-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, P4/rAAFuyZDIy6KrEh7T6wI8+25Zzq+3U8EVZux8BRQ8ToNR1bv5NNgP7Ec4gcQM bBsYjua4BrKHpxdR53ZRxw== 0000891092-04-000632.txt : 20040210 0000891092-04-000632.hdr.sgml : 20040210 20040210162521 ACCESSION NUMBER: 0000891092-04-000632 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040210 ITEM INFORMATION: FILED AS OF DATE: 20040210 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NPS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000890465 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 870439579 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23272 FILM NUMBER: 04582300 BUSINESS ADDRESS: STREET 1: 420 CHIPETA WAY STE 240 CITY: SALT LAKE CITY STATE: UT ZIP: 84108-1256 BUSINESS PHONE: 8015834939 8-K 1 e16876_8k.txt FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 February 10, 2004 ------------------------------------------------ Date of Report (Date of earliest event reported) NPS PHARMACEUTICALS, INC. ------------------------------------------------------ (Exact Name of Registrant as Specified in Its Charter) Delaware 0-23272 87-0439579 - ---------------------------- ---------------- ---------------------- (State or Other Jurisdiction (Commission File (I.R.S. Employer of Incorporation) Number) Identification Number) 420 Chipeta Way Salt Lake City, Utah 84108 ---------------------------------------- (Address of principal executive offices) (801) 583-4939 ---------------------------------------------------- (Registrant's telephone number, including area code) ITEM 12: Results of Operations and Financial Condition The following information is furnished pursuant to Item 12, "Results of Operations and Financial Condition." On February 10, 2004, NPS Pharmaceuticals, Inc. (the "Company") issued a press release announcing the Company's 2004 fourth quarter and year-end operating results. The text of the press release is furnished as Exhibit 99.1 to this Form 8-K. The information in this Form 8-K and the Exhibit attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: February 10, 2004 NPS PHARMACEUTICALS, INC. --------------------------- By: /s/ HUNTER JACKSON Hunter Jackson CEO, President and Chairman of the Board EXHIBIT INDEX Exhibit Number Description - ------- ----------- 99.1 Press Release issued by NPS Pharmaceuticals, Inc. on February 10, 2004 announcing the Company's 2004 fourth quarter and year-end operating results. EX-99.1 3 e16876ex99_1.txt PRESS RELEASE Exhibit 99.1 NPS Pharmaceuticals Reports Fourth Quarter and Year-End Operating Results SALT LAKE CITY, Feb. 10 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today reviewed progress with its late-stage product candidates and reported its operating results for the three months and year ended December 31, 2003. (Logo: http://www.newscom.com/cgi-bin/prnh/20000218/NPSLOGO ) Product Review In 2003 NPS made significant clinical and regulatory progress in advancing its pipeline of product candidates: PREOS(R) * The company completed patient dosing with its proprietary compound PREOS in a pivotal, 18-month study known as TOP (Treatment of Osteoporosis with Parathyroid Hormone). An open-label extension study with former TOP study patients is ongoing. * NPS plans to make a report of top-line results from the TOP study by the end of the first quarter of 2004. Data from other studies with PREOS are expected to be available later this year, or in 2005. The company plans to submit a New Drug Application (NDA) for PREOS to the U.S. Food and Drug Administration (FDA) at the end of the third quarter 2004. * PREOS is also being tested in Europe in women using hormone replacement therapy in a study called POWER (Parathyroid Hormone for Osteoporotic Women on Estrogen Replacement). * Researchers at the University of California San Francisco supervised the completion of a two-year clinical study of PREOS and alendronate (an anti-bone resorption drug) used in combination or in sequence. Final results are expected from the investigation sometime this year. Cinacalcet HCl * In the third quarter of 2003, Amgen Inc., reported that an NDA had been filed for cinacalcet HCl, a small molecule licensed from NPS in 1996. Cinacalcet provides direct control of the secretion of parathyroid hormone, and may be useful as a treatment for hyperparathyroidism (HPT), a condition afflicting many people with chronic kidney disease or kidney failure. * Amgen also announced that the FDA had granted a request for a priority review of the cinacalcet NDA. NPS expects that Amgen will begin marketing cinacalcet in 2004, which will generate royalty revenue for the company. If approved by the FDA, cinacalcet will be the first NPS drug to be made available commercially for patient use. Teduglutide * In 2003, NPS announced the start of a proof-of-concept study with teduglutide in patients with Crohn's disease. Teduglutide is a proprietary protein molecule that acts to stimulate cells that line the gastrointestinal tract to increase in number and size. Therapeutic benefit may be derived from the increased absorptive surface area and enhanced integrity of the intestinal wall that result from this effect. * NPS plans to announce the start of a pivotal trial with teduglutide in patients with short bowel syndrome (SBS) in early 2004. * The company has signed a Mutual Termination Agreement with Technology Partnership Canada (TPC), which relieves NPS of any potential obligations related to the development or commercialization of teduglutide. Isovaleramide * The company is conducting a Phase IIa proof-of-concept study with isovaleramide in patients with migraine headaches. Isovaleramide is a small molecule neuromodulator that is one of several NPS compounds active in preclinical models of central nervous system (CNS) disorders. mGluRs * NPS is collaborating with AstraZeneca to find molecules that act on novel targets known as metabotropic glutamate receptors, or mGluRs. NPS and AstraZeneca are exploring possible applications of these compounds in the treatment of various central nervous system disorders, and in the treatment of gastroesophageal reflux disease, or GERD. Calcilytics * NPS licensee GlaxoSmithKline (GSK) has begun clinical testing of small orally active molecules called calcilytics. Calcilytics have the opposite action of calcimimetic compounds like cinacalcet, and can cause a transient increase in the release of parathyroid hormone, which may be beneficial in treating osteoporosis. If calcilytic compounds are successful, GSK will make milestone and royalty payments to NPS, and NPS will have an option to co-promote calcilytic products with GSK in North America. Financial Results NPS incurred a net loss for the fourth quarter of 2003 of $48.5 million, or $1.31 per share, compared to a net loss in the fourth quarter of 2002 of $25.4 million, or $0.76 per share. For the year ended December 31, 2003, the net loss was $170.4 million, or $4.71 per share, compared to $86.8 million, or $2.79 per share for the year ended December 31, 2002. The net loss for the year ended December 31, 2003 includes expenses of $6.2 million relating to the termination of the company's agreement with the Government of Canada pursuant to the TPC program in the fourth quarter of 2003, and a $39.9 million expense relating to a termination fee paid to Enzon Pharmaceuticals, Inc. in the form of 1.5 million shares of the company's common stock and other costs associated with the terminated merger in June 2003. Revenues for the fourth quarter of 2003 were $2.0 million, compared to revenues of $133,000 for the same period last year. Revenues for the year ended December 31, 2003 were $9.9 million compared to $2.2 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 and a $2.0 million milestone payment received from GSK for the initiation of a clinical study with a new calcilytic compound in the fourth quarter of 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 $38.7 million for the fourth quarter of 2003 compared to $22.7 million for the fourth quarter of 2002. For the year ended December 31, 2003, research and development expenses were $118.2 million compared to $80.9 million for the same period in 2002. The increase in research and development expenses in the fourth quarter of 2003 as compared to the fourth quarter of 2002 is principally due to a $3.5 million increase in the costs associated with continued clinical development of PREOS, a $5.1 million increase in the costs associated with advancing the teduglutide clinical research program, a $1.3 million increase in the costs associated with the manufacture of clinical and commercial supplies of PREOS and teduglutide, and a $2.6 million increase in spending on the company's central nervous system research programs. The increase in research and development expenses during the year ended December 31, 2003, as compared to the prior year, is primarily due to a $16.2 million increase in the costs of advancing the PREOS program, a $5.3 million increase in the costs of advancing the teduglutide program, a $6.3 million increase in the costs associated with the manufacture of PREOS, and a $6.6 million increase in the costs of advancing our central nervous system programs. General and administrative expenses were $6.2 million for the quarter ended December 31, 2003 compared to $4.4 million expended in the same quarter in 2002. For the year ended December 31, 2003, general and administrative expenses were $20.3 million compared to $14.8 million for the same period in 2002. The increases in general and administrative expenses during the three months and year ended December 31, 2003, as compared with the same periods in the prior year, are primarily due to increased marketing activities associated with PREOS and teduglutide and additional administrative costs, including the hiring of additional administrative personnel, with related benefits and costs, and non-cash compensation expense related to modified stock options upon the retirement of certain individuals. Amortization of intangibles of $394,000 and $1.5 million for the three months and year ended December 31, 2003, respectively, are comparable to $331,000 and $1.3 million for the same periods in the prior year. Merger costs and termination fees include $6.2 million relating to the termination of the company's agreement with the Government of Canada related to the TPC program in the fourth quarter of 2003, and $39.9 million relating to the termination of the proposed merger agreement with Enzon in the second quarter of 2003. In December 2003 the company reached an agreement to mutually terminate its contract with the Government of Canada under the TPC program. As a result, the company concluded that it was probable that it would have to repay amounts previously paid by TPC under this agreement and write off receivables due from TPC. In exchange for mutual releases, the company paid $4.3 million to the Government of Canada and released TPC from all outstanding reimbursement obligations, resulting in the write-off of $1.9 million in accounts receivable. NPS was relieved of any further or continuing obligations related to the development or commercialization of teduglutide. The company is continuing its clinical work with this compound. Additionally, pursuant to the terms of the Enzon merger agreement, the company issued Enzon 1.5 million shares of the company's common stock valued at $35.6 million as a termination fee. The company also incurred direct costs relating to the proposed merger of approximately $4.3 million. Other income, net, decreased from $1.8 million to $173,000 for the three months ended December 31, 2003 as compared with the same period in the prior year. Other income, net, decreased from $7.9 million to $3.3 million for the year ended December 31, 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 $3.7 million for the three months and year ended December 31, 2003, respectively, on our $192.0 million 3.0 percent convertible notes. Additionally, interest income decreased $919,000 during the year ended December 31, 2003, as compared to the same period in the prior year, primarily due to lower interest rates during 2003 as compared to 2002. As of December 31, 2003, the company had 37.1 million shares outstanding and $303.9 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 the company's sale in July 2003 of $192.0 million of its 3% convertible notes due 2008. 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 Twelve months Ended through December 31, December 31, December 31, 2003 2002 2003 2002 2003 Revenues from research and license agreements $2,009 $133 $9,919 $2,154 $85,593 Operating expenses: Research and development 38,668 22,655 118,173 80,872 378,588 General and administrative 6,152 4,412 20,337 14,777 94,266 Amortization of intangibles 394 331 1,485 1,322 9,779 In-process research and development acquired -- -- -- -- 17,760 Merger costs and termination fees 5,891 -- 46,114 -- 46,114 Total operating expenses 51,105 27,398 186,109 96,971 546,507 Operating loss (49,096) (27,265) (176,190) (94,817) (460,914) Other income (expenses), net 173 1,754 3,265 7,883 41,871 Loss before taxes (48,923) (25,511) (172,925) (86,934) (419,043) Income tax benefit (438) (112) (2,530) (102) (1,313) Loss before cumulative effect of accounting change (48,485) (25,399) (170,395) (86,832) (417,730) Cumulative effect of accounting change -- -- -- -- (500) Net loss $(48,485) $(25,399) $(170,395) $(86,832) $(418,230) Basic and diluted net loss per common and potential common share $(1.31) $(0.76) $(4.71) $(2.79) Weighted average common and potential common shares outstanding - basic and diluted 36,991 33,620 36,148 31,165 Condensed Consolidated Balance Sheets (In thousands) (Unaudited) December 31, December 31, 2003 2002 Cash, cash equivalents and marketable investment securities $303,874 $234,454 Other current assets 2,755 5,149 Plant and equipment, net of accumulated depreciation and amortization 5,255 4,310 Other assets, net of accumulated amortization 15,624 9,555 Total assets 327,508 $253,468 Current liabilities 22,723 11,106 Convertible notes payable 192,000 -- Total liabilities 214,723 11,106 Paid-in capital and common stock 533,966 489,387 Deferred compensation (3,716) (370) Accumulated other comprehensive income 765 1,180 Deficit accumulated during development stage (418,230) (247,835) Net stockholders' equity 112,785 242,362 Total liabilities and stockholders' equity $327,508 $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 . Conference Call and Webcast Information Today's conference call will be held at 5:00 p.m. EST. To participate, dial 1-800-374-0232 and use confirmation code 4654780. In addition, live audio of the call will be webcast and may be accessed on the Investor Relations page, Calendar of Events section of the company's website (www.npsp.com). The conference call replay may be accessed by dialing 1-800-642-1687 (with confirmation code 4654780). Both the webcast and conference call will be archived until February 17, 2004. 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: our intent to make a report of top-line data by the end of the first quarter 2004 and data from other studies later in 2004 and 2005; our intent to file an NDA for PREOS at the end of the first quarter 2004; our expectation that Amgen will begin marketing cinacalcet HCl in 2004; our intention to announce the start of a pivotal trial with teduglutide in early 2004; and, our intent to commercialize small molecules and recombinant proteins as drugs, specifically, our product candidates, PREOS 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 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 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 February 10, 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 for the year ended December 31, 2003. SOURCE NPS Pharmaceuticals, Inc. -0- 02/10/2004 /CONTACT: David L. Clark, Vice President, Corporate Affairs of NPS Pharmaceuticals, Inc., +1-801-584-5415/ /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 -----END PRIVACY-ENHANCED MESSAGE-----