07.05.2008 20:50:00
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NPS Pharmaceuticals Reports First Quarter 2008 Financial Results and Business Update
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) today reported its financial
results for the first quarter of 2008. Revenues increased to $25.2
million for the first quarter of 2008, as compared to $10.0 million for
the first quarter of 2007. Operating expenses decreased to $20.1 million
for the first quarter of 2008 as compared to $25.9 million for the first
quarter of 2007. The company’s net loss was
$13.1 million for the first quarter of 2008, or $0.28 per diluted share,
versus a net loss of $21.1 million, or $0.45 per diluted share, for the
first quarter of 2007.
First Quarter Highlights
NPS completed the implementation of its new business strategy, which
focused its development programs on specialty indications for
gastrointestinal and endocrine disorders and consolidated operations
into one facility in New Jersey.
NPS appointed Francois Nader, M.D., as president, chief executive
officer and director. Dr. Nader previously served as executive vice
president and chief operating officer of NPS and played a key role in
the development and implementation of the company’s
new business strategy.
NPS appointed Alan G. Harris, M.D., Ph.D., as senior vice president
and chief medical officer. Dr. Harris brings more than 20 years of
pharmaceutical industry experience to NPS with an emphasis on
gastrointestinal and endocrine disorders.
NPS reported positive top-line results from a blinded Phase
3-extension study of GATTEX™ for patients
with short bowel syndrome (SBS) who are dependent upon parenteral
nutrition (PN). Data from this study demonstrated a favorable safety
profile and a number of positive efficacy measures. Sixty-eight
percent (68%) of the 25 patients who had received low-dose GATTEX
therapy and 52% of the 27 patients who had received high-dose GATTEX
therapy achieved a 20% or greater reduction in PN after a total of 52
weeks of therapy.
Three GATTEX-related abstracts were accepted for presentation at the
2008 Digestive Disease Week (DDW) conference, including two oral
presentations of data from the Phase 3 study of GATTEX for
PN-dependent SBS patients.
Kirin launched REGPARA® (cinacalcet
HCl) in Japan for secondary hyperparathyroidism during maintenance
dialysis.
Francois Nader, M.D., president and chief executive officer, stated: "The
first quarter was marked by the continued advancement of our proprietary
and partnered pipeline. We reported positive top-line results from our
Phase 3-extension study of GATTEX for SBS and our partner Kirin launched
REGPARA in Japan. We are finalizing our protocol for a Phase 3
confirmatory study for GATTEX and we remain on track to launch the study
in the third quarter of this year. Our second late-stage program,
NPSP558, for hypoparathyroidism continues to progress with the
initiation of a pivotal study on target for the second half of this
year. Equally important, we continue to manage our expenses in line with
our 2008 cash burn guidance.” 2008 Financial Results Revenues
Revenues increased to $25.2 million for the first quarter of 2008, as
compared to $10.0 million for the first quarter of 2007. The increase is
primarily due to (i) license fee revenue recognized under the company’s
agreement with Nycomed for GATTEX, (ii) royalty revenue on Amgen’s
sales of Sensipar®
(cinacalcet HCl), and (iii) revenues associated with the company’s
agreement with Nycomed for Preotact®
(parathyroid hormone 1-84 [rDNA origin]
injection).
Sensipar royalties are paid directly to a restricted cash account of a
subsidiary of NPS and used to secure non-recourse debt issued in
December 2004 and August 2007. After repayment of the debt, Sensipar
royalties will return to NPS.
Preotact royalties are paid directly to DRI Capital (formerly Drug
Royalty Corporation) in accordance with non-recourse debt issued in July
2007. The Preotact royalties will return to NPS if royalty payments to
DRI Capital exceed two and one-half times the amount of advanced
principal, including any milestone payments.
Research and Development
Research and development expenses were $6.4 million for the first
quarter of 2008 versus $10.2 million for the first quarter of 2007. The
reduction in research and development expenses during 2007 was
attributable to the implementation of the company’s
new strategy and the corresponding reduction in personnel and related
costs, as well as the discontinuation of activities that were no longer
strategically aligned.
General and Administrative
General and administrative expenses were $9.3 million for the first
quarter of 2008 versus $6.6 million for the first quarter of 2007. The
increase in general and administrative expenses is primarily
attributable to expenses associated with the departure of the company’s
former chief executive officer which, pursuant to his employment
agreement, included a cash payment and non-cash charges related to the
acceleration of previously issued equity awards. In addition, the
company incurred higher legal expenses in the first quarter of 2008
principally due to current litigation. These increases were partially
offset by reductions in personnel and associated expenditures due to the
implementation of the company’s new business
strategy.
Restructuring Charges
NPS reported a $282,000 credit for restructuring charges for the first
quarter of 2008 as compared to a $7.1 million expense for the first
quarter of 2007. Restructuring charges primarily comprised employee
termination benefits.
Interest Expense, net
Interest expense, net, was $15.1 million for the first quarter of 2008
versus $5.2 million for the first quarter of 2007. The increase in
interest expense was primarily attributable to the following: (i) the
issuance of non-recourse debt secured by the company’s
Sensipar revenues (Secured 15.5% Class B Notes due 2017) in August 2007,
(ii) the issuance of non-recourse debt secured by the company’s
Preotact revenues in July 2007, and (iii) an increase in the effective
interest rate of the company’s Secured 8.0%
Notes due 2017 (Class A Notes) attributable to an increase in the company’s
sales forecasts for Sensipar. These increases were partially offset by
reductions in interest expense due to the retirement of the company's 3%
convertable notes and the sale of the company's Salt Lake City building
in 2007.
Loss on Investment
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 determining that the change in fair value
of its ARS investments is "other than
temporary” and, as such, NPS recorded an
impairment charge of $3.5 million in the first quarter of 2008.
Cash and Investments
At March 31, 2008, NPS’s cash, cash
equivalents, short- and long-term investments totaled $149.1 million, as
compared to $161.7 million at December 31, 2007. The company’s
cash burn guidance for 2008 remains unchanged at $45 to $55 million and
excludes potential changes in the estimated fair value of the company’s
ARS investments. At March 31, 2008, NPS held AAA-rated ARS investments
with a cost basis of $29.7 million and an estimated fair value of $26.2
million. NPS has classified its ARS investments as a non-current asset
within its balance sheet.
Restatement of 2007 Financial Results
NPS will file an amendment on Form 10-K/A to its annual report for the
year ended December 31, 2007 due to an error in the computation of the
cash sweep premium interest expense associated with the company's Class
A Notes. NPS detected this error during the course of its preparation
and review of its Quarterly Report on Form 10-Q for the period ended
March 31, 2008. While the error affects the interest expense reported in
the company’s financial statements, NPS does
not expect it to affect its current projections for the retirement of
the Class A Notes. The Class A Notes are non-recourse to NPS and are
secured by royalties on sales of Sensipar. NPS expects the corrections
to result in an increase of $3.8 million in accrued expenses and
interest expense; a reduction of $0.1 million in income taxes payable
and income tax expense; and an increase in retained deficit of $3.7
million. For additional information, please refer to the Form 8-K that
NPS filed today with the U.S. Securities and Exchange Commission.
Conference Call Information
NPS will host a conference call beginning today at 5:00 pm Eastern Time.
To participate in the conference call, dial (800) 706-7748 and use pass
code 93538509. International callers may dial (617) 614-3473, using the
same pass code. 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 (888) 286-8010, with pass code 31056689, until midnight
Eastern Time, May 21, 2008. International callers may access the replay
by dialing (617) 801-6888, using the same pass code. The webcast will
also be available through the NPS website for the same period.
About NPS Pharmaceuticals
NPS Pharmaceuticals is developing specialty therapeutics for
gastrointestinal and endocrine disorders with high unmet medical need.
The company is currently advancing two late-stage programs. Teduglutide,
a proprietary analog of GLP-2, is in Phase 3 clinical development for
intestinal failure associated with short bowel syndrome as GATTEX™
and in preclinical development for gastrointestinal mucositis and
necrotizing enterocolitis. NPSP558 (parathyroid hormone 1-84 [rDNA
origin] injection) is in Phase 2 clinical
development as a hormone therapy for hypoparathyroidism. NPS complements
its proprietary programs with a royalty-based portfolio of products and
product candidates that includes strategic partnerships with Amgen,
GlaxoSmithKline, Janssen, Kirin, and Nycomed. Additional information is
available at http://www.npsp.com.
"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’s
business include, but are not limited to, the risk of not successfully
executing its preclinical and clinical studies and not gaining marketing
approvals for GATTEX and NPSP558, the risks associated with the
implementation of a new business strategy, the risks associated with the
company’s auction-rate securities, as well as
other factors expressed in NPS’s periodic
filings with the U.S. Securities and Exchange Commission, including its
Annual Report on Form 10-K and Form 10-Qs. All information in this press
release is as of the date of this release and NPS undertakes no duty to
update this information.
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)
Three Months Ended
March 31,
2008
2007
Revenues
$
25,180
$
9,991
Costs and expenses:
Cost of goods sold
1,350
952
Cost of royalties
1,373
1,047
Cost of license fees
1,920
--
Research and development
6,437
10,245
General and administrative
9,294
6,570
Restructuring charges
(282
)
7,114
Total operating expenses
20,092
25,928
Operating income (loss)
5,088
(15,937
)
Interest expense, net
(15,099
)
(5,174
)
Loss on investment
(3,502
)
--
Other income (expense), net
420
(33
)
Net loss before income tax expense
(13,093
)
(21,144
)
Income tax expense
--
--
Net loss
($13,093
)
($21,144
)
Net loss per common and potential common share:
Basic and diluted
($0.28
)
($0.45
)
Weighted average common and potential common share:
Basic and diluted
47,447
46,625
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