to do that in the fashion that’s consistent with our long-term strategy. And, as we progress through Phase III we’re evaluating a whole range of options about how to best commercialize that asset to assure that our shareholders derive the most benefit from that as well staying true to our long-term vision of the company. Lynne, do you want to add or correct anything to that? B. Lynne Parshall: No.
Stan Crooke
Stay tuned. Navdeep Singh - Goldman Sachs: All right, thanks.
Stan Crooke
We’ll work on it. Navdeep Singh - Goldman Sachs: Thanks Stan.
Stan Crooke
Okay, you bet.
Operator
This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Crooke for any closing remarks. Stan Crooke - Chairman and Chief Executive Officer: Well, thank you very much everyone for your participation in the call. We have a strong three quarters behind this and an exciting quarter left which sets the stage for 2014. So stay tuned lots and lots of news coming in we’ll keep you informed. Thanks very much.
Operator
The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.