Exhibit 99.1
NPS Pharmaceuticals Reports Third Quarter and Nine Month Operating Results
SALT LAKE CITY, Nov. 6 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc.
(Nasdaq: NPSP) today reviewed recent progress with its late-stage product
candidates, announced new executive appointments at the company, and reported
its operating results for the three and nine months ended September 30, 2003.
(Logo: http://www.newscom.com/cgi-bin/prnh/20000218/NPSLOGO )
Product Review
In September 2003 NPS announced that its licensee, Amgen Inc., had
submitted a new drug application (NDA) to the U.S. Food and Drug
Administration seeking approval to market cinacalcet HCl as a therapy for the
treatment of secondary hyperparathyroidism in patients with chronic kidney
disease. Subsequently Amgen has announced that an application for approval to
market cinacalcet HCl has also been submitted to the European Agency for the
Evaluation of Medicinal Products.
Development of the company's proprietary compound, PREOS(R), for the
treatment of osteoporosis, continues to advance with the recent completion of
dosing of patients in the Phase III TOP study. More than 90 percent of
eligible TOP study patients have chosen to continue to receive PREOS
injections for a total of up to 24 months of treatment in an Open Label
Extension Study (OLES). NPS is also studying the use of PREOS in combination
with hormone replacement therapy in the POWER study, and researchers recently
reported interim data from the ongoing PaTH study, which is evaluating PREOS
used alone or in combination with alendronate, a currently available
osteoporosis therapy. Interim findings from the PaTH study, which were
published in the New England Journal of Medicine, confirm the ability of PREOS
to build new bone in the vertebral spine and in the hip when used alone or as
a combination therapy.
NPS also noted that a preclinical study to assess whether various doses of
PREOS cause cancers in rats is nearing the point of a first report of data.
The company has received some initial, incomplete data from the contract
research organization (CRO) responsible for compiling study results, and
expects to receive additional information from the CRO sufficient to announce
preliminary results of the study by the week of November 17.
The company recently announced the commencement of a proof-of-concept
study with teduglutide (formerly ALX-0600) to evaluate its therapeutic
potential in treating patients with Crohn's disease. In previous clinical
tests the compound produced a significant growth effect on cells that line the
intestinal tract, improving patients' ability to absorb nutrients and gain
weight. In addition to the Crohn's disease study, NPS intends to initiate a
pivotal trial with teduglutide in adults with short bowel syndrome by the end
of 2003 or early 2004.
Executive Appointments
NPS also announced the appointments of Gerard Michel as Chief Financial
Officer and Morgan Brown as Vice President, Finance. Mr. Michel served as
Vice President, Corporate Development at NPS prior to his new assignment. As
CFO, he will continue to oversee corporate development activities and will
have additional responsibility for finance, information technologies, and
facilities. Mr. Michel brings broad, cross-functional experience to his new
position in areas such as pharmaceutical strategy, corporate finance, mergers
and acquisitions, and marketing. Prior to joining NPS he worked with the
consulting firm Booz-Allen & Hamilton where he provided strategic and
operational counsel to multi-national pharmaceutical companies, biotechnology
firms, and healthcare organizations. Previously, he worked at Lederle
Laboratories in a variety of U.S. and international marketing, sales, and
corporate development positions. Mr. Michel received an M.S. in microbiology
and an M.B.A. from the University of Rochester. He will be based at the NPS
office in Parsippany, New Jersey.
Mr. Brown is a C.P.A. who has been serving as Corporate Controller and
Senior Director of Financial Reporting at NPS. Prior to joining NPS he worked
with the accounting firm of KPMG where he was employed as a senior manager.
Mr. Brown will be responsible for finance, accounting, and budgeting
functions, and for the implementation and monitoring of internal control
procedures. He will also serve as treasurer, which will include responsibility
for managing cash and marketable securities. Mr. Brown received an M.B.A.
from the University of Utah and a B.S. in accounting from Utah State
University. He will be based in the company's headquarters in Salt Lake City.
Third Quarter Financial Results
NPS incurred a net loss for the third quarter of 2003 of $28.9 million, or
$0.79 per share, compared to a net loss in the third quarter of 2002 of
$18.3 million, or $0.60 per share. For the nine months ended September 30,
2003, the net loss was $121.9 million, or $3.40 per share, compared to
$61.4 million, or $2.02 per share for the nine months ended September 30,
2002. The net loss for the nine months ended September 30, 2003 includes an
expense of $40.2 million relating to a termination fee in the form of
1.5 million shares of the company's common stock and other costs associated
with the terminated merger with Enzon Pharmaceuticals, Inc.
Revenues for the third quarter of 2003 were $7.7 million compared to
revenues of $140,000 for the same period last year. Revenues for the nine
months ended September 30, 2003 were $7.9 million compared to $2.0 million in
the same period of 2002. Substantially all revenues during the periods were
from development and license agreements. The increases in revenues during
2003 as compared to the same periods in the prior year are primarily the
result of a $6.0 million milestone payment NPS received from Amgen, Inc. for
the submission of an NDA to the United States Food and Drug Administration for
cinacalcet HCl in September 2003. Additionally, the company recognized
$1.5 million in revenue during 2003 as a result of our settled arbitration
with Forest Laboratories, Inc., which occurred in July 2003.
Research and development expenses were $31.3 million for the third quarter
of 2003 compared to $16.9 million for the third quarter of 2002. The increase
in research and development expenses compared to the third quarter of 2002 is
principally due to a $10.7 million increase in the costs of advancing the
development of the PREOS program, a $2.0 million increase in the costs
associated with the manufacture of clinical and commercial supplies of PREOS
and teduglutide, and a $1.4 million increase in the costs related to advancing
our central nervous system programs. These increases were offset by a
$1.1 million decrease in the costs of advancing the development of the
teduglutide program. For the nine months ended September 30, 2003, research
and development expenses were $79.5 million compared to $58.2 million for the
same period in 2002. The increase in research and development expenses during
the nine months ended September 30, 2003 as compared to the same period in the
prior year is primarily due to a $11.8 million increase in the costs of
advancing the development of the PREOS program, a $4.8 million increase in the
costs associated with the manufacturing of PREOS and teduglutide, including
costs related to an agreement with Boehringer Ingelheim Austria GmbH for the
manufacture of bulk drug supplies of PREOS for eventual commercial sale, and a
$1.5 million increase in clinical development costs due to advancing central
nervous system drug development programs.
General and administrative expenses were $4.9 million for the quarter
ended September 30, 2003 compared to $3.2 million expended in the same quarter
in 2002. For the nine months ended September 30, 2003, general and
administrative expenses were $14.2 million compared to $10.4 million for the
same period in 2002. The increases in general and administrative expenses
during the nine months ended September 30, 2003 as compared with the same
periods in the prior year are primarily due to market development activities
associated with PREOS and teduglutide and the related hiring of additional
administrative personnel.
Amortization of intangibles of $376,000 and $1.1 million for the three and
nine months ended September 30, 2003, respectively, are comparable to $334,000
and $1.0 million for the same periods in the prior year.
Merger costs and termination fees were $351,000 and $40.2 million for the
three and nine months ended September 30, 2003, respectively, as a result of
the termination of our merger agreement with Enzon Pharmaceuticals, Inc.
Pursuant to the terms of that merger agreement, the company paid a termination
fee in the form of 1.5 million shares of the company's common stock
transferred to Enzon on June 4, 2003. The company also incurred direct costs
relating to the proposed merger of approximately $4.6 million.
Other income, net, decreased from $2.0 million to other expense, net, of
$170,000 for the three months ended September 30, 2003 as compared with the
same period in the prior year. Other income, net, decreased from $6.1 million
to $3.1 million for the nine months ended September 30, 2003 as compared with
the same period in the prior year. The decreases in other income, net, in
both periods are primarily the result of recording interest expense of
$1.7 million and $2.0 million for the three and nine months ended
September 30, 2003, respectively, on our $192.0 million 3.0 percent
convertible notes. Additionally, interest income decreased $1.2 million
during the nine months ended September 30, 2003 as compared to the same period
in the prior year primarily due to lower interest rates during 2003 as
compared to the same period in the prior year.
As of September 30, 2003, the company had 36.9 million shares outstanding
and $346.3 million in cash, cash equivalents, and marketable investment
securities as compared to $234.5 million at December 31, 2002. The increase
in cash, cash equivalents and marketable investment securities was primarily
the result of our sale of $192.0 million, 3.0 percent convertible debentures
that was completed in July 2003. The company received net proceeds of
$185.9 million from the offering after deducting debt issuance costs.
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)
October 22,
1986
(inception)
Three Months Ended Nine months Ended through
September 30, September 30, Sept. 30,
2003 2002 2003 2002 2003
Revenues from
research and
license
agreements $7,700 $140 $7,911 $2,021 $83,584
Operating
expenses:
Research and
development 31,253 16,874 79,505 58,217 339,922
General and
administ-
rative 4,888 3,206 14,185 10,365 88,113
Amortization
of
intangibles 376 334 1,091 991 9,385
In-process
research and
development
acquired -- -- -- -- 17,760
Merger costs
and
termination
fees 351 -- 40,223 -- 40,223
Total
operating
expenses 36,868 20,414 135,004 69,573 495,403
Operating
loss (29,168) (20,274) (127,093) (67,552) (411,819)
Other income
(expense), net (170) 1,990 3,093 6,129 41,700
Loss
before
taxes (29,338) (18,284) (124,000) (61,423) (370,119)
Income tax
expense
(benefit) (395) -- (2,091) 10 (875)
Loss before
cumulative
effect of
accounting
change (28,943) (18,284) (121,909) (61,433) (369,244)
Cumulative
effect of
accounting
change -- -- -- -- (500)
Net loss $(28,943) $(18,284) $(121,909) $(61,433) $(369,744)
Basic and
diluted net
loss per
common and
potential
common share $(0.79) $(0.60) $(3.40) $(2.02)
Weighted average
common and
potential
common shares
outstanding
- basic and
diluted 36,796 30,435 35,864 30,338
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
September 30, December 31,
2003 2002
Cash, cash equivalents and
marketable investment securities $346,302 $234,454
Other current assets 6,087 5,149
Plant and equipment, net of
accumulated depreciation and amortization 5,062 4,310
Other assets, net of accumulated
amortization 15,785 9,555
Total assets 373,236 $253,468
Current liabilities 21,475 11,106
Convertible notes payable 192,000 -
Total liabilities 213,475 11,106
Paid-in capital and common stock 532,543 489,387
Deferred compensation (4,127) (370)
Accumulated other comprehensive income 1,089 1,180
Deficit accumulated during
development stage (369,744) (247,835)
Net stockholders' equity 159,761 242,362
Total liabilities and
stockholders' equity $373,236 $253,468
NPS discovers, develops and intends to commercialize small molecules and
recombinant proteins as drugs, primarily for the treatment of metabolic, bone
and mineral, and central nervous system disorders. The company has drug
candidates in various stages of clinical development backed by a strong
discovery research effort. Additional information is available on the
company's website, http://www.npsp.com .
Call Information
A conference call will be held today at 5:00 p.m. EST. To participate in
the call, dial 1-800-374-0232 and use confirmation code 2671058. In addition,
live audio of the conference call will be simultaneously broadcast over the
internet and may be accessed under the Investor Relations page, Calendar of
Events section of the company's website ( www.npsp.com ). Please click on the
webcast link and follow the prompts for registration and access.
If you are unable to participate in the live call, a replay will be
available at 1-800-642-1687 (with confirmation code 2671058) until
midnight, EST, November 13, 2003. The webcast portion of the call will also
be available on the NPS website for the same period of time.
Cautionary Statement For The Purpose Of The "Safe Harbor" Provisions
Of The Private Securities Litigation Reform Act of 1995
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. Such statements
include those regarding our intent: to file an application with the FDA in the
third quarter of 2004 for marketing approval of PREOS; initiate a pivotal
trial in adult patients with SBS by the end of 2003 or early 2004 for
teduglutide; to comment on the PREOS rat carcinogenicity study the week of
November 17, 2003; and our intent, or the intent of our licensees, to
commercialize small molecules and recombinant proteins as drugs, specifically,
our product candidates, PREOS, teduglutide and cinacalcet HCl. These
statements are based on management'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. Such risks and uncertainties include: we may not be able to
analyze and compile data from the PREOS studies in a timely manner; we may not
be able to agree with the FDA on a clinical plan for teduglutide; the CRO may
not deliver data from the rat carcinogenicity study in a timely manner; we do
not have and may never develop any products that generate revenues; our
product candidates may not prove to be safe or efficacious; the FDA may delay
approval or may not approve any of our product candidates; current
collaborators or partners may not devote adequate resources to the development
and commercialization of our licensed drug candidates, which would prevent or
delay introduction of drug candidates to the market; we may be unable to
generate adequate sales and marketing capabilities to effectively market and
sell our products; failure to secure adequate manufacturing and storage
sources for our products could result in disruption or cessation of our
clinical trials and eventual commercialization of such products; and, we may
not have or be able to secure sufficient capital to fund development and
commercialization of our product candidates. All information in this press
release is as of November 6, 2003, and we undertake no duty to update this
information. A more complete description of these risks can be found in our
filings with the Securities and Exchange Commission, including our Annual
Report on Form 10-K/A for the year ended December 31, 2002, and in our
quarterly report on Form 10-Q for the third quarter of 2003.
SOURCE NPS Pharmaceuticals, Inc.
-0- 11/06/2003
/CONTACT: David L. Clark, Vice President, Corporate Affairs, NPS
Pharmaceuticals, Inc., +1-801-584-5415/
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PRN Photo Desk, photodesk@prnewswire.com/
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/Web site: http://www.npsp.com /
(NPSP)
CO: NPS Pharmaceuticals, Inc.
ST: Utah
IN: HEA MTC BIO
SU: ERN CCA PER