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Isis Pharmaceuticals, Inc. (NASDAQ:ISIS)

Update on FDA Approval of KYNAMRO Conference Call

January 30, 2013 09:30 ET

Executives

Dr. Stanley Crooke - Chairman, President, and Chief Executive Officer

Paula Soteropoulos - Vice President and General Manager, Cardiovascular Group, Genzyme

Rogerio Vivaldi - Senior Vice President and Head of Rare Diseases, Genzyme

Lynne Parshall - Chief Operating Officer

Richard Geary - Senior Vice President, Development

Walter Singleton - Vice President, Development and Chief Medical Officer

Wade Walke - Executive Director, Corporate Communications and Investor Relations

Analysts

Eric Schmidt - Cowen and Company

Chad Messer - Needham & Company

Andrew Goldsmith - Canaccord Genuity

Carol Werther - Summer Street

Stephen Willey - Stifel

Operator

Good day, ladies and gentlemen, and welcome to the Isis Pharmaceutical Conference Call to review the KYNAMRO approval. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Dr. Stanley Crooke. Please go ahead, sir.

Dr. Stanley Crooke - Chairman, President, and Chief Executive Officer

Good morning, everyone and thank you for joining us. Today marks a seminal event for patients with homozygous FH and for Isis, for our technology, and of course, for our partner Genzyme. We are pleased to announce that the FDA has approved KYNAMRO for the treatment of homozygous FH patients.

Joining me on today’s call from Genzyme are Paula Soteropoulos, Vice President and General Manager of the Cardiovascular Group at Genzyme; and Rogerio Vivaldi, Senior Vice President and Head of Rare diseases at Genzyme. And from Isis, we have Lynne Parshall, Chief Operating Officer; Richard Geary, Senior Vice President of Development; Walter Singleton, Vice President of Development and Chief Medical Officer; and Wade Walke, the Executive Director of Corporate Communications and Investor Relations.

Wade, could you read our forward-looking language statements please?

Wade Walke - Executive Director, Corporate Communications and Investor Relations

Thanks, Stan. A reminder to everyone that this webcast includes forward-looking statements regarding the development activity in therapeutic and commercial potential and safety of KYNAMRO. These statements describing Isis’ goals, expectations, financial or other projections, intentions or beliefs, including the planned commercialization of KYNAMRO as a forward-looking statement, it 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 to use of therapeutics, and in the endeavor of building a business around such drugs. Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct could cause its results to differ materially from those expressed or implied by such forward-statements.

Although, Isis’ forward-looking statements reflect 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 the Isis’ programs are described in additional detail in Isis’ Annual Report on Form 10-K for the year ended December 31, 2011 and on 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 will turn the call back over to Stan.

Dr. Stanley Crooke - Chairman, President, and Chief Executive Officer

Thanks, Wade and thanks everyone again for joining us. At Isis, we understand that sick people depend on us. And we are committed to working everyday to bring innovative new medicines to patients, who are in desperate need of new therapies. And today, we have achieved this goal for patients with homozygous FH. This, as I said, is a seminal day for Isis and is a seminal day for the technology to a discovery platform that we at Isis have pioneered.

KYNAMRO is a first systemic anti-sense drug approved for use in man and it provides further validation with the promise of the anti-sense technology that we pioneer. It shows that we can develop drugs that have the potential to bring profound benefit to patients who have a lifelong chronic disease and again are in need of new therapeutic alternatives. That was the hope that we had when we set out to create anti-sense technology and KYNAMRO’s approval along with the successes in the rest of the pipeline shows that that hope is being realized. We are of course very pleased to be working with Genzyme, our development and regulatory partner and our marketing partner. And we believe is a marketing partner that they are among the best in the world and that they will help us bring this drug to bring benefit to patients with homozygous FH.

And now, I will turn over the call over to Lynne to walk you through with this approval needs for patients with HoFH and then Rogerio will discuss marketing and commercial plans for KYNAMRO. And after their remarks, we’ll open up the call for questions.

Lynne?

Lynne Parshall - Chief Operating Officer

Thanks Stan. This is a really exciting day for patients with homozygous FH and we are pleased to be providing these patients with a new therapeutic option. We think KYNAMRO should be the first of many drugs to be commercialized based on the anti-sense technology we have pioneered. We are very pleased that you are joining us for this celebration, for those who followed Isis through the year as you know what this means for us and for our technology.

KYNAMRO should be a valuable new medicine in the armamentarium of the lipidologists for treating homozygous FH patients. KYNAMRO is a focused therapy that directly addresses the issue that causes homozygous FH. These patients are unable to clear cholesterol from their blood resulting in a lifetime of severely elevated levels of LDL cholesterol. As a result, these patients are at significant cardiovascular risk.

Homozygous FH patients may have untreated LDL cholesterol levels of 500 milligrams per deciliter to 1000 milligrams per deciliter or even more and can have heart disease as young as 18 months and heart attacks in their teens. With such extremely high cholesterol level at 20-year-old homozygous FH patients may have arteries that are typical of an 80-year-old. With current therapies, homozygous FH patients maybe successful in significantly reducing their LDL cholesterol, but they still have LDL cholesterol levels that remain much too high.

Before statins, homozygous FH patients frequently died in their teens. While statins have significantly improved their outlook, these patients still died prematurely often in their 30s. Obviously, there is still tremendous need for new therapies for these patients. KYNAMRO was developed to address this need by blocking the production of cholesterol. Until recently, the only alternative these patients had was apheresis and inconvenient invasive procedure that was not likely available. Apheresis was typically done weekly and requires a significant commitment from the patient, their families and their caregivers. That’s the current standard of the care and it’s often inadequate for these patients. With the approval of KYNAMRO, we hope to provide these patients with a new, convenient and non-invasive option to lower their LDL cholesterol.

KYNAMRO has been very thoroughly studied. We conducted a robust Phase 3 program evaluating KYNAMRO with four randomized double-blinded placebo-controlled Phase 3 studies and we conducted the largest study to-date in homozygous FH patients. The data from that study and the three others supporting Phase 3 studies were published in journals such as the Lancet, PLoS ONE and Circulation. And our long-term open label study, we have continued to observe a profile for KYNAMRO that’s similar to the one we observed in our Phase 3 program. KYNAMRO has been supportive for many key lipidologists, a large number of them who are involved in our KYNAMRO clinical trials and will be the same physicians who will be treating these homozygous FH patients. The supportive lipidology community is evidenced by the number of publications and review articles that have been published on KYNAMRO over the last several years. We think this will provide a significant advantage for a successful KYNAMRO launch.

As we look towards the market, we believe that KYNAMRO has several key appealing characteristics that will make it an attractive therapeutic option for the patients with homozygous FH and their physicians. First, KYNAMRO treatment is simple. If administered it’s an easy to use once a week at home subcutaneous injections with the pre-filled syringe, which has very small needle about the size of an insulin needle. A single 200 milligram dose administered once a week means the patient do not have worry about taking the drug on a daily basis. They will not have complex dosing regimens and will have no daily reminders of their disease.

Second, with KYNAMRO homozygous FH patients will only need to continue their standard heart-healthy diet. They will not need a special low-fat diet while taking KYNAMRO and will not require nutritional counseling or vitamin supplements. We believe this will mean a lot to this young and active patient population. Third, patients and physicians should not have to worry drug interactions with KYNAMRO. While they may look healthy, many homozygous FH patients have already had at least one cardiovascular event, which means that many of these patients could be taking more than a dozen drugs a day to manage their disease, including morphine and statins. For these patients, KYNAMRO can be taken together with their other medications because there is no evidence of it interfering with safety or efficacy of their concomitant medications, and physicians should not have to monitor and adjust dosing in response to potential drug interactions or tolerability issues.

As you know, the FDA has requested that KYNAMRO be available through our REMS program. We believe that this is the right approach for this drug and for these patients. Marketing under our REMS program will help to ensure that homozygous FH patients will have access to KYNAMRO. The physicians who treat these patients will understand KYNAMRO and Genzyme will be able to provide them with the tools to maximize patient benefit from KYNAMRO. We view the U.S commercialization as the first step for KYNAMRO, the homozygous FH patients worldwide who desperately need to lower their LDL cholesterol.

Genzyme plans to leverage it’s and Sanofi’s existing infrastructure in cardiology and launch KYNAMRO with very a focused clinical sales force and medical team that targets lipid specialists. These are the physicians who are the best equipped to treat this complex disease. We’re also very optimistic that the future of KYNAMRO in other key markets. Marketing applications for KYNAMRO are under review by the European Medicines Agency, and Genzyme is in the process of filing global application. In addition, Genzyme is conducting a Phase 3 study focused at FH and patients with severe heterozygous FH under a special protocol assessment with the FDA. This study also contains an alternative dosing regimen, which could in the future allow patients choice in their dosing regimen.

Finally before I turn the call over to Paul and Rogerio to talk about Genzyme’s marketing efforts, I want to congratulate the regulatory and development teams at Genzyme and Isis for their dedication and hard work to bring this drug to the market. I’d also like to say that we believe the Genzyme KYNAMRO marketing team is one of the best. We have been very impressed with their planning and outreach efforts including the formation of our free program KYNAMRO Cornerstone that will provide support for physicians, patients, and their families.

Genzyme specialized sales force for KYNAMRO is trained, ready, and set to go. Focus on patient and physician support is impressive, and we believe will significantly contribute to a successful KYNAMRO launch. In addition, KYNAMRO will also benefit from Sanofi’s global infrastructure and sales force, which will augment Genzyme’s efforts in reaching the physicians and ultimately patients who will benefit the most from this drug. We are looking forward to a very successful launch in the United States.

And with that, I will turn the call over to Paula and Rogerio, our Genzyme colleagues, who are ready to implement the KYNAMRO launch.

Rogerio Vivaldi - Senior Vice President and Head of Rare Diseases, Genzyme

Thank you, Lynne. Thank you, Stan. Here’s Rogerio Vivaldi, the Head for the Rare Diseases Division at Genzyme. We are extremely happy to announce the FDA approval of KYNAMRO for the treatment of homozygous FH. This drug KYNAMRO presents really a new therapy and the more important it’s a very significant milestone for Genzyme, for the Rare Disease division and for Isis. And we are really proud to offer this option for patients.

This approval is really at the heart of Genzyme fundamental strengths delivering transformative therapies for patients with rare and unmet medical needs for over 30 years. This is what we do. This is what we do for many, many years, and then we are very, very proud to be able to do again with a new disease using another innovative technology.

Our efforts is in strengthening and further establishing our leadership in HoFH and increasing the awareness of the disease and resources available for patients have been met and with very, very, very good success. We have recent appreciations, we have recent patients, and we feel confident that we understand and that we can provide to this community the patient centricity model that have identified Genzyme as what we do in the rare disease field. I want to recognize their hard, hard work and the commitment of both teams, Genzyme and Isis who supported KYNAMRO from a very, very robust Phase 3 program that was detailed by Lynne before to this U.S. approval today.

We are ready to launch. As Lynne said, we have a team in place trained and ready to launch. We can now begin the process delivering this much, much needed therapy to patients who are at extremely cardiovascular risk and are in need for new treatments to reduce their LDL-C. Our work is not done, as Lynne said, this is the first of many milestones for KYNAMRO, as we work to bring this important new therapy to patients around the globe.

With that, I would like to turn the call back to Stan.

Dr. Stanley Crooke - Chairman, President, and Chief Executive Officer

Thanks, Rogerio. Every single person at Isis feels privileged to be involved in bringing a new medicine to patients. Every single person at Isis shares in that special privilege. And every single person at Isis feels particularly privileged to bring KYNAMRO to patients with this terrible disease. We believe that KYNAMRO will be an important new therapy for these patients who do have significant cardiovascular risk despite best available therapies. And so this is an important day for those of us and all of us too who cares so much about these patients. It is in some ways every bit is important for the technology and for the pipeline.

We believe that the approval of KYNAMRO paves the way for many drugs that we have in development behind KYNAMRO. We have 26 drugs in development. We have 5 drugs that we believe that have the potential to get to the market in the next five years. These are drugs to treat cancer, severe and rare and numerous other diseases, where there is a significant unmet medical need. We think our technology can uniquely fill these unmet medical needs. And we look forward to bringing these important new medicines to the market. Also within the next year or so, we have 9 other drugs hitting critical clinical data milestones in Phase 2, Phase 3. So, KYNAMRO very much is simply the first news event of the year. So, you will need to stay tuned.

Before I – as I bring this to a close, I want to take a moment to acknowledge our long-term shareholders. We have had many shareholders who persevered with us and so we are particularly pleased to share this important event with you. I also want to take a moment to acknowledge Paula. Paula has been the leader of the KYNAMRO team at Genzyme since the beginning of the collaboration. She has been an important champion for the drug. She has played a pivotal role and helping the two companies work better together. And in the process, many of us at Isis have come to think of Paula as a friend. She and her team have put together the marketing and sales plans, the launch plans and the sales team, and it’s that preparation that gives us such great confidence that the commercialization of KYNAMRO will be successful. So, we are particularly pleased to share this event with the entire Genzyme development, regulatory, and commercial team, and particularly pleased to share with Paula.

Paula perhaps – before I turn it over to questions with that introduction, any additional comments that you would like to make.

Paula Soteropoulos - Vice President and General Manager, Cardiovascular Group, Genzyme

Stan, thank you for your kind comments. It actually is a privilege to be able to share this moment with all of our colleagues both at Genzyme and Isis, critically important for homozygous patients to have another option where they have been limited so much in the past. And for me personally, I have gotten to know some of these patients who have successfully been treated on KYNAMRO for several years and who have personally expressed their hope to me for this product and so it very much was a personal commitment to be able to deliver this product to them. And I am also very proud of the collaboration with Isis and really being part of helping the team at Isis to bring forward the first systemic anti-sense and the promise that holds for so many diseases. It truly is exciting not only for homozygous FH, but for all the other diseases that anti-sense has the potential to help support.

So, I do want to say that and Lynne did touch on it, we are launch ready, which is very exciting. We have had a team of dedicated individuals working very hard to make sure that upon approval, we are ready to deliver this product to patients. We have experienced sales and medical field team fully staffed, robust supply, and distribution chain established in place. And as Lynne mentioned, our Cornerstone patient support program is ready to go, ready to go live and that program is a support program that truly will assist patients in helping develop a very routine weekly an injection and incorporate that into their lives, it’s something that is very simple for them to learn, very small needle and we will be providing all the support that they need through education material, nursing support, even in-home nursing support to help them learn as needed.

And also ensuring that they have reimbursement access to help them through that process with their managed care companies, also included would be any co-pay assistance support, and even for those patients who need further support – humanitarian support as well. And so, this is – and the reason it’s called Cornerstone is because it is truly a question of how we at Genzyme deliver our therapies. It isn’t just about the therapeutic product itself, but it also is the full support of the patients, the caregiver, and healthcare providers to ensure that they are able to successfully manage their disease. So, we are very excited to be able to be in this position of launch readiness. And of course, natural question will be asked, okay, when are you officially launching that and just to put a few words to that. But obviously given that we have REMS and that will take some time to educate the physicians on the program, and the drug. And then, once the prescription is written there is a time to verify benefits and ensure coverage. So, that first product out the door will be very dependent on that process.

And with that Stan, again thank you, an exciting day for all of us. So, I’ll turn it back over to you.

Dr. Stanley Crooke - Chairman, President, and Chief Executive Officer

Thanks very much. Perhaps now we can open it up for questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) And our first question is from the line of Eric Schmidt with Cowen and Company.

Eric Schmidt - Cowen and Company

Good morning. Congratulations on this wonderful milestone, and thanks for taking my question. Stan, are you able to provide any information on the patients with homozygous FH who you’ve identified or who you think are candidates? And are you like your competitor going to give out targets for number of patients on therapy over a certain time period?

Paula Soteropoulos

Stan, I can take that. This is Paula. Is that okay, Stan?

Dr. Stanley Crooke

Sure.

Paula Soteropoulos

Okay. So, we won’t be providing the level of detail in terms of target. We have had our field team has been on the ground and developing the relationships and understand the practices in the lipid specialty clinics understand where many of these patients are and we are prepared to address the needs of these patients. But we will not be giving specifics in terms of guidance with regard to how many patients identified and expectations in terms of numbers.

Eric Schmidt - Cowen and Company

And can you provide us any kind of thumbnail on pricing?

Paula Soteropoulos

We will share the price of KYNAMRO at launch. We can tell you that in determining the cost of KYNAMRO, there are several factors that were considered in an effort to optimize patient access. And it is consistent with currently available therapy such as apheresis. And at this point we will be talking about that fairly soon as we launch the product.

Eric Schmidt - Cowen and Company

Okay. And then last question for Paula or anyone else on the call, I know that your trials included some patients below the age of 18. It looks like your label is more specific for those above the age of 18. Do you think you have an opportunity to get at this younger population off-label or via other means?

Paula Soteropoulos

Well, we can’t speak to off-label use. We have data in patients above 12 years old. The data that we have is not enough to be actually formally in the label. Our commitment is to further study or formally in this patient population, but we do have data above 12 years old and those patients did quite well.

Eric Schmidt - Cowen and Company

Thanks, and congrats again.

Dr. Stanley Crooke

Just one additional comment to Paula’s, we very strongly agree with Genzyme that the key initial task is to get these patients identified and referred to lipidologists. There we have been very impressed with the groundwork that Genzyme has been doing over the last couple of years. And we think Genzyme will be aided in that endeavor by the focus on getting FH patients better treated by the National Lipid Association and the American Heart Association and similar organizations around the world. And so I think that’s an important consideration. Next question please?

Operator

Thank you. Our next question is from the line of Chad Messer with Needham & Company.

Chad Messer - Needham & Company

Yeah. Let me add my sincerest congratulations for hitting this important milestone. My question is on the REMS, so both you guys and Juxtapid, there is REMS programs on both, it seems like those are quite important in getting these drugs out to patients. I was just wondering if you saw any salient differences between the two REMS programs?

Dr. Stanley Crooke

No, there really are none. I think it’s very consistent between the two products. And I think the principle focus is to assure long-term liver safety, which obviously is a side effect associated with both the two targets, MTP and apoB reduction in altering lipid content in the liver. So, the focus in our view is entirely appropriate and entirely focused on the property of the targets and the drugs not focused on anti-sense technology in anyway.

Chad Messer - Needham & Company

Okay, alright. Thanks for that. And then my only other question is, this is a great outcome here with the FDA, obviously not as good a first task outcome in Europe. I was wondering if you had any insights into what went different with the two processes, what the EMA might be failing to appreciate at this point that the FDA did appreciate?

Dr. Stanley Crooke

We do, but we’re not going to discuss that today. We’re in the midst of the re-examination in Europe. We are very, very optimistic that that will successful. And once their process is concluded then we may be able to discuss some of the specific differences and different concerns and so on in more detail, but certainly not today.

Chad Messer - Needham & Company

Alright, thank you. Thanks for that update.

Dr. Stanley Crooke

Thanks very much.

Operator

Thank you. Our next question is from the line of Salveen Richter of Canaccord Genuity.

Andrew Goldsmith - Canaccord Genuity

Hi, this is Andrew on the line for Salveen. Let me just add my congratulations to the approval, it’s really wonderful. I was just kind of curious, a couple questions on the launch. The timeframe you said obviously the first product out the door will take some time with the REMS. Do you have a sense of how long that will be and when I guess real official launch will be and can you give more color?

Paula Soteropoulos

Sure. Andrew, it really is dependent on let’s see the first patient that gets the script, which managed care plan they are on, some managed care plans are ready to provide a reimbursement fairly quickly, others actually say they won’t put a new drug on formulary for a period of time. So, that is highly dependent on that. So, really I mean it could be anywhere, it could be four weeks, six weeks, but it could be less. It truly depends on that combination of the timing for REMS and the managed care. But again, it’s something that when we do get that through the process, we’re ready to get that product to the patient.

Andrew Goldsmith - Canaccord Genuity

Yeah, great.

Dr. Stanley Crooke

And one other things that I think will prove to be very important is that KYNAMRO has been thoroughly studied. And every nuance launch of the drug, every work that it has been studied and published extensively. And so I think the lipidology community feels that it knows KYNAMRO and many in the lipidology community participated in the clinical trials, because they were obviously much more broadly involved than simply of two or three apheresis centers. And, I think that will enable both the adoption of KYNAMRO and help us sure that KYNAMRO will be used safely and effectively by these physicians.

Andrew Goldsmith - Canaccord Genuity

Great, thanks. And then maybe kind of tied to that is. Can you give any color on the physicians that you’re going to target if it’s all lipidologists at first and when you might branch into cardiologists and other process for work?

Paula Soteropoulos

Also the first target is definitely lipidologist, these are physicians who really are the right physicians to treat these patients. They give the patient the time that’s needed to really understand their complex disease and support the patients not only through trying different combinations of therapies, but also counseling them and working with their family members. So, they are very much the appropriate target rich patient population. We do know that there are patients that are not referred to lipidologist and that is an opportunity that we have with being part of Sanofi. And already being in that space and being able to explore the best way to leverage that infrastructure to help educate. And importantly help funnel those patients to lipidologist because the cardiologist may identify one of these patients but they truly don’t have the time for the type of counseling that these patients need and the support and also trying to look at different combinations of therapy. So, we still – our focus will be in helping these patients to get funnel to the lipidologist who are remarkable treaters and really are dedicated to the finding solutions for this very complex disease.

Andrew Goldsmith - Canaccord Genuity

Okay. Great, thank you very much.

Paula Soteropoulos

Thank you.

Operator

Thank you. (Operator Instructions) Our next question is from the line of Carol Werther from Summer Street.

Carol Werther - Summer Street

Thanks for taking my question. On the label it says that certain patients would come off the drug after six months if the efficacy isn’t high enough. Can you just describe what proportion of patient do you think that might be and what the cut off might be to make that decision?

Dr. Stanley Crooke

Very small, this drug like every drug have patients do vary in their response to it and then Homozygous FH there is a bit more variability than in other patient populations. But we showed that even the quote low responders that we saw in the original study were really mostly slow responders. And they responded meaningfully slightly after the endpoint. So, we don’t have a specific number, but we think that’s extremely small.

Carol Werther - Summer Street

Okay. Thank you.

Operator

Thank you. Our next question is from the line of Stephen Willey with Stifel.

Stephen Willey - Stifel

Hi, good morning and congratulations on the approval. I was just wondering I guess couple things on the post-marketing side. I guess, one if you can kind of quantify what you think kind of the total cost of the post-marketing studies will be. And then just kind of confirm that, that also kind of flows through the JV in the sense that you don’t start the cost sharing until you reach that profitability threshold. And maybe just provide a little bit of color around the requirement to monitor the generation of double stranded DNA antibodies in patients. And just kind of color around about I guess what appears to be a theoretical immunogenicity concern that the FDA is speaking to there? Thanks.

Dr. Stanley Crooke

So, why don’t we deal with that question first and then, we’ll come back and follow you and others can tackle the first question.

Richard Geary

Yeah. This is Richard. Let me just, I think this is really very straightforward. First of all, KYNAMRO as we’ve been saying it’s the first anti-sense systemically approved for lifetime use, where safety is fair amount. And the FDA rightfully is establishing some post-marketing to look at some theoretical concerns. This one theoretical concern is that there may be a subset of patients with double-strand DNA that may interact with the treatment. So, as we expand into greater number of patients treated for a lifetime, FDA is simply asking us to develop these sensitive assays to look at this potential.

Dr. Stanley Crooke

Yeah. And, I do think towards noting that we have treated 10,000 or so human beings some for as long as four years. We’ve never observed precipitating or neutralizing antibody, we’ve never observed any affect on treatment associated with antibody generation. So, this is very much a theoretical concern and but obviously it’s a – it is a theoretical concern that we’ve been working on for 23 years. And the FDA is simply asking us to make an even more sensitive assay than the one we have. Now to the first question, I’ll...

Lynne Parshall

Sure, we don’t really quantify what our post-marketing commitment dollars will be, but to your question of the how we would share, etcetera. We actually do share that with Isis up until the point of profitability. And then Genzyme will bear the full cost from there.

Stephen Willey - Stifel

Thank you.

Dr. Stanley Crooke

Lynne.

Lynne Parshall

Yeah. And just to add, Steve. We will be giving our financial guidance in our end of the year conference call. And of course, while we won’t give granularity on exactly what that’s going to cost. We will include – we will factor the costs of our commitments to this – the ongoing study of KYNAMRO into our financial projections.

Stephen Willey - Stifel

Great, thanks for the color and congratulations again.

Dr. Stanley Crooke

Thank you. Next question, please.

Operator

And at this time, I’m showing no further questions. I would like to turn the call back over to Dr. Crooke.

Dr. Stanley Crooke - Chairman, President, and Chief Executive Officer

If there are no further questions, I want to thank everyone for your participation and your support over the years. Rogerio any last or final comments before we hang up.

Rogerio Vivaldi - Senior Vice President and Head of Rare Diseases, Genzyme

Yeah, I just want to share with you 21 years ago when I was the first doctor treating a very rare genetic condition Gaucher’s disease in Brazil, I couldn’t imagine how this would transform diseased group of people of the sector genetic disease area. 21 years after, we have meeting genetic disorders. We have thousands of patients that have been having their lives being saved. I think today, we have again an opportunity to transform the disease area to transform thousands of patients’ lives and really to learn every single day learn more and more on how are we going to move with their treatment and with their diseases. So for me, this is kind of a repeating the same story 21 years ago and I am very proud that we are together on this with Isis bringing really a strong biology, bringing this strong biology to a very, very, very much needed disease. So, I am very happy to be here today.

Dr. Stanley Crooke - Chairman, President, and Chief Executive Officer

Thank you, Rogerio. And with that we’ll bring the call to a close. Thanks to everyone for your interest and attention.

Operator

Ladies and gentlemen, we thank you for your participation in today’s conference call. You may now disconnect.

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