Press Release
NPS Pharmaceuticals Reports Strong 2008 Results; Phase 3 Registration Studies Underway for Two Product Candidates
NPS reported improved cash burn (before the impact of changes in
carrying value of the company’s auction-rate security (ARS) investments)
of
NPS expects its 2009 cash burn to be in the range of
For the fourth quarter 2008, NPS reported a net loss of
“During 2008, NPS made great strides advancing our clinical programs and
creating shareholder value,” said
2008 Clinical Program Advancements
In 2008 NPS made strong progress advancing its clinical pipeline, with key highlights summarized below.
GATTEX™ (teduglutide)
-
The company held two pre-new drug application (pre-NDA) meetings with
the
U.S. Food and Drug Administration and finalized the design of the STEPS study. NPS believes positive results will enable the company to seek U.S. marketing approval for GATTEX for patients with parenteral nutrition (PN)-dependent SBS. -
In
December 2008 , patient enrollment began in STEPS – an international, double-blind, placebo-controlled Phase 3 registration study to confirm that GATTEX is well tolerated and reduces PN dependence in SBS patients. - Nycomed opted to support the Phase 3-confirmatory study of GATTEX in SBS on a collaborative basis and share 50% of external clinical trial expenses.
-
Investigators presented Phase 3 data on GATTEX in SBS at the following
medical meetings: the 2008
Digestive Disease Week Congress , the 30thEuropean Society for Clinical Nutrition andMetabolism Congress , theAmerican College of Gastroenterology AnnualScientific Meeting and Postgraduate Course , and the 16th United European Gastroenterology Week. - Preclinical studies evaluating teduglutide in pediatric indications and in chemotherapy-induced gastrointestinal mucositis continued to advance.
NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection)
-
The company obtained input from the
FDA , met with global thought leaders, and finalized the design of the REPLACE study. There is currently no approved replacement therapy for hypoparathyroidism and NPS believes positive results from REPLACE will enable the company to seek U.S. marketing approval for NPSP558 for the treatment of hypoparathyroidism. -
NPS filed an investigational new drug application and in
December 2008 , patient enrollment began in REPLACE – a Phase 3 registration study evaluating NPSP558 for the treatment of adults with hypoparathyroidism. -
Positive interim data from an investigator-initiated Phase 2
proof-of-concept study of NPSP558 in hypoparathyroidism were presented
at the 30th Annual Meeting of the
American Society for Bone and Mineral Research .
Financial Results
In 2007, NPS shifted its focus from large primary care indications to rare gastrointestinal and endocrine disorders with few, if any, therapeutic options, limited competition, and treatment by physician specialists. This strategic shift included cost reductions and the monetization of non-core assets and affects the comparison of the company’s 2008 and 2007 financial results.
For the fourth quarter and full year 2008, NPS reported a net loss of
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), and (iii) Kyowa Kirin’s sales of
REGPARA® (cinacalcet HCl) in
| In millions | Fourth Quarter | Full Year | ||||||||||
| 2008 | 2007 | 2008 | 2007 | |||||||||
| Royalty: | ||||||||||||
| Sensipar | $15.1 | $12.9 | $59.6 | $46.3 | ||||||||
| Preotact | 2.5 | 1.2 | 8.7 | 3.3 | ||||||||
| REGPARA | 0.7 | -- | 1.9 | -- | ||||||||
| Total | $18.3 | $14.1 | $70.2 | $49.6 | ||||||||
The company’s royalty rights related to Sensipar and Preotact currently
secure non-recourse debt. At December 31, 2008, the outstanding
principal balance on the non-recourse debt secured by the company’s
Sensipar royalties was
NPS reported product sales of
NPS reported milestones and license fees of
Research and development
Research and development expenses were
In the fourth quarter of 2008, Nycomed opted to support the Phase 3
STEPS study of GATTEX on a collaborative basis and share 50% of external
clinical trial expenses. As a result, NPS offset its research and
development expenses by
General and administrative
General and administrative expenses decreased to
Gain on sale of asset
In connection with the implementation of its new business plan, NPS sold
its interests in an early-stage research and development collaboration
with
Interest expense
Fourth quarter interest expense was
Loss on marketable investment securities
The company’s ARS investments have experienced failed auctions since the
second half of 2007 due to liquidity issues in the global credit and
capital markets. While all of the company’s ARS investments continue to
pay interest on the full face value of the investments, the severity and
the duration of the decline in fair value of certain of its ARS have
resulted in the company determining that the change in fair value of its
ARS investments is other-than-temporary. NPS recorded an ARS impairment
charge of
Cash and investments
At
Conference Call Information
NPS will host a conference call today at
For those unable to participate in the live call, a replay will be
available at (888) 286-8010, with pass code 73038797, until
About
“NPS” and “NPS Pharmaceuticals” are the company’s registered trademarks. Preotact® is the company’s registered trademark in the U.S. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.
Statements made in this press release, which are not historical in
nature, constitute forward-looking statements for purposes of the safe
harbor provided by the Private Securities Litigation Reform Act of 1995.
These statements are based on the company's current expectations and
beliefs and are subject to a number of factors and uncertainties that
could cause actual results to differ materially from those described in
the forward-looking statements. Risks associated to NPS’ business
include, but are not limited to, the risks associated with any failure
by the company to successfully complete its preclinical and clinical
studies within the projected time frames or not at all, the risk of not
gaining marketing approvals for GATTEX and NPSP558, the risks associated
with the implementation of the new business strategy, the risks
associated with the company’s auction-rate securities, as well as other
risk factors described in NPS’ periodic filings with the
(Financial statements to follow)
|
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES Condensed Consolidated Statements of Operations (In thousands, except per share data) (Unaudited) |
||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2008 | 2007 | 2008 | 2007 | |||||||||||||
| Revenues: | ||||||||||||||||
| Royalties | $ | 18,323 | $ | 14,097 | $ | 70,217 | $ | 49,626 | ||||||||
| Product sales | 2,860 | 5,371 | 4,544 | 20,310 | ||||||||||||
| Milestones and license fees | 2,882 | 14,513 | 27,518 | 16,312 | ||||||||||||
| Total revenues | 24,065 | 33,981 | 102,279 | 86,248 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods sold | -- | 3,305 | 1,350 | 6,180 | ||||||||||||
| Cost of royalties | 1,141 | 1,297 | 5,831 | 4,659 | ||||||||||||
| Cost of license fees | 941 | 1,547 | 5,665 | 1,547 | ||||||||||||
| Research and development | 4,837 | 10,147 | 18,965 | 36,195 | ||||||||||||
| General and administrative | 4,903 | 9,787 | 22,563 | 29,526 | ||||||||||||
| Restructuring charges (credits) | 33 | 1,134 | (272 | ) | 13,386 | |||||||||||
| Gain on sale of assets | -- | (30,000 | ) | -- | (30,000 | ) | ||||||||||
| Gain on sale of assets held for sale | -- | -- | -- | (1,826 | ) | |||||||||||
| Loss (gain) on sale of fixed assets | (186 | ) | 75 | (186 | ) | (6,384 | ) | |||||||||
| Total operating expenses | 11,669 | (2,708 | ) | 53,916 | 53,283 | |||||||||||
| Operating income (loss) | 12,396 | 36,689 | 48,363 | 32,965 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 974 | 2,821 | 4,778 | 9,518 | ||||||||||||
| Interest expense | (16,352 | ) | (16,985 | ) | (65,373 | ) | (41,397 | ) | ||||||||
| Loss on marketable investment securities | (6,207 | ) | (4,078 | ) | (20,950 | ) | (4,113 | ) | ||||||||
| Other income (expense), net | 753 | (87 | ) | 1,277 | (475 | ) | ||||||||||
| Total other expense, net | (20,832 | ) | (18,329 | ) | (80,268 | ) | (36,467 | ) | ||||||||
| (Loss) income before income tax expense | (8,436 | ) | 18,360 | (31,905 | ) | (3,502 | ) | |||||||||
| Income tax expense (benefit) | 41 | 780 | (179 | ) | 780 | |||||||||||
| Net income (loss) | ($8,477 | ) | $ | 17,580 | ($31,726 | ) | ($4,282 | ) | ||||||||
|
Net (loss) income per common and potential common share: |
||||||||||||||||
| Basic | ($0.18 | ) | $ | 0.37 | ($0.67 | ) | ($0.09 | ) | ||||||||
| Diluted | ($0.18 | ) | $ | 0.32 | ($0.67 | ) | ($0.09 | ) | ||||||||
| Weighted average common and potential common share: | ||||||||||||||||
| Basic | 47,898 | 47,026 | 47,699 | 46,804 | ||||||||||||
| Diluted | 47,898 | 57,253 | 47,699 | 46,804 | ||||||||||||
|
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (In thousands) (Unaudited) |
||||||||
| December 31, | December 31, | |||||||
| 2008 | 2007 | |||||||
| Assets: | ||||||||
| Cash, cash equivalents and marketable investment securities | $ | 97,380 | $ | 133,331 | ||||
| Current restricted cash and cash equivalents | 37,016 | 24,560 | ||||||
| Account receivable | 25,406 | 19,518 | ||||||
| Other current assets | 18,694 | 7,676 | ||||||
| Equipment, net | 285 | 309 | ||||||
| Marketable investment securities, less current portion | 8,752 | 28,357 | ||||||
| Debt issuance costs | 5,158 | 7,014 | ||||||
| Other assets | 1,486 | -- | ||||||
| Goodwill, net of accumulated amortization | 9,429 | 11,088 | ||||||
| Total assets | $ | 203,606 | $ | 231,853 | ||||
| Liabilities and Stockholders’ Deficit: | ||||||||
| Current liabilities | $ | 81,889 | 82,164 | |||||
| Convertible notes | 50,000 | 50,000 | ||||||
| Secured notes payable, excluding current* | 268,277 | 286,357 | ||||||
| Other liabilities | 18,526 | 4,988 | ||||||
| Total liabilities | 418,692 | 423,509 | ||||||
| Common stock and additional paid-in capital | 689,994 | 684,002 | ||||||
| Accumulated other comprehensive loss | (200 | ) | (2,504 | ) | ||||
| Accumulated deficit | (904,880 | ) | (873,154 | ) | ||||
| Total stockholders' deficit | (215,086 | ) | (191,656 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 203,606 | $ | 231,853 | ||||
* Non-recourse debt secured by Sensipar® and Preotact® royalty revenue
Source:
NPS Pharmaceuticals, Inc.
Susan Mesco, 908-450-5516
smesco@npsp.com
The reports filed by NPS with the Securities and Exchange Commission and the news releases issued by NPS and posted on this website are current only as of the dates on which they were filed or issued by NPS. Therefore, the contents of these reports and releases can become outdated. We make no commitment, and disclaim any duty, to update these reports and releases. We do not warrant the accuracy or completeness of these materials or the reliability of any advice, opinion, statement or other information displayed or distributed through the website. Readers acknowledge that any reliance on these reports, releases, advice, opinions, statements, or information are at the reader’s sole risk.