Press Release
NPS Pharmaceuticals Reports First Quarter 2009 Financial Results; Registration Studies Advance for Lead Product Candidates
The company used
“We have continued to make steady progress advancing our registration
programs for GATTEX in short bowel syndrome and NPSP558 in
hypoparathyroidism while at the same time managing our resources
carefully,” said
Product Pipeline Update
GATTEX™ (teduglutide)
- Patient enrollment continues in STEPS, 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. The company continues to expect the last patient to enroll in STEPS before the end of the first quarter of 2010. NPS believes positive results from STEPS will enable it to seek U.S. marketing approval for GATTEX for patients with PN-dependent SBS.
- NPS recently executed long-term supply agreements for the commercial manufacture and supply of active pharmaceutical ingredient, finished injectable product, and other commercial supply chain services.
- Three GATTEX-related abstracts were accepted for presentation at the 2009 Digestive Disease Week (DDW) conference: two oral presentations and one poster presentation of sub-study data from the completed Phase 3 study of GATTEX in short bowel syndrome.
- Preclinical studies evaluating teduglutide in pediatric indications and in chemotherapy-induced gastrointestinal mucositis continued to advance.
NPSP558 (parathyroid hormone 1-84 [rDNA origin] injection)
- Enrollment is proceeding in REPLACE, a Phase 3 registration study evaluating NPSP558 for the treatment of adults with hypoparathyroidism. NPS continues to expect to complete patient enrollment before the end of the first quarter of 2010. NPS believes positive results from REPLACE will enable it to seek U.S. marketing approval for NPSP558 for patients with hypoparathyroidism.
- The company recently executed agreements for the long-term commercial manufacture and supply of active pharmaceutical ingredient and other commercial supply chain services.
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), and (iii) Kyowa Kirin’s sales of
REGPARA® (cinacalcet HCl) in
| In millions | First Quarter | |||||
| 2009 | 2008 | |||||
| Royalty: | ||||||
| Sensipar | $ | 11.6 | $ | 10.7 | ||
| Preotact | 2.1 | 1.8 | ||||
| REGPARA | 0.7 | 0.2 | ||||
| Total | $ | 14.4 | $ | 12.7 | ||
The company’s royalty rights related to Sensipar and Preotact currently
secure non-recourse debt. At
NPS reported product sales of
NPS recognized license fee revenue related to the company’s
Research and development
Research and development expenses were
General and administrative
General and administrative expenses decreased to
Interest expense
First 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 beginning today at
For those unable to participate in the live call, a replay will be
available at (888) 286-8010, with pass code 59746301, 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 the company’s
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 company’s strategy, the risks associated with
the company’s auction-rate securities, as well as other risk factors
described in the company’s periodic filings with the
|
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES Condensed Consolidated Statements of Operations (In thousands, except per share data) (Unaudited) |
||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2009 | 2008 | |||||||
| Revenues: | ||||||||
| Royalties | $ | 14,408 | $ | 12,698 | ||||
| Product sales | -- | 1,684 | ||||||
| Milestones and license fees | 1,921 | 10,798 | ||||||
| Total revenues | 16,329 | 25,180 | ||||||
| Costs and expenses: | ||||||||
| Cost of goods sold | -- | 1,350 | ||||||
| Cost of royalties | -- | 1,373 | ||||||
| Cost of license fees | 358 | 1,920 | ||||||
| Research and development | 5,832 | 4,857 | ||||||
| General and administrative | 4,553 | 10,592 | ||||||
| Total operating expenses | 10,743 | 20,092 | ||||||
| Operating income | 5,586 | 5,088 | ||||||
| Other (expense) income: | ||||||||
| Interest income | 600 | 1,846 | ||||||
| Interest expense | (15,691 | ) | (16,945 | ) | ||||
| Loss on marketable investment securities | (2,204 | ) | (3,502 | ) | ||||
| Other (expense) income, net | (41 | ) | 420 | |||||
| Total other expense, net | (17,336 | ) | (18,181 | ) | ||||
| Loss before income tax benefit | (11,750 | ) | (13,093 | ) | ||||
| Income tax benefit | (1,014 | ) | -- | |||||
| Net loss | ($10,736 | ) | ($13,093 | ) | ||||
|
Net loss per common and potential common share: |
||||||||
| Basic and diluted | ($0.22 | ) | ($0.28 | ) | ||||
| Weighted average common and potential common share: |
|
|||||||
| Basic and diluted | 47,959 | 47,447 | ||||||
|
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (In thousands) (Unaudited) |
||||||||
| March 31, | December 31, | |||||||
| 2009 | 2008 | |||||||
| Assets: | ||||||||
| Cash, cash equivalents and current marketable investment securities | $ | 92,128 | $ | 97,380 | ||||
| Current restricted cash and cash equivalents | 49,570 | 37,016 | ||||||
| Account receivable | 18,192 | 25,406 | ||||||
| Litigation settlement receivable | 16,000 | 16,000 | ||||||
| Other current assets | 1,885 | 2,694 | ||||||
| Equipment, net | 423 | 285 | ||||||
| Marketable investment securities, less current portion | 6,548 | 8,752 | ||||||
| Debt issuance costs, net | 4,701 | 5,158 | ||||||
| Other long-term assets | 1,874 | 1,486 | ||||||
| Goodwill | 9,429 | 9,429 | ||||||
| Total assets | $ | 200,750 | $ | 203,606 | ||||
| Liabilities and Stockholders’ Deficit: | ||||||||
| Current liabilities | $ | 89,794 | $ | 81,889 | ||||
| Convertible notes | 50,000 | 50,000 | ||||||
| Secured notes payable, less current portion* | 265,841 | 268,277 | ||||||
| Other long-term liabilities | 20,360 | 18,526 | ||||||
| Total liabilities | 425,995 | 418,692 | ||||||
| Common stock and additional paid-in capital | 690,751 | 689,994 | ||||||
| Accumulated other comprehensive loss | (380 | ) | (200 | ) | ||||
| Accumulated deficit | (915,616 | ) | (904,880 | ) | ||||
| Total stockholders' deficit | (225,245 | ) | (215,086 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 200,750 | $ | 203,606 | ||||
| * Non-recourse debt secured by Sensipar® and Preotact® royalty revenue | ||||||||
Source:
NPS Pharmaceuticals, Inc.
Susan Mesco, 908-450-5516
smesco@npsp.com
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