Press Release
NPS Pharmaceuticals Reports Second Quarter 2009 Financial Results; Two Phase 3 Registration Programs Continue to Advance on Stated Timelines
The company’s cash, cash equivalents and short- and long-term
investments totaled
“We continue to be proactive in managing the business to ensure we
deliver on our stated objectives,” said
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
| 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
NPS earned a
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 were
Interest expense
Second quarter interest expense was
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
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 passcode 26612097, 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
(Financial statements to follow)
|
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES Condensed Consolidated Statements of Operations (In thousands, except per share data) (Unaudited) |
|||||||||
| Three Months Ended | Six Months Ended | ||||||||
| June 30, | June 30, | ||||||||
| 2009 | 2008 | 2009 | 2008 | ||||||
| Revenues: | |||||||||
| Royalties | $22,827 |
$17,493 |
$37,235 |
$30,191 |
|||||
| Product sales | 8 | -- | 8 | 1,684 | |||||
| Milestones and license fees | 2,814 | 9,466 | 4,735 | 20,264 | |||||
| Total revenues | 25,649 | 26,959 | 41,978 | 52,139 | |||||
| Costs and expenses: | |||||||||
| Cost of goods sold | -- | -- | -- | 1,350 | |||||
| Cost of royalties | -- | 1,612 | -- | 2,985 | |||||
| Cost of license fees | 123 | 1,919 | 481 | 3,839 | |||||
| Research and development | 6,427 | 3,998 | 12,259 | 8,855 | |||||
| General and administrative | 4,981 | 3,096 | 9,534 | 13,688 | |||||
| Total operating expenses | 11,531 | 10,625 | 22,274 | 30,717 | |||||
| Operating income | 14,118 | 16,334 | 19,704 | 21,422 | |||||
| Other (expense) income: | |||||||||
| Interest income | 400 | 975 | 1,000 | 2,821 | |||||
| Interest expense | (11,800) | (15,671) | (27,491) | (32,616) | |||||
| Loss on impairment of marketable investment securities | -- | (456) | (2,206) | (3,909) | |||||
| Other (expense) income, net | (101) | (76) | (140) | 295 | |||||
| Total other expense, net | (11,501) | (15,228) | (28,837) | (33,409) | |||||
| Income (loss) before income tax benefit | 2,617 | 1,106 | (9,133) | (11,987) | |||||
| Income tax benefit | -- | (97) | (1,014) | (97) | |||||
| Net income (loss) | $2,617 | $1,203 | ($8,119) | ($11,890) | |||||
|
Net income (loss) per common and potential common share: |
|||||||||
| Basic | $0.05 | $0.03 | ($0.17) | ($0.25) | |||||
| Diluted | $0.05 | $0.03 | ($0.17) | ($0.25) | |||||
| Weighted average common and potential common share: | |||||||||
| Basic | 48,017 | 47,670 | 47,988 | 47,559 | |||||
| Diluted | 48,034 | 47,744 | 47,988 | 47,559 | |||||
|
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES Condensed Consolidated Balance Sheets (In thousands) (Unaudited) |
|||||
| June 30, | December 31, | ||||
| 2009 | 2008 | ||||
| Assets: | |||||
| Cash, cash equivalents and current marketable investment securities | $83,670 | $97,380 | |||
| Current restricted cash and cash equivalents | 9,765 | 37,016 | |||
| Account receivable | 24,226 | 25,406 | |||
| Litigation settlement receivable | -- | 16,000 | |||
| Other current assets | 3,101 | 2,694 | |||
| Equipment, net | 395 | 285 | |||
| Marketable investment securities, less current portion | 8,343 | 8,752 | |||
| Debt issuance costs, net | 4,295 | 5,158 | |||
| Other long-term assets | 1,696 | 1,486 | |||
| Goodwill | 9,429 | 9,429 | |||
| Total assets | $144,920 | $203,606 | |||
| Liabilities and Stockholders’ Deficit: | |||||
| Current liabilities | $40,415 | $81,889 | |||
| Convertible notes and capital lease obligation | 50,000 | 50,014 | |||
| Non-recourse debt, less current portion* | 255,200 | 268,277 | |||
| Other long-term liabilities | 19,179 | 18,512 | |||
| Total liabilities | 364,794 | 418,692 | |||
| Common stock and additional paid-in capital | 691,723 | 689,994 | |||
| Accumulated other comprehensive income (loss) | 1,402 | (200) | |||
| Accumulated deficit | (912,999) | (904,880) | |||
| Total stockholders' deficit | (219,874) | (215,086) | |||
| Total liabilities and stockholders' deficit | $144,920 | $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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