Press Release
NPS Pharmaceuticals Reports Third Quarter Results and Improved Cash Burn Guidance
-- Conference call today at
Revenues were
The company’s cash, cash equivalents and short- and long-term
investments totaled
“We continue to aggressively manage our cash burn,” said
“Our REPLACE study is also advancing, although we have experienced slower-than-expected enrollment largely due to prolonged turnaround times for certain outsourced activities related to site-readiness. We have taken a number of corrective actions and we now expect to achieve full enrollment in the middle of 2010. All of our regulatory-readiness and commercial supply chain activities for GATTEX and NPSP558 are advancing as planned.”
Product Pipeline Update
Teduglutide
- The STEPS study remains on track to reach full patient enrollment before the end of the first quarter of 2010. Substantially all sites are actively screening patients and nearly half of the currently targeted number of patients has been enrolled. STEPS is an international, double-blind, placebo-controlled Phase 3 registration study to confirm that GATTEX® (teduglutide) is well tolerated and reduces parenteral nutrition (PN) dependence in short bowel syndrome (SBS) patients. NPS is advancing STEPS with the support of its partner, Nycomed, and the two companies are sharing external clinical costs.
- The STEPS 2 study is now underway. STEPS 2 is an open-label follow-on study that will enroll patients who have participated in the STEPS study and elect to continue on GATTEX (teduglutide) for up to an additional 24 months. NPS is advancing STEPS 2 with the support of its partner, Nycomed, and the two companies are sharing external clinical costs.
-
Clinical investigators presented new data from the completed 24-week,
placebo-controlled Phase 3 clinical trial at the 2009
American College of Gastroenterology AnnualScientific Meeting and Postgraduate Course . In one presentation, data showed that teduglutide significantly improved lean body mass and total bone mineral content in PN-dependent SBS patients. A separate presentation showed that teduglutide improves intestinal electrolyte and wet weight absorption in SBS patients. -
The company is completing preclinical studies evaluating teduglutide
in chemotherapy-induced gastrointestinal mucositis or CIGIM and
recently completed a pre-investigational new drug application
(pre-IND) meeting with the
U.S. Food and Drug Administration (FDA ) about the path forward for this indication. - Preclinical activities evaluating teduglutide in pediatric indications continue to advance.
NPSP558 (parathyroid hormone 1-84)
- Substantially all original sites are now actively screening patients for the REPLACE study; however, the study has experienced slower-than-expected enrollment to date. NPS has taken a number of corrective actions to accelerate enrollment in REPLACE, including transitioning certain activities to a new service provider, adding new sites, and expanding the base of eligible patients to better match the target patient population. NPS now expects to achieve full enrollment in REPLACE near the middle of 2010, rather than the first quarter of 2010. REPLACE is an international, double-blind, placebo-controlled Phase 3 registration study evaluating NPSP558 for the treatment of hypoparathyroidism in adults.
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), and (iv) Ortho-McNeil-Janssen’s
sales of Nucynta™ (tapentadol). Royalty revenue was
| In millions | Third Quarter | |||||||
| 2009 | 2008 | |||||||
| Royalty: | ||||||||
| Sensipar | $16.5 | $19.0 | ||||||
| Preotact | 2.5 | 2.2 | ||||||
| REGPARA | 1.0 | 0.5 | ||||||
| Nucynta | 0.1 | -- | ||||||
| Total | $20.1 | $21.7 | ||||||
Each calendar year, the company’s royalty percentage on Sensipar increases as cumulative annual sales thresholds are achieved. Achievement of these sales thresholds increases the royalty rate in the period the threshold is reached and triggers a true-up payment for prior sales during the year. The decline in Sensipar royalties for the third quarter of 2009 versus the third quarter of 2008 is attributable to earning the true-up payment in the second quarter of 2009 as compared to the third quarter of 2008.
The company’s royalty rights related to Sensipar and Preotact currently secure non-recourse debt. 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, any residual royalties revert to NPS.
Research and development
Research and development expenses were
General and administrative
General and administrative expenses were
Interest expense
Third 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 third 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 92620208, until
About
“NPS” and “NPS Pharmaceuticals” are the company’s registered trademarks. GATTEX® and Preotact® are the company’s registered trademarks 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 | Nine Months Ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||
| Revenues: | ||||||||||||
| Royalties | $20,112 | $21,703 | $57,347 | $51,894 | ||||||||
| Product sales | -- | -- | 8 | 1,684 | ||||||||
| Milestones and license fees | 7 | 4,372 | 4,742 | 24,636 | ||||||||
| Total revenues | 20,119 | 26,075 | 62,097 | 78,214 | ||||||||
| Costs and expenses: | ||||||||||||
| Cost of royalties | 500 | 1,705 | 500 | 4,690 | ||||||||
| Cost of goods sold | -- | -- | -- | 1,350 | ||||||||
| Cost of license fees | -- | 885 | 481 | 4,724 | ||||||||
| Research and development | 9,828 | 5,273 | 22,087 | 14,128 | ||||||||
| General and administrative | 5,827 | 3,667 | 15,361 | 17,355 | ||||||||
| Total operating expenses | 16,155 | 11,530 | 38,429 | 42,247 | ||||||||
| Operating income | 3,964 | 14,545 | 23,668 | 35,967 | ||||||||
| Other income (expense): | ||||||||||||
| Interest income | 374 | 983 | 1,374 | 3,804 | ||||||||
| Interest expense | (12,099 | ) | (16,405 | ) | (39,590 | ) | (49,021 | ) | ||||
| Loss on impairment of marketable investment securities | -- | (10,782 | ) | (2,206 | ) | (14,691 | ) | |||||
| Other (expense) income, net | (40 | ) | 177 | (180 | ) | 472 | ||||||
| Total other expense, net | (11,765 | ) | (26,027 | ) | (40,602 | ) | (59,436 | ) | ||||
| Loss before income tax benefit | (7,801 | ) | (11,482 | ) | (16,934 | ) | (23,469 | ) | ||||
| Income tax benefit | (35 | ) | (123 | ) | (1,049 | ) | (220 | ) | ||||
| Net loss | ($7,766 | ) | ($11,359 | ) | ($15,885 | ) | ($23,249 | ) | ||||
|
Net loss per common and potential common share: |
||||||||||||
| Basic | ($0.16 | ) | ($0.24 | ) | ($0.33 | ) | ($0.49 | ) | ||||
| Diluted | ($0.16 | ) | ($0.24 | ) | ($0.33 | ) | ($0.49 | ) | ||||
| Weighted average common and potential common share: | ||||||||||||
| Basic | 48,110 | 47,777 | 48,029 | 47,632 | ||||||||
| Diluted | 48,110 | 47,777 | 48,029 | 47,632 | ||||||||
|
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (In thousands) (Unaudited) |
||||||
| September 30, | December 31, | |||||
| 2009 | 2008 | |||||
| Assets: | ||||||
| Cash, cash equivalents and current marketable investment securities | $80,076 | $97,380 | ||||
| Current restricted cash and cash equivalents | 27,233 | 37,016 | ||||
| Account receivable | 20,447 | 25,406 | ||||
| Litigation settlement receivable | -- | 16,000 | ||||
| Other current assets | 4,648 | 2,694 | ||||
| Equipment, net | 363 | 285 | ||||
| Marketable investment securities, less current portion | 7,885 | 8,752 | ||||
| Debt issuance costs, net | 3,882 | 5,158 | ||||
| Other long-term assets | 691 | 1,486 | ||||
| Goodwill | 9,429 | 9,429 | ||||
| Total assets | $154,654 | $203,606 | ||||
| Liabilities and Stockholders’ Deficit: | ||||||
| Current liabilities | $60,365 | $81,889 | ||||
| Convertible notes and capital lease obligation | 50,000 | 50,014 | ||||
| Non-recourse debt, less current portion* | 248,042 | 268,277 | ||||
| Other long-term liabilities | 18,614 | 18,512 | ||||
| Total liabilities | 377,021 | 418,692 | ||||
| Common stock and additional paid-in capital | 696,191 | 689,994 | ||||
| Accumulated other comprehensive income (loss) | 2,207 | (200 | ) | |||
| Accumulated deficit | (920,765 | ) | (904,880 | ) | ||
| Total stockholders' deficit | (222,367 | ) | (215,086 | ) | ||
| Total liabilities and stockholders' deficit | $154,654 | $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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