-----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, HO1mmltz2Yzcj8zV/mSX4tV0i8M2LsZrQDMf0pQ6lI/klZlRrZVWiBkg5Nnt+/5k aQY4T748xQsGAg+FPxGUSA== 0000950130-97-003385.txt : 19970801 0000950130-97-003385.hdr.sgml : 19970801 ACCESSION NUMBER: 0000950130-97-003385 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19970730 ITEM INFORMATION: Other events FILED AS OF DATE: 19970731 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEUROMEDICAL SYSTEMS INC CENTRAL INDEX KEY: 0000866933 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-TESTING LABORATORIES [8734] IRS NUMBER: 133526980 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26984 FILM NUMBER: 97649128 BUSINESS ADDRESS: STREET 1: TWO EXECUTIVE BLVD STE 806 CITY: SUFFERN STATE: NY ZIP: 10901 BUSINESS PHONE: 9143683600 MAIL ADDRESS: STREET 1: TWO EXECUTIVE BLVD STREET 2: SUITE 306 CITY: SUFFERN STATE: NY ZIP: 10901-4164 8-K 1 FORM 8-K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 8-K Current Report Pursuant to Section 13 or 15(d) of The Securities Act of 1934 Date of Report (Date of earliest event reported): July 30, 1997 NEUROMEDICAL SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 0-26984 13-3526980 (State or other (Commission File No.) (I.R.S. Employer jurisdiction Identification No.) of incorporation) Two Executive Boulevard, Suite 306 10901-4164 Suffern, New York (Zip Code) (Address of principal executive offices) Registrant's telephone number, including area code: (914) 368-3600 ITEM 5. - ------- NEUROMEDICAL SYSTEMS, INC. 1997 SECOND QUARTER AND SIX MONTHS FINANCIAL RESULTS Neuromedical Systems, Inc. today announced second quarter and six month financial results for the period ended June 30, 1997. The Company also announced that it received approval from the United States Food and Drug Administration (FDA) of a Pre-Market Approval (PMA) Supplement covering the use of its second generation PAPNET(R) Review Station, Review II. In addition, the Company announced that it was establishing a Pathology Advisory Board consisting of leading pathologists to advise the Company on medical communications, product development and clinical trials, and that it had formed a dedicated Laboratory Support Group to better serve its laboratory customers. Revenues for the second quarter were $2,230,000, an increase of 119% from $1,017,000 reported in the second quarter of 1996. During the second quarter of 1997, 62% of the Company's revenue was derived from the United States, with the balance coming from Western Europe, Australia and the greater China market (including Hong Kong, the Peoples Republic of China and Taiwan). Net loss for the quarter was $8,769,000, or $.28 per share, compared to a net loss of $7,378,000, or $.25 per share, for the second quarter of 1996. Revenues for the six months period ended June 30, 1997 were $3,881,000, an increase of 133% from $1,668,000 reported for the first six months of 1996. The net loss for the six months of 1997 was $18,494,000, or $.60 per share, compared to a net loss of $14,225,000, or $.49 per share, for the same period of 1996. During the second quarter, the Company received approval by the Food and Drug Administration (FDA) for a PMA Supplement covering the use of a new MS Windows(R)-based Review Station for use with the PAPNET Testing System. Review II uses CD/ROM technology for faster retrieval of PAPNET images and has an on- board database for tracking PAPNET reviewed cases. Review II also has an interface with a motorized stage, allowing the cytotechnologist to cut down the amount of time it now takes to locate the suspicious cells detected by the PAPNET Testing System on the Pap smear slide. The new Review Station, being a Windows-based system, offers connection to existing laboratory systems. Review II is available for immediate delivery to customers. The Company also announced that it is establishing an advisory board of leading pathologists to advise the Company on medical communications, product development and clinical trials. The role of the Pathology Advisory Board will be to focus on building advocacy within the professional communities and to advise the Company on product development and clinical trials. In addition, NSI has formed a Laboratory Support Group to focus and improve customer support and service. The Laboratory Support Group includes cytotechnologists to work with the laboratory professionals directly performing the PAPNET test, and engineers to help laboratories integrate PAPNET testing into their routine flow of work. -2- The Company also announced that it intends to seek approval of the PAPNET Testing System as an integrated primary screening device in the United States. In certain overseas markets, the PAPNET Testing System has already been used effectively on a commercial basis as an integrated primary screener, and several peer-reviewed scientific articles have supported use of the PAPNET system in that mode. During the second quarter, NSI received smears directly from 138 laboratories in the United States. This represents an increase of 10 direct laboratory customers over the first quarter of 1997. (In addition, there are approximately 120 laboratories that can refer smears for PAPNET testing if requested by their customers.) NSI also continued to expand its international laboratory customer base. During the quarter, the Company received smears for PAPNET(R) testing from 48 laboratories in Europe and 11 laboratories in Australia. In Asia, the Company continued to expand its business in Hong Kong and mainland China through the acquisition in June 1997 of New System International, Ltd. During the quarter, the Company received slide processing revenue from 47 laboratories and hospitals in Hong Kong, Taiwan and mainland China. Safe Harbor Statement --------------------- Except for the historical information contained herein, the matters discussed in this press release may include forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 which reflect the Company's current views with respect to further events and financial performance. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or those anticipated. For information regarding these risks and uncertainties, see the Cautionary Statements set forth in the Company's Securities and Exchange Commission fillings, including its Annual Report on Form 10-K for the year ended 1996 and Exhibit 99.1 attached thereto. The words "believe", "expect", "anticipate", and similar expressions identify forward- looking statements, which speak only as of their dates. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. ### -3- NEUROMEDICAL SYSTEMS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS JUNE 30, DECEMBER 31, -------------- ------------------ 1997 1996 -------------- ------------------ (unaudited) ASSETS Cash and marketable securities $ 62,132,000 $ 83,391,000 Other current assets 3,386,000 3,185,000 Property, plant and equipment, net 16,792,000 16,388,000 Other assets 2,319,000 1,240,000 ------------ ------------ Total Assets $ 84,629,000 $104,204,000 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities $ 9,886,000 $ 9,510,000 Other liabilities 9,612,000 11,166,000 Stockholders' equity 65,131,000 83,528,000 ------------ ------------ Total Liabilities and Stockholders' Equity $ 84,629,000 $104,204,000 ============ ============ NEUROMEDICAL SYSTEMS, INC. CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS (unaudited)
THREE MONTHS ENDED SIX MONTHS ENDED JUNE 30, JUNE 30, ---------------------------------- ---------------------------------- 1997 1996 1997 1996 -------------- ------------------ -------------- ------------------ REVENUES $ 2,230,000 $ 1,017,000 $ 3,881,000 $ 1,668,000 ------------ ------------ ------------ ------------ COSTS AND EXPENSES Cost of sales 2,659,000 1,933,000 5,252,000 3,624,000 Marketing 4,833,000 3,856,000 10,311,000 7,373,000 Research and development 2,041,000 1,529,000 3,989,000 3,079,000 General and administrative 2,058,000 1,815,000 3,998,000 3,556,000 ------------ ------------ ------------ ------------ Total Costs and Expenses 11,591,000 9,133,000 23,550,000 17,632,000 ------------ ------------ ------------ ------------ Other income (expense), net 592,000 738,000 1,175,000 1,739,000 ------------ ------------ ------------ ------------ NET LOSS $ (8,769,000) $ (7,378,000) $(18,494,000) $(14,225,000) ============ ============ ============ ============ NET LOSS PER SHARE $ (0.28) $ (0.25) $ (0.60) $ (0.49) ============ ============ ============ ============ WEIGHTED AVERAGE SHARES OUTSTANDING 30,916,000 29,089,000 30,871,000 28,949,000 ============ ============ ============ ============
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 in Suffern, New York on this 30th` day of July, 1997. NEUROMEDICAL SYSTEMS, INC. By: /s/ David Duncan, Jr. --------------------- David Duncan, Jr. Vice President, Finance and Administration and Chief Financial Officer -5- EX-27.1 2 FINANCIAL DATA SCHEDULE
5 1000 6-MOS DEC-31-1997 JUN-30-1997 31,950 30,182 2,345 (250) 0 65,518 28,705 (11,913) 84,629 9,886 9,612 0 0 3 65,128 84,629 0 3,881 0 5,252 0 0 800 (18,494) 0 (18,494) 0 0 0 (18,494) (.60) (.58)
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