Ionis Pharmaceuticals, Inc.

Ionis Pharmaceuticals, Inc.

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Biotechnology

Ionis Pharmaceuticals, Inc. (IONS) Q1 2008 Earnings Call Transcript

Published at 2008-05-12 13:26:07
Executives
Stan Crooke - Chairman and CEO Lynne Parshall - COO and CFO Jeff Jonas - EVP Kristina Lemonidis - Associate Director of IR
Analysts
Mark Monane - Needham and Company Eric Schmidt - Cowen and Company Carol Werther - Summer Street Research Debjit Chattopadhyay - Boenning & Scattergood
Operator
Good day everyone. Welcome to Isis Pharmaceutical's First Quarter Financial Results Conference Call. (Operator Instructions) Leading the call today from Isis is Dr. Stan Crooke, Isis Chairman and CEO. Dr. Crooke, please begin.
Stan Crooke
Thanks, Melissa. Good morning and thanks everyone for joining us on today's conference call to discuss the financials for our first quarter 2008. Joining us on today's call are Lynne Parshall, COO and CFO; Jeff Jonas, Executive Vice President; Beth Hougen, Vice President of Finance; and Kristina Lemonidis, Associate Director of Investor Relations. Financially and in all other respect, 2007 was a transformational year for Isis, and the momentum that we created in 2007 is continuing as we progress into 2008. On today's call, Lynne will review for you the financial results and the business strategy that we expect will continue to build our financial strength. I will then spend a minute speaking briefly about the progress we are making with the mipomersen development plant, progress in the rest of our pipeline, progress in our Ibis and regular subsidiaries, as well with other satellite company's. Kris, will you now present the forward-looking statement.
Kristina Lemonidis
Sure. Thanks, Stan. Good morning everybody. A reminder to everyone that this webcast includes forward-looking statements regarding Isis Pharmaceutical business, financial position and outlook for Isis, as well as its Ibis Biosciences subsidiary, and its Regulus joint venture, and the therapeutic and commercial potential of the company's technologies and products in development. Any statements describing Isis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered at risk statements, including those statements that are described in Isis' goals or projections. 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 in human therapeutics; and developing and commercializing systems identifying infectious organisms that are effective and commercially attractive; and in the endeavor of building a business around such products. Isis' forward-looking statements also involve assumptions that if they never materialized or proved correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although, Isis' forward-looking statements reflect good faith judgment of its management, these statements are based only on facts and factors 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 31st, 2007, which is on file with the SEC. Copies of this and other documents are now available from the company. I would like to turn the call over to Lynne.
Lynne Parshall
Thanks, Kristina. As usual I am assuming you all had the opportunity to read the press release which we issued this morning. So, I will not reiterate what is detailed in there. However, I do want to spend a little time to highlight what we believe is a quarter of excellent financial performance. We had nearly a nine-fold increase in revenue from $2.5 million to $21.4 million, with only a $5.4 million in increase in expenses, when comparing the first quarter of 2008 to the same quarter in 2007. We had an increase in cash of $146 million, all since the end of the year, as we ended the first quarter with nearly $340 million. And we are on track to meet our guidance for 2008, for pro forma NOL of less than $15 million, and cash of at least $450 million, which does not include any additional cash from Abbott, should it require Ibis. This financial performance is a direct result of Isis's unique business strategy successfully implemented. And of course, underpinning that strategy is Isis technology dominance in RNA therapeutics and the scientific investments we’ve made that are now resulting in very attractive drugs. In 2007, both BMS and J&J's Ortho-McNeil division completed significant corporate partnerships with us, which set the stage for 2008. We and BMS just recently announced a development candidate less than a year into that collaboration, and we're excited to add another lipid-lowering drug to our pipeline and then move it forward towards the clinic with our partner. Our Ortho-McNeil collaboration is also going extremely well, with Phase I clinical trials on the glucagon receptor antagonist drug progressing nicely. Of course, the key event of this quarter was the completion of our mipomersen auction, with the selection of Genzyme as our partner six months earlier than planned. Stan will discuss Genzyme and mipomersen in some detail later in the call. I'll just focus here on the financial contributions of all three of these transactions. The positive effects of these transactions are readily apparent in this quarter in both our cash and our revenue, as they will be for the rest of the year and going forward. Of course we’ve received only the first $150 million from Genzyme and expect to complete that transaction shortly, which should add another $175 million. Our satellite company strategy is a key aspect of our business strategy. Two very important transactions have already occurred in 2008. These are evidenced through the value of our strategy that allows us to move forward novel technologies arising out of Isis innovation to create even more value for our shareholders. In January, we announced a strategic relationship between Abbott and Ibis. The financial benefits of this transaction are obvious, in the short term, as it provides funding for Ibis to move aggressively towards its largest market in-vitro diagnostics; and in the longer term, as Isis shareholders will receive a total of $215 million to $230 million, should Abbott purchase Ibis. And we will continue to participate in Ibis' commercial success, even after an Abbott purchase, through an earn-out of up to 5% of sales. Very importantly, our Ibis team is fully engaged with a very experienced Abbott team in mapping up the milestones to be achieved to reach medium and long-term commercial success in diagnostics. Almost as soon as we could get it up and running, Regulus, our microRNA joint venture inked its first corporate partnership with GSK. Regulus, which we formed with our partners at Alnylam, was initially funded with $10 million from Alnylam. It incorporates the strong intellectual property position of both companies, a world class Scientific Advisory Board, and a very strong and going management team. It's no surprise that Regulus quickly established itself as a leader in this new and very exacting area of drug discovery. We now have ensured that both Ibis and Regulus are fully funded; adding $40 million of cash so far this year; enabling Isis to participate in two very exciting technology areas; and benefiting Isis shareholders in a financially attractive way. Plus, each of these joint ventures has obtained a partner that will accrete value to the programs. In other words, our strategy is successfully at work. As our satellite companies mature, we continue to see value both in drugs moving forward in the pipeline and in payments associated with its progress. In addition to Regulus and Ibis, we've seen great progress so far this year from our satellite companies including OncoGenex, who recently announced more positive clinical news on OGX-011, a drug of which that we own 30%. As a result of ATL's license VLA-4 antagonist for multiple sclerosis to Teva Pharmaceuticals, we will receive one-third of all sub-license fees and milestone payments as Teva moves the drug through development as well as the share of royalties. We are pleased to have this drug in the hands of a strong multi-national company as it enters the next stage of development. Finally, Altair Therapeutics just recently began dosing patients with our inhaled antisense drug to treat asthma. We'll not only have an equity stake in Altair as with the rest of our satellite companies, but we'll also receive a portion of sub-license revenues and royalties as the drug moves forward. So in the first few months of the year, we've made significant progress in meeting our 2008 goals and we are looking forward to more exciting news to come. We have a large pipeline of drugs and clinical development. Several of these are in critical clinical trials for which we will report data later this year. We will also be initiating clinical trials and additional drugs, such as our CRP inhibitor. Our pipeline will continue to grow, fueled by our efficient and robust drug discovery platform. This year, we plan to add two to four new drugs to our pipeline, and are far along in meeting this goal having added one already. Our strategy enables us to remain small with an efficient research organization focused on what we do best; discovering and developing drugs. Now, with our recent partnering successes, we have the financial strength to fully implement this strategy. Indeed for us, this is only the beginning. Now I'll turn the call back over to Stan
Stan Crooke
Thanks Lynne. I certainly do agree that we've completed a series of transactions that has truly transformed our financial outlook. Of course, mipomersen remains our most important asset. We have completed our Phase II program that demonstrates mipomersen is a very attractive drug candidate. Mipomersen is a unique first-in-class agent that lowers all atherogenic lipids. It works in all patient population studies; works equally well in the presence or absence of other lipid-lowering therapies; and is unlikely to have drug-drug interactions, muscle, heart or central nervous systems side effects. There is essentially no near-term competition for mipomersen and our development is focused on bringing mipomersen to patients with clear unmet medical needs. I am pleased to tell you that our Homozygous FH Phase III study is going well and enrollment is right on track. Since the FDA provided guidance, we and our friends at Genzyme have made excellent progress in revising the development plan in accordance with that guidance. We hope to provide more definitive information about our plans after we meet with the FDA. As you probably know, Genzyme highlighted mipomersen at their Analysts Day last week, which is available on the Genzyme website, recommended to you. From our perspective, the key take-home messages from the Genzyme presentation are: First, Genzyme like Isis is intensely committed to and excited about mipomersen. Some question whether Genzyme was the best partner for mipomersen. I think the progress that the two companies have made in the past two weeks: the commitment of Genzyme and the fact that mipomersen is clearly in Genzyme's sweet spot are tests to the wisdom of our decision. Second, you are beginning to see progress in our thinking post the FDA call. On our call two weeks ago, we presented the worst case scenario, and we had just received the call from the FDA. But we told you then that the FDA asked us to submit a plan and we expected to develop a better solution. We now believe that we can potentially expand the initial indication for mipomersen to include a range of very high risk patients, including (inaudible) patients. Of course the drug will be priced appropriately for these needing patients. We believe that a broader registration may be possible much earlier in Europe than in the US, and we are actively working towards this. We are also confident that the outcome study that we plan will be of modest size and duration, because we will be treating patients at very high cardiovascular risk and therefore these patients get higher event rates. Third, Genzyme remains very enthusiastic about the safety profile as well as the efficacy of mipomersen. We now know, based on other actions that the FDA has taken, that we are in a new and very conservative regulatory environment. It is considered remarkable that in this very conservative regulatory environment, the FDA has given us the option with this totally new class of (inaudible) to pursue an early indication without an outcome study. Fourth, we're just beginning to discuss all of the issues with the FDA. We continue to believe that we can get to a better place than where we are today. For example, we had asked to be allowed to submit our first NDA for Homozygous FH, a severe alter orphan indication, with one completed carcinogenicity study and one in progress. These are routine studies and our request is absolutely reasonable. We plan to continue to discuss this with the FDA as we generate more data because any shift in this position adopted by the FDA could allow us to bring the mipomersen to these patients with this desperate need earlier. Fifth, Genzyme believes that the overall value of mipomersen is as great, or greater than ever, just as we do. Finally, we and Genzyme are revising our agreement in line with the changes in the development plan. The license we have is one of the richest licenses ever for Phase II products. The basis for the deal is a 50-50 split with the current and future value of mipomersen, split between Isis and Genzyme. And the changes and turns will be modest and will reflect the changes in the development plan. The deal will be fair and attractive to both partners. You should remember that we have many companies that are intensely interested and remain intensely interested in mipomersen. Genzyme has already put $150 million into Isis as a first step in our relationship. We do think we are making excellent progress with Genzyme and are on schedule even with the disruption that the FDA response created to meet the second quarter timing for completion of the deal. So, we do plan to complete the license of mipomersen to Genzyme this quarter. This year we'll complete a number of analyses of clinical data on mipomersen that will continue to provide more information on the safety profile of the drug. Later in the year we'll present initial data from the imaging study designed to measure the affects of mipomersen on fat levels in liver. We also will update our open label extension study results. The update we just provided continues to support the fact that the longer you dose, the better mipomersen looks, i.e. with longer term chronic dosing, mipomersen continues to be very well tolerated. Further we’ll be starting numerous other key studies this year and we will continue to aggressively move mipomersen towards the market. With regard to the rest of our cardiovascular and metabolic pipelines, we expect to have an important year. We expect our CRP antisense drug to enter clinical trails later in the year. In the initial trial on normal volunteers, we’ll evaluate the affects of that drug on CRP levels. So we’ll have an early opportunity to see its pharmalogical affects. We just announced that BMS and we have selected a development candidate for PCSK9, another novel lipid-lowering target and we are getting IND enabling studies underway now. In the metabolic pipeline, we are very encouraged by the progress in the key trial with Isis 113715, our PTP-1b inhibitor in combination with sulfonaurea. We believe that this trial is likely to demonstrate that when added to sulfonaurea in stable diabetics, that Isis 113715 safely reduces glucose, safely reduces hemoglobin A1c, and remarkably it also reduces LBL cholesterol. Thus, I would have the exciting profile of being a novel insulin sensitizer that is an additive to all type II diabetes drugs. It has no drug interactions, does not result in weight gain, metabolic acid doses or nausea, and can be self administered on a convenient weekly schedule. And at the same time that it is lowering glucose and lowering hemoglobin A1c, it lowers cholesterol for you as well. We are also pleased with the progress on the glucagon receptor drug license to Ortho-McNeil. Remember, in this Phase I study we are evaluating the effects of our drug in a glucagon challenge test. Our hope is that Ortho-McNeil will initiative Phase II trails this year. Our glucocorticoid program continues to make progress as well, and we are looking forward to beginning clinical trails with our SGLT2 inhibitor, which we identified to develop a candidate late last year. I know of no company, large or small, with its exciting and novel cardiovascular metabolic pipeline as we enjoy. At the ADA in a few weeks we will add to the excitement by sharing the progress we're making in obesity and its related areas. In fact, I believe we have nine posters in presentations at the ADA this coming June. Our cancer and anti-inflammatory pipelines are progressing well also. OncoGenex continues to report excellent progress with OGX-011 and OGX-427. At ASCO OncoGenex is presenting additional Phase II data on OGX-011; the clusterin drug in patients with prostate cancer. We believe this data will continue to be very encouraging. Lilly is initiating Phase II trails with our surviving inhibitor. At ASCO, Lilly will be reporting data from its extensive Phase I experience in which it evaluated doses as high as 1,000 milligrams per week and assess drug concentrations, and the affect of the drug on survival levels in human tumors. These results set the stage for Lilly to initiate its Phase II trails. In the anti-inflammatory pipeline, ATL will shortly report Phase II data on our BLA(4) drug in patients with MS. As mentioned, ATL has recently licensed this drug to Teva. Altera has initiated Phase I studies with our first aerosol drug to treat Asthma. As this is our first aerosol drug, it's of course exciting. But more importantly, we are now expanding opportunities for the technology with another new route of administration and the rest of the pipeline continues to make great progress too. Finally Ibis and Regulus continue to make excellent progress. Ibis has just completed a non-exclusive distributorship relationship with Abbott, which means that Abbott is now selling the Ibis product line. This is a next step in our Abbott relationship and it's an important step that has been accomplished in this quarter. Ibis and Abbott are making excellent progress on validation of new kits, regulatory plans and improved instrumentation. We're looking forward to a very productive year out of both Ibis and its collaboration with Abbott. Like Ibis, Regulus is an oil-burner too. In addition to the important collaboration recently announced with GSK, we're seeing excellent progress in basic research on microRNA therapeutics and advances in the lead programs. We are very pleased with the quality of the team we've put together. And again, I think you'll be hearing lots of news about Ibis, lots of news about Regulus, and lots of news from the rest of the pipeline, as the rest of the year progresses. In summary, we are financially strong. Mipomersen is poised to make excellent progress. Our pipeline is robust and progressive. Our satellite companies are creating value. And we're making all this progress with all these drugs, technologies, and relationships, with a projected NOL of less than $15 million this year. And with that, I'll now open it up for questions. And Melissa if you can set us up the questions, please?
Operator
Thank you. (Operator Instructions). We'll go first to Salveen Kochnover with Jefferies and Company.
Unidentified Analyst
Hi, this is Brandon [ph] for Salveen. I have a couple of questions for you. First, can you talk about your discussions with the FDA and whether you guys have a scheduled meeting around the apheresis eligible indication, and the broader high-risk population? What gives you confidence that you guys will have the information needed to close the deal with Genzyme by the second quarter? And second, when we look at pricing, would it be fair to say that the cost of apheresis is an accurate benchmark?
Stan Crooke
It was little hard to hear you. I think I heard all the questions. First, with regards to Genzyme, as Genzyme made it clear in their meeting, we are moving along towards completing the relationship on schedule in this quarter. And that relationship would be based on the original premise of the agreement of 50:50 spilt. And there would minor adjustments that would be required, as we have changed the development plan and moved the outcome study forward. We think that the guidance that the FDA has given us is really focused on bringing the drug first to patients with very high risks. Homozygous FH, we have used that term, has always been a clinical diagnosis, and we made it clear, I think, for more than two years that the homozygous FH patient population we are planning study, would be a clinically diagnosed group of patients. Those are patients at very high risk. Patients that are apheresis or apheresis eligible are similarly at a very high risk. And so, we believe this as a sound basis for moving forward in patients who have an equivalent very high risk for cardiovascular events to that of homozygous FH patients. And I am not sure I understood the question about apheresis costs, other than just to say that patients at very high cardiovascular risks, whether the homozygous FH is clinical diagnosed or whether they are apheresis eligible or others, all have very high LDL levels and all have significant cardiovascular risks. Therefore, all will be subject to many medical costs that certainly justify a new invention that can reduce LDL and reduce a number of the clinical advance that are both life threatening and costly.
Unidentified Analyst
Do you have a scheduled meeting with the FDA in terms of talking around the apheresis eligible indication or the broader high risk population?
Stan Crooke
We are putting our plans together and we are moving forward with the FDA, and I prefer to leave it at that level of detail.
Unidentified Analyst
Thank you.
Operator
We will go next to Mark Monane of Needham and Company. Mark Monane - Needham and Company: Good morning, everybody. I am here with my colleague Allan Carr. We have a few questions for you. Allan Carr - Needham and Company: Stan, can you clarify where things stand with the payments from Genzyme. I understand that there is a $150 million stock purchase that's already happened. But is that upfront fee, is that a certainty or is that something that is going to be discussed with Genzyme in formalizing the deal later this quarter?
Stan Crooke
Yes, of course we have the $150 million. And as I said, the transaction will be fair and attractive. And we believe that the $175 million will be forthcoming. Allan Carr - Needham and Company: Are you saying that that one is likely or a certainty? I guess I am just trying to get some clarification on that.
Stan Crooke
Lynne, do you want to respond?
Lynne Parshall
We are in the process of finalizing the details of the development plan and the details of the agreement with Genzyme. Any dial could be turned, but I agree with Stan. I think it is unlikely that the $175 million will be a dial that will be tuned. Allan Carr - Needham and Company: Okay. Another quick question on Ibis and Abbott, you had a quite a bit growth in 2007 in terms of contract for Ibis. Do we expect to see more of that this year, or whether it would be more focused on meeting milestones in your deal with Abbott?
Stan Crooke
Both. We are expecting meaningful growth in contract revenue, and we are expecting some of those contracts to move from research contracts to fee for service relationships. We obviously are heavily focused with Abbott on commercial sales, and we see good progress there. And we are also focused on bringing large number of new kits for the infectious in vitro diagnostics business forward. We are focused on improving the instrumentation as well. So you should expect progress on all fronts. Obviously, the next financial event for Ibis is the $20 million additional investment from Abbott which happens in July if I remember correctly. Allan Carr - Needham and Company: Okay. Thanks.
Lynne Parshall
Stan, may I make one clarification to what you just said?
Stan Crooke
Sure
Lynne Parshall
In general people will remember that our Ibis government contract revenue has been in sort of $9 million to $11 million, and those government contracts in general now that they're very application-focused are between in general 18 months to 24 months. And so Ibis has already made significant progress this year that we've announced in getting new government contracts, but in general those are replacing contracts as they end. So our goal is to continue a steady stream of government contract revenue for Ibis in the same kinds of levels that we've had going through this year and going from this year to next. And we're right on track to do that. Allan Carr - Needham and Company: On the 715 program, can you comment what kind of drop of hemoglobin A1c, which might be clinically relevant? In the first presentation earlier that we saw that it was a relatively well population, so there is only so much you can go down to in terms of hemoglobin A1c. Can you comment on and before we see the data, what would be relevant for bringing it forward into further studies.
Stan Crooke
Well, I think a relevant additional drop in hemoglobin A1c after 13 weeks in a patient population on sulfonylurea would be a 0.5%. We are certainly hoping for more. And these patients, in contrast to the initial study, are all well established diabetics and who have been treated with stable sulfonylurea for some time. So the hemoglobin A1cs are higher than in the earlier trail, but the most important point is that the placebo effect that you see in diabetic, in newly diagnosed diabetics which is really not a placebo effect, but it is a response to diet and exercise and all of the things that medical care can bring to somebody who is typically overweight and diabetic. In a more stable diabetic population you expect to see less of a placebo response, and therefore you are able to discriminate a drug effect with fewer patients. Allan Carr - Needham and Company: That was helpful. Mark Monane - Needham and Company: And a last question on PCSK9. As you talk with the FDA on mipomersen, does it help with framing the development plan for this normal cholesterol agent as well or there is separate discussion. How do you use, do you Bristol Myers Squibb are you working on envisioning some new guidance in this new era?
Stan Crooke
I think that conversation about mipomersen is certainly relevant, but probably more relevant are all of the actions that the FDA has taken with our drug, other cardiovascular, and other metabolic drugs. I think the lessons being taught are very clear, that new agents are going to require more than surrogate outcomes. And any company that fails to respond to those trends will be making a mistake. Mark Monane - Needham and Company: Thanks to the added information and congratulation on the progress for the team for this quarter.
Stan Crooke
Thanks guys.
Operator
We will take our next question from Eric Schmidt with Cowen and Company. Eric Schmidt - Cowen and Company: Good morning, Stan. On the Genzyme collaboration, why would Genzyme be entitled to better terms? It sounds like you and they had both always expected to run this outcomes study. So, I am trying to figure out kind of what their leverage point is with you, if any?
Stan Crooke
Well, the most important change is that we are moving the outcome study up earlier, and that increases development expenses. Secondly, there is a delay in the commercialization for polygenics, because we had to finish the outcome study before we can seek approval. So, that does change both the cost structure and the timing of sales and profits at least for that indication. The other thing that is changing, obviously, is we had planned for heterozygous FH filing in the United States. It seems as though heterozygous FH filing will certainly be rolled into sort of a general filing rather than polygenics. So those are the things that we are grappling with as we look at the plan and we look at the cost and we look at how to apportion the 50-50 split in current and future value. Lynne, do you want to add or subtract anything to that?
Lynne Parshall
No. Eric Smith - Cowen and Company: And I guess, if I’m reading your comments right, it sounds like you are optimistic the $175 million upfront payment remains. You are optimistic the 50-50 structure remains. So --
Stan Crooke
Yes I am. And I’m certain that the 50-50 structure will remain. Eric Smith - Cowen and Company: So can I assume that may be what might change is your cost, I guess you are capped at a certain dollar value cost. I remember it was a little less than $100 million, and that might be potentially what could be renegotiated?
Stan Crooke
I think the thing to focus on is that we have one of the richest licenses in the history of the industry for a Phase II drug. That will continue and the basis of the deal will be a 50-50 transaction, and we will not do the deal unless it's fair and attractive to both partners. Eric Smith - Cowen and Company: On 715, I may have missed this but is the data definitely going to be presented at the ADA?
Stan Crooke
No, we’ve always said that the data would be later this year. So the ADA is in June. Eric Smith - Cowen and Company: So it will be not be at the ADA.
Stan Crooke
But 715 will not be at the ADA Eric Smith - Cowen and Company: Okay. And two book-keeping questions for Lynne on Ibis, are you just going to continue to consolidate the financials there as you have in the past, up until I guess the Abbott acquisition?
Lynne Parshall
Yes. Eric Smith - Cowen and Company: Okay and secondly, can you tell us what the final shares outstanding were for the end of the quarter? I don’t know exactly when Genzyme made that purchase.
Lynne Parshall
They made it this quarter and I apologize. I am not at the office with everybody else. I don't have that number in front of me, but we can have somebody call you back and give it to you. Eric Smith - Cowen and Company: Thanks so much.
Stan Crooke
Did it happen in the first quarter or second quarter?
Lynne Parshall
Genzyme equity was in the first quarter.
Stan Crooke
I don’t know this, really $95 million of that said is the outstanding share count. Does that answer your question? Next question please.
Operator
And we will go next to Carol Werther with Summer Street Research. Carol Werther - Summer Street Research: Hi, thanks for taking my question. Stan, can you give us any kind of idea of how large the outcome study might have to be? And if you have to include both, does it have to be a mortality end point?
Stan Crooke
Well, obviously we are in the midst of planning this and negotiating with the FDA. I think the thing that we and Genzyme would feel comfortable saying is that the mortality study we envision will be a few thousand patients and a few years. Not the very large outcome studies that have been performed, because we are looking at very high risk patients or at high risk patients. And we will certainly look at more morbidity and mortality, and we will have multiple opportunities to evaluate the data throughout the trail. We'll probably, and in separate places, be looking at other surrogate or other measures of outcome as well. And I think that's about as much detail as we dare go into until we get the actual study negotiated with the FDA. Jeff, is that fairly on point?
Jeff Jonas
I think that's right. Almost certainly we'll use other events besides mortality just for that number one. And the other point to make is that the earlier studies we're seeking to validate LDL lowering as an end point, which we don't need to do any longer. So we don't have to power studies as the earlier studies were. So we're very confident that we can find a high risk population that will allow this to perceive with a modest number of patients over a shorter period of time. But again, echoing Stan, I think until the details are finalized and accepted. I think I would try not going to say more about it. Carol Werther - Summer Street Research: That's good, now I understand. The other question I have is regarding the cash guidance that you've given for this year. Does that include signing additional partnerships?
Lynne Parshall
No, it does not. Carol Werther - Summer Street Research: And any clue as to how many you might find this year? What should we expect the run rate that you have been doing in the last 12 months?
Stan Crooke
Well, we've signed Genzyme, Abbott and GSK in the first quarter. That's a fairly good start. We have a lot of interest, so it would not surprise us if we have more partnering news for you as the year progresses. Carol Werther - Summer Street Research: Okay great thank you.
Operator
(Operator Instructions) At this time we'll go next to Debjit Chattopadhyay with Boenning & Scattergood Debjit Chattopadhyay - Boenning & Scattergood: Gentlemen good morning, and thank you for taking my question. Stan, you guys already have the 100 milligram dose [code] for the 715 that has not been taken?
Stan Crooke
Yes. Debjit Chattopadhyay - Boenning & Scattergood: And in the call you mentioned that you feel confident that you would see reductions in HbA1c levels and glucose levels as well, but do you think the optimism is based on the 100 mg go-out data, which is actually sub-optimism, wasn't it?
Stan Crooke
Sure, the optimism is based on everything that we know about the drug. The optimism is based on the other Phase II work that we did, the mechanism and the profile of the drug in animals and everything else that we know with regard to the drug including a safety. Debjit Chattopadhyay - Boenning & Scattergood: And the multiple sclerosis drug, which is now with Teva, is that a Phase II data that we can expect? And is that a second or third quarter event?
Stan Crooke
Yes, it’s a Phase II program. That’s a program where patients that had limiting relapsing multiple sclerosis and were treated with the VLA-4 drug for three months, and then evaluated post treatment. So it's Phase II program, and it’s due in the second quarter. Obviously we are not in control of that. ATL and Teva are in control of that. But I think the study is completed, it's being analyzed now. Debjit Chattopadhyay - Boenning & Scattergood: And the 715 data, that's most likely a third quarter event?
Stan Crooke
It’s later this year, I think that's, we said later this year and I think that’s about as precious as we want it to be. It's a little difficult to know exactly when the data will be analyzed and it's even more difficult to know how we'll manage it with regard to trying to present it at a scientific meeting. I think you just have to hang on and we will give you more guidance as the year progresses. Debjit Chattopadhyay - Boenning & Scattergood: And as far as the regular registration for mipomersen in Europe, there seems to be an optimism that you could get away with an LDL lowering endpoint. Both you and Genzyme have basically mentioned the same thing. Is there a basis for that? I mean, why would European regulators prefer an LDL lowering, the surrogate endpoint, as opposed to a hard endpoint?
Stan Crooke
There is a basis for the optimism. It is based on interactions with regulatory agencies in Europe on an ongoing basis, and I think I would leave it there. Debjit Chattopadhyay - Boenning & Scattergood: Thank you very much, and good luck with your pronunciation with the FDA.
Stan Crooke
Thank you. There is one other point that I wanted to make with regard to Carol's question. Of course our cash position and burns do not include additional investments from Abbott for Ibis, and we are very optimistic that this transaction will complete, and that's another $200 million plus. We are certainly optimistic about what will take place.
Operator
And it appears we have no further questions at this time. I'd like to turn the call back to our speakers for any additional or closing remarks.
Stan Crooke
If there are no other questions, Lynne, anything you want to add?
Lynne Parshall
No, thanks Stan.
Stan Crooke
Jeff?
Jeff Jonas
No. Thank you, Stan.
Stan Crooke
If not, then thank you very much for your attention. We all look forward to another exciting quarter coming up. Thanks.
Operator
And once again that does conclude today's call. We do appreciate your participation and you may disconnect at this time.