CV Therapeutics Inc. Q4 2007 Earnings Call Transcript

CV Therapeutics Inc. (CVTX)

Q4 2007 Earnings Call

February 26, 2008 5:00 pm ET

Executives

John Bluth - Executive Director Corporate Communications & IR

Louis Lange - Chairman and CEO

Dan Spiegelman - CFO

Analysts

Jim Birchenough - Lehman Brothers

Alan Carr - Needham

S. Ramekin

Eric Schmidt - Cowen & Co.

George Zavoico - Cantor Fitzgerald

William Flattery

Bret Holley - CIBC World Markets

Presentation

Operator

Good afternoon. My name is [Lamarck], and I will be your conference operator today. At this time, I would like to welcome everyone to the CV Therapeutics Fourth Quarter 2007 Conference Call. (Operator Instructions)

Thank you. Mr. Bluth, you may begin your conference.

John Bluth

Thank you. Welcome to the CV Therapeutics Fourth Quarter 2007 and Year End Conference Call. I am joined today by Dr. Louis Lange, our Chairman and Chief Executive Officer, and Dan Spiegelman, our Chief Financial Officer.

Let me remind everyone that some of the following remarks may include forward-looking statements. These statements include those relating to our future product development, regulatory review and approval of our products, clinical programs, commercialization efforts and financial performance.

The company's actual results may differ materially from those suggested here. I encourage you to review the cautionary statements contained under the heading Risk Factors in our most recent quarterly report on Form 10-Q and other documents that we have filed with the SEC for additional information concerning factors that could cause differences. We disclaim any intent or obligation to update these forward-looking statements.

Ranexa has been approved in the United States by the FDA for its specified indication. Regadenoson and our other pipeline product candidates have not been approved by the FDA or by regulatory authorities outside the United States. CV Therapeutics pipeline product candidates have not been determined to be safe or effective in humans for any uses.

Now I'd like to turn the call over to Louis to provide a business update, and Dan will provide a financial review for the quarter.

Louis Lange

Thanks, John, and thanks all of you for joining our call. As we move through the first half of 2008, we are approaching several important milestones. In the coming weeks and months, we hope to have new product approvals for Regadenoson in the US and Ranexa in Europe. We could also see significant improvements to our US Ranexa label with the potential for new first-line angina indication and new promotable claims for the reduction of hemoglobin A1C, and the reduction of arrhythmias in coronary patients.

We are actively exploring potential global and territorial collaborations for Ranexa, as we move towards potential approval in Europe and reevaluate how this potential new Ranexa label, in combination with promotion to primary care positions, could affect revenues in the US.

Of course March 14th, two weeks from Friday, is the PDUFA action date for our Regadenoson NDA. If approved, we would receive a $12 million milestone from our North American commercial partner, Astellas. Additionally, we would receive a very significant royalty from Astellas on Regadenoson and a separate royalty on another of their products.

Astellas has established Adenoscan as the clear market leader in myocardial perfusion imaging. We look forward to providing you with an update once we have received the decision from the FDA on the NDA.

We invented Regadenoson and CVT, and brought it through 10 successful clinical trials to potential approval in less than a decade. And remember- outside of North America, we retain commercial rights to Regadenoson and currently plan to submit a Marketing Authorization Application to the EMEA by the end of 2008 for review in Europe.

Right now, the EMEA is actively reviewing our MAA for approval of Ranexa. Based on what we know today- well, it's never over till it's over- we believe that we are on track for potential approval by the middle of the year. The approval of Ranexa in Europe would be a significant advance for patients and, as we previously discussed, we would expect to enter into a commercial partnership in Europe some time after approval.

In the US, July 27th is the common PDUFA date for pending NDA requesting a new first-line angina indication and significant reduction in cautionary language, as well as a separate NDA requesting promotable claims for the reduction of arrhythmias in coronary patients and a separate NDA requesting promotable claims for the reduction of hemoglobin A1C in coronary patients as well.

In the meantime, our Ranexa business saw double-digit growth in the fourth quarter. As we announced in January and confirmed in our press release earlier today, we saw a nice double-digit increase for Ranexa sales in Q4 '07. This was the fourth consecutive quarter of double-digit Ranexa revenue growth.

Also in the fourth quarter, cash consumption dropped $20.5 million, a 15% reduction from the previous quarter and we ended the year with $179 million in cash. With $21 million in Renexa revenues for the fourth quarter, we began 2008 with Ranexa net revenue run of somewhere between $80 and $100 million on an annualized basis.

We expect cash consumption in 2008 to be less than $100 million and we expect cash consumption in '09 to be less than $50 million. This assumes only continued modest Renexa revenue growth and Regadenoson approval in 2008. So we feel very good about the financial foundation of the company's existing business, as we move closer to additional potential upside from the milestones I described.

In addition to the commercial opportunities from Ranexa and Regadenoson, CVT continues to have a noteworthy scientific presence and exceptional product pipeline.

Next month, 11 abstracts will be presented at the American College of Cardiology Annual Meeting in Chicago. Our press release from last week contains the titles and presentation times, but I would like to highlight a few of the presentations we believe are particularly interesting.

One is the study led by Dr. Art Moss at the University of Rochester, evaluating the effect of Ranexa on patients with Long-QT3 Syndrome, an often fatal, genetically determined proarrhythmic condition caused by defect in the specific sodium channel where Ranexa has its activity. This study evaluated the mechanism action and potential effects of ranolazine in patients with Long-QT Syndrome.

Also at ACC, MERLIN TIMI-36 investigators will present data from the prospectively identified MERLIN TIMI-36 Quality of Life Analysis, considering the reductions in the emergency room visits and physician visits associated with decreased angina frequency.

We plan to quantify the potential pharmacoeconomic benefits of Ranexa in several future publications.

In addition, we will present data at ACC on the potential mechanism of action for Ranexa to reduce hemoglobin A1C by increasing glucose stimulated insulin secretion from the pancreas. This was one of the many topics we touched on during our Investor Science Day in New York, earlier this month, where our senior scientists had an opportunity to review our promising pipeline in depth.

With all of the upcoming milestones we have in front of us, the next few months should be of some of the most exciting in the company's history and provide us with multiple opportunities to deliver innovative new products to customers in the US and Europe and to drive shareholder value.

Now I'd like to turn the call over to Dan for our financial review.

Dan Spiegelman

Thank you, Lou. Earlier today, we issued our Fourth Quarter and Full Year Financial Press Release. Complete details are available on the press release so I encourage you to refer to that document for further information.

Today I will focus my comments on revenues, costs and expenses, and cash utilized. Starting with Revenues: for the quarter ended December 31, we recorded $20.9 million of net product sales of Ranexa, a 14% increase compared to $18.4 million of net product sales recorded in quarter ended September 30, 2007.

Please remember that the third quarter net product sales included $1.1 million resulting from a reduction in our estimated future product returns. For the 2007 full year, we recorded $66.7 million of net product sales of Ranexa compared to $18.4 million in 2006. Since we launched Ranexa in March of 2006, we have recorded $85.1 million in total net product sales.

In terms of inventory levels of Ranexa at wholesalers and pharmacies, our information indicates that total inventory levels increased slightly during the quarter, with the wholesalers and pharmacies together holding a combined total of roughly 10 weeks of inventory versus 9 weeks at the end of the third quarter. This increase appears to primarily be due to an increase in total pharmacy inventories as 'weeks on hand' at the wholesaler level remained constant with the three to four week range seen in prior quarters.

Total revenues for the fourth quarter and full year of $22.4 million and $82.8 million, also included $1.5 million and $16.2 million respectively of collaborative research revenue, primarily related to our collaboration with Astellas for Regadenoson. The full year figure includes a $7 million milestone payment recorded in the second quarter for the filing of a NDA for Regadenoson.

Turning now to Total Costs and Expenses: Total Costs and Expenses for the quarter were $55.8 million compared to $53.7 million for the prior quarter ended September 30 and to $82.3 million for the same quarter in 2006. The $2.1 million increase of total expenses in the quarter compared to the prior quarter was primarily due to small increases in both Ranexa sales and marketing expenses, and research and development costs. In addition, general and administrative costs increased due to a one-time litigation related settlement, and cost of sales was higher due to the increase in net product sales of Ranexa.

Looking forward we continue to expect that the Q3 and Q4 Operating Expenses, not including Cost of Sales of approximately $50 million to $55 million per quarter, will be maintained into 2008.

Netting Revenues and Expenses, for the fourth quarter we reported a net loss of $34.1 million, or $0.57per share. This compares to a net loss of $34.2 million, or $0.58 per share, for the prior quarter ended September 30, 2007 and to a net loss of $68.1 million, or $1.18 per share, for the same quarter in 2006.

For the full year ended December 31, '07 we reported a net loss of $181 million, or $3.05 per share, compared to a net loss of $274 million, or $5.49 per share, for the prior year.

In terms of our cash position at December 31, we had cash, cash equivalents, marketable securities, and restricted cash of approximately $179 million compared to $199.5 million at September 30, 2007. Our total Cash Utilized for the quarter was $20.5 million. This compares to Cash Utilized for the prior quarter of $24.2 million.

In general, in 2008, you can expect an approximately $5 million to $10 million per quarter favorable difference between the Income Statement Net Loss and Cash Utilized. This difference is due to the impact of the non-cash expenses, such as stock compensation, depreciation, and debt issuance costs.

In addition, please note that the first quarter of the year will typically have a smaller Income Statement to Cash Utilization difference and has a larger cash usage than the other quarters due to the timing of certain compensation and tax payments. Additional quarter-to-quarter variability in the Income Statement to Cash Utilization difference is due to other changes in working capital.

In terms of cash usage going forward, there are two main items to consider. On the revenue side, based on the potential approval and launch of Regadenoson in 2008, and based on Ranexa sales growth in 2008 at the same level seen in 2007, but not including any potential increases that could be driven from the potential Ranexa label change in July 2007, we expect total top line revenues to exceed $100 million in 2008.

Moreover, we plan to continue controlling operating expenses at roughly the same levels seen this past quarter which allows us to target cash use in 2008 of less than $100 million and in 2009 of less than $50 million.

Now I will turn the call over to the operator for Q&A. Operator?

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of Jim Birchenough.

Louis Lange

Hi, Jim.

Jim Birchenough - Lehman Brothers

Hi, guys. Just a couple of questions, one on your cash burn guidance. You are already on a cash burn run rate for less $85 million and you've got Regadenoson that could get approved, and continued growth of Ranexa. So, I was just wondering why you are suggesting less than $100 million and seeming to get a bit of cushion where you could guide presumably to much lower burn?

Dan Spiegelman

Well, part of it is to give some cushion and the other part deals with the fact that, as I tried to indicate, we would expect cash used in the first quarter to be higher than what we've seen in the last couple of quarters due to annual timing differences.

Jim Birchenough - Lehman Brothers

Any particular reason for the cushion, Dan?

Dan Spiegelman

Just being appropriately conservative.

Jim Birchenough - Lehman Brothers

And then just in terms of thinking about the ex-US opportunity, what sort of economics are you looking for Ranexa ex-US? And how do you think about that, in terms of balancing a global opportunity that might be more attractive once you get a label revision?

Louis Lange

Well, Jim, I think that, once the drug hopefully gets approved, we will want and need a partner. We're in a lot of discussions both territorial and global. And I think it's our goal to maximize the business opportunity, for us and the shareholders. And they all come with different bells and whistles. So I can't be specific about it. But I think the one thing that I would say is the company, the other company has to believe in this drug and we have to believe that they can sell it. So that's very important to us whether that's global or just in Europe.

Jim Birchenough - Lehman Brothers

And just a final question and I will get back in the queue. You have been within two weeks of PDUFA with Renexa, both negatively and positively. You are two weeks in front of PDUFA with Regadenoson. How confident are you that it's going to go positively?

Louis Lange

Well, they are completely different products. Remember a lot of the issues around Ranexa concerned to QT interval. We are dealing with a very straight forward development program where we had 10 studies, the pivotals both work. We invented the molecule. We created every scrap of data associated with it. So I am hoping for the best, but I don't think there is any language that we could say today would be exactly accurate looking forward two and half weeks. So I think that once the FDA, they have been working diligently on this, signs the letter… I think we just have to wait for them.

Jim Birchenough - Lehman Brothers

Okay, I guess what I am getting at is, you went through a final process back into the fourth quarter of '03 and you went through a process a few years ago before you got Ranexa approved. I am just wondering if the dynamic you have with the FDA is more in keeping with the latter scenario that worked out for you?

Louis Lange

Well, it's a hard question to answer Jim. It's different from both and, remember, it's in a different division. So I don’t think you can draw generalities. I know people were saying at the Avastin decision, now the FDA is getting easier. I think those are all one-off cases and I don't really pick any. We have many, many interactions with the FDA on other products as well. And it's all one-off cases, I would say.

Jim Birchenough - Lehman Brothers

Okay. Thanks.

Louis Lange

Sure.

Operator

And your next question comes from the line of Allen Carr.

Louis Lange

Hi, Alan.

Alan Carr - Needham

Hi, good afternoon everyone. Thanks for taking my question. It's been about six to eight months or so, I guess, since you guys announced reductions in the sales force. I was wondering if you could reflect on that a bit, whether or not you think that made the right scale reduction and reductions in the right places, and do you plan on making any changes to that going forward?

Louis Lange

Yeah, I think we did. I think we instantly became profitable with respect to the sales reps. We continue to grow revenue. We're very close to breakeven on the commercial side. And we've added a few reps back- not too many, but we added a few in the Northeast where business is growing and will continue to marginally.

I don't see a big change right now in the salesforce either way, but of course if revenues grow, I mean for anybody, after we have the label change where the partner that would be a different level of discussion. But I think we did a thoughtful analysis and I think the reps are doing a good job right now.

Alan Carr - Needham

Okay. And in terms of partnering again, could you elaborate a bit on that. You were talking about regional partnerships, but did you say you are still talking about global partnerships and that sort of thing for help in US?

Louis Lange

Yeah, I did. We are in discussions both with global and territorial companies, and the goal there of course is to maximize the business for the company. And it's a matter of figuring out how we best do that, that's the goal of the partnership discussions.

Alan Carr - Needham

And one other quick one, what did you say the milestone was for Regadenoson approval?

Louis Lange

The PDUFA date is the 14 of March.

Alan Carr - Needham

14th, so…

Louis Lange

Two weeks from Friday, and we are still optimistic about it and the milestone payment is $12 million from Astellas.

Alan Carr - Needham

Okay, good. Thanks very much.

Operator

Your next question is from the line of [S. Ramekin].

S. Ramekin

I had a quick one on gross margin. I see that the gross margin for the fourth quarter is about 86% down from 90% previously. I am just trying to understand the dynamics behind it and also how should we think about it going forward? Thanks.

Dan Spiegelman

The gross margin by my numbers, what I have right in front of me, as we calculated our percentages are 85% in the fourth quarter and 86% in the third quarter. And those numbers are roughly what I would expect going forward. Depending on how you're calculating it in the third quarter, you might have had a slightly higher gross margin because of the fact of the one time additional revenue because we reduced the returns reserve in the third quarter.

S. Ramekin

Okay, thank you.

Operator

Your next question is from the line of Eric.

Louis Lange

Hi, Eric.

Eric Schmidt - Cowen & Co.

Hey guys, how are you?

Louis Lange

Fine.

Eric Schmidt - Cowen & Co.

Lou, just with regard to potential partnership discussions, commercial discussions for Ranexa, I guess, should we assume that with EU approval hopefully coming in the summer time and of FDA label expansion coming around the same time that you would likely want to see what the [gods] deal you before you will like to partner this or give away potentially too much of the upside?

Louis Lange

Well, I think we will careful about, but on the other hand, Eric, I think there are other forces at work too. There is a dry pipeline in pharma and so I think there is the eye of the beholder on the other side. So we've got some interesting discussion going on. I can’t tell you about the timing and how these things will stay together but I am encouraged by what I am seeing.

Eric Schmidt - Cowen & Co.

Okay. And with your statement about EU approval maybe happening this summer, is there a CHMP meeting in the next month or so here that you expect a favorable review of that?

Louis Lange

I believe that CHMP meets every month. And then those meetings are not public, unlike many of the advisor panel meetings of the FDA.

Eric Schmidt - Cowen & Co.

But you expect Ranexa to be reviewed at the next meeting?

Louis Lange

I don’t know exactly what the time line will be but we expect it to be approved by the middle of the year and so they, barring major change, they will be reviewing it in the next meetings or so. So yes absolutely.

Eric Schmidt - Cowen & Co.

And then a question for Dan, sort of a revenue recognition question around the $12 million milestone and Regadenoson royalties. Is that milestone going to be lump sum in Q1 as far as your P&L goes?

Dan Spiegelman

Yes.

Eric Schmidt - Cowen & Co.

And royalties how does that work from day one you are approved, do you start accruing royalty revenues and at what rate?

Dan Spiegelman

So the royalties on Regadenoson begin accruing as soon as Regadenoson sales start.

Eric Schmidt - Cowen & Co.

I am sorry I meant Adenoscan royalties.

Dan Spiegelman

Yeah on the other product the way that works is, we start generating those royalties in what will at the end of the day be the third quarter, because it starts in the first full quarter, it's 45 days after approval, and so that would be the third quarter.

Eric Schmidt - Cowen & Co.

Okay and can you help us set on the rate?

Dan Spiegelman

It’s a single digit number in that particular case, it’s tiered. So there is, it depends what sales are in the quarter, but it is single digit and to recall- the purpose of it is to make the total royalty burden to it, to Astellas, the royalty they pay us, plus the royalty they pay King, to be quite a bit above the royalty they would owe us on Regadenoson.

Eric Schmidt - Cowen & Co

Okay.

Dan Spiegelman

So it's a single digit modest royalty. It's nice, it's real money, but is not a huge number and it's not a business driver unto itself.

Eric Schmidt - Cowen & Co

Okay. Thanks a lot.

Louis Lange

Thanks, Eric.

Operator

(Operator Instructions) Your next question is from the line of George Zavoico.

George Zavoico - Cantor Fitzgerald

Hi, Lou. Hi, Dan.

Louis Lange

Hi. How are you, George?

George Zavoico - Cantor Fitzgerald

Good, thanks. A quick question for you, you mentioned that you're going to look for a partnership after the approval.

Louis Lange

In Europe.

George Zavoico - Cantor Fitzgerald

In Europe, not in the US. You might get, you might be looking for something before?

Louis Lange

Yeah, George, somebody has got their cell phone on. And it always, to say that the July 27 date is after the European date and so logically there is more opportunity to do a European only deal earlier. But that having been said, we have global and European discussions going on and I can't tell you what would be the best opportunity for the coming [?]. But we have some interesting opportunities I suspect.

George Zavoico - Cantor Fitzgerald

Okay. So I'm just wondering about how much value perhaps you might place on the risk before the PDUFA date. But it sounds like at least in the US and the FDA, you would get greater value obviously in the deal after approval. And I was wondering how much you are weighing the pros and cons of that?

Louis Lange

I think that is a theoretical supposition actually. First of all with 10,000 patients in placebo control studies and 6,500 of them in MERLIN, the database is robust, pharma is used to assessing those kinds of risk. Those risks are about as low as they get with respect to clinical and regulatory hurdles. So, I think that you could make the case that will have an impact, but I think you could make the case it won't. And I think it depends on what we think would be the best opportunity to move ahead. Obviously, we are not interested in giving away a lot of upsides here. But I think that this one is a lot easier to analyze than many and especially since it's already approved in the US.

George Zavoico - Cantor Fitzgerald

Yeah, that’s true and I guess, having said that you are not really in a position where anything needs to be rushed and that's a good position to be in?

Louis Lange

Yeah, we're in a great position, Eric, and just remember that, ranolazine probably works in atrial fibrillation, we are designing an outpatient AS study. Its got very good data in diabetes and so, there are various potential partners that are quite excited about the other indications of Ranexa and might want to help us and help do them faster and in more parallelity. So, there are a lot of things to take into account.

George Zavoico - Cantor Fitzgerald

Having said that, can you guide us in 2008, what kind of changes to expect in R&D expenses.

Louis Lange

We haven’t made any changes and I think we just talked about those in the last couple of calls, I don’t know. Dan, you want explain?

Dan Spiegelman

We expect expense levels in both areas to be relatively constant from the third and fourth quarters of 2007?

Louis Lange

Obviously, if we do a partnership or something else major happens, then we will come back to you.

George Zavoico - Cantor Fitzgerald

Okay. Terrific, thank you very much.

Louis Lange

Thank you, bye.

Dan Spiegelman

Bye, bye.

Operator

Your next question is from the line of [William Flattery].

William Flattery

Thanks very much, guys. Just a little bit of insight as to how you would hope to develop the Diastolic Dysfunction, observations that have been made with and around Ranexa's utility?

Louis Lange

Yes, good question Bill. Well, I think that you will hear some very interesting data at the ACC in regards to that, that's step one. Step two is we have a few investigators who are piloting their own data that we expect to get this year and we are in the process of evaluating whether or not we take Diastolic Dysfunction ahead, as opposed to Atrial Fibrillation. My gut is it would be AF right now, Bill, but it could be Diastolic partially- or probably be both. So when you start feel back but you'll see some very interesting data to the ACC. 1.24-15

William Flattery

Lou just a quick follow up. What are the metrics that one looks at in terms of determining utility in Diastolic Dysfunction? Unless these patients have normal ejection fractions at rest, if that's distress I guess, so how does one really capture utility in that setting Diastolic Dysfunction.

Louis Lange

Well there are different levels of evidence, certainly in the cardiology community, just an echo study would be very interesting to people. So showing an improvement in Diastolic Dysfunction with echo would be exciting to many practitioners that are cardiologists. Beyond that, you are right, we could be looking at global assessment of symptoms, we could be doing walk times, and those are the various parameters that one could measure. But I will tell you that there is nothing that really works on the echo either, so echo data itself would begin to stir a lot of interest.

William Flattery

And if I could, sorry for the last the follow-up: what duration of treatment do you think you would have to expose a patient to before you would begin to see some treatment effect?

Louis Lange

Yeah, another good question. Well because of the safety that we have been able to demonstrate in the MERLIN TIMI 36 study, we don’t have to do chronic outcome studies in heart failure, since we have already shown that there is nothing untoward going. So again these are on the brief side, like any [?] of the study we are contemplating Atrial Fibrillation and so forth where the study duration is probably on the (inaudible) 0.48-16 three to six months.

William Flattery

Okay perfect. Thanks very much. I appreciate it.

Louis Lange

Yeah thanks Bill.

Operator

Your next question is from line of [Bret Holley].

Louis Lange

Hi.

Bret Holley - CIBC World Markets

Hi, Lou. I was wondering what the current headcount is? And can you give an update on the PBM stats, how many of the top-PBMs you are currently on?

Louis Lange

Yeah, the headcount hasn't changed very much since the downsizing. It is somewhere between 500 and 550 people. And the PBM stat is, we continue to go well, we've got about little over 55% of patients at tier-2. It's actually running very nicely. I think the current number is 59%, 133 million covered lives. And we're still working through it, that's good, but we continue to grow that. So we're pleased, but we're still working hard on it. We have a great reimbursement group.

Bret Holley - CIBC World Markets

Thank you.

Louis Lange

Thanks.

Operator

You do you have a follow-up question from the line Jim Birchenough.

Louis Lange

Hi.

Jim Birchenough - Lehman Brothers

So prescriptions have been flattening out a bit in the last few weeks. And I'm just wondering, how you're going to make use of ACC to really reinvigorate those scripts, and in particular just wondering, with things like Diastolic Dysfunction and anti-arrhythmia, benefit even the HB1C reduction. Is there anything your reps can do in the near term to pursue those conversations with physicians?

Louis Lange

Well, good question. There are fairly a lot of Monday holidays and a lot of our plan of action meetings with the sales force have taken a few sale days away. But that having been said, if you look at quarter-over-quarter, we're still growing, and I wouldn't get too excited about three weeks.

There are a lot of activities going on with respect to the plan of action meetings in ACC and so forth. But the long term trend line is that it is monotonically rising. We're adding 260, 290 new docs every week. And so we're basically pretty pleased with it. I think we may see more after the label changes, but we're grinding the way at it.

Jim Birchenough - Lehman Brothers

Just a final question, and just if you could maybe describe the IP position you have on Ranexa and how any follow-on product might be brought forward to give a longer sustainability to the franchise and how a partner fits into that in terms of timing of moving a follow-on product forward?

Louis Lange

Well, look the patents go to 2019, and they protect the concentration range, they protect the PK to any NDA filing it would have to have and they can't do that without infringing. That core to protect the formulations, we have made, as I said, a science stage and so very, very nice progress in the follow-on project. We don’t really need a partner to accelerate or move that. We're in pretty good shape on our own there. Of course a partner would always be welcome to maybe develop it broadly, but I am very pleased with the patent state and I think the follow-on would take this into 2030 and beyond. And I think it's a franchise, it is like a sodium channel that we're going to come close to owning I suspect.

Jim Birchenough - Lehman Brothers

Excellent.

Louis Lange

Thanks, Jim. Okay. I guess there are no more questions, so we appreciate your attending the call. Just a quick summary. Obviously, it’s a pivotal year for us, we got five NDA, FNDA equivalents, the first one is in a couple of weeks with Regadenoson. The next one is the European possible approval and there we've got NDA, sNDA's for Ranexa at the end of July. So, very exciting, we're also selling [throughout] and it is growing and the pipeline is terrific as we said on Science Day. So, I look forward to updating you soon on some of these regulatory submissions. Thank you very much.

Operator

And this concludes today's conference call. You may now disconnect.

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