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Executives

Francois Nader - President & Chief Executive Officer

Luke Beshar - Senior Vice President & Chief Financial Officer

Susan Mesco - Director of Investor Relations & Corporate Communications

Analysts

Marco Crosio – Jeffries & Co.

George Farmer - Canaccord Adams

Eric Alexander - CRT

Lucy Lu - Citigroup

Davis Bu - Goldman Sachs

Leah Hartman - CRT Capital

NPS Pharmaceuticals Inc. (NPSP) Q4 2008 Earnings Call March 13, 2009 6:00 AM ET

Operator

Good day ladies and gentlemen, and welcome to the fourth quarter 2008 NPS Pharmaceuticals earnings conference call. My name is Josh and I’ll be your coordinator for today. At this time all participants are in a listen-only mode. We’ll be facilitating a question-and-answer session towards the end of this conference. (Operator Instructions)

I would now like to turn the presentation over to our host for today’s call, Director of Investor Relations and Corporate Communications, Susan Mesco. You may proceed.

Susan Mesco

Thanks Josh. Good morning and welcome to our quarterly conference call. Before we start let me remind you of the SEC Safe Harbor Provisions. Please note that comments made today about future events and potential developments are forward-looking statements based on management’s current expectations.

All of our projections and forward-looking statements represent our judgment as of today. Our statements may involve risks and uncertainties that are described more fully in our filings with the SEC, which are available from the SEC or our website.

Joining me on today’s call are members of our management team, including our President and Chief Executive Officer, Dr. Francois Nader and our Senior Vice President and Chief Financial Officer, Luke Beshar.

It is now my pleasure to turn the call over to our CEO, Francois Nader.

Francois Nader

Thank you Susan and good morning everyone. This is our first call of 2009 and it comes after a very productive year for NPS. I’m very proud of the accomplishments of our team in 2008, having achieved all of the key corporate objectives we set in the beginning of 2008.

NPS is now on very solid footing with two Phase III registration studies actively recruiting, a strong royalty based portfolio, over $106 million in cash and investments and the potential to add more capital through monetizing non-core assets from our partner royalties.

With the recent launch of steps for GATTEX in short bowel syndrome and replace for NPSP558 in hypoparathyroidism, we are moving closer to providing new therapeutic options for patients with these two orphan disorders. I would like now to walk you through some additional 2008 highlights and summarize our key 2009 priorities.

With GATTEX, we completed the first Phase III expansion study in short bowel syndrome and reported the one-year data at the American College of gastroenterology conference. We held two pre-NDA meetings with the FDA, to finalize our regulatory path forward for the short bowel syndrome indication and the design of steps, the confirmatory Phase full year registration study.

We announced steps in December that global study is designed to confirm the results of the first Phase III study that showed the ability of GATTEX to reduce dependents on parenteral nutrition. The primary end point of that is a 20% or more reduction of parenteral nutrition needs in patients with SBS, after six months of treatment with GATTEX when compared to baseline. We were very pleased by the eagerness of the key opinion leaders to participate in the study and we expect to complete enrollment before the end of the first quarter of 2010.

Our partnership with Nycomed is progressing very, very well. They have opted to support the SBS indication and are co-founding the external cost of steps. This decision is contributing to a faster execution of the study in addition to providing considerable cost savings to NPS. Additionally, we have advanced pre-clinical studies of GATTEX in pediatric indications and in GI mucositis.

For NPSP558, our 1-84 parathyroid hormones for the treatment of hypoparathyroidism, we collaborated with the FDA and with the global thought leaders to design a Phase III registration study of 558 that we refer to as REPLACE. The primary end point of this 110 patient, 24-week study, is to demonstrate that once daily, subcutaneous dosing with 558 is safe and will achieve or maintain normal serum calcium while reducing calcium and Vitamin D supplementation by 50% or more when compared to baseline.

The study would assess three doses of PTH, 50 microgram once a day, 75 microgram once a day and 100 micrograms once a day against placebo. We enrolled our first patient in REPLACE in December 2008, because therapeutic options for hypoparathyroidism are limited and suboptimal, physician and patient interest in the study has been very high. We expect to complete enrollment in late ‘09 or early 2010 and we will report top line results in the second half of 2010.

Having designed REPLACE with consensus from the key hypoparathyroidism experts in the U.S. and in Europe, we believe that the treatment algorithm could become the first standard of clinical care for hypoparathyroidism.

Switching now to our partner programs, our Sensipar and Preotact programs have continued to grow strongly year-over-year. Additionally, we began receiving royalties’ sales of REGPARA in Japan by Kyowa Kirin and we are very encouraged with the Phase growth they are seeing so far.

Looking ahead, our four key objectives are as follows: First, complete the enrollment of our two pivotal registration studies, a REPLACE in hypoparathyroidism and steps in short bowel syndrome within the next 12 months. Second, put the necessary manufacturing agreements in place for our future commercial supply chain.

Third, manage our operating expenses to achieve a cash burn of $55 million to $65 million. Fourth, evaluate opportunities to further strengthen our balance sheet in order to take our two lead products, GATTEX and 558 to the Finish Line and launch them successfully.

We have a number of potential sources of capital from our royalty agreements and the monetization of non-core assets. Consistent with our track record, we will seek additional capital if and when need be in a strategic manner that would be in the interest of our shareholders.

I will now turnover the call to Luke for his financial review, after which we will open the call to your questions. Luke.

Luke Beshar

Thank you Francois and good morning everyone. Our fourth quarter results reflected a number of key financial highlights including, strong royalty revenues from our partnerships, an annual cash burn for 2008 that was significantly below our improved cash guidance and we ended the year with a substantial cash position which will enable us to continue to meet our clinical priorities despite the current challenges in the financial markets.

Now on the specifics; NPS today reported a fourth quarter net loss of $8.4 million or $0.18 a share. However these results include the negative effect of a $6.2 million or $0.13 share, non-operating charge, resulting from an other than temporary decline in the estimated current value of our auction rate security investments, which I will discuss more fully in a moment.

Fourth quarter revenues are comprised of royalties, product sales, milestones and license fees. Royalties increased by 30% to $18.3 million for the fourth quarter versus $14.1 million last year. This year-over-year growth was due to the following factors.

The continued success for Sensipar; our royalties increased by 17% for the quarter coming in at $15.1 million versus $12.9 million last year. Amgen, recently reviewed Sensipar at their fourth quarter Analyst Day, noting that Sensipar could achieve blockbuster status within the next five years.

Secondly, Preotact royals doubled, coming in at $2.5 million for the fourth quarter 2008 versus $1.2 million last year and finally, REGPARA royalties were $778,000 for the quarter. As Francois mentioned we continue to be encouraged by the promising long term revenue potential of this unencumbered royalty stream. As you may recall, our partner Kyowa Kirin introduced REGPARA in Japan in early 2008 and in less than a year has resulted in a $3 million plus annual royalty stream to NPS.

Our revenues also reflect bulk inventory sales to Nycomed and in the fourth quarter 2008, we sold $2.9 million of bulk Teduglutide inventory, while in the fourth quarter 2007 we sold $5.4 million of bulk PREOTACT inventory.

We recognized $2.9 million of licensing fees in the fourth quarter of 2008, which includes $2 million in revenue related to a non-exclusive license we granted to Hoffman-La Roche in December for our GlyT1 inhibitor patents, as well as the recognition of deferred revenue from our 2007 GATTEX license agreement with Nycomed. In the fourth quarter of 2007, we recognized $14.5 million of milestones and licensing fee related to our agreement to Nycomed for GATTEX and for PREOTACT.

Now, turning to expenses. R&D expenses in the fourth quarter decreased by more than half, coming in at $4.8 million versus $10.1 million last year, due to the completion of our Phase III SBS study in 2007 and the lower costs from our restructuring. G&A expenses also decreased in its order of magnitude coming in at $4.9 million in the fourth quarter versus $9.8 million last year, principally due to the cost benefits of our 2007 restructuring.

Interest expense was relatively flat at $16.4 million for the fourth quarter versus $17 million last year. As a reminder, the vast majority of our debt is non-recourse to NPS and is fully secured by our Sensipar and PREOTACT royalties.

At December 31, 2008, we held auction-rate securities with an estimated fair value of $8.8 million. This valuation reflects other than temporary charge of $6.2 million in fourth quarter. The ARS Markets remain challenged with 30 day auctions having consistently failed since the second half of 2007. However, all of our auction rate securities continue to pay interest on the full face value of the investments. We are closely monitoring marketing additions and we’ll classify our ARS investments as long term assets until market conditions improve.

Regarding our cash, we continue to maintain tight management at the end of the quarter, with $106.1 million in cash and investments. Our cash burn for 2008 was approximately $35 million and well below our previous revised guidance of $40 million to $46 million. This improvement was due to the shifting into 2009 of certain expenses associated with our development programs for GATTEX and SBS and NPSP558 in hypoparathyroidism, as well as our ongoing cost containment initiatives. Consistent with prior periods our cash burn excludes any change in the carrying value of our ARS investments.

With respect to this year’s guidance, we expect our 2009 cash burn to be in the range of $55 million to $65 million. The key drivers for the increase in the burn from 2008 are the shifting of some of our R&D costs that have been forecast for 2008 into this year.

CRO, another clinical costs associated with the steps to replace Phase III registration studies, manufacturing and supply chain related activities for GATTEX, NDA readiness and other regulatory initiatives, lower interest income due to lower investments and lower interest rates. Partially offsetting these increases is a forecasted decline in 2009 G&A expenses as we continue to implement cost containment initiatives.

We have over $106 million in cash and investments. We do not have an immediate need for cash. However, we want to maintain adequate resources to take GATTEX and NPSP558 to the finish line. So as Francois mentioned, we will be opportunistic in evaluating opportunities to strengthen our balance sheet.

We are fortunate that we do have a number of potential sources of capital. For instance, we have a milestone payment from our PREOTACT royalty revenue of $25 million that we may receive in 2010, if certain sales thresholds of PREOTACT are achieved in 2009.

Our out-licensing initiatives continue for our GlyT1 inhibitor and D-serine analog compounds for CNS disorders. Last quarter, we were successful in granting a $2 million non-exclusive GlyT1 license to Roche and we continue to talk to other interested parties about these assets. We have Canadian net operating losses from our Allelix subsidiary that we maybe able to monetize.

Our royalties from REGPARA are unencumbered and growing nicely. Our Sensipar royalties continue to grow and these have only been partially monetized. We also have development milestones associated with Nycomed’s advancement of Teduglutide in the EU.

Nycomed is planning for 2010 submission in Europe and they do not expect the step study results to be part of that submission and we have the option of traditional capital markets. I’d expect we would only pursue this option if the timing was right and was ultimately in the best interest of our shareholders when compared to the other options.

So to summarize the fourth quarter, we launched Phase III registration studies for both our lead product candidates, GATTEX and NPSP558. We saw strong revenue growth from a royalty based programs, underscoring the value of this portfolio. We continue to enjoy the benefits of last years cost containment initiatives.

We managed our cash burn diligently with better than expected results in 2008, and going forward we will look carefully at ways we can strengthen our balance sheet in a manner that is in the best interest of our shareholders.

With that, I’ll turn the call over to the operator to begin our Q-and-A session. Josh, can you open the mic please?

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of Marco Crosio - Jeffries.

Marco Crosio - Jeffries

So my first one is, can you give us a little more color on how you’re proceeding towards enrollment goals in trial completion for both 558 and GATTEX please?

Francois Nader

Marco, very good question, needless to say that our clinical operations teams are very actively working on recruitment and insuring that all the sites are up and running. It’s very early times and especially when it is a global study, things take time.

However I’m pleased to report that we are very much on tracked to complete enrollment for GATTEX, the step study within the next 20 months, as we projected and to complete the recruitment of REPLACE by the end of this year or very early next year. We will, however during the year give you some updates on the enrollment as it becomes a little bit more tangible and as soon as we can project the landing time.

Operator

Your next question comes from the line of George Farmer - Canaccord Adams.

George Farmer - Canaccord Adams

Luke, I just want to clarify something. Did you say that Nycomed is intending to file GATTEX or Teduglutide in 2010 for short bowel syndrome?

Luke Beshar

That’s correct George, that’s our understanding that Nycomed indicated to us.

George Farmer - Canaccord Adams

So, even without the steps trial data; they feel they don’t need that data?

Luke Beshar

They’ve indicated that is their current plan. That’s correct.

George Farmer - Canaccord Adams

Okay and if they don’t need to, why wait until 2010? Why can’t they do it later this year?

Luke Beshar

Yes, that’s a question I really can’t answer. You have to pose it to Nycomed.

George Farmer - Canaccord Adams

Okay and then regarding 558, I guess we’re waiting for some full Phase II data from investigator Columbia from the study we’re evaluating that. Is there any clarity that one will be able to see that full data set?

Francois Nader

George, I wish we could give you a specific answer. We know that Dr. Bo Joelsson is actively working on plans to communicate the data. We’re very anxious for him to communicate this data. We don’t have a set target yet and we’ll let you know as soon as we know.

George Farmer - Canaccord Adams

Okay and Luke, also can you give us any sort of sense of what kind of Preotact run rate would be required for IDRI to ultimately pull the trigger on the $25 million payment in 2010?

Luke Beshar

George, that’s not public information, so I’m not ready to so that. What we will do, as we get further into the year we’ll get visibility, we’ll give better clarity in terms of what the probably success is.

What I will tell you is that given the trajectory that Preotact’s currently on, it is on and is tracking exactly where it needs to track to in order to hit that target. There is growth baked into those assumptions for ‘09 and I think after the first and second quarters as we see results, we’ll have a lot better clarity in terms of what the probability of success of hitting that trigger is.

Operator

Your next question comes from Eric Alexander - CRT.

Eric Alexander - CRT

My question was simply in regards to the end point; if you could expand for the steps trial, are you going to use the same 20% reduction in TPN or try for a broader combined end point or can you expand it all on that?

Francois Nader

Sure, Eric. This is a confirmatory study and therefore we will be using the same primary end point as we used in the first Phase III study and it is indeed a 20% reduction of parenteral nutrition, when we compare the end of month six to the baseline, actually it’s week 20 to 24 very specifically.

We will use a number of secondary end points to expand on for example, the number of patients who will get off parenteral nutrition or the mean reduction of parenteral nutrition volume, but the FDA insisted that we use the same primary end point as the first study, so that they have two studies to work from.

Eric Alexander - CRT

Did you note in the first trial or can you expand on whether or not there was variation in terms of the protocols people were using to reduce PTN, given kind of the wide ranging nature of where these patients were found. I guess the question then, are there tighter guidelines in terms of how physicians are to reduce TPN to try and take away any sort of randomness here to the process?

Francois Nader

Well, we limited the randomness the first time around by an algorithm that called for up to 10% reduction or increase of parenteral nutrition every month. So, it was pretty much I would say dictated by the protocol. Fair to say though that the data that we reported were the actual use of parenteral nutrition by patient, versus the prescription by physician and we believe that reporting the data from patients is much more accurate because this is the actual use.

What we were told by the investigators is, given what we know about GATTEX and its pharmacological property and its pharmacological activity, 10% more or less per month seems to be a little bit too tight and our investigators felt that we can be a little bit more aggressive.

So in this new protocol now, the algorithm calls for a plus or minus 30% from month-to-month, so this gives the investigators the ability to be a little bit more aggressive when it comes to parenteral nutrition, but again as with the first protocol, we will capture both the prescription data and the actual use data and the data that will be reported will be the actual use data.

Operator

Your next question comes from Lucy Lu - Citigroup.

Lucy Lu - Citigroup

Can you please just talk about what kind of market research you’ve done to find out the prevalence, as well as the incidence of hypoPTH patients who actually need daily injectable hormone replacement? That’s my first one and I have a follow-up.

Francois Nader

That’s a very good question because there is a scarcity of data related to the prevalence or incidence actually of hypoparathyroidism. So, we had to go through multiple sources to land on a number that is 65,000 patients in terms of incidence not per year, but 65,000 patients suffering from hypoparathyroidism in the U.S.

Now, based on different sources the number could be as low as 48,000 to 50,000 and as high as 90,000 patients. Now, when it comes to the incidence it’s a little bit more complicated because as you know, about 60% of the hypoparathyroidism patients or cases are from rejection of the thyroid and the rejection of the parathyroid gland.

Depending on the literature, the number of cases resulting from Thyroidectomy really varies between 2% and 7%. So I don’t have the exact number of new cases per year, but 60% of the cases in general results from surgery, the rest are related to other causes.

Lucy Lu - Citigroup

Then Luke, can you please talk about when you expect to pay-off the non-recourse debt secured on Sensipar and also what is NPV, Net Present Value of the Sensipar royalty to NPS after you pay-off the debt and also talk about that; basically give us two scenarios: one basically assume always positive or negative? Thank you.

Luke Beshar

Sure. We currently anticipate that since the A&B Bonds will be paid-off at the end of 2012 and in early 2013 that the revenue streams from Sensipar will come back to NPS and at that point there’ll be north of $100 million a year.

The NPV is depending on your assumed discount rate, it’s between $200 and $275 million today is our current estimate based on those forecasts; and the evolved study, we understand from Amgen that they will not have results until the second half of 2010 and when that comes out we’ll be able to evaluate how that impacts our long term forecasts.

Operator

Your next question comes from Davis Bu - Goldman Sachs.

Davis Bu - Goldman Sachs

If I could follow-up on a previous question, when you were talking about the changes to the TPN protocol, two questions there; one is, so I assume that this was also discussed with the FDA and the FDA was onboard with that and also related to that, are there any other salient changes to the protocol between the confirmatory study and the original Phase III study?

Luke Beshar

Yes, good morning Davis and yes, all these changes were discussed with the FDA and actually we sent the final protocol to the FDA and it was added to our IND. Basically, again, the position that the FDA took is the fact that this is a confirmatory study. So from the prospect of the two studies, the first one and this new one, they have to look very much similar.

Now, there are some nuances. One nuance for example is the fact that in the first study, we had one primary end point that we expended, then we had 13 secondary end points and about nine tertiary end points, which made it a very complicated and heavy study.

We have simplified this nuance by eliminating a number of secondary and tertiary end points, either because we received and we already have the data we need or because we don’t need to have them or do them again or they will be redundant . For example, we had two quality of life instruments in the previous one. With this one we have only one and it is specific for short bowel syndrome patients.

Now, in terms of inclusion/exclusion criteria, we also learned from the first study and adapted our exclusion/inclusion criteria accordingly. For example, we learned from the first study that virtually every patient, who suffered from short bowel syndrome, every patient has some kind of liver dysfunction. So in the first study our range for liver function enzymes for example was pretty tight. We loosened it up a little bit.

Another criteria was the body mass index, BMI, which was a little bit too high the first time around. We learned very quickly that usually these patients are somehow sensation, so we modified the BMI accordingly and the same with the renal function.

Now in terms of conduct of this study, I think the overall protocol will look exactly the same with the nuances that I mentioned earlier. For example, with the possibility of decreasing parenteral nutrition by up to 30%, who will spend also more time and effort with the patient and with the physician in ensuring that during the optimization Stabilization phase, they will reduce their parenteral nutrition need as much as possible before being randomized.

So overall I would say the study looked the same, but there are significant nuances and this makes this particular one much, much easier to conduct.

Davis Bu – Goldman Sachs

And just to tie up, just to confirm, I think this is pretty straightforward, so if you do complete enrollment in the first quarter of 2010, should we then expect to see the data by the end of 2010?

Francois Nader

This is a projection at least; just to underline the fact that the study is in two parts. You have the optimization stabilization which could go up to two months, and then you have six months of actual treatment. So by the time we enroll our last patient, we have to add about eight months and then you know the regular time to digest the data and come up with the top line results.

Operator

Your next question comes from Leah Hartman - CRT Capital.

Leah Hartman - CRT Capital

Many of my questions have been answered, but I did want to double check if you’re willing to disclose the number of sites that are up and running in the steps trial and then the goal of the number of sites you have to ultimately have.

Francois Nader

Yes, Leah good morning. It’s way too early to disclose the number of sites, simply because as you know for a global study, things are progressing as planned. At the same time, I don’t know that any number today would be meaningful.

In terms of total number of sites, we’re looking at about I would say 30 to 35 sites globally, and these sites will be about one-third here in the U.S. and two-thirds ex-U.S., practically meaning Canada and Europe, which is somehow the same or similar number to the number of sites we had the first time around.

Leah Hartman - CRT Capital

That was my next question; and then on the balance sheet side, Luke would you be willing to give me the breakout of the balances outstanding under the A’s and the B’s at the end of the year?

Luke Beshar

Sure Leah, I can do that for you. At the end of the year the total outstanding in the A’s was $130 million; the B’s was about $124 million and the DRI was about 50 and that’s all long term; the exception on the A’s, 35 of that would be current.

Operator

At this time, we are showing no further questions available. Dr. Nader, you may proceed.

Francois Nader

Thank you, Josh and thank you everyone for your questions. In closing just let me say that we are very, very confident about the future success of NPS, with two active Phase III programs, a strong growth debate portfolio, over $106 million in cash and investments and the potential to add more capital if and when needed.

2009 will be a key execution year in clinical development based on very, very aggressive enrollment timeliness. In parallel, we will be in active preparation mode in technical operations and in regulatory affairs.

Last, but certainly not least and from a financial perspective, we’ll maintain a tight cash management. We will strategically strengthen our balance sheet and we will continue to focus on growing shareholder value through an optimum balance of risk, reward and resources. Well we look forward to providing you with additional updates on the business in the future and thank you for your continued support of NPS and have a great, great day.

Operator

Thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect. Have a great day.

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Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

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