NPS Pharmaceuticals (NPSP)

[tenantprotection]

VOTE CAME BACK POSITIVE

Just heard that the vote was I believe 12/0 positive vote. The drug is beneficial

[gixxer11]

Any news on ADCOM meeting ?? Can't find anything

Tia

[surf1944]

7:13AM NPS Pharm: FDA advisory committee to review Gattex new drug application for the treatment of adults with short bowel syndrome (NPSP) 10.19 : Co announced that NASDAQ has halted trading of the company's common stock. The U.S. FDA Gastrointestinal Drugs Advisory Committee is meeting today to review Gattex, a novel, recombinant analog of human glucagon-like peptide 2 being developed for the treatment of adults with short bowel syndrome. The Gastrointestinal Drugs Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases and makes appropriate recommendations to the FDA. (shares halted)

[jord9977]

I never ended up buying it haha wish I did now.

[surf1944]

8:14AM NPS Pharm reports FDA posts briefing documents for Advisory Committee meeting reviewing Gattex (teduglutide) for adult short bowel syndrome (NPSP) 9.13 : Co announced that the U.S. Food and Drug Administration (FDA) has posted briefing materials for the October 16, 2012 Gastrointestinal Drugs Advisory Committee meeting to review Gattex (teduglutide). Gattex is a novel, recombinant analog of human glucagon-like peptide 2 (a protein involved in the rehabilitation of the intestinal lining) being developed for the treatment of adults with short bowel syndrome. The Advisory Committee meeting is scheduled for 8:00 a.m. ET on Tuesday, October 16, 2012. The briefing materials can be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/ucm291609.htm.

The Prescription Drug User Fee Act (PDUFA) date for completion of the review of the company's New Drug Application (NDA) for Gattex is December 30, 2012. The Gastrointestinal Drugs Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases and makes appropriate recommendations to the FDA.

[gixxer11]

Hmmmmm - funny crammmmmer mentioned this ticker last night lol

[jord9977]

This stock will be moving up in anticipation of FDA data later this month.

[surf1944]

8:15AM NPS Pharm expects to file Natpara BLA in mid-2013; change in forecasted timeline is due to a request from the Medical Device Division (NPSP) 7.87 : Co announced today that it expects to submit its Biologic License Application (BLA) for Natpara (recombinant human parathyroid hormone (rhPTH [1-84])) in mid-2013. The change in the company's forecasted timeline is due to a request from the Medical Device Division of the U.S. Food and Drug Administration (FDA) to modify the company's instructions for using the injection pen device to deliver Natpara. The FDA has not requested any new clinical data or clinical studies of Natpara. The requested changes will require the company to repeat its Usability Testing of the injection pen device using the modified instructions before submitting its BLA.

[m177]

in NPSP nice uptrend starting?? hope so

[surf1944]

8:56AM NPS Pharm receives notice from FDA of Advisory Committee Meeting for Gattex (teduglutide) (NPSP) 7.74 : Co announced that the FDA has notified the Company that its New Drug Application (NDA) for Gattex (teduglutide) will be discussed at the Gastrointestinal Drugs Advisory Committee meeting scheduled for Oct16, 2012. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA is December 30, 2012. Gattex is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in normal intestinal function and fluid and nutrient absorption. The proposed indication for Gattex is the treatment of adult patients with short bowel syndrome.

[surf1944]

8:05AM NPS Pharm announces extension of action date for Gattex NDA to December 30, 2012 (NPSP) 7.18 : Co announced that it has received a communication from the U.S. Food and Drug Administration extending the Prescription Drug User Fee Act (PDUFA) action date for its New Drug Application for Gattex (teduglutide) by three months to December 30, 2012. The FDA extended the action date to provide time for a full review of the submission; such extensions are provided for by regulation when information is submitted within three months of a PDUFA action date.

[surf1944]

NPSP PDUFA
Sun, September 30, 12am – Mon, October 1, 12am
Calendar
FDA Calendar

[Imperial Whazoo]

A few links to PRs that explain the late Friday rise in price.

A.) http://www.npsp.com/page/investors-pr/?trxml_v=nrd&trxml_nr_id=1706165

B.) http://www.npsp.com/page/investors-pr/?trxml_v=nrd&trxml_nr_id=1706165

C.) http://www.npsp.com/page/investors-pr/?trxml_v=nrd&trxml_nr_id=1707687

Of interest, IMHO.

Imperial Whazoo

[surf1944]

8:03AM NPS Pharm: Digestive Disease week presentations support therapeutic potential for Gattex as novel treatment for adult short bowel syndrome (NPSP) 7.13 : Co reports data for Phase 3 Gattex. In Phase 3 studies, Gattex was shown to significantly reduce PN/IV fluid dependence in patients with SBS with some patients achieving complete independence. The data showed that of 173 patients who received Gattex: Three patients achieved independence during the randomized, double-blind phase of Study CL0600-004, of which two patients received 0.05 mg/kg/day Gattex and one patient received 0.10 mg/kg/day Gattex. One patient achieved independence during the extension phase of Study CL0600-004. Three patients achieved independence during the extension phase of STEPS, the company's 24-week, placebo-controlled Phase 3 registration study. Patients were weaned from PN/IV fluid as early as 12 weeks and as late as 52 weeks after initiation of Gattex, suggesting that long-term Gattex use is associated with continued reduction of PN/IV fluid requirements. Baseline demographics and disease characteristics were highly variable and the adverse event profile was similar to the overall study population with the most frequently reported adverse events being gastrointestinal related.

[surf1944]

NPS Pharmaceuticals to Report First Quarter 2012 Financial Results
Business WirePress Release: NPS Pharmaceuticals, Inc. – Fri, Apr 27, 2012 8:15 AM EDT

BEDMINSTER, N.J.--(BUSINESS WIRE)--

NPS Pharmaceuticals, Inc. (Nasdaq: NPSP - News) announced today that it will report its first quarter 2012 financial results on Thursday, May 3, 2012 at approximately 4:30 p.m. ET. The press release will be followed by a conference call and webcast at 5:00 p.m. ET.

To participate in the conference call, dial [phone] and use passcode 96110515. International callers may dial [phone], using the same passcode. In addition, a live audio of the conference call will be available over the Internet. Interested parties can access the event through the investors’ calendar of events page on the NPS website, http://www.npsp.com.

If you are unable to participate in the live call, a replay will be available at [phone], with passcode 40466462 until midnight ET, May 17, 2012. International callers may access the replay by dialing [phone], using the same passcode. The webcast will also be available through the NPS website for the same period.

About NPS Pharmaceuticals

NPS Pharmaceuticals is a biopharmaceutical company focused on bringing orphan products to patients with rare disorders and few, if any, therapeutic options. NPS is advancing two late-stage registration programs. A New Drug Application is undergoing FDA review for Gattex® (teduglutide) as a treatment for adult short bowel syndrome (SBS) and a Phase 3 registration study has been completed for Natpara™ (recombinant human parathyroid hormone (rhPTH [1-84]) in adult hypoparathyroidism. NPS’ earlier stage pipeline includes two calcilytic compounds, NPSP790 and NPSP795, with potential application in rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia with hypercalciuria (ADHH). NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Kyowa Hakko Kirin, Nycomed, and Janssen Pharmaceuticals, Inc.

Contact:
NPS Pharmaceuticals, Inc.
Gail Brophy, 908-450-5335

[surf1944]

4:32PM NPS Pharm beats by $0.01, beats on revs (NPSP) 7.39 -0.04 : Reports Q4 (Dec) loss of $0.10 per share, $0.01 better than the Capital IQ Consensus Estimate of ($0.11); revenues rose 9.6% year/year to $26.3 mln vs the $25.68 mln consensus. The co's net cash burn in 2011 was $90 million, which is within the range of the improved guidance of $85 to $92 million provided in November 2011. NPS expects its 2012 cash burn to be in the range of $105 to $125 million. The co's cash burn is defined as the net change in cash, cash equivalents, and marketable investment securities, excluding proceeds from external financing activities.

[Penny Roger$]

~ Monday! $NPSP ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $NPSP ~ Earnings expected on Monday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








http://stockcharts.com/h-sc/ui?s=NPSP&p=D&b=3&g=0&id=p88783918276&a=237480049




http://stockcharts.com/h-sc/ui?s=NPSP&p=W&b=3&g=0&id=p54550695994



~ Google Finance: http://www.google.com/finance?q=NPSP
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=NPSP#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=NPSP+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=NPSP
Finviz: http://finviz.com/quote.ashx?t=NPSP
~ BusyStock: http://busystock.com/i.php?s=NPSP&v=2


<<<<<< http://www.earningswhispers.com/stocks.asp?symbol=NPSP >>>>>>



http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.

[surf1944]

8:02AM NPS Pharm announces FDA acceptance of New Drug Application for GATTEX for the Treatment of adult short bowel syndrome (NPSP) 7.58 : Co announced the FDA has accepted and filed for review the company's NDA for GATTEX (teduglutide) for the treatment of adults with short bowel syndrome. The acceptance of the GATTEX NDA is the FDA's determination that the application is sufficiently complete to permit a substantive review.

[surf1944]

NPS Pharmaceuticals (NPSP), a clinical-stage biopharmaceutical company, engages in the development specialty therapeutics for gastrointestinal and endocrine disorders. The company's primary clinical programs consist of two therapeutic proteins to restore or replace biological functions, including GATTEX (teduglutide) that is in Phase 3 clinical development and is intended for parenteral nutrition dependent short bowel syndrome; and NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection), which is in Phase 3 clinical development and is intended for use as a hormone replacement therapy for hypoparathyroidism." (Business Description from Yahoo Finance)

4 reasons NPSP is worth a gamble at under $7 a share:

Insiders are showing confidence by gobbling up 70,000 shares in fourth quarter of 2011.
The median analysts' price target is more than double the current price at $14 a share. S&P has a "Buy" rating and a $13 price target on the stock.
Gilead Science's (GILD) acquisition of Pharmasset has kicked off an M&A surge in the biotech space. Given NPS's late stage pipeline and valuation, it would hardly be a surprise to see this company be bought out at a large premium.
The company has plenty of cash on the balance sheet and improving cash flow, so it has the financial strength to easily survive until some of its late stage drugs are approved.

http://seekingalpha.com/article/321380-2-high-risk-high-reward-biotechs-that-could-double?source=yahoo

[surf1944]

8:08AM NPS Pharm misses by $0.04, beats on revs (NPSP) 5.25 : Reports Q3 (Sep) loss of $0.14 per share, $0.04 worse than the Capital IQ Consensus Estimate of ($0.10); revenues rose 16.6% year/year to $24.6 mln vs the $21.52 mln consensus. Company expects to end 2011 with at least $160 million in cash and investments.

[lazyeye]

up $1 off lows today...what a great opp to make $$$ this morning off the "overreactor" masses...

[mlkrborn]

NPS Pharmaceuticals shares defended at Citigroup
theflyonthewall

Companies:
o NPS Pharmaceuticals, Inc.

On Monday October 31, 2011, 11:01 am

Citigroup said new cancer cases will not impact Gattex's regulatory path.

[lazyeye]

3 people die from cancer in trials: all 3 were heavy smokers and 1 of them had Hodgkins...not fault of NPSP.

And they drive this down to $4.40?

WTH?

It's buy time imo based on big overreaction.

[surf1944]

9:04AM NPS Pharm announces positive results for GATTEX (NPSP) 7.76 : Co announced new data from STEPS 2, a long-term open-label study, showing that GATTEX was associated with achieving and maintaining clinically meaningful reductions in parenteral nutrition (PN) and intravenous (IV) fluid volume in adult subjects with short bowel syndrome. Short bowel syndrome is a rare and debilitating condition in which the body is unable to absorb enough nutrients and/or fluids through the gastrointestinal tract and patients chronically rely on intravenous feeding to survive. NPS remains on track to submit its New Drug Application for GATTEX in short bowel syndrome later this year

[surf1944]

NPS Pharmaceuticals (NPSP): NPS Pharmaceuticals primarily focuses on developing treatments for patients with uncommon gastrointestinal issues, and endocrine disorders. The market is largely untapped thus far.

GATTEX, NPS' leading candidate, treats short-bowel syndrome. SBS typically results from Crohn's disease or other bowel disorders; SBS is severe damage to the intestines which results in malnutrition, severe diarrhea, dehydration, fatigue, and severe weight-loss.

GATTEX has had fantastic results from its phase III trial, including recent news that it met its primary efficacy endpoint in the trial; "reducing parenteral nutrition dependence in adults with short-bowel syndrome." The "parenteral nutrition dependence" is a $100,000 annual procedure that repairs the intestines in needy patients. The issues of the procedure of course include cost, that it doesn't improve the body's ability to actually absorb nutrients itself (it simply delivers them through an IV), and that it can lead to fatal complications.

GATTEX has an orphan drug designation from the FDA.

NPSP558 is also being developed by the company. The drug is intended for usage in patients hypoparathyroidism, "a rare endocrine disorder in which the body produces insufficient amounts of parathyroid hormone. The company's 10-K report states that at least 60,000 U.S. cases are prevalent yearly.

The stock trades at $6.75.

http://seekingalpha.com/article/301730-2-biotechs-with-strong-pipelines?source=yahoo

[surf1944]

2. NPS Pharmaceuticals, Inc. (NPSP): Engages in the development specialty therapeutics for gastrointestinal and endocrine disorders. Market cap of $575.61M. RSI(14) at 33.60. Net institutional shares purchased over the current quarter at 20.3M, which is 23.69% of the company's 85.70M share float. The stock is a short squeeze candidate, with a short float at 5.27% (equivalent to 5.57 days of average volume). It's been a rough couple of days for the stock, losing 6.3% over the last week.

http://seekingalpha.com/article/293515-12-oversold-biotech-stocks-being-bought-up-by-smart-money?source=yahoo

[mlkrborn]

PS Pharmaceuticals Highlights Hypoparathyroidism Data to be Presented at Annual Meeting of American Society for Bone and Mineral Research
Last update: 9/16/2011 2:26:00 PM
-- Investigator-initiated studies highlight four-year results for NPSP558, as well as medical costs and co-morbidities of hypoparathyroidism ---
BEDMINSTER, N.J., Sep 16, 2011 (BUSINESS WIRE) -- -- Abstracts available and can be viewed online at --
NPS Pharmaceuticals, Inc. (NPSP), a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced that data about hypoparathyroidism will be presented at the 2011 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in San Diego, CA, September 16-20, 2011. NPSP558, the company's bioengineered replica of human parathyroid hormone (rhPTH 1-84), is currently in development as the first hormone replacement therapy for hypoparathyroidism. The presentations will include findings from investigator-initiated studies of rhPTH (1-84) and new information about the costs and co-morbidities associated with hypoparathyroidism.
"We believe the data being presented are very encouraging and further support the potential of using NPSP558 to treat the underlying cause of hypoparathyroidism by replacing the missing parathyroid hormone," said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. "These data also underscore the importance of individualizing replacement therapy for hypoparathyroidism patients, as we are doing it in our Phase 3 REPLACE study of NPSP558, which is on track for top-line results later this year."
"Hypoparathyroidism has widespread consequences ranging from asymptomatic presentation to fatal hypocalcemia" Bart Clarke, MD, associate professor of medicine at the Mayo Clinic. "It is the only endocrine disorder for which we do not have a replacement hormone available to treat the underlying condition. Doctors currently can only provide supportive care aimed at managing the symptoms associated with hypocalcemia through calcium and vitamin D supplements. Patients are faced with striking a balance between managing their symptoms and avoiding the long-term risks associated with current treatments, which can result in kidney stones, kidney damage, and even kidney failure. Patients need better treatment options, ideally the ability to achieve a more physiological outcome by delivering the missing hormone."
Identified below are the titles and links to the abstracts for the NPS and investigator-initiated research.
Oral Presentations:
PTH (1-84) Replacement Therapy in Hypoparathyroidism (HypoPT): A Randomized Controlled Trial on Pharmacokinetics and Dynamic Effects Following 24 Weeks of Treatment Lead Author: Tanja Sikjaer, Aarhus University Hospital, Denmark Abstract No. 1098 Sunday, September 18, 2011; 9:45 a.m. PT
Treatment of Hypoparathyroidism with PTH (1-84) Is Safe and Effective For Up to 4 Years Lead Author: Natalie Cusano, Columbia University College of Physicians and Surgeons Abstract No. 1097 Sunday, September 18, 2011; 9:30 a.m. PT
Poster Presentations:
Co-Morbid Medical Conditions Associated with Prevalent Hypoparathyroidism: A Population-Based Study Lead Author: Bart Clarke, Mayo Clinic College of Medicine Abstract No. SA0170 Saturday, September 17, 2011; 11 a.m. to 1 p.m. PT
Medical Care Costs for Persons with and without Prevalent Hypoparathyroidism: A Population-Based Study Lead Author: Cynthia Leibson, Mayo Clinic, Department of Health Sciences Research Abstract No. MO0170 Monday, September 19, 2011; 11:30 a.m. to 1:30 p.m. PT
Relationships Between Pharmacokinetic Profile of Human PTH(1-84) and Serum Calcium Response in Postmenopausal Women Following 4 Different Methods of Administration Lead Author: John Fox, NPS Pharmaceuticals Abstract No. MO0173 Monday, September 19, 2011; 11:30 a.m. to 1:30 p.m. PT
About Hypoparathyroidism
Hypoparathyroidism is a rare disorder in which the body produces insufficient levels of parathyroid hormone, the principal regulator of calcium and phosphorus. When the body has too little parathyroid hormone, blood calcium levels drop and phosphorus levels increase, which can cause muscular and neurological symptoms, as well as bone impairments. There is no approved treatment for hypoparathyroidism. It is one of the few remaining hormone deficiency syndromes in which replacement therapy using the native hormone is not clinically available. Hypoparathyroidism is currently managed with large doses of oral calcium and active vitamin D supplementation to raise the calcium levels in the blood and reduce the severity of symptoms. Over time, calcium may build up in the body and result in serious health risks, including calcifications in the kidneys, heart or brain.
About NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection)
NPSP558, a bioengineered replica of human parathyroid hormone 1-84, is being evaluated in a Phase 3 registration study, known as REPLACE, as the first hormone replacement therapy for the underlying cause of hypoparathyroidism. Because it mimics the action of natural parathyroid hormone, NPSP558 has the potential to treat hypoparathyroidism and offer a more physiological treatment outcome than what is available with existing treatments.
Results from an investigator-initiated Phase 2 open-label proof-of-concept study demonstrated that NPSP558 potentially can be used as a therapeutic agent in hypoparathyroidism. The study showed that NPSP558 treatment in hypoparathyroidism significantly reduces supplemental calcium and 1,25-dihydroxy-vitamin D requirements while maintaining serum calcium levels. Data were published in January 2010 in the international peer-reviewed journal Osteoporosis International.
NPS has received orphan drug status for NPSP558 for the treatment of hypoparathyroidism. The company's partner Nycomed markets PTH (1-84) ex-US as Preotact(R) for the treatment of osteoporosis in post-menopausal women at high risk of fractures.
About NPS Pharmaceuticals
NPS Pharmaceuticals is an outsourcing-based development company focused on bringing biopharmaceuticals to patients with rare disorders and few, if any, therapeutic options. The company is advancing two Phase 3 registration programs, GATTEX(R) (teduglutide) in short bowel syndrome (SBS) and NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection) in hypoparathyroidism. NPS' earlier stage pipeline includes two calcilytic compounds, NPSP790 and NPSP795, with potential application in rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia with hypercalciuria (ADHH). NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Kyowa Hakko Kirin, Nycomed, and Ortho-McNeil Pharmaceutical.
"NPS", "NPS Pharmaceuticals", and "GATTEX" are the company's registered trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.
SOURCE: NPS Pharmaceuticals, Inc.

[surf1944]

NPS Pharm NPSP Brean Murray Buy $14

[surf1944]

http://www.nasdaq.com/asp/holdings.asp?symbol=NPSP&selected=NPSP&FormType=form4

[surf1944]

http://www.secform4.com/insider-trading/890465.htm

[surf1944]

http://www.nasdaq.com/asp/holdings.asp?symbol=NPSP&selected=NPSP&FormType=Institutional

[surf1944]

1:26AM NPS Pharm upsizes offering by 2 mln shares and prices 11 mln shares of common stock at $9.00 per share; net proceeds ~$93 mln (NPSP) 9.24

[surf1944]

NPS Pharm NPSP ThinkEquity Buy $15 » $18

Read more: http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm#ixzz1Gm2LP47u

[Bart Myers]

Jefferies is out with its report today on NPS Pharmaceuticals (NASDAQ: NPSP), reiterating Buy.

In a note to clients, Jefferies writes, "We view NPSP as a significantly de-risked story following 2nd confirmatory Gattex Ph3 data, but it's currently trading below the levels prior to the Ph3 data. From our expert discussions, we are bullish on NPSP at current valuation."


Source: http://www.benzinga.com/analyst-ratings/analyst-color/11/03/929888/jefferies-reiterates-buy-on-nps-pharmaceuticals-npsp#ixzz1GlyUi3V8

[surf1944]

6:31AM NPS Pharm reports that its Phase 3 pivotal study of GATTEX met the primary efficacy endpoint of reducing parenteral nutrition dependence in patients with adult short bowel syndrome (NPSP) 7.61 : Co announces that its Phase 3 pivotal study of GATTEX met the primary efficacy endpoint of reducing parenteral nutrition dependence in patients with adult short bowel syndrome. The 24-week randomized, double-blind study, known as STEPS, was designed to compare the efficacy, safety and tolerability of GATTEX to placebo. The study reached statistical significance for the primary efficacy endpoint, defined as the percentage of patients who achieved a 20% or greater reduction in weekly PN volume at Weeks 20 and 24, compared to baseline. In an intent-to-treat analysis, 63% (27/43) of GATTEX-treated patients responded versus 30% (13/43) of placebo-treated patients. Patients treated with GATTEX for 24 weeks also achieved significantly greater reductions in weekly PN volume versus placebo. On average, patients who received GATTEX experienced a 4.4 liter reduction in weekly PN volume from a pre-treatment baseline of 12.9 liters; patients who received placebo experienced a 2.3 liter reduction from a pre-treatment baseline of 13.2 liters.

[surf1944]

NPS Pharmaceuticals Announces Pricing of Public Offering of Common Stock

http://finance.yahoo.com/news/NPS-Pharmaceuticals-Announces-bw-2207534884.html?x=0&.v=1

[surf1944]

NPS Pharmaceuticals to Present at UBS Global Life Sciences Conference

http://finance.yahoo.com/news/NPS-Pharmaceuticals-to-bw-2795731264.html?x=0&.v=1

[surf1944]

NPS Pharmaceuticals, Inc. Q2 2010 Earnings Conference Call Transcript

http://seekingalpha.com/article/218702-nps-pharmaceuticals-inc-q2-2010-earnings-conference-call-transcript?source=yahoo

[surf1944]

2-Jun-10 ThinkEquity Initiated Buy

[surf1944]

NPS Pharmaceuticals, Inc. Q1 2010 Earnings Call Transcript

http://seekingalpha.com/article/203355-nps-pharmaceuticals-inc-q1-2010-earnings-call-transcript?source=yahoo

[surf1944]

NPS Pharmaceuticals to offer 7.5 million shares
NPS Pharmaceuticals announces planned public offering of 7.5 million common shares

Thursday April 15, 2010, 4:46 pm
BEDMINSTER, N.J. (AP) -- NPS Pharmaceuticals Inc. said Thursday it plans to offer 7.5 million shares of its common stock in a public offering.

Pricing and further details were not disclosed.

Canaccord Adams is acting as sole book-running manager and Needham & Company LLC and Summer Street Research Partners are acting as co-managers for the offering.

NPS said it expects to grant the underwriters a 30-day option to buy up to an additional 1.1 million shares to cover any overallotments.

Shares in the company rose 8 cents to $6.22 in Thursday trading after reaching an all-time high of $6.26.

The stock is up 83 percent in 2010.

[surf1944]

NPS Pharm NPSP Needham Buy $9

[surf1944]

NPS Pharmaceuticals: Good News on Horizon?

NPS Pharmaceuticals (NPSP) (4.67) is an intriguing biotech that fits nicely into our Emerging Growth Portfolio for 2010. It was recommended in our bi-monthly newsletter March 12.

This $193 million medicine manufacturer is developing new treatment options for patients with rare gastrointestinal and endocrine disorders. The company is currently conducting two Phase 3 registration programs.

Teduglutide, a proprietary analog of GLP-2, is being evaluated as GATTEX(R) in a Phase 3 registration study known as STEPS for intestinal failure associated with short bowel syndrome and is in preclinical development for gastrointestinal mucositis and other pediatric indications.

NPSP558 (recombinant parathyroid hormone 1-84 [rDNA origin] injection) is being evaluated in a Phase 3 registration study known as REPLACE as a hormone replacement therapy for hypoparathyroidism.

Phase 3 is the last phase in the clinical trial process that drug companies must undergo before the FDA makes its final approval on the studied molecule. It is rare that you find a company this small with more than one product being prepared to gain FDA approval.

In NPSP’s earnings release published earlier this month, management gave investors a positive sign that both Phase 3 trials are going according to plan. Enrollment in the Phase 3 trial on GATTEX is complete and investors should expect trial results by the end of the year. Additionally, enrollment in the REPLACE study for the compound NPSP 558 for hypoparathyroidism is taking place rapidly and on schedule.

Financially, the company is sound and has plenty of cash and market receivables on hand to see that both these drugs make it to the FDA for final approval. The company reports having $75 million on hand and it added another $38.4 million of capital from the sale of its REGPARA royalty rights on March 1. So that makes for a war chest of $113 million. Not bad for a company only worth $192 million on paper.

Also, the company reduced its cash burn nearly 14% from original estimates -- spending only $42 million rather than the $50 million originally projected this year.

NPSP earns royalties on (i) Amgen's (AMGN) sales of Sensipar(R) (cinacalcet HCl), (ii) Nycomed's sales of Preotact(R) (recombinant parathyroid hormone 1-84 [rDNA origin] injection), (iii) Kyowa Kirin's sales of REGPARA(R) (cinacalcet HCl), and (iv) Ortho-McNeil's sales of Nucynta(R) (tapentadol). Royalty revenue grew to $22.0 million and $79.3 million for the fourth quarter and full year 2009, respectively, versus $18.3 million and $70.2 million for the fourth quarter and full year 2008, respectively

On the bottom line, NPSP reported a net loss of $2.0 million or $0.04 per diluted share for the fourth quarter of 2009, compared to a net loss of $8.5 million or $0.18 per diluted share for the fourth quarter of 2008. For the full year, NPS reported a net loss of $17.9 million or $0.37 per diluted share for 2009, versus a net loss of $31.7 million or $0.67 per diluted share for 2008. They also cut selling, general & administrative expenses by 10% year over year.

The company has several marketing agreements with key pharmaceutical companies regarding a few of its core products which makes it more likely that the drugs currently in Phase 3 clinical trials will see market. By having two compounds this close to approval and some cash on hand, NPSP could see a nice move in 2010 based merely on the speculation of approvals. Our target price is $6.

Disclosure: Author long NPSP

http://seekingalpha.com/article/195751-nps-pharmaceuticals-good-news-on-horizon

[surf1944]

8:02AM NPS Pharm receives $38.4 million for sale of REGPARA royalty rights (NPSP) 3.59 : The co announces the sale of its royalty rights from sales of REGPARA (cinacalcet HCl) to a fund managed by DRI Capital for $38.4 million. Royalties in excess of cumulative royalties of $96 million or 2.5 times the upfront purchase price have been retained by NPS... Under the agreement, Fund is entitled to receive royalty payments related to net sales of REGPARA occurring on or after July 1, 2009. NPS has received approximately $3.5 million in cumulative royalty revenue on net sales of REGPARA arising prior to July 1, 2009. NPS expects to report cash, cash equivalents and short- and long-term investments of approximately $70 to $75 million at December 31, 2009 versus $106 million at December 31, 2008.

[surf1944]

NPS Pharmaceuticals Receives $38.4 Million for Sale of REGPARA Royalty Rights

Press Release Source: NPS Pharmaceuticals, Inc. On Tuesday March 2, 2010, 8:00 am
BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (Nasdaq: NPSP - News) today announced the sale of its royalty rights from sales of REGPARA® (cinacalcet HCl) to a fund managed by DRI Capital, Inc., (Fund) for $38.4 million. Royalties in excess of cumulative royalties of $96 million or 2.5 times the upfront purchase price have been retained by NPS.

“This transaction allows us to access significant capital in a manner that is non-dilutive to our shareholders,” said Francois Nader, M.D., president and chief executive officer of NPS Pharmaceuticals. “The proceeds from this sale will support our two registration programs, teduglutide in short bowel syndrome and NPSP558 in hypoparathyroidism.”

NPS licensed cinacalcet HCl to Kyowa Kirin Pharma, a wholly-owned subsidiary of Kyowa Kirin Holdings, for the drug’s development and commercial sale in China, Japan, North and South Korea, and Taiwan. Following review by the Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s Ministry of Health, Labor and Welfare (MHLW) approved the drug for the treatment of patients with secondary hyperparathyroidism during dialysis therapy.

Kyowa Kirin began commercializing cinacalcet HCl in Japan as REGPARA® during the first quarter of 2008.

Under the agreement, Fund is entitled to receive royalty payments related to net sales of REGPARA occurring on or after July 1, 2009. NPS has received approximately $3.5 million in cumulative royalty revenue on net sales of REGPARA arising prior to July 1, 2009. NPS expects to report cash, cash equivalents and short- and long-term investments of approximately $70 to $75 million at December 31, 2009 versus $106 million at December 31, 2008.

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4:33PM NPS Pharm misses by $0.04, misses on revs (NPSP) 3.07 : Reports Q3 (Sep) loss of $0.16 per share, $0.04 worse than the First Call consensus of ($0.12); revenues fell 23.0% year/year to $20.1 mln vs the $23.7 mln consensus.

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NPS Reports Two Teduglutide Abstracts Accepted for Presentation at American College of Gastroenterology Annual Scientific Meeting

Press Release
Source: NPS Pharmaceuticals, Inc.
On 8:30 am EDT, Wednesday October 21, 2009

Companies:NPS Pharmaceuticals, Inc.
BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (Nasdaq: NPSP - News) today reported that two abstracts supporting the efficacy of GATTEX™ (teduglutide) in patients with short bowel syndrome (SBS) were accepted for presentation at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting and Postgraduate Course taking place in San Diego, October 23-28.

The details of the two poster presentations, which will be presented on October 25, 2009 from 3:30 – 7:00 PM PT, are summarized below.

Abstract P272: “Teduglutide (TG), a Dipeptidyl-peptidase IV Resistant Glucagon-like Peptide 2 (GLP-2) Analogue, Improves Lean Body Mass and Total Mineral Content in Short Bowel Syndrome (SBS) Patients Depending on Home Parenteral Nutrition (PN). Dual Energy X-ray Absorptiometry (DEXA) Results from a Randomized, Placebo-controlled, 24-week Study” by P. Jeppesen et al.

Abstract P273: “Teduglutide (TG) Improves Electrolyte and Wet Weight Absorption in Short Bowel Syndrome Patients, but this is not correlated to increases in Plasma Citrulline (PC)” by P. Jeppesen et al.

The ACG 2009 program and abstracts are available online and can be accessed at http://www.acg.gi.org/acgmeetings/ by clicking on the schedule page and searching abstracts for teduglutide.

About Short Bowel Syndrome (SBS)

SBS is a highly disabling condition that impairs quality of life and can lead to serious life-threatening complications. SBS typically arises after extensive resection of the bowel. There are an estimated 10,000 to 15,000 SBS patients in North America who are dependent on parenteral nutrition (PN), the cost of which can exceed $100,000 annually per patient. SBS patients suffer from malnutrition, severe diarrhea, dehydration, fatigue, osteopenia, and weight loss due to an inability to absorb adequate amounts of nutrients, fluid, and electrolytes. The goals of current treatment are to maintain fluid, electrolytes and nutrient balances through dietary management, including the use of PN. Long-term complications of the condition may include an increased risk of systemic infections due to the presence of an intravenous feeding line, degenerative changes in the bones and nerves due to vitamin and mineral deficiencies, and liver failure. Potential benefits derived from reduced dependence on PN may include improved nutrition and hydration, lower rates of infections, and improved quality-of-life due to more time away from PN, which may provide greater mobility and improved sleep.

About GATTEX™ (teduglutide)

GATTEX (teduglutide) is a proprietary analog of human glucagon-like peptide 2 that stimulates the repair and regeneration of cells lining the intestine. GATTEX is in Phase 3 clinical development to reduce dependence on parenteral nutrition (PN) in patients with short bowel syndrome (SBS). NPS has reported positive findings from completed studies in which GATTEX demonstrated a favorable safety profile and significant reductions in mean PN volume from pretreatment baseline were observed. NPS is also advancing preclinical studies to evaluate teduglutide in additional intestinal failure related conditions.

NPS has granted Nycomed the rights to develop and commercialize teduglutide outside of North America and the two companies are collaborating on the development of teduglutide for the treatment of gastrointestinal disorders.

Teduglutide has received orphan drug designation for the treatment of SBS from the U.S. Food and Drug Administration and the European Medicines Agency.

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NPS Pharmaceuticals Reports Second Quarter 2009 Financial Results; Two Phase 3 Registration Programs Continue to Advance on Stated Timelines
-- Conference call today at 9:00 AM ET --

Press Release
Source: NPS Pharmaceuticals, Inc.
On Thursday August 6, 2009, 8:30 am EDT

Companies:NPS Pharmaceuticals, Inc.
BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (NASDAQ: NPSP - News) today reported its financial results for the second quarter of 2009. The company reported net income of $2.6 million, or $0.05 per diluted share, for the second quarter of 2009 as compared to net income of $1.2 million, or $0.03 per diluted share, for the second quarter of 2008.

The company’s cash, cash equivalents and short- and long-term investments totaled $92.0 million at June 30, 2009 versus $106.1 million at December 31, 2008. NPS used $8.5 million in cash during the second quarter of 2009 (excluding changes in the carrying value of auction-rate securities or ARS investments). The company’s cash burn guidance for 2009 remains unchanged at $55 to $65 million and, consistent with prior periods, excludes potential changes in the estimated fair value of the company’s ARS investments.

“We continue to be proactive in managing the business to ensure we deliver on our stated objectives,” said Francois Nader, M.D., president and chief executive officer of NPS Pharmaceuticals. “Our timelines for completing enrollment in the STEPS and REPLACE studies before the end of the first quarter of 2010 are on track as are our preparations for regulatory review and commercialization of these product candidates. In addition, we are aggressively managing our burn and our cash position remains strong. We are actively evaluating multiple opportunities to further strengthen our balance sheet and the financing facility we announced today adds to our potential suite of options for raising new capital.”

Product Pipeline Update

GATTEX™ (teduglutide)


NPS continues to expect STEPS to complete enrollment before the end of the first quarter of 2010. NPS and its partner, Nycomed, have secured health authority clearance in all 10 countries with STEPS study sites and expects substantially all study sites to be actively screening patients before the end of the third quarter of 2009. STEPS is an international, double-blind, placebo-controlled Phase 3 registration study to confirm that GATTEX is well tolerated and reduces parenteral nutrition (PN) dependence in short bowel syndrome (SBS) patients. NPS believes positive results from STEPS will enable it to seek U.S. marketing approval for GATTEX for patients with PN-dependent SBS.
The STEPS 2-year extension study (STEPS 2) is on track to begin during the third quarter of 2009. The extension study will enroll patients who have completed 24-weeks of GATTEX therapy and elect to enter the open-label long-term study for up to an additional 24 months. The company’s partner, Nycomed, has opted to support the extension study on a collaborative basis and the companies will share 50% of external clinical trial expenses.
Clinical investigators presented new data from three sub-studies in patients with SBS who received GATTEX™ during the completed 24-week, placebo-controlled Phase 3 clinical trial at the 2009 Digestive Disease Week or DDW conference. The presentations showed that GATTEX enhances intestinal mass and function.
Preclinical activities evaluating teduglutide in pediatric indications and in chemotherapy-induced gastrointestinal mucositis continue to advance.

NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection)


NPS continues to expect to complete enrollment in REPLACE before the end of the first quarter of 2010. NPS has secured health authority clearance in all seven countries with REPLACE study sites. The company expects substantially all study sites will be actively screening patients before the end of the third quarter of 2009. REPLACE is a Phase 3 registration study evaluating NPSP558 for the treatment of hypoparathyroidism in adults. NPS believes positive results from REPLACE will enable it to seek U.S. marketing approval for NPSP558 for patients with hypoparathyroidism.

Financial Results

Revenues

Revenues are comprised of royalties, product sales, and milestones and license fees.

NPS earns royalties on (i) Amgen’s sales of Sensipar® (cinacalcet HCl), (ii) Nycomed’s sales of Preotact® (parathyroid hormone 1-84 [rDNA origin] injection), (iii) Kyowa Kirin’s sales of REGPARA® (cinacalcet HCl) in Japan, and (iv) Ortho-McNeil-Janssen’s sales of Nucynta™ (tapentadol). Royalty revenue grew to $22.8 million for the second quarter of 2009, versus $17.5 million for the second quarter of 2008, as follows:

In millions Second Quarter
2009 2008
Royalty:
Sensipar $19.3 $14.9
Preotact 2.4 2.2
REGPARA 0.9 0.4
Nucynta 0.2 --
Total $22.8 $17.5


The company’s royalty rights related to Sensipar and Preotact currently secure non-recourse debt. At June 30, 2009, the outstanding principal balance on the non-recourse debt secured by the company’s Sensipar royalties was $228.2 million. After repayment of the debt and interest, Sensipar royalties will return to NPS. When Preotact royalty payments exceed two and one-half times the amount of advanced principal, the royalties revert to NPS.

NPS earned a $2.2 million milestone during the second quarter of 2009 related to Preotact achieving certain sales levels during the quarter.

NPS recognized license fee revenue related to the company’s September 2007 agreement with Nycomed for GATTEX of $624,000 for the second quarter of 2009 versus $9.5 million for the second quarter of 2008. These amounts pertain to the up-front license fee received in 2007, which NPS initially recorded as deferred revenue.

Research and development

Research and development expenses were $6.4 million for the second quarter of 2009 versus $4.0 million for the second quarter of 2008. The increase in research and development expense was due to the advancement of the company’s registration programs for GATTEX in short bowel syndrome and NPSP558 in hypoparathyroidism.

General and administrative

General and administrative expenses were $5.0 million for the second quarter of 2009 versus $3.1 million for the second quarter of 2008. The change in general and administrative expense was largely due to credits for legal fees reimbursed from the company’s insurance carriers that positively affected the second quarter of 2008.

Interest expense

Second quarter interest expense was $11.8 million for 2009 versus $15.7 million for 2008. The decrease was primarily due to lower interest expense associated with the company’s non-recourse debt. With the exception of $50 million of the company’s convertible notes due in 2014, all of the company’s outstanding debt is non-recourse and is secured by its Sensipar and Preotact royalties.

Loss on investments

The company’s auction-rate securities or ARS investments have experienced failed auctions since the latter part of 2007 due to liquidity issues in the global credit and capital markets. While all of the company’s ARS continue to pay interest, the severity and the duration of the decline in fair value have resulted in the company recognizing “other than temporary” changes in the fair value of its ARS investments. There was no impairment charge in the second quarter of 2009 versus an impairment charge of $456,000 in the second quarter of 2008.

Cash and investments

At June 30, 2009, the company’s cash, cash equivalents, and short- and long-term investments totaled $92.0 million compared to $106.1 million at December 31, 2008. Included in these amounts are ARS investments with an estimated fair value of $8.3 million at June 30, 2009 and $8.8 million at December 31, 2008. The principle value of these ARS investments is $29.7 million. NPS has classified its ARS investments as non-current assets within its balance sheets.

Conference Call Information

NPS will host a conference call beginning today at 9:00 am Eastern Time. To participate in the conference call, dial [phone] and use passcode 43462149. International callers may dial [phone], using the same passcode. In addition, a live audio of the conference call will be available over the Internet. Interested parties can access the event through the NPS website, http://www.npsp.com.

For those unable to participate in the live call, a replay will be available at [phone], with passcode 26612097, until midnight ET, August 19, 2009. International callers may access the replay by dialing [phone], using the same passcode. The webcast will also be available through the NPS website for the same period.

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GATTEX(TM) Abstracts to be Presented at ACG Meeting; 52-Week Data from Phase 3 Clinical Trial Scheduled for Plenary Session
Tuesday September 23, 4:10 pm ET

BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals, Inc. (Nasdaq: NPSP - News) today reported that three abstracts summarizing data from the company’s Phase 3 studies of GATTEX™ (teduglutide) in patients with short bowel syndrome (SBS) were accepted for presentation at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course in Orlando, Florida, October 3-8, 2008, including an oral presentation of 52-week data from the Phase 3 study of GATTEX™ in SBS patients. The abstract titles and presentation times are summarized below.

Plenary Session

“Treatment Out to 1 Year with a GLP-2 Analog, Teduglutide, Safely Reduces Parenteral Nutrition (PN) Needs in PN-Dependent Short Bowel Syndrome (SBS) Patients” by R. Gilroy et al. will be presented on October 8, 2008.

Poster Sessions

“Teduglutide, a GLP-2 Analog Enhances Intestinal Structure in Short Bowel Syndrome (SBS) Patients Dependent of Parenteral Nutrition (PN)” by K. Tappenden et al. will be presented on October 5, 2008.

“Pharmacokinetic/Pharmacodynamic Correlation Between Teduglutide, an Analog of GLP-2, and Citrulline, a Biomarker of Small Intestinal Enterocyte Functional Mass in Short Bowel Patients” by B. Messing et al. will be presented on October 7, 2008.

The ACG preliminary program is available online and can be accessed at www.acg.gi.org/acgmeetings/.

About GATTEX™ (teduglutide)

GATTEX (teduglutide) is a proprietary analog of human glucagon-like peptide 2 that stimulates the repair and regeneration of cells lining the intestine. GATTEX is in Phase 3 clinical development to reduce dependence on parenteral nutrition (PN) in patients with short bowel syndrome (SBS). NPS has reported positive findings from recently completed studies in which GATTEX demonstrated a favorable safety profile and significant reductions in mean PN volume from pretreatment baseline were observed. NPS is also advancing preclinical studies to evaluate teduglutide as a possible treatment for gastrointestinal mucositis, a complication of certain cancer treatments, and gastrointestinal disorders that affect premature infants, including pediatric SBS.

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NPS Pharmaceuticals to Report GATTEX(TM) Data at ESPEN, ACG, UEGW Congresses
Thursday September 11, 4:05 pm ET

BEDMINSTER, N.J.--(BUSINESS WIRE)--NPS Pharmaceuticals (Nasdaq: NPSP - News) today reported that data from clinical studies of GATTEX™ (teduglutide) in intestinal failure associated with short bowel syndrome will be presented at upcoming medical meetings.

At the 30th Congress of the European Society for Clinical Nutrition and Metabolism (ESPEN) taking place in Florence, Italy September 13-16, 2008 clinical data from a 24-week Phase 3 study of GATTEX for short bowel syndrome (SBS) patients who are dependent upon parenteral nutrition have been accepted for presentation. “The Novel Recombinant GLP-2 Analog, Teduglutide, Reduces Parenteral Nutrition (PN) Requirements in PN-Dependent Short Bowel Syndrome Patients: Results of a Multi-Center, International Placebo-Controlled Study” by Messing et al. will be presented on September 14, 2008 in an oral presentation. “The Glucagon-Like Peptide-2 (GLP-2) Analog, Teduglutide, improves Fluid Balance in Short Bowel Syndrome (SBS) Patients Dependent on Parenteral Nutritional Support (PN)” by Jeppesen et al. will be presented on September 14, 2008 at a poster session.

The ESPEN program and abstracts are available online and can be accessed at www.espen.org.

Investigators will present additional data on GATTEX in SBS, including 52-week data from the Phase 3 program, at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course in Orlando, Florida, October 15-18, 2008 and the 16th United European Gastroenterology Week (UEGW 2008) in Vienna, Austria October 18-22, 2008.