Exhibit 99.1
NPS Pharmaceuticals Reports First Quarter 2004 Results
SALT LAKE CITY, May 6 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc.
(Nasdaq: NPSP) announced today operating and financial results for the first
quarter ended March 31, 2004.
Product Update
NPS has made significant advancements in 2004 in its product development
efforts, and has reported progress by its licensee, Amgen, Inc., with
cinacalcet HCl.
PREOS(R)
* In March, NPS made its initial report of data from the Phase 3 TOP
(Treatment of Osteoporosis with PTH) study with PREOS, its
osteoporosis drug candidate. The study showed a statistically
significant reduction of 59% in the relative risk of new or worsened
vertebral fractures in women with low bone mineral density.
Approximately 81% of study participants did not have a fracture of the
spine prior to entering the study, which represents a broad spectrum
of women from the general osteoporosis population. Bone mineral
density increased significantly in study participants. The most
common side effects in the study were elevated serum and urine
calcium. The company is preparing to submit a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA).
* The company has been conducting a study with PREOS in Europe in women
with osteoporosis who are taking hormone replacement therapy. This
study, called POWER (PTH for Osteoporotic Women on Estrogen
Replacement), was scheduled to provide for 24 months of dosing with
PREOS in combination with estrogen. Due to new data regarding the
risks associated with hormone replacement therapy the POWER study has
been shortened to 18 months from the start of dosing. Data from the
first year of the POWER study will be included in the NDA for PREOS.
* Recently NPS has announced the execution of a marketing and license
agreement for PREOS with Nycomed Group, a Danish pharmaceutical
marketing firm. In exchange for rights to market and sell PREOS in
Europe, Nycomed agreed to purchase 1.33 million newly issued common
shares of NPS stock for $40 million, and committed to $25 million of
milestone payments and a minimum investment of another $25 million in
European clinical trial work. Nycomed will pay royalties to NPS on
sales of PREOS.
* NPS also announced the hiring of several experienced pharmaceutical
executives to bolster the company's commercial organization. Margaret
Crowley has been appointed senior director, marketing, David Pierson
is serving as senior director, sales, and Stephen Morris, Ph.D., M.D.,
was appointed senior director, medical affairs. These appointments
further strengthen the company's ability to participate in the
commercialization of PREOS and other future NPS products.
Cinacalcet HCl
* Cinacalcet HCl, a calcimimetic drug licensed by NPS to Amgen Inc., is
now being sold under the brand name Sensipar(TM). Amgen received
approval from the FDA to market Sensipar to chronic kidney disease
patients on dialysis with secondary hyperparathyroidism (HPT) and to
patients with primary HPT resulting from parathyroid carcinoma. Amgen
also received approvable letters from the FDA for Sensipar to treat
patients with chronic kidney disease without dialysis and all patients
with primary HPT. Regulatory approval of Sensipar resulted in a
$10 million milestone payment by Amgen to NPS.
* NPS has also received a $2 million milestone from its Asian licensee,
Kirin Brewery, for the start of Phase 3 trials with cinacalcet HCl in
dialysis patients in Japan.
Teduglutide
NPS has initiated a pivotal Phase 3 study with its proprietary product
candidate, teduglutide, in patients with short bowel syndrome (SBS).
Teduglutide is a peptide that acts to stimulate the proliferation and growth
of cells that line the gastrointestinal tract. Therapeutic benefit in various
diseases may be derived from the increased absorptive surface area and
enhanced integrity of the intestinal wall that result from this effect. A
proof-of-concept study is also underway with teduglutide in patients with
Crohn's disease.
Legal Proceedings
Recently the company was served with a legal complaint filed on April 27,
2004 in the Superior Court of Cobb County in the state of Georgia by PharmData
Inc., a contract research organization that has provided data compilation and
analysis services for NPS. The complaint alleges breach of agreement due to a
failure by NPS to make specified monthly payments in exchange for PharmData's
reservation of service capacity, or provision of services.
NPS intends to vigorously contest the legal proceeding brought by
PharmData, and is evaluating its legal options while preparing a counter-suit.
NPS believes that PharmData procured the agreement on the basis of illegal
payments to a former NPS employee. The company has repudiated the contract
and will seek release from its contractual obligations to PharmData and relief
from PharmData's claims for compensation in yet-to-be-determined amounts and
reimbursement of legal costs.
PharmData has been engaged in the compilation and analysis of data from
certain toxicity studies with PREOS(TM), the company's osteoporosis drug
candidate. NPS emphasized that the dispute does not involve the handling of
data from the pivotal Phase 3 study with PREOS. The company expects to
proceed to compile and analyze data from the studies in question for inclusion
in the New Drug Application (NDA) for PREOS, to be filed with the U.S. Food
and Drug Administration. NPS cautioned however, that the dispute with
PharmData could possibly cause some delay in the filing of the NDA depending
on how rapidly data entry with a new contract research organization could
begin and be completed. The company is making every effort to avoid or
minimize any such delay. NPS does not anticipate that the current legal
proceedings will have a material adverse impact on its ability to pursue its
plan for the regulatory approval of PREOS, or on the company's financial
position.
As the company, its Audit Committee, and outside counsel to the Audit
Committee work to complete their investigation of the circumstances involving
the repudiated contract and the alleged improper payments to a former NPS
employee by PharmData, there is the possibility that the company will not file
its quarterly report on Form 10-Q by May 10, 2004 and instead seek an
extension until May 17, 2004.
Financial Results
Financial results for the first quarter of 2004 included a net loss of
$35.7 million, or $0.96 per share, compared to a net loss in the first quarter
of 2003 of $28.1 million, or $0.80 per share.
Revenues for the first quarter of 2004 were $12.0 million compared to
revenues of $138,000 for the same period last year. Substantially all
revenues come from license fees, research and development support or milestone
payments from licensees and collaborators. The increase in revenues in the
first quarter of 2004 is due to a $10.0 million milestone payment received
from Amgen, Inc. for approval by the FDA of the NDA for Sensipar(R) in March
2004, and a $2.0 million milestone payment received from Kirin Brewery for the
commencement of Phase 3 clinical trials with cinacalcet HCl in Japan.
Research and development expenses were $40.6 million for the first quarter
of 2004 compared to $24.8 million for the first quarter of 2003. The increase
in research and development expenses during the first quarter of 2004 as
compared to the same period in the prior year is primarily due to a
$9.7 million increase in costs associated with the manufacture of clinical and
commercial supplies of PREOS and teduglutide, including amounts paid and due
to a contract manufacturer for reservation fees in accordance with an
agreement for "fill and finish" production of clinical and commercial supplies
of PREOS; a $1.9 million increase in the costs of advancing the teduglutide
clinical program; and a $2.5 million increase in the costs related to
advancing the company's central nervous system programs.
General and administrative expenses increased to $6.5 million for the
first quarter of 2004 from $5.0 million expended in the first quarter in 2003.
The increase in general and administrative expenses is primarily due to an
$883,000 increase in costs related to marketing activities associated with
PREOS and teduglutide, and a $675,000 increase in costs related to
administrative personnel, and accounting and information technology costs.
Other expense, net, was $58,000 for the first quarter of 2004 compared to
other income, net, of $1.9 million for the first quarter of 2003. The
decrease is primarily the result of interest expense of $1.7 million recorded
in the first quarter of 2004 on the company's $192.0 million 3.0 percent
convertible notes, which were issued in June 2003. A similar expense was not
recorded in the first quarter of 2003.
As of March 31, 2004, the company had 37.2 million shares outstanding and
$262.2 million in cash, cash equivalents, and marketable investment securities
as compared to $303.9 million at December 31, 2003. Cash, cash equivalents,
and marketable investment securities have decreased as a result of funding
current operations, including the company's significant research and
development efforts.
NPS PHARMACEUTICALS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)
Three Months Ended March 31,
2004 2003
Revenues from research
and license agreements $12,011 $138
Operating expenses:
Research and development 40,598 24,821
General and administrative 6,531 4,979
Amortization of intangibles 394 343
Total operating expenses 47,523 30,143
Operating loss (35,512) (30,005)
Other income (expense), net (58) 1,915
Loss before taxes (35,570) (28,090)
Income tax expense 81 --
Net loss $(35,651) $(28,090)
Basic and diluted net loss per common
and common - equivalent share $(0.96) $(0.80)
Weighted average common and
common-equivalent shares
outstanding - basic and diluted 37,182 35,132
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
March 31, December 31,
2004 2003
Cash, cash equivalents and marketable
investment securities $262,233 $303,874
Other current assets 13,948 2,755
Restricted cash and cash equivalents 5,269 --
Plant and equipment, net of accumulated
depreciation and amortization 7,202 5,255
Other assets, net of accumulated
amortization 14,819 15,623
Total assets $303,471 $327,508
Current liabilities $32,141 $22,723
Convertible notes payable 192,000 192,000
Total liabilities 224,141 214,723
Common stock and additional paid-in
capital 536,383 533,966
Deferred compensation (3,418) (3,716)
Accumulated other comprehensive
income (loss):
Net unrealized gain on marketable
investment securities 1,132 1,266
Foreign currency translation (886) (501)
Accumulated deficit (453,881) (418,230)
Net stockholders' equity 79,330 112,785
Total liabilities and stockholders'
equity $303,471 $327,508
Information
The management of NPS will discuss the company's first quarter results and
other related matters on a conference call today at 3:00 p.m. MDT (5:00 p.m.
EDT). To participate in the conference call, dial 800-374-0232 and use access
code 6842515. International callers may dial 706-634-6338 using the same
access code. 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 800-642-1687 (with access code 9795684) until
midnight May 23, 2004. The replay number for international callers is
706-645-9291. The web- cast portion of the call will also be available on the
NPS web site 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
Note: 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 the likelihood that PREOS will be an
appropriate therapy for patients who have osteoporosis; NPS's plans to file an
NDA for PREOS by the of 2004; the filing of the NDA for PREOS may be delayed a
few weeks to months as a result of the PharmData litigation; and, that the
quarterly report on form 10-Q will be filed with the SEC by May 17, 2004.
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 collect, assemble and analyze data from the PREOS trials in a
timely manner; the data from the TOP study may not justify filing an NDA for
PREOS; we have never filed an NDA and may not be able to do so in a timely
manner; we may not be able to secure the services of another contract research
organization to provide the services previously being rendered by PharmData;
the independent investigator may not complete the investigation timely,
resulting in the 10-Q being filed late; Nycomed may not be able to
successfully market and sale PREOS in Europe; 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 May 6, 2004, 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 10K/A for the year ended
December 31, 2003.
SOURCE NPS Pharmaceuticals, Inc.
-0- 05/06/2004
/CONTACT: David L. Clark, Vice President, Corporate Affairs of NPS
Pharmaceuticals, Inc., +1-801-583-4939/
/Company News On-Call: http://www.prnewswire.com/comp/613587.html /
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20000218/NPSLOGO
PRN Photo Desk, photodesk@prnewswire.com/
/Company News On-Call: http://www.prnewswire.com/comp/613587.html /
/Web site: http://www.npsp.com /
(NPSP)
CO: NPS Pharmaceuticals, Inc.
ST: Utah
IN: MTC HEA BIO
SU: ERN CCA MAV