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Executives

Susan Mesco – Senior Director, IR and Corporate Communications

Dr. Francois Nader – President and CEO

Eric Pauwels – Chief Commercial Officer

Luke Beshar – Chief Financial Officer

Analysts

Eun Yang – Jefferies

David Nierengarten – Wedbush Securities

Alan Carr – Needham & Company

James Molloy – ThinkEquity

NPS Pharmaceuticals, Inc. (NPSP) Q2 2012 Results Earnings Call August 1, 2012 5:00 PM ET

Operator

Good day, ladies and gentlemen. And welcome to the Second Quarter 2012 NPS Pharmaceuticals Earnings Conference Call. My name is Keith, and I’ll be your operator for today. At this time, all participants are in a listen-only mode. Later on we are going to conduct a question-and-answer session. (Operator instructions)

As a reminder, today’s conference is being recorded for replay purposes. And with that, I’d now like to turn the conference over to your host for today, Ms. Susan Mesco, Senior Director of Investor Relations and Corporate Communications. Please go ahead.

Susan Mesco

Thank you, Keith. Welcome to our second quarter conference call. Before we start, let me remind you that today’s call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties. Please refer to our filings with the SEC, which are available from the SEC or our website for information concerning the risk factors that could affect the company.

Joining me on today’s call are members of our executive management team, including Dr. Francois Nader, our President and CEO; Eric Pauwels, our Chief Commercial Officer; and Luke Beshar, our CFO.

I will now turn the call over to Dr. Francois Nader.

Dr. Francois Nader

Thank you, Susan, and good afternoon, everyone, and thank you for joining us today. Since we last spoke, the NPS team has made a lot of important progress supporting the U.S. regulatory review of GATTEX for short bowel syndrome and preparing for our BLA for NATPARA in hypoparathyroidism.

We also completed a successful transaction with Amgen that significantly enhance our financial position by generating sufficient resources to launch both GATTEX and NATPARA and in doing so transform NPS into a premier orphan drug business.

I would like to begin today’s call with an update on GATTEX or teduglutide. We were very, very excited that our partner Nycomed received a positive opinion from the CHMP recommending approval of Revestive as GATTEX will be known in Europe for the treatment of adult short bowel syndrome. We expect the European commission to grant marketing authorization for Revestive around the end of August.

The European approval will bring us one step closer to our goal of making teduglutide available for all patients with short bowel syndrome who might benefit from the breakthrough treatment.

On the clinical side, we are continuing to advance STEPS 2, our two-year open label stuffy of GATTEX. The GATTEX safety profile has remained consistent with no unexpected serious adverse events to report.

As of today, 40 patients remain on GATTEX in STEPS 2 and 26 patients have completed the study. We expect STEPS 2 to conclude in early 2013 and we will present full result as soon as possible thereafter.

Those things have also started in STEPS 3, a small one-year U.S-only study that will enroll those patients who have completed two years of GATTEX in STEPS 2.

Now switching to regulatory, the FDA has been actively reviewing our NDA for GATTEX. We have been interacting with the agency in support of their review and we continue to be optimistic about the approval of GATTEX in the U.S.

FDA has also completed a number of pre-approval inspections at our contract manufacturers, none of which resulted in any issues that we believe would negatively attract our approval timelines.

A couple of weeks ago, we received a tentative date from FDA for an advisory committee meeting to discuss the efficacy and safety of GATTEX. Because this date falls beyond our current PDUFA date of September 30, we would not expect an FDA decision on our application before the fourth quarter of this year.

The advisory committee date will officially be confirmed once it is published by FDA in the federal register and this will happen approximately one month prior to the meeting. As you know, we have been planning for an advisory committee meeting for several months now. The NPS team has been working with distinguished outside experts, including former FDA reviewers and panel members to prepare for a successful outcome.

We are also holding a number of mock advisory committee meetings and will continue to diligently ensure readiness. In parallel to our regulatory and clinical activities we have made significant progress toward the successful launch of GATTEX in the U.S.

At this time, I would like to invite Eric Pauwels, our Chief Commercial Officer to share with you some specific about the GATTEX launch strategy. Eric?

Eric Pauwels

Thank you, Francois, and good afternoon, everyone. I have a pleasure of leading a commercial team. We are very excited about the opportunity to launch GATTEX as an ultra orphan GI product serving short bowel patients with clear unmet need.

Let’s start with the commercial leadership. Our core management team has been in place now for a few months. Given the unique commercial challenges in launching orphan products, I’m very pleased that we are able to attract passionate industry veterans who came to NPS from senior leadership roles at very successful orphan and rare-disease biopharmaceutical company.

In preparing for the launch of GATTEX, we’ve been addressing four top priorities. First, patient identification; second, our patient services hub; third, our market access strategy; and fourth, the field force plan. I’d like to quickly touch on each of these areas.

First, identifying patients in the ultra orphan space is a key challenge. Therefore, our commercial team has made this priority one. While prevalent studies in rare disorders provide the highest possible potential. They are not a substitute for actual patient finding and counting.

We are using multiple patients finding program, including patient advocacy, social media and other online forms like ShortBowelSupport.com to ensure that we identify as many patients as possible ahead of the GATTEX launch. These programs, as will as final product labeling will help our efforts to quantify further characteristic of the addressable population for GATTEX therapy.

Our second priority is patient services. This is an absolute mission critical component for our commercial strategy. Our centralized patient services hub which we will call NPS ADVANTAGE will be a valuable vehicle for our in-house NPS coordinators to assist patients in healthcare providers.

Our goal is to ensure high touch point, worry free GATTEX experience, tailored to the individual needs of the patient. Including, reimbursement support, coordination of clinical services related to the administration of the drug, weaning of parental nutrition, diet nutritional support, managing side effects and other patient need. The implementation of NPS ADVANTAGE is on track and we are working to ensure operational readiness by the GATTEX approval date.

With respect to our third priority, market access, our team is taking a comprehensive approach to ensuring broad access to GATTEX. We are building a GATTEX value proposition to present the payers. It will be based on highlighting the SBS disease burden, the current treatment options, GATTEX clinical data such as PN reduction and discontinuation, and the value that can be assigned to the patient perspective.

Our access team understands the nature of orphan reimbursement and the hurdles of co-pay, so we also developing a suite of patient assistance programs addressing patient need irrespective of insurance coverage.

Finally, turning to the field force preparation, our sizing and territory alignment plan have progressed according to schedule and continue to indicate that we can successfully commercialize GATTEX with the small and focused field force.

In summary, the team has made excellent progress and we look forward to getting this breakthrough treatment into the hands of SBS patients who desperately need it.

With that, I will now turn the call back to Francois.

Dr. Francois Nader

Thank you, Eric. I would like now to update you on our second lead product, NATPARA. We recently held our pre-BLA meeting with FDA and we are currently preparing our BLA for submission before the end of this year.

As noted in today’s press release, the contract manufacturing organization responsible for the fill-and-finish process for NATPARA is currently unable to produce product that meet our specifications. However, 140 consecutive production runs for the finish product of this compound has been successfully produced over a five-year period.

We expect to resolve this issue to support an end of 2012 BLA submission. However, if it does not resolve in a timely manner, the timeline may be delayed. If that is the case, we will certainly let you know.

In addition to pre-NATPARA presentations at the ENDO meeting in June, investigators from Mass General, and Brigham and Women's hospital in Boston, presented a cohort study of long-term follow-up of patients with hypoparathyroidism.

I would like to spend a moment expanding on these very interesting findings. Investigators conducted a detailed chart review of 120 hypoparathyroidism patients with an average observation period of seven years. The demographics were very similar to what we saw in replace.

Despite the fact that these patients were treated with calcium and vitamin D supplementation, they nevertheless suffered from serious complications. The reported renal effect was striking. Almost 40% of the patients had hypercalciuria, 40% had renal dysfunction, 30% had renal calcifications or stones and 2% of the patients in the database required renal transplantation.

When the researchers studied the patients who had brain imaging, over 50% had basal ganglia calcifications. This data showed a substantial burden that hypoparathyroidism creates for patients and the healthcare system.

Meanwhile, our pre-launch activities for NATPARA continue to underscore the significant opportunity that this product could represent for NPS and for the patients, as the first FDA approved parathyroid hormone replacement therapy.

At our post Endo Analyst Briefing Meeting in June, we shared some compelling patient testimonies, in which hypoparathyroidism patients discussed the daily challenges they face, the limitations of current positive approaches and their concerns about the long-term complications like renal damage and brain calcifications.

To better illustrate, the physical, emotional and quality of life challenges that hypoparathyroidism patients experienced everyday, NPS just completed the largest patient epidemiological survey that we called Paradox. This was done in partnership with the Hypoparathyroidism Association and with a Mayo Clinic.

Data from Paradox are being analyzed as we speak, but I would like to share some of the study demographics that help characterized the hypoparathyroidism patient population. The study cohort consistent of 374 hypoparathyroidism patients, 85% were female with a mean age of 49 years old.

78% of respondents stated that surgery was the cause of their hypoparathyroidism. 62% of patients reported, they currently have low levels of serum calcium and this despite taking medications to manage it. About 30% of patients self-reported their hypoparathyroidism as being severe. 50% reported their condition as moderate and only 20% as mild.

In addition, our market research shows that there is a significant disconnect between physician and patient perspective about the disease burden. With input from hundreds of patients, we believe the data from the Paradox study will help us bridge this gap. We hope to report the complete results of the study in the very near future.

To further support education and awareness and in connection with the Annual Meeting of the Hypoparathyroidism Association, we launch hypoparathyroidism.com, an interactive and educational website for patients and caregivers who are dealing with this rare and complex disorder.

Despite the short lapse of time since launch, so far the feedback on hypoparathyroidism.com from patients, from physicians and from advocacy has been excellent.

The more we learn about hypoparathyroidism, the more we believe that NATPARA will be a major advance at the first and only replacement therapy, targeting the underlying disease.

So, in summary, we’ve been very busy preparing for a significant transformation of NPS from a development only organization to a premier orphan drug business. In the months ahead, we look forward to reporting a number of key milestones, such as the European marketing authorization for Revestive in adult short bowel syndrome later on this month and FDA Advisory Committee meeting to discuss the safety and efficacy of GATTEX, the potential U.S. approval of GATTEX in the fourth quarter and the subsequent launch. And for NATPARA, we are actively working towards submitting a BLA before the end of this year.

That concludes my remarks and I will now turn the call over to Luke for his financial report. Luke?

Luke Beshar

Thanks, Francois, and good afternoon to everyone joining today’s call. From a financial perspective, this has been a strong quarter, highlighted by the recent announcement of terrific agreement with Amgen. This transaction significantly enhances our cash flow and provides sufficient capital to support commercial launches of both GATTEX and NATPARA in a non-dilutive manner.

The agreement has two components. First, Amgen paid us a one-time payment of $25 million in exchange for any royalties that we would have otherwise earned from non-U.S. territories in 2019 and in first quarter 2020. This $25 million translates the NPV of Mimpara royalties if the product had grown at a compounded annual growth rate of 11% between now and 2019 or 2020.

Second, we revised repayment terms of the royalty advanced that Amgen paid us last year. Previously, 100% of the cash from our Sensipar royalties were being withheld by Amgen to repay the advance.

Going forward, repayment will be limited to $8 million per quarter and any royalties in excess of that amount will be paid to us in cash. So, for example, Amgen will retain $8 million of the second quarter 2012 royalties to service the advanced and we will receive a cash payment of approximately $16 million on August 15th.

We expect to fully repay the advance in mid-2015. After repayment, we’ll receive our full Sensipar royalty, which we estimate to be in excess of $100 million per year, until the U.S. pat expires in March of 2018 and then more than $30 million for the reminder of 2018.

So to summarize, the transaction has already generated $25 million. And going forward we expect it to provide at least $50 million to $60 million per year of cash through repayment of the Amgen advance in mid 2015. And after repayment, we will receive cash for our full royalty, which we estimate to be in excess of $100 million or more per year through March of '18, and then $30 million of the balance of that year.

Now onto the financials for the second quarter, starting with revenue. We reported $54 million of total revenues for the second quarter of 2012 versus $27 million last year. The increase was driven by $25 million of revenue for the previously discussed one-time payment we received from Amgen for the sale of our rights to receive royalties earned after 2018.

Our second source of revenues is our royalty base portfolio, which continues to be an obviously valuable piece of our business. Royalties for the second quarter totaled $29 million verus $27 million last year. The largest piece of our royalties, since by NATPARA came in at $24 million for second quarter versus $23 million in 2011.

While Sensipar end market sales grew 17% in the second quarter of 2012, our royalty revenue did not track at this rate. Because last year second quarter royalties were favorably impacted by catch-up provision within the Sensipar license agreement that increases our royalty percentage upon achievement of certain accumulative annual sales thresholds.

Because the higher royalties tiers were achieved at a faster pace in 2012, the standalone first and second quarter are not directly comparable to the prior year periods. Year-to-date royalties are much better proxy for the growth of this asset, as they are comparable in both years and Sensipar royalties grew 15% of this period.

Royalties in a center, which remains in uncovered asset increased to approximately $800,000 versus a $0.5 million last year. Our other two royalty streams Preotact and REGPARA have been monetized and we do not receive any cash payments for royalties earned.

With respect to Preotact, Nycomed is facing the same type of production issue with the manufacturer of finish products that we are facing with NATPARA and expect experience in out of stock situation in certain countries starting in August 2012. Since we had monetized the Preotac royalty stream, we do not expect this matter will have any financial impact on NPS.

Moving out to the expense side of the P&L. Second quarter research and development expenses were $33 million versus $70 million in 2011. This increase was largely related to the commercial production of pre-launch GATTEX inventory into a much lesser extent to costs and expenses related to GATTEX in that product registration programs.

G&A expenses were $9.7 million in the second quarter of 2012, as compared to $5.5 million last year. The growth in general and administrative expenses primarily related to pre-launch commercial activities for GATTEX and NATPARA.

Second quarter interest expense declined to $5 million versus $10 million last year. The improvement was largely attributable to a significant reduction in our Sensipar-secured, non-recourse debt, which at June 30 was $92 million, along with the reduction in interest is associated with this debt from 15.5% to 9%.

Turning to cash, we ended the second quarter with cash of the $110 million or $135 million on a pro forma basis, when we include the $25 million payment from Amgen that we were received in early July.

Our 2012 cash burn guidance adjusted to reflect the Amgen agreement is now $60 million to $70 million. And we expect to end the year with at least $92 million in cash and cash investments. As previously mentioned, we will now have more than adequate capital take us through the commercial launches of our two big products, GATTEX and NATPARA.

That concludes our prepared remarks for this afternoon. I will now turn the call over to our operator to take your questions. Keith, you can take it from here please.

Question-and-Answer Session

Operator

(Operator Instructions) And your first question comes from the line of Eun Yang with Jefferies. Please go ahead.

Eun Yang – Jefferies

Thanks. So, Francois, you said fair to assume that FDA panel for GATTEX to be on October 15th?

Dr. Francois Nader

I did not say that, sorry. What I said is that the FDA informed us about a tentative date and unfortunately we can not disclose it, as for FDA requires and also the fact that, based on their own words and communication it is still tentative. And they will inform you through a general information once they left the date on the Federal register. They said it usually happens about 30 days before the due date.

Eun Yang – Jefferies

Okay. And then you mentioned there, because more likely that FDA panel is going to after this, currently scheduled the PDUFA date, you do not expect any decision from the FDA before quarter-to-quarter, but then you also mentioned the STEPS 2 data will be coming out only 2013, do you think that the FDA may want us this test to study before they make a final decision?

Dr. Francois Nader

Based on our interactions with the FDA so far, this did not come up as a question or a request. We provided the FDA with ongoing interim data, as we did to you. And the last, I would say key information had to do with the fact that we had four additional patients who were weaned off. This was an important communication as we communicated in due time to both EMA and FDA. But there was no additional request from FDA and certainly nothing that leads us to think today that they will have to wait until STEPS 2 is completed.

Eun Yang – Jefferies

Okay. I have final quick questions to Luke. R&D, sorry, the pre-launch here, the inventory production for GATTEX contributed to higher R&D in the second quarter. Do you think that the second quarter run rate is going to be -- the R&D spending is going to be the run rate for the rest of the year?

Luke Beshar

Well, they should reach us. I don’t have the detail by line item on the P&L, Yang, but as you said our cash burn is $60 million to $70 million for the full year. And if you backout the effect of the Amgen agreement, it puts us pretty much in the range we were pre the Amegen agreement. And that we burned 50 sub million through the first half and our product guidance is 105 to 125. So, I think the second quarter and the first half is representative of the full year might be a little light, but I mean not materially different.

Eun Yang – Jefferies

Okay. And then milestone, have you disclose what that would be upon approval?

Luke Beshar

I’m sorry, did you ask about the milestone for…

Eun Yang – Jefferies

Of that data, yeah, yeah …

Luke Beshar

No. We have -- what we have -- we’re not allowed to disclose that. It’s under confidential agreement. What we have said is that it’s a mid seven digit royalty and I mean milestone that’s due upon the first law of commercial sale and any of the big five EU countries.

Eun Yang – Jefferies

Okay. Thank you.

Luke Beshar

And that’s it.

Operator

And your next question is from line of David Nierengarten with Wedbush Securities. Please go ahead.

David Nierengarten – Wedbush Securities

Hi. A quick question on the NATPARA manufacturing, is that with the manufacturing of the actual hormone or does that have something do with the delivery devices, I believe, as you mentioned have been metered-dose, I’m just curious? Thanks.

Luke Beshar

It’s actually -- it doesn’t -- we don’t believe it has to do with API. It’s a final fill finish manufacturing process where the product is labilized and then put into a pool with a rubber stopper and water, we’re -- nearly prior to injection, the patient pushes the plunger in hand and reconstitutes the product.

David Nierengarten – Wedbush Securities

Okay. Thanks.

Operator

Your next question is from the line of Alan Carr with Needham & Company. Please go ahead.

Alan Carr – Needham & Company

Hi. Thanks for taking my question.

Dr. Francois Nader

Sure, Alan.

Alan Carr – Needham & Company

And it’s fair to assume, I guess, Nycomed is having the same problem. All are using the same CMO here right?

Dr. Francois Nader

That is -- they are having same technical problems and they have the same CMO. That’s correct, Alan.

Alan Carr – Needham & Company

What -- okay, now timelines for NATPARA, then do you expect the six month review and what sort of timing for launch after that review process will be soon after or there will be a delay?

Dr. Francois Nader

Well, a couple of things. NATPARA will be reviewed under PDUFA 5. So that’s an important piece of data here because as you know, PDUFA 5 compared to PDUFA 4 had a couple of months extension or lengths, if you will, for both the priority review and the standard review.

We are planning to file as we did for GATTEX for a priority review but obviously the decision to grant us a priority or not is in the hands of the FDA. And based on the recent track records of orphan products that were granted priority review, 80% were oncology product which means that everything else was about 20%. This being said there is no harm in asking for a priority review and we’ll know soon thereafter whether or not we will be granted a priority review.

Lastly, I would say NATPARA has the advantage because it will be launched after GATTEX. So from a commercial infrastructure perspective, almost everything will be in place. From a commercial support, almost everything will be in place. From a medical affair, almost everything will be in place. And frankly, the significant, I would say, difference will be our field organization. And this is a decision that Eric and his team will have to make in due time to whether or not to have two separate sales organization or not.

But this is frankly a very tactical decision. So under the scheme of things, we would certainly leverage the commercial infrastructure of GATTEX. And we don’t see any reason as we’re sitting here today to delay the launch. There is no practical reason to do that.

Again, we’re many months away from this. And if it’s any different between now and then, we’d certainly let you know.

Alan Carr – Needham & Company

I was wondering if you could also characterize your pre-BLA meeting and to the extent that the manufacturing issue was a gating event for BLA submission?

Dr. Francois Nader

I would say the two events are independent. The pre-BLA meeting was very positive. We took this opportunity frankly to ask a long-laundry list of questions to the FDA pertaining to the filing. And they were cordial enough to give us virtually all the answers that we needed.

The most striking outcome of the pre-BLA meeting is there was nothing in the pre-BLA meeting that gave us pause or had us to re-think our target filing by the end of the year. The technical question, the manufacturing issue is something that we’re actively working on. And as I said it and Luke said it, we continue to be confident that this will not impact our filing date.

If it’s any different here, also we’ll let you know.

Alan Carr – Needham & Company

All right.

Luke Beshar

If you could just add to that Alan, the registration batches that we ran, that were, in support of the BLA, we ran it on a commercial scale. This is something that developed subsequent to that.

Alan Carr – Needham & Company

Okay. And then last one, how many patients are in STEPS 3?

Dr. Francois Nader

Roger.

Dr. Roger Garceau

Currently, there are six patients at three sites for STEPS 3.

Alan Carr – Needham & Company

Okay.

Dr. Roger Garceau

In U.S.

Alan Carr – Needham & Company

Thanks for taking my question. Thanks again.

Dr. Francois Nader

Sure. Thank you.

Eric Pauwels

Thanks Alan.

Operator

Your next question is from the line of James Molloy with ThinkEquity. Please go ahead.

James Molloy – ThinkEquity

Hey, guys. Thanks for taking my questions.

Dr. Francois Nader

Sure.

James Molloy – ThinkEquity

With the -- on the manufacturing, I know that you probably want to know when it’s going to get fixed. What’s the next data point we should watch for? Is there any sort of time line that we should be looking for, we might hear whether this issue will be fixed or not?

Dr. Francois Nader

The short answer is the critical milestone. I mean, let me start by saying, frankly, the main reason we talked about it on this call today is spirit of transparency. And this is how we run this business and it was very appropriate for us to have this disclosure.

This being said, rather than talking about profits, I’d like to talk about outcome. At the end of the day, we want to file NAPTARA and file it successfully. And we are -- as we are here now, still planning to file -- we're on track to file it by year-end. If this is not possible than we will let you know. And frankly, the trigger is very simple.

Once we fix the issue, our teams will have to put the CMC file together and it takes time and it takes separation and it takes a number of different eternal steps. So if we can fix the issue before, I mean, in due time, then we will meet the end of year target. If not, then we will have to move the target and this is where you will know that the issue was not solved or was not solved in time.

James Molloy – ThinkEquity

Maybe you want to tell us what that date is you have to hit by?

Dr. Francois Nader

I’m sorry.

James Molloy – ThinkEquity

That was…

Dr. Francois Nader

Jim, that’s an internal -- it's an internal metric. We don’t share.

James Molloy – ThinkEquity

Okay.

Dr. Francois Nader

On the other hand, as the CMC section is in the throws of being prepared, much -- vast majority of the work.

Luke Beshar

It is being prepared and is independent of this question. I guess, we ran registration batches at commercial scale. Those -- that’s what we decided in the CMC section. We just have to be -- obviously be able to replicate that at the time of filing and this little -- this glitch we had gave us cause to pause and as Francois said we need to be transparent with you about it.

James Molloy – ThinkEquity

I very much appreciate that. When we go to GATTEX, PDUFA, I mean, certainly you guys have been making it clear that it’s likely you’ll get a push-out on PDUFA, three months seems reasonable and certainly what it is doing lately that puts you into late December. Does it make sense we launch in December as we assume if your ad com post the September PDUFA here and you’re out in December, you will launch sometime first quarter of ’13?

Dr. Francois Nader

Well, certainly cannot answer statistically about it. We have to say that the three months extension is one of the options and the option is usually triggered by questions from the FDA that requires us to trial and serve them. In turn, the FDA will consider as a significant amendment and they will trigger the three months automatic expansion.

As you just said, the FDA actually extended a couple of other rate review prophecies by the automatic three months because of this amendment. There are two other options, one is to let the PDUFA date slip and then its open ended. And the third option is to serve us with a complete response letter that will be answered by the ad com which we see happening at least in one case.

All this being said, the three months extension is probably the most logical or the most philosophical but until we know, it’s very difficult for us to comment on whether or not, this is what will happen. This being said also, again, I mean, the timing of the launch is --we will be ready and actually we will be ready if the launch would have been September 30 but if the launch of this is deferred, we will be even more ready.

James Molloy – ThinkEquity

Thanks for taking my questions. Thank you.

Operator

And ladies and gentlemen, that was our last question. I’d like to turn the call back over to Dr. Nader.

Dr. Francois Nader

Thank you very much for your questions and time today. We look as usual. We look forward to reporting additional progress and speaking to you again soon. And with that, I wish all of you a happy good evening. Thank you.

Operator

Ladies and gentlemen that will conclude today’s conference. Thank you very much for joining us. You may now disconnect. Have a good day.

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