-----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, I17woXNmvfr04kPQVrnEYdklfWmIMA+9GyG9u9ojTEQRm26MkE114XKlZQpQe1jE glLZmVm4L7HTPvibVhzKqw== 0000950149-95-000628.txt : 19951004 0000950149-95-000628.hdr.sgml : 19951004 ACCESSION NUMBER: 0000950149-95-000628 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 19950702 FILED AS OF DATE: 19951002 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: NELLCOR INC /DE/ CENTRAL INDEX KEY: 0000799290 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 942789249 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: 1934 Act SEC FILE NUMBER: 000-14980 FILM NUMBER: 95578187 BUSINESS ADDRESS: STREET 1: 4280 HACIENDA DRIVE CITY: PLEASANTON STATE: CA ZIP: 94588 BUSINESS PHONE: 4158875858 MAIL ADDRESS: STREET 1: 4280 HACIENDA DRIVE CITY: PLEASANTON STATE: CA ZIP: 94588 FORMER COMPANY: FORMER CONFORMED NAME: NELLCOR DELAWARE INC DATE OF NAME CHANGE: 19860929 10-K405 1 FORM 10-K405 1 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (MARK ONE) /X/ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED JULY 2, 1995 OR / / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER 0-14980 NELLCOR PURITAN BENNETT INCORPORATED (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) DELAWARE 94-2789249 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 4280 HACIENDA DRIVE 94588 PLEASANTON, CALIFORNIA (Zip Code) (Address of principal executive offices) Registrant's telephone number, including area code: (510) 463-4000 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.001 par value (Title of class) Preferred Share Purchase Rights (Title of class) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No --- --- Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. /X/ Approximate aggregate market value of the registrant's Common Stock held by non-affiliates (based on the closing sales price of such stock as reported in the Nasdaq National Market) on September 1, 1995 was $1,445,463,015.00.* Number of shares of Common Stock, $.001 par value, outstanding as of September 1, 1995 was 28,358,496. 2 DOCUMENTS INCORPORATED BY REFERENCE
DOCUMENT FORM 10-K PART -------- -------------- (1) Annual Report to Stockholders for Fiscal Year Ended July 2, 1995 I, II, IV (2) Proxy Statement for Annual Meeting of Stockholders scheduled to III be held on October 19, 1995
- --------- * Excludes 291,253 shares of Common Stock held by all directors and executive officers at September 1, 1995. Exclusion of such shares should not be construed to indicate that any such person possesses the power, direct or indirect, to direct or cause the direction of the management or policies of the registrant or that such person is controlled by or under common control with the registrant. 3 PART I ITEM 1. BUSINESS. GENERAL Nellcor Puritan Bennett Incorporated (together with its wholly-owned subsidiaries, the "Company") is a corporation organized under the laws of the State of Delaware in 1986 and, until the acquisition of Puritan-Bennett Corporation in August 1995, operated under the name Nellcor Incorporated. The Company designs, manufactures and markets monitoring, diagnostic and therapeutic instruments, sensors, airway adapters and detectors for the safety and management of respiratory-impaired patients wherever they are treated. The Company's arterial blood oxygen, respiratory gas, blood pressure and apnea instruments provide intermittent and continuous, real-time, noninvasive monitoring of physiologically unstable patients. The Company's wide variety of oximetry sensors are used with its own instruments, instruments that incorporate the Company's oximetry OEM module and instruments produced by manufacturers licensed to use the Company's sensors. With the acquisition of Puritan-Bennett Corporation, the Company believes that it has combined the leaders in patient safety monitoring and respiratory products to create the preeminent company serving the needs of the respiratory-impaired patient worldwide. The acquisition of Puritan-Bennett Corporation enables the Company to offer its customers a comprehensive line of products for the monitoring, diagnosis and treatment of the respiratory-impaired patient across the spectrum of acute, alternate and home care. The Company's expanded product line includes pulse oximetry monitors and sensors, critical care and portable ventilators, home oxygen therapy products such as liquid oxygen systems and oxygen concentrators, sleep apnea diagnostic and therapy products and medical gas products and distribution systems. The Company's products are sold worldwide, principally through a direct sales force, assisted by clinical education consultants and specialists, corporate accounts and independent distributors. FISCAL YEAR 1995 AND RECENT DEVELOPMENTS Acquisitions On August 25, 1995, the Company completed its acquisition of Puritan-Bennett Corporation pursuant to the terms of an Agreement and Plan of Merger entered into by the two companies on May 21, 1995. On May 4, 1995, EdenTec Corporation, the Company's home health care subsidiary, acquired Pierre Medical, a privately-held French manufacturer of noninvasive ventilators, sleep apnea therapy systems, oxygen concentrators and related respiratory products. In August 1995, EdenTec Corporation acquired Melville Software Ltd., a privately held Canadian manufacturer of sleep diagnostic products used in sleep labs. See "Acquisitions" below. Products Early in the second quarter of fiscal year 1995, the Company received marketing clearance from the United States Food and Drug Administration (FDA) for PEDI-CAP(TM) , a version of the Company's EASY CAP(R) CO(2) detector, developed specifically for infants and children. These disposable, non-invasive CO(2) detection devices are used to verify and monitor correct endotracheal tube placement in emergency 3 4 situations. Worldwide commercial shipments of the PEDI-CAP product began in the second quarter of fiscal year 1995. During the second quarter of fiscal year 1995, the Company also began limited shipments of its N-400 fetal pulse oximeter in Europe. The N-400 is used to measure fetal oxygen levels during labor and delivery and is expected to aid obstetricians in evaluating fetal well-being. In the fourth quarter of fiscal year 1995, the Company filed an application for an Investigational Device Exemption (IDE) for the N-400 with the FDA. Clinical trials, which will evaluate the N-400 fetal pulse oximeter as a tool to reduce Cesarean sections, are expected to begin by the end of the second quarter of fiscal year 1996. In March 1995, the Company was awarded ISO 9001 certification for its facilities, signifying that the Company has met a set of international standards for product design, manufacturing, installation and service. ISO, the International Organization for Standardization, a worldwide federation of the national standards bodies for over 90 countries, represents an effort to promote international commerce through standardization. ISO 9001 certification is the first step necessary in order for the Company to affix the CE (Conformitee European) mark to its products. During the fourth quarter of fiscal year 1995, the Company received United States marketing clearance from the FDA for the first two modules of the NELLCOR SYMPHONY(TM) monitoring system, the N-3000 pulse oximeter and the N-3100 noninvasive blood pressure monitor. The NELLCOR SYMPHONY monitoring system is designed for use primarily in noncritical care areas throughout the hospital, particularly on the general care floor, as well as in alternate care settings. The N-3000, the Company's next generation pulse oximeter, incorporates OXISMART(TM) advanced signal processing and alarm management technology. It is designed to address the problem of nuisance alarms by identifying and rejecting artifacts caused by patient movement or electronic and optical noise interference, resulting in enhanced performance in high-motion, low-perfusion patient environments. The N-3100 blood pressure monitor incorporates advanced noninvasive blood pressure monitoring and employs clinically proven oscillometric technology. Commercial shipments of the N-3000 and the N-3100 in the United States began in June 1995. Sales of the products outside of the United States began in February 1994 and July 1994, respectively. Litigation In July 1996, the U.S. Federal District Court in Delaware issued a decision in favor of the Company, ruling that four key oximeter and sensor technology patents are valid and would be infringed by Ohmeda Inc. ("Ohmeda"), a subsidiary of BOC Health Care Inc. ("BOC"), if Ohmeda sold either its adult or neonatal OxyTip sensors for use with non-Ohmeda monitors. BOC had filed the suit in December 1992, seeking a declaratory judgment that the Company's patents were invalid and would not be infringed. BOC has filed notice of its intention to appeal the decision of the court. See "Item 3, Legal Proceedings." ACQUISITIONS Puritan-Bennett Corporation The Company has set the strategic objectives of focusing on the diagnosis, monitoring and treatment of the respiratory-impaired patient across the worldwide continuum of care and of growing through product line extensions, other internal developments and through acquisitions and strategic combinations in order to broaden its product line and enhance its competitive position. The Company entered into an Agreement and Plan of Merger with Puritan-Bennett Corporation on May 21, 1995. The transaction was approved at special meetings of the stockholders of 4 5 both companies held on August 24, 1995. On August 25, 1995, the Company acquired Puritan-Bennett by means of a wholly-owned subsidiary of the Company merging with and into Puritan-Bennett, with Puritan-Bennett being the surviving corporation and becoming a wholly-owned subsidiary of the Company. The merger with Puritan-Bennett is intended to qualify as a tax-free reorganization and will be accounted for as a pooling of interests. Under the terms of the Agreement and Plan of Merger, each outstanding share of Puritan-Bennett common stock was converted into the right to receive .88 share of the Company's common stock, resulting in the Company issuing approximately 11.5 million shares, valued at approximately $600 million, based on $52 1/8 per share, the closing price of the Company's common stock on August 25, 1995. As of September 1, 1995, approximately 28.4 million shares of the Company's common stock were outstanding. The Company believes that its acquisition of Puritan-Bennett represents the combination of market leaders in patient safety monitoring and respiratory products to create the preeminent company serving the needs of the respiratory-impaired patient worldwide. For a summary description of Puritan-Bennett products, see "Puritan-Bennett Products" below. With the acquisition, the Company believes that it is the leading provider of pulse oximetry monitoring and sensors, critical care ventilators, oxygen systems and home sleep diagnostic and therapeutic products across the spectrum of acute, alternate and home care. With revenues of over $600 million, facilities around the world and an employee force of over 4,000, the Company believes that it is the leader in the respiratory product market and will enjoy growth opportunities in both established and new markets as a result of a combination of product breadth and increased marketing flexibility. Moreover, an enhanced product line will provide the Company with broader access to the largest domestic and international respiratory markets in the hospital, subacute care, emergency medical services and the home. The Company also believes that the acquisition of Puritan-Bennett provides the opportunity for cost savings through consolidation of facilities and operations and for revenue and earnings growth rates greater than those possible for either company alone. The achievement of these goals, however, is dependent on the successful integration of two companies that had previously operated independently. The successful integration of the operations of the companies will require the dedication of substantial management resources. There can be no assurance that difficulties encountered in integrating the operations of the companies will be overcome or that the goals and benefits expected from a successful integration will be realized. Moreover, the process of integrating operations could cause an interruption of, or loss of momentum in, the activities of either or both of the companies' businesses. Difficulties encountered in connection with the integration of the two companies could have an adverse effect on the business, results of operations or financial condition of the Company going forward. Set forth below is certain summary, unaudited supplemental combined condensed financial information combining the Company's financial data for each of the five fiscal years ended July 2, 1995 with Puritan-Bennett's financial data for each of the three fiscal years ended January 31, 1995 and Puritan-Bennett's two fiscal years ended December 31, 1991. 5 6 SUPPLEMENTAL COMBINED FINANCIAL DATA
Years ended (unaudited) (In thousands, except per share JULY 2, 1995 JULY 3, 1994 JULY 4, 1993 JULY 5, 1992 JULY 7, 1991 amounts) Revenue $ 600,066 $ 544,227 $ 518,246 $ 452,286 $ 410,805 R & D expenses 47,203 48,867 48,545 46,256 33,661 Net income 49,463 (6,422) 39,715 21,867 32,135 Earnings per share 1.77 (0.23) 1.46 0.83 1.26 Working capital 244,395 206,709 224,772 179,374 177,606 Total assets 565,704 489,942 470,014 397,442 335,993 Long-term obligations 85,026 66,117 64,351 49,085 46,293 Stockholders' equity 361,905 316,625 326,187 275,421 238,752
Pierre Medical On May 3, 1995, EdenTec Corporation, the Company's home health care subsidiary, acquired Pierre Medical, a privately held French manufacturer of respiratory products used in the home. Pierre Medical manufactures and markets noninvasive ventilators, sleep apnea therapy systems, oxygen concentrators and related respiratory products for sale in Western Europe, primarily in France and Germany. The acquisition of Pierre Medical has been accounted for as a purchase. Melville Software In August 1995, EdenTec Corporation acquired Melville Software Ltd., a privately held Canadian company, that manufactures and markets sleep diagnostic products used in sleep labs, including SANDMAN(TM), a line of sleep disorder diagnostic systems sold primarily in the United States and Canada. Melville products are currently approved for sale throughout North America. PRODUCTS With the acquisition of Puritan Bennett, the Company's expanded product line includes pulse oximetry moniters and sensors, critical care and portable ventilators, home oxygen therapy products, sleep apnea diagnostic and therapy products and medical gas products and distribution systems. Following is a summary discription of the Company's products. Oximetry Instruments The Company's pulse oximeters provide noninvasive measurement of a patient's arterial blood oxygen saturation. The Company's principal oximetry instruments are the N-180, N-185, N-200 and N-3000 pulse oximeters and the N-20 and N-30 portable pulse oximeters. In addition, the Company's OXINET(R) pulse oximetry network permits remote monitoring of multiple patients from a centralized location. The N-180, N-185 and N-200 pulse oximeters provide continuous monitoring of arterial blood oxygen saturation and heart rate and are designed for use in all areas of the hospital, including intensive care units, intermediate care and step-down units and general care floors, and in the alternate site care market, including surgicenters, subacute care and skilled nursing facilities and the home. The Company's N-20 and N-30 portable pulse oximeters provide periodic (and in the case of the N-30, temporary 6 7 continuous) monitoring of arterial blood oxygen saturation and heart rate and are designed for use in areas of the hospital and the alternate site care market where continuous monitoring is not necessary or viable, for example, on the general care floor, in the home and in prehospital, emergency care and ambulatory settings. During the fourth quarter of fiscal year 1995, the Company received marketing clearance from the FDA for the N-3000 pulse oximeter and began commercial shipments of the product in the United States in June 1995. The Company began selling the N-3000 pulse oximeter outside of the United States in February 1994. The N-3000, the Company's next generation pulse oximeter, provides continuous monitoring of arterial blood oxygen saturation and heart rate and is the first module of the NELLCOR SYMPHONY multiparameter monitoring system designed for use primarily in noncritical care areas throughout the hospital, particularly on the general care floor, as well as in alternate care settings. The N-3000 incorporates OXISMART advanced signal processing and alarm management technology. It is designed to address the problem of nuisance alarms by identifying and rejecting artifacts caused by patient movement or electronic and optical noise interference, resulting in enhanced performance in high-motion, low-perfusion patient environments. The Company's OXINET pulse oximetry network is designed for use in hospital and alternate care settings and allows for the continuous monitoring of up to eight patients from one centralized location using multiple N-3000 or N-200 pulse oximeters and a central computer display. The Company is planning to expand into the labor and delivery market with the N-400 fetal pulse oximeter, a product for monitoring the blood oxygen saturation of a fetus during labor and delivery. The Company believes that the information provided by the N-400 will aid obstetricians significantly in evaluating fetal well-being. During the second quarter of fiscal year 1995, the Company began limited shipments of the N-400 fetal pulse oximeter in Europe. In the first quarter of fiscal year 1994, the FDA notified the Company that the N-400 fetal pulse oximeter must be submitted for approval for marketing clearance in the United States under Premarket Approval Application (PMA) regulations and not under the 510(k) premarket notification clearance process. A PMA application, compared to the 510(k) procedures, requires more laboratory and clinical testing data and more detailed design and manufacturing information, and therefore, requires more time for the gathering of data and preparation of the PMA application. Historically, the time elapsed between the submission of a PMA application and receipt of premarket approval is significantly longer than that for clearance to market under the 510(k) procedures. Since being informed of the need to file a PMA for the N-400, the Company has focused on finalizing an IDE protocol to be used in the conduct of United States clinical trials of the N-400. In the fourth quarter of fiscal year 1995, the Company filed an application for an IDE for the N-400 with the FDA. Clinical trials, which will evaluate the N-400 fetal pulse oximeter as a tool to reduce Cesarean sections, are expected to begin by the end of the second quarter of fiscal 1996. Given the uncertainties and delays associated with the FDA and the PMA process, there can be no assurance that the Company will receive approval from the FDA to market the N-400 in the United States or, when such approval, if it is granted, can be expected. For a summary discussion of the FDA regulatory framework, see "Regulatory Matters" below. 7 8 OEM Oximetry Modules The Company's OEM oximetry modules are sold to manufacturers of multi-parameter monitoring systems which incorporate the Company's oximetry technology into their own systems. See "Competition" below. The Company currently has agreements with 36 OEM customers. These customers include medical equipment manufacturers in the United States, Europe, Japan and Latin America. During fiscal year 1995, nine new OEM agreements were entered into with, among others, Bese Bioengenharia Sist. Equip. S/A. of Brazil, Fukuda M-E Kogyo Company of Japan and Dima Italia SAS of Italy. Multi-function Monitors/Systems The Company's ULTRA CAP(R) N-6000 combination pulse oximeter/capnograph combines pulse oximetry with advanced carbon dioxide monitoring technology. While providing continuous monitoring of arterial blood oxygen saturation, the N-6000 also measures the concentration of carbon dioxide in a patient's breath. In some clinical situations, abnormal patterns and levels of carbon dioxide may indicate a ventilation problem before blood oxygen levels become depressed. The ULTRA CAP monitor is designed for use primarily in critical care settings, particularly intensive care units, hospital emergency rooms and post-anesthesia care units, and can be used in other hospital settings such as the operating room and during intra-hospital transport. Pryon Corporation (Menomonee Falls, Wisconsin) designed and manufactures the ULTRA CAP for Nellcor on a private label basis. As discussed above, during the fourth quarter of fiscal year 1995, the Company received marketing clearance from the FDA for the first two modules of the NELLCOR SYMPHONY monitoring system, the N-3000 pulse oximeter and the N-3100 noninvasive blood pressure monitor. Oximetry Sensors The Company produces and sells a full line of proprietary adhesive (patient dedicated) and reusable oxygen transducers (reusable sensors) for use with the Company's own instruments, monitors and monitoring systems incorporating the Company's OEM oximetry module, and monitors and monitoring systems licensed to use its sensors. The Company's sensors include the adhesive (patient dedicated) OXISENSOR(R) II line of sensors, the combination adhesive/reusable OXICLIQ(R) sensor line and reusable sensors such as the DURASENSOR(R), DURA-Y(R), and OXIBAND(R) oxygen transducers. During fiscal year 1995, the Company broadened its line of sensors with the addition of the neonatal model of its OXICLIQ oxygen transducer. Moreover, in fiscal year 1995, the Company received marketing clearance from the FDA for the DURA-Y ear clip which allows the DURA-Y sensor to be attached to a patient's ear. During fiscal year 1995, the Company also expanded its sensor recycling program which now includes more than 480 hospitals in the United States. Hospitals participating in the recycling program are able to reduce sensor costs and medical waste by purchasing adhesive sensors that have been returned to the Company for recycling. The recycling process consists of re-manufacturing, testing and sterilization of the sensors. In fiscal year 1995, sales of the Company's oximetry products, which include oximetry instruments, sensors and OEM modules, accounted for more than three-quarters of the Company's net revenue. This is comparable to the portion of the Company's net revenues accounted for by sales of oximetry products in each of fiscal years 1994 and 1993. 8 9 End-Tidal CO2 Detector/Indicator The Company's EASY CAP end-tidal CO2 detector is a disposable, noninvasive carbon dioxide detection device used in emergency departments, on resuscitation carts and during patient transport. The single-use EASY CAP device contains a specially-impregnated paper which reacts to the presence of carbon dioxide by changing color and provides a quick and easy way to verify and monitor correct endotracheal tube placement during emergency situations. In the second quarter of fiscal year 1995, the Company received marketing clearance from the FDA for PEDI-CAP, a version of the EASY CAP device, developed specifically for use with infants and children. Worldwide commercial shipments of the PEDI-CAP product began in the second quarter of fiscal year 1995. The Company's STAT CAP(R) airway CO2 indicator is a small (hand-held), light-weight, electronic instrument that provides a semi-quantitative estimate (a numerical range) of end-tidal CO2. Its durability, portability and long battery life make the STAT CAP indicator particularly well-suited for use in emergency care and transport, both in the hospital and ambulance. The STAT CAP can assist clinicians in verifying proper placement of an endotracheal tube and can be used in emergency situations to evaluate ventilation or effectiveness of cardio pulmonary resuscitation. Sleep Disorder Products The Company's wholly-owned subsidiary, EdenTec Corporation, designs, manufactures and markets infant and adult apnea monitors, recorders and diagnostic systems for use in the hospital and the home. EdenTec's ASSURANCE(R) 2000 Heart and Respiration Monitor provides continuous noninvasive monitoring to detect central apnea, slow breathing, and slow and fast heart rate. The addition of the EDENTREND(R) Memory Module to the ASSURANCE 2000 enables the monitor to record, store and report alarm events for up to 45 days. In the second quarter of fiscal year 1994, EdenTec introduced for sale outside of the United States the ASSURANCE(R) 3000 Heart and Respiration Monitor. The ASSURANCE 3000 Heart and Respiration Monitor has more memory than the ASSURANCE 2000 and is lighter and more compact. EdenTec's EDENTRACE II(TM) Recording System is designed to assist in the diagnosis of sleep apnea in sleep labs, hospitals, clinics and the home. The recording system monitors and records up to six physiologic parameters including heart rate, respiratory effort, airflow, oxygen saturation with motion annotation, body position and snoring sounds. The EDENTRACE II PLUS Recording System, like the EDENTRACE II, is designed to assist in the diagnosis of sleep apnea. However, the EDENTRACE II PLUS Recording System can be used on infants as well as adults. EdenTec also markets the EDENTRACE(R) Analysis Software for use with the EDENTRACE II and the EDENTRACE II PLUS Recording Systems to aid clinicians in the archiving, retrieval and analysis of patient data. On May 3, 1995, EdenTec Corporation acquired Pierre Medical. Pierre Medical manufactures and markets noninvasive ventilators, sleep apnea therapy systems, oxygen concentrators and related respiratory products for sale in Western Europe, primarily in France and Germany. Its products include the O'MEGA(TM) oxygen concentrator for patients requiring supplemental oxygen, the O'NYX(TM) noninvasive ventilator that provides bilevel pressure (ventilation) for patients who have difficulty breathing, and the MORPHEE PLUS(TM) computerized, nasal CPAP device that administers air pressure to a patient's airway, via nasal mask, for treatment of obstructive sleep apnea. The Company may seek United States marketing clearance for select Pierre Medical products. 9 10 HEALTHQUIZ(TM) System The HEALTHQUIZ system is a patient-driven, automated, medical history system which combines a simple, user-friendly, hand- held device with proprietary application software that can be tailored to a variety of uses and health care settings. HEALTHQUIZ(TM) PRESCREEN(TM), the first application software commercialized for use with the HEALTHQUIZ device, is designed to aid clinicians in conducting pre-anesthetic assessments of patients. The HEALTHQUIZ PRESCREEN software application allows a patient to answer a series of yes/no questions and uses branching logic to collect a standardized, pre-anesthetic patient history and provides clinicians with summary reports that calculate a patient-specific anesthesia risk score and suggest appropriate lab tests. A second software application for use with the HEALTHQUIZ device, HEALTHQUIZ(TM) PREVENT(TM), when completed, will be designed to allow patients to complete their own health histories and provide clinicians with summary reports and preventive care recommendations. The HEALTHQUIZ system is not subject to the 510(k) premarket notification process or the PMA process. Sales of the HEALTHQUIZ system have been limited since it was introduced in the fourth quarter of fiscal year 1994. The Company regularly reviews its net investment in the HEALTHQUIZ system assets and the related market opportunities. Blood Pressure Monitors The NELLCOR(R) N-CAT(R) noninvasive blood pressure monitor displays continuous blood pressure information, including a waveform. This contrasts with conventional noninvasive blood pressure monitors, which provide only intermittent measurements. Because the N-CAT monitor performs best in the absence of motion, Nellcor has marketed the instrument only for use in areas of low patient motion such as hospital operating rooms. In the second half of fiscal 1991, Nellcor began commercial shipments of the N-CAT continuous noninvasive blood pressure monitor developed and manufactured by Colin Electronics of Japan (Colin). Shipments of the N-CAT monitor to date have been limited, and, since the fourth quarter of fiscal 1992, shipments have been suspended pending evaluation of new versions of the product software developed by Colin intended to improve the product's operating performance. Costs associated with this evaluation were not material in fiscal year 1995 and were expensed as incurred. After evaluating the most recent enhancements to the product's software, the Company is now satisfied with the performance of the N-CAT monitor. Because of modifications made to the product's software, Colin may be required to resubmit a 510(k) to the FDA for clearance to market the product in the United States. As discussed above, during the fourth quarter of fiscal year 1995, the Company received marketing clearance from the FDA for the N-3100 noninvasive blood pressure monitor and began commercial shipments of the product in the United States in June 1995. The Company began selling the N-3100 noninvasive blood pressure monitor outside of the United States in July 1994. The N-3100 blood pressure monitor incorporates advanced noninvasive blood pressure monitoring and employs clinically proven oscillometric technology. PURITAN-BENNETT PRODUCTS Ventilators and Related Products 7200(R) SERIES ventilator system The 7200 SERIES ventilator system is a critical care ventilator purchased primarily by hospitals to assist or manage patient respiration in a variety of acute care settings. The 7200 SERIES ventilator is designed to ease the work of patient breathing and lessen patient discomfort. It automatically performs pulmonary function diagnostic tests and reduces therapists' time attending to patients and preparing the ventilator for patient use. The 7200 SERIES ventilator is finding increasing use in sub- acute care settings, where chronically ventilator-dependent patients, who are otherwise stable, require sophisticated ventilation modes to improve the prospects of weaning. The 7200 SERIES ventilator is sold in three basic 10 11 configurations to cover the wide range of cost/performance applications and provides upgrade paths to incorporate new options as they become available. 7250(R) METABOLIC MONITOR Metabolic monitoring is the measurement of oxygen consumption and carbon dioxide production to determine patient nutritional requirements and metabolic status. The 7250 METABOLIC MONITOR measures a patient's inspired oxygen and carbon dioxide and compares these measurements with the patient's expired oxygen and carbon dioxide. From such measurements and the volume of inspired and expired gas, the 7250 METABOLIC MONITOR calculates oxygen consumption and carbon dioxide production. From these calculated parameters, the monitor can determine values used for deciding daily caloric intake needs. Metabolic monitoring, in general, is a tool for detecting and monitoring conditions that can affect clinical outcomes such as nutritional support, drug titration and respiratory muscle workload, and that can affect weaning from mechanical ventilation. The 7250 METABOLIC MONITOR can be integrated with the 7200 SERIES ventilator, is relatively simple to use and provides more accurate, continuous measurements of a patient's energy expenditure. CLINIVISION(R) CLINIVISION is a personal, computer-based, patient care and respiratory therapy department management information system that integrates the patient data captured and processed by the 7200 SERIES ventilator, as well as other clinical data, into a management information system that can be used by respiratory therapy department directors and therapists to manage and monitor patient care and staffing requirements. Once interfaced to the host hospital's information system, CLINIVISION electronically handles admitting, discharge, transfer, and order entry data, as well as transmitting billing and results reporting. Last fiscal year, Puritan-Bennett introduced new enhancements to CLINIVISION's system communications and report generation features. RADIOLINK(TM) 3.0 allows users to transfer new work orders or work order changes to therapists while working in remote parts of the hospital. The RADIOLINK product uses spread spectrum radio frequency transmission, adding cable-free data communication capabilities to the CLINIVISION system. With RADIOLINK 3.0, the Company has also added electronic mail, allowing supervisors to relay messages from any workstation to therapists on the floor. Last fiscal year, Puritan-Bennett also released PHONELINK(TM) 2.0. With this feature, therapists can download information from any phone, rather than having to return to the hospital or office to transfer information. In December 1994, Puritan-Bennett introduced CLINIVISION "Lite", an entry level, lower cost single workstation system that enables smaller hospitals to take advantage of productivity tools they need but without as substantial a capital outlay. COMPANION(R) 2801 PORTABLE VENTILATOR In addition to the 7200 SERIES critical care ventilator, Puritan-Bennett also manufacutes the COMPANION 2801 PORTABLE VENTILATOR for sale outside of the United States. The COMPANION 2801 PORTABLE VENTILATOR is used by patients requiring breathing assistance as a result of neuromuscular disease, chronic obstructive pulmonary disease or spinal cord injury. The COMPANION 2801 PORTABLE VENTILATOR is compact in size, operates from either AC power or 12VDC battery power and incorporates an internal battery for short-term emergency power outages. The COMPANION 2801 PORTABLE VENTILATOR can be used at the patient's bedside, mounted on wheelchairs or in automobiles and airplanes. Portable ventilators offer a reduced cost alternative to hospital care for patients who can be discharged to their home or a skilled nursing facility or other alternate care site. Puritan-Bennett manufactures the COMPANION 11 12 2801 PORTABLE VENTILATOR in the Republic of Ireland where it is marketed to customers outside the United States. Home Oxygen Therapy Products COMPANION(R) 492a/590/550 The Company's principal home oxygen therapy products are oxygen concentrators and liquid oxygen systems. The COMPANION 492a and 590 oxygen concentrators (four and five liter per minute capacity units) extract oxygen from room air and provide a supply of oxygen to home-bound patients who require a continuous supply of oxygen and whose prescribed flow rates do not exceed five liters per minute. The COMPANION 492a and 590 oxygen concentrators incorporate an optional OCI(R) indicator (Oxygen Concentration Indicator) that continuously monitors the oxygen percentage of the output of the device and alerts the patient in the event of performance degradation, automatically shutting the device down in the event of significant deterioration. In the event of such a shut down, the patient reverts to an alternate supply of oxygen. By utilizing an oxygen concentrator at home, a patient reduces the frequency with which a finite oxygen supply needs to be renewed. The OCI indicator option on the COMPANION 492a and 590 allows a home care provider to verify over the phone that the concentrator is generating high oxygen concentrations, detect problems early before they become expensive ones and reduce trips for routine filter replacement. For patients requiring a continuous supply of oxygen, Puritan-Bennett also manufactures several liquid oxygen systems. Liquid oxygen systems store oxygen at a very low temperature in liquid form. Puritan-Bennett's stationary unit can be refilled at home and can be used to fill a portable device, thereby permitting enhanced patient mobility. The COMPANION(R) 550 ambulatory unit for mobile patients utilizes a proprietary, pneumatic oxygen conserving device that requires no batteries and is significantly smaller and lighter than its predecessor, while providing essentially the same duration of use. The COMPANION or Mark "Low Loss" Oxygen Reservoir is designed to refill portable liquid oxygen units for extended periods of time with reduced evaporation loss. Sleep Disorder Products Puritan-Bennett manufactures the COMPANION(R) 318 Nasal CPAP System, a therapeutic device for patients with adult sleep apnea, the temporary cessation of breathing while asleep. The COMPANION 318 Nasal CPAP System is smaller than competitive products and offers additional diagnostic tools for sleep lab clinicians. Last fiscal year, Puritan-Bennett introduced the COMPANION(R) 320 I/E Bi-level(R) Respiratory System for patients requiring higher respiratory pressures to overcome airway obstruction. In late January 1994, Puritan-Bennett acquired SEFAM S.A., a French manufacturer of sleep diagnostic and therapeutic products. SEFAM products include the REM+ CONTROL CPAP device for treating sleep disorders and the RESPISOMNOGRAPHE and the MINISOMNO(TM) diagnostic systems used by hospital sleep labs and home care providers. Medical Gas Products and Distribution Systems The production and distribution of medical gases represents Puritan-Bennett's oldest product line. Puritan-Bennett is the largest producer of nitrous oxide in North America. This gas is used in anesthesia and analgesia and is sold by Puritan-Bennett under its own label and through distributors. The Company also distributes other medical gases, including oxygen, Sodalime (used to absorb CO2 during anesthesia) and special gas mixtures that are used for calibration, testing, and other purposes. Puritan-Bennett also manufactures the hospital distribution systems for medical gases. 12 13 Spirometry The PB100 Spirometer is a small, hand held spirometer that offers true portability. The patient data memory card and the rechargeable batteries allow testing of multiple patients at off-site locations. The RENAISSANCE(R) Spirometry System consists of the PB100 Spirometer and a base station used for downloading patient information to a choice of printers along with the option of sending patient data to a computer. Two disposable pneumotachs eliminate cleaning and minimize the risk of cross-infection for both patients and staff. PRODUCT DEVELOPMENT The Company is continuing to develop new products to address existing and new markets. The introduction of new products may be prevented or delayed by engineering obstacles, regulatory procedures, clinical trials, production difficulties and other factors. In addition, the costs of producing, promoting and servicing new products are generally greater than in the case of mature, higher volume products. New product introductions can also temporarily reduce revenues by interfering with sales of existing products. As the Company's existing products reach life cycle maturity, the Company's ability to develop or acquire new products and technologies increases in importance. The Company has and will continue to pursue technology, new product and business acquisition opportunities intended to broaden the Company's product offerings. Examples of such activities include the acquisitions of Pierre Medical and Puritan-Bennett Corporation. Such activities may result in increased expenses which could have an adverse impact on the Company's net income. MARKETS Customers The Company's traditional customers have been the critical care units of hospitals, for example, operating rooms, post-anesthesia recovery rooms and intensive care units. However, with the increasing pressure to lower health care costs, more patients are being treated in lower-cost areas in and outside the hospital. The Company's products are now purchased for use throughout the hospital, including intermediate care and step-down units, labor and delivery rooms, emergency rooms and general care floors, and marketed and sold into the alternate site care market, including surgicenters, subacute care and skilled nursing facilities, ambulatory emergency care settings and the home. With the acquistion of Puritan-Bennett the Company expects the home care market to become a more significant part of its customer base. The Company's sales are broadly based, and no individual customer accounts for more than 10% of the Company's total net revenues. Market Trends As health care increasingly becomes managed care, patient care is shifting to lower-cost areas of the hospital and alternate care sites outside of the hospital, including subacute care centers, skilled nursing facilities and the home. Additionally, in an effort to create larger, more cost-effective entities capable of competing for managed care contracts, health care providers are consolidating and vertically integrating, and hospitals are joining local or regional multiple hospital systems in greater numbers. As a result of these ongoing changes in the delivery of health care, the Company expects that a greater proportion of its future revenue will come from sales of its products to a smaller customer base, primarily comprised of larger, consolidated health care providers and buying groups, and from sales of its products into the growing alternate site care market, especially the home. Moreover, in the current health care business environment, hospitals, which are the Company's principal customers, face increasing pressure to control costs. This pressure may, in the future, lead to a decrease in the average selling prices for a number of the Company's products, which could adversely affect the Company's gross margin. 13 14 Health Care Reform The health care industry in the United States continues to experience a period of extensive change. Changes in the law or new interpretations of existing laws may have a dramatic effect on the definition of permissible or impermissible activities, the relative costs associated with doing business and the amount of reimbursement by both government and third-party payors. In addition, economic forces, regulatory influences and political initiatives are subjecting the health care industry to fundamental change. Health care reform proposals have been formulated by the current administration and by members of Congress. In addition, state legislatures periodically consider various health care reform proposals. Federal, state and local government representatives will, in all likelihood, continue to review and assess alternative health care delivery systems and payment methodologies, and ongoing public debate of these issues can be expected. The ultimate timing or effect of legislative efforts cannot be predicted, and short-term cost containment initiatives may vary substantially from long-term reforms and may impact the business of the Company in different ways. Although the Company believes that it is well positioned to respond to changes resulting from health care reform, no assurance can be given that any such efforts or reforms will not have an adverse effect on the future business, results of operations or financial condition of the Company. MARKETING AND SALES North America. In North America, the Company sells its products principally through its direct sales force, supplemented by several full-line sales distributors, rental and "just-in-time" distributors and several sensor distributors. With the acquisition of Puritan-Bennett, the Company is expecting to consolidate its sales force under area directors and regional business managers who will oversee sales forces for the hospital and home care markets, and sensor and ventilator specialists. The Company will also employ clinical education consultants (CECs), who are typically registered nurses, respiratory therapists or nurse anesthetists, and who provide customers with continuing education and in-service training on the use of the Company's products. The CECs also maintain contact with clinicians and medical organizations to educate medical professionals on new clinical applications for monitoring or assessment for which the Company's products can be used. The Company 's CEC organization is accredited by the American Nurses Association as a provider of continuing nursing education. Latin America. In early fiscal year 1993, the Company increased its marketing and sales efforts in this market. Sales into Latin America are through distributors. The Company has distributors in all major Latin American countries, including Mexico and Brazil. Europe. The Company has devoted significant resources to the development of its European markets and administrative infrastructure. The Company continues to expand sales, service and distribution efforts in this market. Through its acquisition of Puritan-Bennett and Pierre Medical, the Company has broadened its product offerings in the European home care market. The Company has sales and marketing offices and direct sales forces throughout Western Europe, including in the Netherlands, France, Germany, the United Kingdom, Belgium and Spain. Sales in Europe are made through the Company's direct sales forces and distributors. Asia. The Company has a sales and marketing office in Hong Kong. The Company has distributors in most major countries in Asia. Japan. In fiscal year 1995, the Company increased to 50 percent its ownership interest in Nellcor-CMI, Inc. (NCI), the Company's Tokyo-based joint venture with Century Medical, Inc. With a greater 14 15 level of investment in the venture and increased management involvement and marketing resources, the Company plans to pursue more aggressively opportunities for the Company's products in Japan. The Company sells its products in Japan through NCI's direct sales force and distributors. Sales outside the United States (including sales by the Company's subsidiaries) accounted for approximately 23 percent of net revenue in fiscal year 1995, 18 percent of net revenue in fiscal year 1994 and 17 percent of net revenue in fiscal year 1993. Financial information concerning the Company's foreign and domestic operations and export sales is found in Note 9 to the Financial Statements in the Company's 1995 Annual Report to Stockholders, which is incorporated herein by reference. Timing of Orders and Shipments; Backlog. Historically, orders in the first fiscal quarter have been lower than in the second, third and fourth quarters. Of the orders received by the Company in any fiscal quarter, a disproportionately large percentage has typically been received and shipped toward the end of that quarter. Accordingly, backlog has historically been modest and not an accurate predictor of future revenues, and results for a given quarter can be adversely affected if there is a substantial order shortfall late in that quarter. Total backlog at the end of fiscal year 1995 and fiscal year 1994 was approximately $9.8 million and $10.7 million, respectively. The decrease in backlog in fiscal year 1995 was primarily due to increased shipments of the N-3000 pulse oximeter as compared to fiscal year 1994. Approximately 14% of the total backlog as of the end of fiscal year 1995 is shippable in fiscal years after 1996. COMPETITION The medical device industry is characterized by rapidly evolving technology and increased competition. Competitors of the Company include large medical companies, some of which have greater financial and technical resources and broader product lines than the Company. The Company believes that the principal competitive factors in its product markets are product features, price, quality, customer service, performance, market reputation, breadth of product offerings and effectiveness of sales and marketing efforts. The Company also believes that the speed with which companies can identify customer needs and develop products to meet those needs are important competitive factors. The Company believes that it competes favorably with respect to each of these factors. However, there are a number of companies that currently offer, or are in the process of developing, products that compete with products offered by the Company. Some of these competitors may have substantially greater capital resources, research and development staffs and experience in the medical device industry, including with respect to regulatory compliance, and in the development, manufacturing and sale of medical products similar to those offered by the Company. There can be no assurance that some of these competitors will not succeed in developing technologies and products that are more effective than those currently produced by the Company or that would render some products offered by the Company obsolete or non-competitive. Moreover, competition based on price is expected to become an increasingly important factor in customer purchasing patterns as a result of cost containment pressures on, and consolidation in, the health care industry. Such competition has exerted, and is likely to continue to exert, downward pressure on the prices that the Company is able to charge for its products. There can be no assurance that the Company will be able to offset such downward price pressure through corresponding cost reductions. The Company's principal competitor in pulse oximetry in the United States is Ohmeda, Inc., a subsidiary of BOC Health Care, Inc. ("BOC"). The Company and BOC have cross-licensed certain patents from one another (see "Licenses and Patents" and "Item 3. Legal Proceedings." below). The Company also faces competition from manufacturers of multi-parameter monitoring systems, including Hewlett-Packard Co., SpaceLabs Medical, Inc., Datascope Corporation and Protocol Systems, Inc., whose systems frequently include pulse oximetry. In response, the Company sells OEM oximetry modules and 15 16 has licensed certain systems manufacturers to make their instruments compatible with the Company's sensors. The Company has entered into OEM and/or licensing agreements with the major systems manufacturers in the United States, including Hewlett-Packard Co., SpaceLabs Medical, Inc., Datascope Corporation and Protocol Systems, Inc. RESEARCH AND DEVELOPMENT The principal focus of the Company's research and development effort is to apply technology to well-defined clinical problems through innovative engineering. In this process, the Company is also focused on the development of products specifically designed to meet customer demands for performance, cost-effectiveness and environmental responsibility. With the acquisition of Puritan-Bennett, the Company expects to fund an investment in research and development of more than $50 million in fiscal year 1996. Introduction of any product now under development will require completion of development and engineering work, successful conclusion of clinical trials, compliance with regulatory procedures and the transfer of the product to production. There can be no assurance that the Company's product development work will result in viable new products. The Company's research and development expenditures were approximately $27.2 million (10% of net revenue) in fiscal year 1995, $24.0 million (10.2% of net revenue) in fiscal year 1994 and $22.7 million (10.4% of net revenue) in fiscal year 1993. MANUFACTURING AND SUPPLIERS The Company's products are assembled using both standard components and components manufactured to the Company's specifications such as printed circuit board assemblies. The Company's instruments contain microprocessors for which proprietary software is designed, written and tested by the Company. The Company maintains test and inspection procedures for components and assembled instruments. The Company currently procures most of its components from outside suppliers, including foreign vendors. Though multiple sources are generally available for these components, the Company also relies upon single-source suppliers to provide certain components for its products. To the extent the Company relies on single-source suppliers, there can be no assurance that supply shortages or interruptions will not arise, which, if they were to occur, could increase the cost or delay the shipment of the Company's products or cause the Company to incur costs to develop alternative sources. Any of these occurrences could have a material adverse effect on the Company's results of operations. With the acquisition of Puritan-Bennett, the Company will produce some components for its own products made from a wide variety of raw materials that are generally available in quantity from alternate sources of supply. Because the Company believes that prompt shipment of orders is important to compete effectively, the Company has maintained substantial inventories of raw material, work in process and finished goods to be able to respond rapidly to customer demands. Should the Company's order forecasts exceed the orders actually achieved, excess inventories may prove unsalable or salable only at reduced prices. The Company maintains reserves for obsolete or excess inventory which it believes to be adequate. 16 17 LICENSES AND PATENTS At July 2, 1995, the Company held 57 United States patents and 75 patents in foreign countries. With the acquisition of Puritan-Bennett, the Company holds 111 United States patents and 105 patents in foreign countries. The Company has patent applications pending in the United States and in selected foreign countries covering features of its current products and products under development. There can be no assurance that any patents will be issued on the pending applications or that any of its issued patents will withstand challenge. Although the patents that the Company has been issued are of value and those for which the Company has applied would be of additional value, the Company believes that other factors are of greater competitive importance (see "Competition" above). Many patents in the general area of the Company's current products and products under development have been and may in the future be issued to others. The Company has entered into license agreements under which it may practice certain patents for the lives of the patents. The Company may in the future determine that it is advisable to seek licenses on other such patents. There can be no assurance that such licenses will be available or, if available, will be available on terms favorable to the Company. In 1986, the Company and BOC Health Care, Inc., the parent corporation of Ohmeda, one of Nellcor's principal competitors, entered into cross licenses of certain oximetry patents (see "Item 3. Legal Proceedings." below). The Company has also granted licenses under its sensor coding patents to Hewlett-Packard Company, Siemens Medical Electronics, Inc., SpaceLabs, Inc. and Marquette Electronics, Inc. These licenses permit those companies to manufacture monitors that are compatible with the Company's oximetry sensors but do not permit the manufacture of sensors incorporating the patented invention. The Company believes that these licenses, together with the Company's sale of pulse oximetry modules on an OEM basis, have expanded the base of instruments using the Company's proprietary sensors and are helping to promote market acceptance of adhesive sensors as a standard of care. The Company has granted licenses to Hewlett-Packard Company, Siemens Medical Electronics, Inc., and Bruel & Kjaer Export under its variable pitch beeper patent. The licenses permit those companies to make and sell oximeter monitors whose pulse-to-pulse beep tones vary in pitch as the patient's saturation changes. REGULATORY MATTERS FDA Regulation The Company manufactures and sells medical devices. The FDA regulates the development, testing, manufacturing, packaging, distribution and marketing of medical devices in the United States, including the products manufactured by the Company. The development, testing, manufacturing, packaging, distribution and marketing of medical devices in the United States are regulated under the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the "1976 Amendments"), the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992 and additional regulations promulgated by the FDA. The State of California (through its Department of Health Services ("DHS")), where the Company has several manufacturing plants, as well as other states, also regulate the manufacture of medical devices. The Company believes that it is substantially in compliance with applicable FDA and DHS regulations. In general, these statutes and regulations require that manufacturers adhere to certain standards designed to ensure the safety and effectiveness of medical devices. Under the 1976 Amendments, each 17 18 medical device manufacturer must comply with statutes and regulations applicable generally to manufacturing practices, clinical investigations involving humans, sale and marketing of medical devices, post-market surveillance, repairs, replacements and refunds, recalls, and other matters. The FDA is authorized to obtain and inspect devices and their labeling and advertising, and to inspect the facilities in which they are manufactured in order to ensure that a device is not improperly manufactured or labeled. The 1976 Amendments also require compliance with specific manufacturing and quality assurance standards, including regulations promulgated by the FDA with respect to good manufacturing practices. FDA regulations require that each manufacturer establish a quality assurance program by which the manufacturer monitors the manufacturing process and maintains records that show compliance with the FDA regulations and the manufacturer's written specifications and procedures relating to the devices. Compliance with the good manufacturing practices regulation is necessary to receive FDA approval to market new products and is necessary for a manufacturer to be able to continue to market approved product offerings. The FDA makes unannounced inspections of medical device manufacturers and may issue reports of observations where the manufacturer has failed to comply with all appropriate regulations and procedures. Failure to comply with applicable regulatory requirements can, among other consequences, result in warning letters, civil penalties, injunctions, suspensions or losses of regulatory clearances, product recalls, seizure or administrative detention of products, operating restrictions through consent decrees or otherwise, refusal of the government to approve product license applications or allow a manufacturer to enter into supply contracts, and criminal prosecution. There has been a trend in recent years both in the United States and outside the United States toward more stringent regulation of, and enforcement of requirements applicable to, medical device manufacturers. The continuing trend of more stringent regulatory oversight in product clearance and enforcement activities has caused medical device manufacturers to experience longer approval cycles, more uncertainty, greater risk and higher expenses. At the present time, there are no meaningful indications that this trend will be discontinued in the near-term or the long-term either in the United States or abroad. The FDA requires that a new medical device or a new indication for use of or other significant change in an existing medical device obtain either 510(k) premarket notification clearance or an approved PMA prior to being introduced into the market in the United States. The 510(k) premarket notification process is applicable when the new product being submitted to the FDA can be compared to a pre-existing commercially available product that performs similar functions (a "substantially equivalent product"). If a product does not meet the eligibility requirements for the 510(k) process, then it must be submitted, instead, under the PMA process. The process of obtaining 510(k) clearance may take at least six months from the date of filing of the application and generally requires the submission of supporting data, which can be extensive and extend the process for a considerable length of time. In addition, the FDA may require review by an advisory panel as a condition for 510(k) clearances, which can further lengthen the process. The PMA process generally takes more than two years from initial filing and requires the submission of extensive supporting data and clinical information. In recent years, there has been a trend for the FDA to require more supporting data with respect to both 510(k) clearance notifications and PMA filings. Historically, substantially all of the products of the Company have been submitted to the FDA under the 510(k) premarket notification clearance process. However, the Company was informed in early fiscal year 1994 that the N-400 fetal pulse oximeter would have to be submitted under the PMA process. Moreover, as the Company broadens is product base, new products could be required to be submitted under the PMA process rather than the 510(k) process. 18 19 Foreign Regulation Sales of medical devices outside the United States are subject to foreign regulatory requirements that vary widely from country to country. The time required to obtain clearance to sell medical devices in foreign countries may be longer or shorter than that required for FDA clearance, and requirements for licensing may differ significantly from FDA requirements. Some countries have historically permitted human studies earlier in the product development cycle than regulations in the United States. Other countries, such as Japan, have standards similar to those of the FDA. This disparity in the regulation of medical devices may result in more rapid product clearance in certain countries than in the United States, while clearance in countries such as Japan may require longer periods than in the United States. In addition, the European Union has developed a new approach to the regulation of medical products that may significantly change the situation in those countries. The receipt or denial of FDA clearance for a particular product may affect the receipt or denial of regulatory clearance for that product in certain other countries. FDA/Puritan-Bennett Consent Decree Puritan-Bennett has been subject to significant FDA enforcement activity with respect to its operations in recent years. In January 1994, Puritan-Bennett entered into a consent decree with the FDA pursuant to which Puritan-Bennett agreed to maintain systems and procedures complying with the FDA's good manufacturing practices regulation and medical device reporting regulation in all of its device manufacturing facilities. Under the decree, domestic shipments of Puritan-Bennett's portable ventilator products and intra-arterial blood gas monitoring systems were suspended until the FDA could become satisfied with Puritan-Bennett's manufacturing practices for such products. Both Burton A. Dole, Jr., Puritan-Bennett's former Chairman, President and Chief Executive Officer, and John H. Morrow, its former Executive Vice President and Chief Operating Officer, are parties to the consent decree. Under the terms of the Agreement and Plan of Merger between the Company and Puritan-Bennett, following consummation of the acquisition, Mr. Dole became the Chairman of the Company's Board of Directors and Mr. Morrow became Executive Vice President of the Company and President of the Company's Home Health Care Business. Impact of Puritan-Bennett Consent Decree Puritan-Bennett has experienced and will continue to experience incremental operating costs due to ongoing compliance requirements and quality assurance programs initiated in part as a result of the FDA consent decree. The Company expects for Puritan-Bennett to continue to incur additional operating expenses associated with its ongoing regulatory compliance program, but the amount of these incremental costs currently cannot be completely predicted and will depend upon a variety of factors, including future changes in statutes and regulations governing medical device manufacturers and the manner in which the FDA continues to enforce and interpret the requirements of the consent decree. 19 20 There can be no assurance that the Company will not experience problems associated with FDA regulatory compliance, including increased general costs of ongoing regulatory compliance and specific costs associated with the Puritan-Bennett consent decree. The Company could experience a material adverse effect on business, operations, profitability and outlook from, among other things: (i) requirements associated with the Puritan-Bennett consent decree; (ii) requirements arising from continuing company-wide adherence to quality assurance and good manufacturing practices; (iii) the results of future FDA inspections of the operations and facilities of the Company; and (iv) any modification, extension or adverse interpretation of the Puritan-Bennett consent decree or any product recall, plant closure or other FDA enforcement activity with respect to the Company. Environmental Regulation The Company is subject to various environmental laws and regulations both in the United States and abroad. The operations of the Company, like those of other medical device companies, involve the use of substances regulated under environmental laws, primarily in the manufacturing and sterilization processes. While it is difficult to quantify the potential impact of compliance with environmental protection laws, management believes that such compliance will not have a material effect on the Company's financial position. The Company believes that it is substantially in compliance with applicable environmental laws and regulations. PRODUCT LIABILITY EXPOSURE Because most of the Company's products are intended to be used in hospitals on patients who are physiologically unstable and may be severely ill, the Company is exposed to serious potential product liability claims. From time to time, patients on whom the Company's products are being used will sustain injury or death related to their medical treatment or condition, and this could lead to product liability claims against the Company. The Company has in fact received notice of claims of product liability. The Company believes that none of these claims, either alone or in the aggregate, will have a material adverse affect on the Company's financial position or results of operation. There is no assurance, however, that the Company will not in the future be subject to a claim that could have a material adverse impact on the Company's financial position, results of operations, reputation or ability to market its products. The Company presently carries product liability insurance coverage in amounts which the Company feels are sufficient to protect the Company. However, it is possible that this coverage could be insufficient to cover claims which might be made against the Company. The availability and cost of such coverage varies from time to time and could be affected by product liability claims. At times in the past, coverage has been more difficult and more expensive to obtain than at present. There is no assurance that the Company will always be able to obtain adequate product liability coverage on terms it finds acceptable, or that the Company will be able to obtain such insurance at all. EMPLOYEES At July 2, 1995, the Company had a total of 1788 employees, including 889 employees in the United States, 754 employees in Mexico and 145 employees in other countries. Many of the Company's employees are highly skilled, and competition in recruiting and retaining such personnel is intense in the labor markets in which the Company operates. Locating persons with experience in regulated industries is particularly difficult. The Company believes that its continued success 20 21 is predicated in part on its ability to continue to attract highly qualified management, marketing, medical and technical personnel. Other than a total of approximately 15 Puritan-Bennett employees, none of the Company's employees is subject to a collective bargaining agreement. The Company believes that its relations with its employees are good. EXECUTIVE OFFICERS OF THE REGISTRANT Set forth below is information regarding current executive officers who are not also directors.
NAME AGE POSITION WITH THE COMPANY --------------------- --- ------------------------------------ Laureen DeBuono 38 Executive Vice President, Human Resources, General Counsel and Secretary Michael P. Downey 48 Executive Vice President, Chief Financial Officer Robert L. Doyle 52 Executive Vice President, Worldwide Sales and Distribution Russell B. Hays 50 Executive Vice President, President, Hospital Business John H. Morrow 50 Executive Vice President, President, Home Care Business Kenneth Sumner, Ph.D. 53 Vice President, Regulatory/Clinical Affairs and Quality Assurance David B. Swedlow, M.D. 49 Vice President, Medical Affairs and Technology Development
MS. DEBUONO joined the Company in April 1992 as General Counsel and Secretary and currently serves as Executive Vice President, Human Resources, General Counsel and Secretary. Prior to joining the Company, Ms. DeBuono was Division and Corporate Counsel with The Clorox Company, a diversified consumer products company, from 1987 to 1992, and Corporate Counsel with Varian Associates, Inc., an electronics device company, from 1984 to 1987. MR. DOWNEY joined the Company in 1986 as Corporate Controller and became Vice President, Finance in April 1987 and Vice President, Chief Financial Officer in July 1989. Mr. Downey currently serves as Executive Vice President, Chief Financial Officer. Prior to joining the Company, Mr. Downey was Vice President, Finance with Shugart Corporation, a manufacturer of disk drives, from 1984 to 1986. MR. DOYLE joined the Company upon consummation of the acquisition of Puritan-Bennett by the Company in August 1995. Mr. Doyle was elected Senior Vice President of Puritan-Bennett in 1988 and became Senior Vice President, Marketing in 1991. MR. HAYS joined the Company in June 1995. Prior to joining the Company, Mr. Hays served as the President and Chief Executive Officer of Sequenom from 1993 to 1995. Previously, Mr. Hays served as President and Chief Executive Officer of Enzytech, Inc. from 1992 to 1993, and in various capacities at Baxter Healthcare Corporation from 1985 to 1992. He also served as a General Manager at Stryker 21 22 Corporation from 1981 to 1985 and in various capacities at Baxter Travenol Laboratories, Inc. from 1976 to 1981. MR. MORROW joined the Company upon consummation of the acquisition of Puritan-Bennett by the Company in August 1995. Mr. Morrow was elected Vice President of Puritan-Bennett in 1979 and has served as its Executive Vice President and Chief Operating Officer since 1989. Prior to joining Puritan-Bennett, Mr. Morrow was a management consultant with McKinsey & Company, Inc. from 1970 to 1979. MR. SUMNER joined the Company in September 1994 as Vice President, Regulatory/ Clinical Affairs and Quality Assurance. Immediately prior to joining the Company, Mr. Sumner served as Vice President, Regulatory Affairs and Quality Assurance with Cytyc Corporation, a privately-held medical device company. From 1990 to 1993, Mr. Sumner was with the Cardiology Group of C.R. Bard, Inc. as Vice President, Medical and Regulatory Affairs, and, from 1980 to 1990, Mr. Sumner was Director of Clinical and Regulatory Affairs at Zimmer, Inc., an orthopedic medical device division of Bristol-Myers Squibb, Co. DR. SWEDLOW joined the Company in June 1987 as Vice President, Medical Affairs and currently serves as Vice President, Medical Affairs and Technology Development. Prior to joining the Company, Dr. Swedlow was employed by the University of Pennsylvania as an Assistant Professor of Anesthesia and Pediatrics at the University of Pennsylvania School of Medicine and as an Anesthesiologist and Critical Care Attending Physician and Director of Research in the Department of Anesthesia and Critical Care of The Children's Hospital of Philadelphia. Compliance with Section 16(a) of the Securities Exchange Act of 1934. Section 16(a) of the Securities and Exchange Act of 1934, as amended, requires the Company's executive officers and directors to file reports of beneficial ownership on Form 3 and changes in beneficial ownership on Forms 4 or 5 with the Securities and Exchange Commission ("SEC"). Executive officers and directors are also required by SEC rules to furnish the Company with copies of all Section 16(a) reports filed. As part of a Section 16 compliance program established by the Company for its executive officers and directors, the Company undertakes to file these reports on their behalf. Based solely on its review of the Forms 3 and 4 filed on behalf of its executive officers and directors, as well as written representations from these individuals that no Form 5 filings are required, the Company believes that, during the fiscal year ended July 2, 1995, all Section 16(a) filing requirements applicable to its executive officers and directors were complied with pursuant to SEC rules. ITEM 2. PROPERTIES. The Company's headquarters occupy a newly constructed 141,000 square foot two-story facility built for the Company in Hacienda Business Park, Pleasanton, California. The Pleasanton facility is being leased under a lease with an initial 12-1/2 year term with options to renew for two additional five-year periods at a rent approximating the then fair market value. The Company also maintains its manufacturing facilities and related offices in 90,000 square feet in Chula Vista, California (near San Diego) and 60,000 square feet in Tijuana, Mexico, occupied under leases expiring in March 2000 and December 1994, respectively (the lease expiring in December 1994 has 9 one-year renewal options). The Company leases additional office space in Lenexa, Kansas, which is used 22 23 for certain of the Company's research and development, and Coral Springs, Florida, which is used to service Latin America . EdenTec maintains leased facilities in Eden Prairie, Minnesota. The Company leases additional space for its international operations in the Netherlands, France, United Kingdom, Belgium, Germany, Spain and Hong Kong. With the acquisition of Puritan-Bennett, the Company has acquired additional owned and leased facilities. The Company believes that its facilities are adequate for its space requirements through fiscal 1996. If additional space is required in the future, the Company believes that suitable facilities can readily be leased on commercially reasonable terms. ITEM 3. LEGAL PROCEEDINGS. From time to time, the Company has received, and in the future may receive, notice of claims against it, which in some instances have developed, or may develop, into lawsuits. The claims may involve such matters, among others, as product liability, patent infringement and employment related claims. In management's opinion, the ultimate resolution of claims currently pending, either individually or in the aggregate, will not have a material adverse effect on the Company's financial condition or results of operations. There can be no assurance that the Company's financial condition or results of operations will not be materially adversely affected as a result of future claims that may be commenced against the Company. In September 1984, the Company was sued for patent infringement relating to its pulse oximeters by BOC Health Care, Inc. ("BOC"), the parent corporation of Ohmeda, Inc. ("Ohmeda"), one of the Company's principal competitors. In June 1986, the parties settled and agreed to dismiss BOC's infringement claims and the Company's antitrust and unfair competition counterclaims. As part of the settlement, the parties consented to a judgment that the BOC patent was valid and entered into cross licenses of certain oximetry patents, and applications therefor, of each party for the duration of the applicable patents. On August 26, 1992, the Company brought an action in U.S. District Court for declaratory judgment against Camino Laboratories, Inc. (San Diego, CA) ("Camino") seeking a judgment that the Company's pulse oximeter systems and sensor products do not infringe United States Patent No. 4,446,715 or Reexamination Certificate B1 4,446,715, owned by Camino. The Company filed an amended complaint on September 1, 1992, adding a count for declaratory judgment that Camino's claims were barred in whole or in part by laches. On September 17, 1992, Camino filed an answer, jury demand and counterclaim against the Company, asserting that the Company's oximeters and sensors infringe Camino's patent and seeking damages for past infringement and an injunction against future infringement. In the fourth quarter of fiscal year 1994, the Company agreed to settle its patent litigation with Camino. Under the terms of the settlement, Camino agreed not to sue the Company or its current or future customers relating to the use or sale of the Company's sensors and monitors intended for use with such sensors. A cash payment of $15 million was made by the Company to Camino and was recorded as a non-operating expense. This settlement neither recognizes the validity nor acknowledges infringement of the Camino patent at issue. On December 10, 1992, the Company brought an action in Alameda County Superior Court, Eastern Division, State of California, for misappropriation of trade secrets, unfair competition and for return of property against BOC and Square One Technology ("Square One"). On December 18, 1992, the Company filed an amended complaint naming Daniel S. Goldberger, a former Company employee and partner in Square One, as an individual defendant. The Company sought damages, assignment of patent rights and injunctive relief to bar BOC, Square One and Mr. Goldberger from continuing to sell a pulse 23 24 oximeter sensor based on a trade secret design that the Company claimed was developed at the Company and was misappropriated by Square One and Mr. Goldberger. Also on December, 10, 1992, BOC, Square One and Mr. Goldberger brought an action in United States District Court for the District of Delaware against the Company, seeking a declaratory judgment that certain patents of the Company were invalid and/or not infringed by the manufacture, use or sale of the BOC pulse oximeter sensor which was the subject matter of the California Superior Court action described above. In the third quarter of fiscal year 1994, the Company agreed to settle the trade secrets litigation with BOC and Square One. Under the terms of the agreement, the patent in issue was assigned to the Company. The Company also received a pretax $2 million payment and will receive ongoing royalties. The $2 million payment was recorded as non-operating income. In July 1995, the U.S. Federal District Court in Delaware issued a decision in favor of the Company, ruling that four key oximeter and sensor technology patents are valid and would be infringed by Ohmeda, if Ohmeda sold either its adult or neonatal OxyTip sensors for use with non-Ohmeda monitors. BOC has filed notice of its intention to appeal the decision of the court. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY OWNERS. None 24 25 PART II ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS. The Company's common stock is traded on the Nasdaq National Market under the symbol NELL. The following table sets forth the high and low prices for the Company's common stock as reported in that system for each quarter in the Company's fiscal years 1995 and 1994. These prices reflect interdealer prices, without retail mark-up, mark-down or commission.
HIGH LOW ---- --- Fiscal 1995: Fourth Quarter............. $47.75 $36.00 Third Quarter.............. 38.25 31.50 Second Quarter............. 34.00 28.25 First Quarter.............. 31.50 26.00 Fiscal 1994: Fourth Quarter............. 28.75 24.375 Third Quarter.............. 29.50 24.25 Second Quarter............. 26.50 19.75 First Quarter.............. 23.50 19.00
At September 1, 1995, the Company had approximately 1,586 stockholders of record (not including beneficial holders of stock held in street name). The Company has not paid or declared dividends on its common stock. The Company presently intends to retain its earnings for use in its business and therefore does not anticipate paying any cash dividends in the foreseeable future. ITEM 6. SELECTED FINANCIAL DATA. The following table presents the Company's historical financial results prior to the Company's acquisition of Puritan-Bennett on August 25, 1995. SELECTED FINANCIAL DATA
Years ended ---------------------------------------------------------- (In thousands, except per JULY 2, JULY 3, JULY 4, JULY 5, JULY 7, share amounts) 1995 1994 1993 1992 1991 Net revenue $ 264,040 $ 234,972 $ 218,186 $ 196,164 $ 158,929 Gross profit 160,859 141,266 129,424 117,067 86,962 Income from operations 54,345 42,851 37,837 30,987 22,360 Litigation settlements - (13,000) - - - Income before income taxes 59,947 32,998 40,846 34,342 25,812 Net income 37,165 20,557* 25,120 21,293 16,262 Net income per share 2.20 1.22* 1.50 1.31 1.05 Working capital 170,823 154,827 143,686 108,527 96,201 Total assets 296,469 238,148 225,606 188,654 142,836 Stockholders' equity 240,721 204,113 192,464 154,492 121,384
25 26 No cash dividends have been declared or paid in the five-year period ended July 2, 1995 *Net of after-tax charge of $8.0 million ($0.48 per share) from litigation settlements. ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. The section labeled "Management's Discussion and Analysis of Financial Condition and Results of Operations" appearing on pages 34 through 38 of the Company's 1995 Annual Report to Stockholders is incorporated herein by reference. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA. The Report of Independent Accountants appearing on page 39, the Consolidated Financial Statements and Notes to Consolidated Financial Statements appearing on pages 19 through 33, and the section entitled "Selected Quarterly Data" appearing on page 39 of the Company's 1995 Annual Report to Stockholders, are incorporated herein by reference. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE. None. 26 27 PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT. (a) The section labeled "Proposal One -- Election of Directors" appearing on pages 2 through 19 of the Company's Proxy Statement dated September 15, 1995 and filed with the Securities and Exchange Commission on the same date is incorporated herein by reference. (b) Information concerning the Company's executive officers who are not directors is set forth in Part I of this Report on Form 10-K. ITEM 11. EXECUTIVE COMPENSATION. The sections labeled "Executive Compensation" and "Compensation Committee Report on Executive Compensation", appearing on pages 9 through 18 of the Company's Proxy Statement dated September 15, 1995 are incorporated herein by reference. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT. The section labeled "Beneficial Owners of Voting Securities" appearing on pages 7 and 8 of the Company's Proxy Statement dated September 15, 1995 is incorporated herein by reference. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS. The section labeled "Indebtedness of Management" appearing on page 14 of the Company's Proxy Statement dated September 15, 1995 are incorporated herein by reference. 27 28 PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K. (a) 1. INDEX TO FINANCIAL STATEMENTS THE FOLLOWING FINANCIAL STATEMENTS ARE INCLUDED IN THE COMPANY'S 1995 ANNUAL REPORT TO STOCKHOLDERS AND ARE INCORPORATED HEREIN BY REFERENCE PURSUANT TO ITEM 8:
PAGE IN 1995 ANNUAL REPORT TO STOCKHOLDERS --------------- Consolidated Balance Sheet at July 2, 1995 and July 3, 1994 19 Consolidated Statement of Income for each of the three years in the period ended July 2, 1995 20 Consolidated Statement of Stockholders' Equity for each of the three years in the period ended July 2, 1995 21 Consolidated Statement of Cash Flows for each of the three years in the period ended July 2, 1995 22 Notes to Consolidated Financial Statements 23-33 Report of Independent Accountants 39 Selected Quarterly Data (Unaudited) 39
2. INDEX TO FINANCIAL STATEMENT SCHEDULES All schedules are omitted because they are not applicable or not required or because the required information is included in the consolidated financial statements or notes thereto. 28 29 3. EXHIBITS EXHIBIT NO. DESCRIPTION OF EXHIBIT 2.1 Agreement and Plan of Merger, dated as of May 21, 1995, as amended, among Registrant, a wholly-owned subsidiary of Registrant and Puritan-Bennett Corporation (filed as Annex A to Form S-4 Registration Statement No. 33-61169 and incorporated herein by reference). 2.2 Amendment No. 1 to Agreement and Plan of Merger, dated as of June 30, 1995, among Registrant, a wholly-owned subsidiary of Registrant and Puritan-Bennett Corporation (filed as Annex B to Form S-4 Registration Statement No. 33-61169 and incorporated herein by reference). 3.1 Restated Certificate of Incorporation of Registrant (filed as Exhibit 3.1 to the Report on Form 10-K for the year ended July 7, 1991 and incorporated herein by reference). 3.2 Certificate of Determination of Preferences of Series A Junior Participating Preferred Stock (filed as Exhibit 3.2 to the Report on Form 10-K for the year ended July 7, 1991 and incorporated herein by reference). 3.3 By-laws of Registrant, as amended (filed as Exhibit 3.3 to the Report on Form 10-K for the year ended July 3, 1994 and incorporated herein by reference). 4.1 Rights Agreement, dated as of September 1, 1992, between Registrant and The First National Bank of Boston, as Rights Agent (incorporated by reference to Exhibit 2.1 of Amendment No. 1 to the Registrants' Registration Statement as Form 8-A filed with the Commission on July 13, 1995). Reference is also made to Exhibits 3.1, 3.2 and 3.3. 4.2 Credit Agreement, dated as of November 16, 1994, entered into by Registrant, the Banks Named Therein and ABN AMRO Bank N.V., San Francisco International Branch, as Agent (filed as Exhibit 10.1 to the Report on Form 10-Q for the period ended January 1, 1995 and incorporated herein by reference). 10.1 Lease Agreement dated August 17, 1983 between Registrant and Crow-Spieker-Singleton #87, together with Lease Amendment No. One thereto, dated January 3, 1994, Lease Amendment No. Two thereto, dated as of May 5, 1986, and related letters dated July 31, 1984 and October 15, 1984 (filed as Exhibit 10.1 to Form S-1 Registration Statement No. 33-8211, filed August 22, 1986 and incorporated herein by reference). 10.2 Lease Agreement dated March 31, 1986 between Registrant and Crow-Spieker-Singleton #115 (filed as Exhibit 10.2 to Form S-1 Registration Statement No. 33-8211, filed August 22, 1986 and incorporated herein by reference). 10.3 Letters dated June 17, 1987 and April 28, 1987 relating to the terms of the Lease Agreement listed as Exhibits 10.1 and 10.2 (filed as Exhibit 10.4 to the Report on Form 10-K for the year ended June 28, 1987 and incorporated herein by reference). 10.4 Lease Agreement dated October 21, 1987 between egistrant and Crow-Spieker-Singleton #87 (filed as Exhibit 19.1 to the Report on Form 10-Q for the period ended December 27, 1987 and incorporated herein by reference). 10.5 Lease Agreement dated July 10, 1989 between egistrant and Baja de Mar, S.A. de C.V. (filed as Exhibit 10.14 to the Report on Form 10-K for the year ended July 2, 1989 and incorporated herein by reference). 29 30 10.6 Lease Agreement dated February 1, 1990 between Registrant and Eastlake Development Company (filed as Exhibit 19.1 to the Report on Form 10-Q for the period ended April 1, 1990 and incorporated hereby by reference). 10.7 First Amendment dated September 26, 1990 to Lease Agreement listed as Exhibit 10.6 (filed as Exhibit 10.13 to the Report on Form 10-K for the year ended July 1, 1990 and incorporated herein by reference). 10.8 Lease Agreement dated April 18. 1991 between Registrant and Britannia Developments, Inc. (filed as Exhibit 10.8 to the Report on Form 10-K for the year ended July 7, 1991 and incorporated herein by reference) and the First Amendment to the Lease Agreement dated February 13, 1992 between the Registrant and Britannia Developments, Inc. 10.9 Settlement Agreement effective as of June 1, 1986 between Registrant and The BOC Group (portions with respect to which confidentiality has been requested were filed separately with the request for confidential treatment) (filed as Exhibit 10.4 to Amendment No. 3 to Form S-1 Registration Statement No. 33-8211, filed April 16, 1987 and incorporated herein by reference). 10.10 Settlement Agreement dated as of December 15, 1986 between Registrant and Robert F. Shaw and related documents (filed as Exhibit 10.21 to Amendment No. 3 to Form S-1 Registration Statement No. 33-8211, filed April 16, 1987 and incorporated herein by reference). *10.11 Registrant's 1982 Incentive Stock Option Plan, as amended (filed as Exhibit 10.16 to the Report on Form 10- K for the year ended June 26, 1988 and incorporated herein by reference), and forms of documents in connection with the 1982 Plan (filed as Exhibit 28.1 to Amendment No. 1 to Form S-8 Registration Statement No. 33-16590, filed August 31, 1987 and incorporated herein by reference). *10.12 Registrant's 1985 Equity Incentive Plan, as amended filed as Exhibit 10.22 to the Report on Form 10-K for the year ended July 1, 1990 and incorporated herein by reference) and forms of documents used in connection with the 1985 Plan (filed as Exhibit 10.22 to the Report on Form 10-K for the year ended July 1, 1990 and incorporated herein by reference). *10.13 Registrant's 1988 Stock Option Plan for Non-Employee Directors and forms of documents used in connection with such Plan, as amended (filed as Exhibit 10.13 to the Report on Form 10-K for the year ended July 7, 1991 and incorporated herein by reference). *10.14 Registrant's 1991 Equity Incentive Plan (filed as Exhibit 10.14 to the Report on Form 10-K for the year ended July 7, 1991 and incorporated herein by reference). *10.15 Notice of Grant of Stock Options and Stock Option Grant Agreement dated March 30, 1988 between Registrant and Frederick M. Grafton (filed as Exhibit 10.21 to the Report on Form 10-K for the year ended June 26, 1988 and incorporated herein by reference). 30 31 10.16 Fourth Amended Registration Rights Agreement dated as of December 31, 1984, January 15, 1985, March 6, 1985, March 29, 1985 and April 19, 1985 between Registrant and certain purchasers of its securities (filed as Exhibit 10.15 to Form S-1 Registration Statement No. 33-8211, filed August 22, 1986 and incorporated herein by reference). 10.17 Amendment to Fourth Amended Registration Rights Agreement listed as Exhibit 10.16 dated as of August 19, 1986 (filed as Exhibit 10.21 to Amendment No. 1 to Form S-1 Registration Statement No. 33-8211, filed September 10, 1986 and incorporated herein by reference). 10.18 Second Amendment to Fourth Amended Registration Rights Agreement listed as Exhibit 10.16 dated as of December 24, 1986 (filed as Exhibit 10.20 to Amendment No. 3 to Form S-1 Registration Statement No. 33- 8211, filed April 16, 1987 and incorporated herein by reference). *10.19 Indemnification Agreement dated as of June 17, 1986 between Registrant and Robert S. Smith (filed as Exhibit 10.16 to Form S-1 Registration Statement No. 33-8211, filed August 22, 1986, and incorporated herein by reference). *10.20 Form of Indemnification Agreement entered into between Registrant and each of its directors, current officers and one former officer (filed as Exhibit 10.22 to Amendment No. 3 to Form S-1 Registration Statement No. 33-8211, filed April 16, 1987 and incorporated herein by reference). 10.21 License Agreement between Registrant and Andros Analyzers Incorporated dated October 30, 1987 (portions with respect to which confidentiality has been requested were filed separately with the request for confidential treatment) (Filed as Exhibit 10.37 to the Report on Form 10-K for the year ended June 26, 1988 and incorporated herein by reference). *10.22 Letter agreement between Registrant and Paul J. Malloy, dated September 11, 1989 (filed as Exhibit 10.18 to the Report on Form 10-K for the year ended July 2, 1989 and incorporated herein by reference), letter agreement between Registrant and James E. Corenman, dated May 19, 1989 (filed as Exhibit 10.19 to the Report on Form 10-K for the year ended July 2, 1989 and incorporated herein by reference), letter agreement and letter of indemnification between Registrant and Robert S. Smith dated August 5, 1989 (filed as Exhibit 10.20 to the Report on Form 10-K for the year ended July 2, 1989 and incorporated herein by reference), letter agreement between Registrant and Charles C. Wilson dated October 5, 1989 (filed as Exhibit 10.35 to the Report on Form 10-K for the period ended July 1, 1990 and incorporated herein by reference), letter agreement between Registrant and L. Jack Lloyd dated March 16, 1990 (filed as Exhibit 10.36 to the Report on Form 10-K for the period ended July 1, 1990 and incorporated herein by reference) and letter agreement between Registrant and Tibor Foldvari dated June 27, 1990 (filed as Exhibit 10.37 to the Report on Form 10- K for the period ended July 1, 1990 and incorporated herein by reference). 31 32 *10.23 Agreement and General Release dated as of July 24, 1991 between Registrant and Lauren F. Yazolino (filed as Exhibit 10.23 to the Report on Form 10-K for the year ended July 7, 1991 and incorporated herein by reference) and the First Amendment to the Agreement and General Release dated May 1, 1992. *10.24 Employment Agreement dated effective as of May 23, 1989 between Registrant and Virginia Perry, Vice President, Quality Assurance and Regulatory Affairs (filed as Exhibit 10.38 to the Report on Form 10-K for the period ended July 1, 1990 and incorporated herein by reference). *10.25 Employment Agreement dated as of September 2, 1991 between Registrant and Theodore H. Toch, Vice President and General Manager, Instruments (filed as Exhibit 10.25 to the Report on Form 10-K for the year ended July 7, 1991 and incorporated herein by reference). 10.26 Agreement and Plan of Reorganization dated as of March 2, 1990 by and among Registrant, Nellcor Merger Corporation, Radiant Systems, Inc., Jeffrey J. Alholm and Edward Kleban and related Letter Agreement and Exchange Agreement (filed as Exhibits 19.2, 19.3 and 19.4 to the Report on Form 10-Q for the period ended April 1, 1990 and incorporated herein by reference). 10.27 Buy-Sell Agreement for Rights and Products between Registrant and Colin Medical Instruments dated April 23, 1990, as amended July 24, 1990 (filed as Exhibit 10.34 to the Report on Form 10-K for the period ended July 1, 1990 and incorporated herein by reference). 10.28 Amendment dated February 8, 1991 to the Buy-Sell Agreement for the Rights and Products listed as Exhibit 10.27 (filed as Exhibit 10.28 to the Report on Form 10-K for the period ended July 7, 1991 and incorporated herein by reference) and the Third Amendment dated June 1, 1992 to the Buy-Sell Agreement aforementioned. 10.29 Stock Purchase Agreement dated August 12, 1991 among Registrant, EdenTec Corporation and the Stockholders and Optionholders of EdenTec Corporation and related Employment Agreements between Registrant and Edward Schuck and Bruce Bowman, respectively (filed as Exhibit 10.29 to the Report on Form 10-K for the year ended July 7, 1991 and incorporated herein by reference). 10.30 Asset Purchase Agreement dated September 20, 1991 among Registrant, Fenem, Inc., Carl Fehder, M.D. and Edward Nemerovsky (filed as Exhibit 10.30 to the Report on Form 10-K for the year ended July 7, 1991 and incorporated herein by reference). *10.31 Letter agreement dated November 1, 1992, regarding Offer of Employment between Registrant and David J. Illingworth (filed as Exhibit 10.31 to the Report on Form 10-K for the year ended July 4, 1993 and incorporated herein by reference). 32 33 *10.32 Promissory Note secured by Deed of Trust, dated February 18, 1993 made by David J. Illingworth in favor of Registrant (filed as Exhibit 10.32 to the Report on Form 10-K for the year ended July 4, 1993 and incorporated herein by reference). *10.33 Separation Agreement and General Release between Registrant and Theodore H. Toch dated as of January 15, 1993 (filed as Exhibit 10.33 to the Report on Form 10-K for the year ended July 4, 1993 and incorporated herein by reference). *10.34 Separation Agreement and General Release between Registrant and Walter J. McBride dated as of March 9, 1993 (filed as Exhibit 10.34 to the Report on Form 10-K for the year ended July 4, 1993 and incorporated herein by reference). *10.35 Separation Agreement between Registrant and Robert M. Johnson dated November 24, 1993 (filed as Exhibit 10.35 to the report on Form 10K for the year ended July 3, 1994 and incorporated herein by reference). *10.36 Agreement between Registrant and Virginia Perry dated March 16, 1994 (filed as Exhibit 10.36 to the report on Form 10K for the year ended July 3, 1994 and incorporated herein by reference). *10.37 Separation Agreement between Registrant and Julio Guardado dated May 16, 1994 (filed as Exhibit 10.37 to the report on Form 10K for the year ended July 3, 1994 and incorporated herein by reference). *10.38 Separation Agreement between Registrant and Patricia E. Bashaw dated May 27, 1994 (filed as Exhibit 10.38 to the report on Form 10K for the year ended July 3, 1994 and incorporated herein by reference). *10.39 Agreement between Registrant and David L. Schlotterbeck dated June 13, 1994 (filed as Exhibit 10.39 to the report on Form 10K for the year ended July 3, 1994 and incorporated herein by reference). *10.40 Forms of Chief Executive Officer, Executive Officer and Key Employee Severance Agreements (filed as Exhibits 10.2, 10.3 and 10.4 to the Report on Form 10Q for the period ended January 1, 1995 and incorporated herein by reference). *10.41 Registrant's 1994 Equity Incentive Plan, as amended (filed as Exhibit 4.5 to Form S-8 Registration Statement No. 33-87490 and incorporated herein by reference). *10.42 Registrant's 1995 Merger Stock Incentive Plan (filed as Exhibit 4.5 to Form S-8 Registration Statement No. 33-62465 and incorporated herein by reference). 11.1 Statement of computation of Net Income per share. 13.1 Excerpts from 1995 Annual Report to Stockholders. 21.1 List of Subsidiaries (filed as Exhibit 21.1 to the Report on Form 10K for the year ended July 3, 1994 and incoroprated herein by reference). 23.1 Consent of Independent Accountants (Price Waterhouse). Reference is made to page S-1 hereof. 27 Financial Data Schedule - ------- * An asterisk next to the number of an exhibit indicates that the exhibit is a management contract or compensatory plan or arrangement. 33 34 (b) REPORTS ON FORM 8-K Form 8-K dated March 13, 1995, filed April 3, 1995, reporting (i) the acquisition of Pierre Medical by EdenTec Corporation, the Company's home health care subsidiary, and (ii) a $2.1 million equity investment by the Company in Heartstream, Inc. Each of these disclosures were pursuant to Item 5 ("Other Event"). Form 8-K dated May 21, 1995, filed May 23, 1995, reporting the entering into by the Company and Puritan-Bennett Corporation of an Agreement and Plan of Merger dated as of May 21, 1995 pursuant to Item 5 ("Other Event"). 34 35 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. NELLCOR PURITAN BENNETT INCORPORATED By: /s/ C. Raymond Larkin, Jr. ------------------------------------- C. Raymond Larkin, Jr. President and Chief Executive Officer Date: September 29, 1995 Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated
SIGNATURE TITLE DATE --------- ----- ---- /s/ C. Raymond Larkin, Jr. - ------------------------------ Director, President and Chief September 29, 1995 C. Raymond Larkin, Jr. Executive Officer (Principal Executive Officer) /s/ Burton A. Dole, Jr. - ------------------------------ Director, Chairman of September 29, 1995 Burton A. Dole, Jr. the Board /s/ Michael P. Downey - ------------------------------ Executive Vice President September 29, 1995 Michael P. Downey and Chief Financial Officer (Principal Financial & Accounting Officer) /s/ Robert J. Glaser, M.D. - ------------------------------ Director September 29, 1995 Robert J. Glaser, M.D. /s/ Frederick M. Grafton - ------------------------------ Director September 29, 1995 Frederick M. Grafton /s/ Donald L. Hammond - ------------------------------ Director September 29, 1995 Donald L. Hammond /s/ Thomas A. McDonnell - ------------------------------ Director September 29, 1995 Thomas A. McDonnell
35 36
SIGNATURE TITLE DATE --------- ----- ---- /s/ Walter J. McNerney - ------------------------------ Director September 29, 1995 Walter J. McNerney /s/ Edwin E. van Bronkhorst - ------------------------------ Director September 29, 1995 Edwin E. van Bronkhorst
36 37 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 33-16590, 33-25586, 33-25587, 33-32521, 33-38241, 33-45010, 33-87490, 33-87492, 33-87496, 33-62463, and 33-62465) of Nellcor Incorporated of our report dated July 26, 1995, except as to Note 11, which is dated as of August 24, 1995, appearing on page 39 of the Annual Report to Stockholders which is incorporated in this Annual Report on Form 10-K for the year ended July 2, 1995. /s/ PRICE WATERHOUSE LLP PRICE WATERHOUSE LLP San Francisco, California September 29, 1995 S-1
EX-11.1 2 EXHIBIT 11.1 1 EXHIBIT 11.1 NELLCOR PURITAN BENNETT INCORPORATED STATEMENT OF COMPUTATION OF NET INCOME PER SHARE (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
Fiscal Year --------------------------------------------- JULY 2, JULY 4, JULY 5, 1995 1993 1992 ------- ------- ------- Computation of common and equivalent shares outstanding: Common Stock 16,624 16,715 16,471 Stock options 299 128 274 ------- ------- ------- Total weighted average common and common equivalent shares outstanding 16,923 16,843 16,745 ======= ======= ======= Net Income $37,165 $20,557 $25,120 ======= ======= ======= Net income per common and common equivalent share $2.20 $1.22 $1.50 ======= ======= =======
EX-13.1 3 EXHIBIT 13.1 1 EXHIBIT 13.1 CONSOLIDATED BALANCE SHEET (In thousands, except share amounts)
July 2, 1995 July 3, 1994 - ----------------------------------------------------------------------------------------------------------------- ASSETS Current assets: Cash and cash equivalents $ 75,642 $ 68,163 Marketable securities (Note 2) 65,039 53,470 Accounts receivable, net of allowance for doubtful accounts of $1,274 ($1,128 at July 3, 1994) 44,304 34,308 Inventories (Note 1) 31,446 27,238 Deferred income taxes (Note 6) 4,898 3,581 Other current assets 2,038 1,650 --------- --------- Total current assets 223,367 188,410 --------- --------- Property and equipment, at cost: Machinery and equipment 57,057 47,814 Demonstration equipment 12,155 13,093 Furniture and fixtures 7,737 7,304 Leasehold improvements 4,947 5,276 --------- --------- 81,896 73,487 Accumulated depreciation (46,083) (39,315) --------- --------- Net property and equipment 35,813 34,172 --------- --------- Intangibles and other assets, net (Notes 3 and 4) 35,289 15,566 ========= ========= $ 294,469 $ 238,148 ========= ========= LIABILITIES & STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 20,697 $ 14,229 Accrued liabilities: Payroll and payroll related 16,711 11,091 Warranty 4,195 1,882 Other 8,070 4,811 Income taxes payable (Note 6) 3,207 1,570 --------- --------- Total current liabilities 52,880 33,583 Deferred income taxes (Note 6) 868 452 --------- --------- Total liabilities 53,748 34,035 Commitments and contingencies (Notes 8 and 10) Stockholders' equity (Note 7): Preferred stock, $.001 par value; 5,000,000 shares authorized; none outstanding Common stock, $.001 par value; 50,000,000 shares authorized; 17,854,250 shares issued and outstanding (17,058,059 in 1994) 18 17 Additional paid-in-capital 111,012 90,302 Treasury stock, at cost (1,148,000 shares in 1995; 522,500 shares in (34,539) (13,630) 1994) Retained earnings 164,494 127,329 Accumulated translation adjustment (259) 100 Notes receivable from stockholders (5) (5) --------- --------- Total stockholders' equity 240,721 204,113 ========= ========= $ 294,469 $ 238,148 ========= =========
See accompanying notes to consolidated financial statements 2 CONSOLIDATED STATEMENT OF INCOME (In thousands, except per share amounts)
Years ended July 2, 1995 July 3, 1994 July 4, 1993 - -------------------------------------------------------------------------------------- Net revenue $ 264,040 $ 234,972 $ 218,186 Cost of goods sold 103,181 93,706 88,762 --------- --------- --------- Gross profit 160,859 141,266 129,424 --------- --------- --------- Operating expenses: Research and development 27,225 23,980 22,696 Selling, general and administrative 79,289 73,935 68,891 Restructuring charge (Note 5) --- 500 --- --------- --------- --------- 106,514 98,415 91,587 --------- --------- --------- Income from operations 54,345 42,851 37,837 Interest income 6,139 4,209 3,410 Litigation settlements, net (Note 10) --- (13,000) --- Other income (expense), net (537) (1,062) (401) --------- --------- --------- Income before income taxes 59,947 32,998 40,846 Provision for income taxes (Note 6) 22,782 12,441 15,726 --------- --------- --------- Net income $ 37,165 $ 20,557 $ 25,120 ========= ========= ========= Income per common and common equivalent share $ 2.20 $ 1.22 $ 1.50 ========= ========= ========= Weighted average common and common equivalent shares used in the calculation of income per share 16,923 16,843 16,745 ========= ========= =========
See accompanying notes to consolidated financial statements 3 CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (In thousands, except share amounts)
COMPENSATION AND NOTES COMMON STOCK ADDITIONAL ACCUMULATED RECEIVABLE ---------------------- PAID-IN RETAINED TRANSLATION FROM SHARES PAR VALUE CAPITAL EARNINGS ADJUSTMENT STOCKHOLDERS - -------------------------------------------------------------------------------------------------------------------- BALANCE AT JULY 5, 1992 16,122,099 $16 $ 73,174 $ 81,652 $ 204 $(554) Issuance of common stock and related tax benefits of 591,163 1 12,521 $3,621 under employee stock plans Compensation related to acquisition of Radiant Systems (Note 7) 549 Accumulated translation adjustment (219) Net income 25,120 ---------- --- -------- -------- ----- ----- BALANCE AT JULY 4, 1993 16,713,262 17 85,695 106,772 (15) (5) Issuance of common stock and related tax benefits of $2,394 under employee stock plans 554,797 10,460 Acquisition of treasury stock (Note 7) Acquisition and retirement of common stock (Note 7) (210,000) (5,853) Accumulated translation adjustment 115 Net income 20,557 ---------- --- -------- -------- ----- ----- BALANCE AT JULY 3, 1994 17,058,059 17 90,302 127,329 100 (5) Issuance of common stock and related tax benefits of $3,487 under employee stock plans 796,191 1 20,710 Acquisition of treasury stock (Note 7) Accumulated translation adjustment (359) Net income 37,165 ---------- --- -------- -------- ----- ----- BALANCE AT JULY 2, 1995 17,854,250 $18 $111,012 $164,494 $(259) $ (5) ========== === ======== ======== ===== ===== TREASURY STOCK ---------------------- SHARES PAR VALUE - -------------------------------------------------------------- BALANCE AT JULY 5, 1992 0 $ 0 Issuance of common stock and related tax benefits of $3,621 under employee stock plans Compensation related to acquisition of Radiant Systems (Note 7) Accumulated translation adjustment Net income --------- -------- BALANCE AT JULY 4, 1993 0 $ 0 Issuance of common stock and related tax benefits of $2,394 under employee stock plans Acquisition of treasury 522,500 (13,630) stock (Note 7) Acquisition and retirement of common stock (Note 7) Accumulated translation adjustment Net income --------- -------- BALANCE AT JULY 3, 1994 522,500 (13,630) Issuance of common stock and related tax benefits of $3,487 under employee stock plans Acquisition of treasury stock 625,500 (20,909) (Note 7) Accumulated translation adjustment Net income --------- -------- BALANCE AT JULY 2, 1995 1,148,000 $(34,539) ========= ========
See accompanying notes to consolidated financial statements 4 CONSOLIDATED STATEMENT OF CASH FLOWS (In thousands)
Years ended July 2, 1995 July 3, 1994 July 4, 1993 - ---------------------------------------------------------------------------------------------------------------------- Cash flows from operating activities: Net income $ 37,165 $ 20,557 $ 25,120 Adjustments to reconcile net income to cash provided by operating activities: Depreciation and amortization 16,089 16,281 13,153 Compensation to Radiant stockholders (Note 7) --- --- 549 Deferred income taxes (Note 6) 901 400 (493) Increases (decreases) in cash flows, net of effects of purchases of companies, as a result of changes in: Accounts receivable (3,336) (1,218) (3,046) Inventories (1,251) (4,676) 51 Other current assets (3,181) (1,319) 1,764 Other assets (5,007) (1,949) (588) Accounts payable 3,340 1,809 685 Accrued liabilities 8,082 404 1,108 Income taxes payable 1,601 (1,845) (1,083) -------- --------- --------- Cash provided by operating activities 54,403 28,444 37,220 -------- --------- --------- Cash flows from investing activities: Capital expenditures (11,906) (14,133) (14,767) Cash used to purchase securities held-to-maturity (47,245) (87,212) (156,078) Proceeds from maturities of securities held-to- maturity 35,676 104,643 144,860 Investment in non-marketable equity securities (2,100) --- --- Payment for purchase of Pierre Medical, net of cash acquired (Note 3) (21,415) --- --- Other investing activities (305) (680) --- -------- --------- --------- Cash provided by (used for) investing activities (47,295) 2,618 (25,985) -------- --------- --------- Cash flows from financing activities: Proceeds from the issuance of common stock under the Company's stock plans and related tax benefits, net of notes receivable from stockholders 20,710 10,460 12,521 Purchase of treasury stock, including shares retired (20,909) (19,483) --- -------- --------- --------- Cash provided by (used for) financing activities (199) (9,023) 12,521 -------- --------- --------- Effect of exchange rate changes on cash balances 570 218 (790) -------- --------- --------- Increase in cash and cash equivalents 7,479 22,257 22,966 Cash and cash equivalents at the beginning of the year 68,163 45,906 22,940 ======== ========= ========= Cash and cash equivalents at the end of the year $ 75,642 $ 68,163 $ 45,906 ======== ========= =========
See accompanying notes to consolidated financial statements 5 NOTE 1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES PRINCIPLES OF CONSOLIDATION. The financial statements include the accounts of Nellcor Incorporated and its wholly owned subsidiaries (the Company). All significant intercompany transactions have been eliminated. The Company uses the equity method of accounting for investments that represent greater than 20% of the net book value of the investee at the date of investment. Investments which represent less than 20% of the net book value of the investee at the date of investment are recorded at cost. All such investments were immaterial as of July 2, 1995. FISCAL YEAR. The Company's fiscal year ends on the first Sunday in July, which results in a 52 or 53-week fiscal year. Fiscal 1993, 1994 and 1995 were 52-week years. FOREIGN CURRENCY TRANSLATION. The financial statements of the Company's subsidiaries located in Europe use the local currency as their functional currency. Assets and liabilities denominated in foreign currencies are translated at the rates of exchange at the balance sheet date. Income and expense items are translated at average monthly rates of exchange. Any resulting translation adjustments are recorded as a separate component of stockholders' equity. Realized and unrealized gains and losses on foreign currency transactions and hedge contracts are included in non-operating income and expense. Foreign currency transaction gains or losses have not been material in any year or period presented. REVENUE RECOGNITION AND PRODUCT WARRANTY. The Company recognizes revenue at the time of shipment of product and provides currently for the estimated cost to repair or replace products under the warranty provisions in effect at the time of sale. CASH EQUIVALENTS. The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. These investments are stated at cost which approximates fair value due to their short maturity. INVENTORIES. Inventories are stated at the lower of cost (first-in, first-out) or market (net realizable value). Allowances are made for slow-moving, obsolete, unsalable, or unusable inventories. Inventories were as follows (in thousands):
July 2, 1995 July 3, 1994 - ---------------------------------------------------------------------------------- Raw materials $14,437 $10,040 Work-in-process 4,843 5,180 Finished goods 12,166 12,018 ======= ======= $31,446 $27,238 ======= =======
PROPERTY AND EQUIPMENT. Depreciation is provided using the straight-line method and estimated useful lives of three to seven years. Leasehold improvements are amortized over the life of the lease, or the estimated useful life of the asset, whichever is shorter. Depreciation expense was approximately $10.2 million in fiscal 1995, $10.6 million in fiscal 1994, and $9.0 million in fiscal 1993. INTANGIBLE AND OTHER ASSETS. Intangible and other assets, including excess of cost over net assets acquired, are amortized on a straight-line basis over useful lives ranging from two to fifteen years. An impairment of intangible assets is recognized when it is deemed probable that the carrying amount of an asset cannot be fully recovered, based on estimated future cash flows of the related business. 6 INCOME TAXES. Deferred income taxes are computed using the liability method. Under the liability method, taxes are recorded based on the future tax effect of the difference between the tax and financial reporting bases of the Company's assets and liabilities. In estimating future tax consequences, all expected future events are considered, except for potential income tax law or rate changes. The Company adopted Statement of Financial Accounting Standards No. 109 (SFAS 109) "Accounting for Income Taxes" in fiscal 1994. Adoption of SFAS 109 did not have a material effect on the Company's financial position or result of operations. INCOME PER SHARE. Income per share is based upon weighted average common shares and includes the dilutive effect of stock options outstanding (using the treasury stock method). RECLASSIFICATIONS. Certain reclassifications have been made to the consolidated financial statements in the prior years to conform to the 1995 presentation. NOTE 2 FINANCIAL INSTRUMENTS AND OFF BALANCE SHEET RISK FOREIGN CURRENCY INSTRUMENTS. The Company enters into foreign currency exchange contracts, primarily forward currency contracts, to reduce exposure to currency exchange risk. The effect of this practice is to minimize the impact of foreign exchange rate movements on the Company's operating results as gains and losses on these contracts offset losses and gains on the assets, liabilities and transactions being hedged. The Company does not engage in foreign currency speculation. The counterparties to foreign currency exchange contracts are major domestic and international financial institutions. To decrease the risk of non-performance which may result in currency losses, the Company diversifies its selection of counterparties. At July 2, 1995, the Company had foreign currency forward exchange contracts with a notional amount of $35.4 million ($9.8 million at July 3, 1994), and a fair market value of approximately $35.9 million ($10.0 million at July 3, 1994), all of which were denominated in European currencies. The fair market value was determined based upon foreign currency exchange rates in effect at the end of each fiscal period. The Company records both the amortized premium and any unrealized gain or loss on outstanding foreign currency forward exchange contracts as non-operating income or expense. For both fiscal 1995 and fiscal 1994, all outstanding foreign currency exchange contracts were due to mature within six months of fiscal year end. CREDIT FACILITY. The Company has a $50 million credit facility with a group of four banks which provides an option to convert outstanding borrowings to a term loan repayable over four years. The rate of interest payable under this facility is a floating rate, which is a function of the London Interbank Offered Rate. A facility fee equal to 0.25% of the total commitment is paid quarterly. The credit agreement contains various covenants which require the Company to maintain a specified financial ratio, limit liens, regulate asset disposition and subsidiary indebtedness and restrict certain acquisitions and investments. At July 2, 1995, the Company was in compliance with these covenants and no borrowings had been made. MARKETABLE SECURITIES. During fiscal 1995, the Company adopted Statement of Financial Accounting Standards Number 115 "Accounting for Certain Investments in Debt and Equity Securities" (SFAS 115). SFAS 115 requires that all such investment securities be classified into one of three categories: held-to-maturity, available-for-sale, or trading. Implementation of SFAS 115 did not have a material effect on Nellcor's financial position or results of operations. The Company's marketable securities, generally, are in high-quality government, municipal and corporate obligations with original maturities of up to two years. The Company has established guidelines relative to investment quality, diversification and maturities to maintain appropriate levels of safety and liquidity. 7 At July 2, 1995, the Company had marketable securities totaling $65.0 million, of which $60.2 million were classified as held-to-maturity. These held-to-maturity securities, which the Company has the positive intent and ability to hold to maturity, are stated at cost, which approximates amortized cost. Realized gains and losses resulting from the sale of marketable securities during the period and unrealized gains and losses at July 2, 1995, were immaterial. As of July 2, 1995, the Company's available-for-sale investments, which the Company does not intend to hold to maturity, totaled $4.8 million. No sales of available-for-sale marketable securities, or transfers between hold-to-maturity and available-for-sale marketable securities, were made during the year. The difference between the carrying value of the Company's available-for-sale securities and the market value as shown below was immaterial as of July 2, 1995. Marketable securities classified as held-to-maturity and available-for-sale at July 2, 1995 are summarized below (in thousands). Fair value of marketable securities is based upon quoted market prices.
Gross Gross Unrealized Unrealized Security Type Cost Gains Losses Fair Value - ------------- ------- ---------- ---------- ---------- Current assets: Marketable securities HELD-TO-MATURITY: Debt issued by the U.S. Treasury and other $22,958 $17 $ (8) $22,967 U.S. government corporations and agencies Debt securities issued by the states of the 37,236 47 (185) 37,098 United States and political subdivisions of the states AVAILABLE-FOR-SALE: Mortgage backed securities 4,845 17 (93) 4,769 ------- --- ----- ------- Marketable securities $65,039 $81 $(286) $64,834 ======= === ===== =======
CONCENTRATION OF CREDIT RISK. The Company provides credit in the form of trade accounts receivable to hospitals, private and governmental institutions and health care agencies, medical equipment distributors and rental companies, and doctors' offices. The Company does not generally require collateral to support customer receivables. The Company performs ongoing credit evaluations of its customers and maintains allowances which management believes are adequate for potential credit losses. The credit risk associated with the Company's trade receivables is further limited due to dispersion of the receivables over a large number of customers in many geographic areas. Payment of certain accounts receivable is made by the national health care systems of several member countries of the European Economic Community. Although the Company does not currently anticipate credit problems associated with these receivables, payment is contingent upon the economic stability of these countries. The Company limits credit risk exposure to foreign exchange contracts by periodically reviewing the credit worthiness of the counterparties to the transactions. 8 NOTE 3 ACQUISITION ACQUISITION OF PIERRE MEDICAL. On May 3, 1995, the Company's EdenTec subsidiary acquired Pierre Medical, a privately-held French manufacturer of respiratory products used in the home, for $21.5 million in cash. In the event that certain performance milestones are achieved subsequent to the acquisition, additional compensation totaling 30 million French Francs ($6.2 million as of July 2, 1995) would be payable to the former principal stockholders of Pierre who continue to manage the company. Such amounts will be expensed when, and if, earned. Pierre Medical manufactures and markets noninvasive ventilators, sleep apnea therapy systems, oxygen concentrators and related respiratory products in Western Europe, primarily in France. The acquisition of Pierre Medical has been accounted for as a purchase and, accordingly, Pierre Medical's results are included in Nellcor's financial statements subsequent to the acquisition date. Identifiable net assets acquired consisted of approximately $4.0 million of working capital. The excess of cost over identifiable net assets of $18.1 million, including acquisition related costs, is being amortized over 15 years, the period of the estimated future benefit. The final allocation of the purchase price to other identifiable intangible assets, including determining or reevaluating the likelihood of the future recoverability of these intangible assets, is dependent upon the outcome of the Company's merger with Puritan-Bennett Corporation (see Note 11) and any resulting effect the merger might have upon the operations of Pierre Medical. In connection with the acquisition, supplemental cash flow information is as follows (in thousands): Fair value of assets acquired, except for cash and cash equivalents $ 26,999 Liabilities assumed (5,584) ======== Cash paid to acquire Pierre Medical, net of cash and cash equivalents acquired $ 21,415 ========
The following pro forma combined financial results of Nellcor and Pierre Medical for Fiscal 1995 and Fiscal 1994 have been prepared assuming that the acquisition of Pierre Medical occurred at the beginning of each such period. In preparing the pro forma information, adjustments have been made for the amortization of goodwill, utilization of the Company's cash and marketable securities to purchase Pierre Medical, and income taxes.
- ----------------------------------------------------------------------------------- Pro Forma Information (Unaudited) July 2, 1995 July 3, 1994 - ----------------------------------------------------------------------------------- (in thousands, except per share amounts) Net revenues $275,015 $244,138 Net income 37,729 20,199 Net earnings per share $ 2.23 $ 1.20 ======== ========
9 NOTE 4 INTANGIBLES AND OTHER ASSETS Intangibles and other assets consist of:
(in thousands) July 2, 1995 July 3, 1994 - --------------------------------------------------------------------------------------- Cost: Excess of cost over net assets acquired (Note 3) $ 30,142 $ 11,325 Other intangibles from acquisitions, and purchased 9,965 11,040 technologies and rights (Note 3) Other 11,621 5,844 -------- -------- Total cost 51,728 28,209 -------- -------- Total accumulated amortization (16,439) (12,643) -------- -------- Intangibles and other assets, net $ 35,289 $ 15,566 ======== ========
NOTE 5 RESTRUCTURING CHARGE The Company incurred a restructuring charge of $500,000 before taxes during the first quarter of fiscal 1994 associated with the consolidation of the Company's Instruments and Monitoring Systems divisions. The charge was recorded as an operating expense in the first quarter of fiscal 1994. NOTE 6 PROVISION FOR INCOME TAXES The provision for income taxes consists of the following (in thousands):
Years ended July 2, 1995 July 3, 1994 July 4, 1993 ------------------------------------------------------------------------ Federal: Current $ 18,701 $ 10,796 $10,934 Deferred (260) (1,050) 1,203 -------- -------- ------- 18,441 9,746 12,137 -------- -------- ------- State: Current 3,355 2.683 2,976 Deferred (56) (404) 215 -------- -------- ------- 3,299 2,279 3,191 -------- -------- ------- Foreign: Current 1,294 416 398 Deferred (252) --- --- -------- -------- ------- 1,042 416 398 -------- -------- ------- $ 22,782 $ 12,441 $15,726 ======== ======== =======
Pretax income from foreign operations used to determine related tax liabilities amounted to $2.3 million, $1.3 million and $0.9 million for fiscal 1995, 1994, and 1993, respectively. The most significant components of the Company's deferred tax assets and liabilities at July 2, 1995 and July 3, 1994 are as follows (in thousands): 10
July 2, 1995 July 3, 1994 ---------------------------------- ----------------------------------- Deferred Tax Deferred Tax Deferred Tax Deferred Tax Assets Liabilities Assets Liabilities ------------ ------------ ------------ ------------ Inventory and product $2,899 $ 2,110 allowances Property, plant and equipment $1,046 $ 453 Intangible Assets 832 1,852 Compensated absences 753 607 State income tax accrual 1,392 979 Accounts receivable 642 693 Tax/book year-end difference 1,504 1,516 Other Accruals 2,550 1,588 1,151 1,061 ------ ------ ------- ------ 9,068 4,137 7,392 3,030 Less: Valuation Allowance (900) (1,233) ------ ------ ------- ------ Deferred Income Taxes $8,168 $4,138 $ 6,159 $3,030 ====== ====== ======= ======
As of July 2, 1995, the Company had net operating loss carry forwards resulting from the acquisition of EdenTec, which expire beginning in fiscal year 2000 and ending in fiscal year 2006. A deferred tax asset has been recorded for the tax benefit of these net operating loss carry forwards, with a corresponding valuation allowance of $0.9 million provided for the net operating loss carry forwards which may not be realized. Net operating loss carry forwards realized during fiscal 1995 resulted in a $0.3 million decrease in the valuation allowance and a corresponding reduction in the remaining net book value of the EdenTec goodwill. Tax benefits resulting from future net operating loss carry forwards will first be applied to reduce the remaining goodwill, and then to any other intangible assets associated with the acquisition of EdenTec. Deferred tax assets and liabilities at July 2, 1995 and July 3, 1994, are comprised of (in thousands):
July 2, 1995 July 3, 1994 -------------------------------------------- ----------------------------------------------- Tax Tax Tax Tax Assets Liabilities Net Assets Liabilities Net ------ ------------ ------ ------------- ------------ ------ Current $7,244 $(2,346) $4,898 $5,459 $(1,878) $3,581 Long-term 924 (1,792) (868) 700 (1,152) (452) ------ ------- ------ ------------- ------- ------ Total $8,168 $(4,138) $4,030 $6,159 $(3,030) $3,129 ====== ======= ====== ============= ======= ======
The difference between the Company's effective income tax rate and the United States federal statutory income tax rate is summarized as follows:
Years ended July 2, 1995 July 3, 1994 July 4, 1993 - ------------------------------------------------------------------------------------- Federal statutory rate 35.0% 35.0% 34.0% State income taxes, net of federal 3.6 4.5 5.2 benefit Research and experimental credits (1.0) (1.5) --- Tax legislation changes (2.2) --- Other .4 1.9 (0.7) ---- ---- ---- Effective tax rate 38.0% 37.7% 38.5% ==== ==== ====
The Company paid income taxes of approximately $18.2 million, $13.3 million, and $11.8 million in fiscal 1995, 1994, and 1993, respectively. 11 NOTE 7 STOCKHOLDERS' EQUITY COMMON STOCK. As of July 2, 1995, an aggregate of 4,773,785 shares of authorized but unissued common stock remained reserved for issuance under the 1994 Equity Incentive Plan (the "1994 Plan"), the 1991 Equity Incentive Plan, as amended (the "1991 Plan"), the 1988 Stock Option Plan for Non-Employee Directors, as amended (the "1988 Plan"), and the 1986 Employee Stock Participation Plan, as amended (the "ESPP"). STOCK OPTION PLANS. 1994 and 1991 Plans The Company maintains two employee stock option plans, the 1994 Plan and the 1991 Plan. In October, 1994, the Company obtained stockholder approval of the 1994 Plan, which authorizes the issuance of up to 1,500,000 shares of common stock to executive officers, other key employees and consultants in the form of incentive and nonqualified stock options, stock bonuses and restricted stock. The 1994 Plan satisfies the performance-based compensation requirements of The Omnibus Budget Reconciliation Act of 1993. The Company obtained shareholder approval of the 1991 Plan in October, 1991. Upon stockholder approval of the 1991 Plan, the Company's 1982 Incentive Stock Option Plan (the "1982 Plan") and the 1985 Equity Incentive Plan (the "1985 Plan") were terminated; however, shares available for issuance under these plans at the time of termination, including shares underlying outstanding options, that later expire or are canceled, were pooled with the 750,000 additional shares reserved for issuance under the 1991 Plan. In October 1992, the Company obtained stockholder approval to an amendment to the 1991 Plan increasing the number of shares authorized for issuance under the 1991 Plan by an additional 1,500,000 shares. Options granted under the 1994 and 1991 Plans generally vest on a quarterly basis over a period of four years from the date of grant. A one-year waiting period is required before vesting in the case of initial grants. The 1994 and 1991 Plans authorize the grant of incentive stock options at exercise prices equal to the fair market value of the Company's common stock on the date of grant and permit the grant of nonqualified stock options at exercise prices not less than 85 percent of fair market value on the date of grant. To date, only nonqualified stock options with exercise prices equal to the fair market value of the underlying common stock on the date of grant have been granted under both Plans. No stock bonus or restricted stock grants have been made under the 1994 or 1991 Plans. As of July 2, 1995, options representing 946,130 shares, including options issued under the 1994 and 1991 Plans and the terminated 1982 and 1985 Plans, were outstanding and exercisable at an aggregate exercise price of approximately $22.8 million, and the Company, as of such date, had 2,201,041 shares available for issuance under the 1991 and 1994 Plans. Certain options issued under the 1994 and 1991 Plans permit exercise prior to vesting. As to these options, if the optionee's relationship with the Company is terminated prior to the complete vesting of the options, the Company has the right to repurchase unvested shares at the exercise price plus interest. As of July 2, 1995, no shares were subject to repurchase by the Company under these options. 12 The following is a summary of option activity under the 1994 and 1991 Plans:
Range of Exercise Options Outstanding Prices (Per Share) ---------------------------------------------- ----------------------- Aggregate Exercise Available Price (in for Grant Number thousands) High Low - --------------------------------------------------------------------------------------------------------------------------------- BALANCE AT JULY 5, 1992 648,958 2,260,813 $ 39,565 $32.00 $ 7.88 Increase in options available for grant 1,500,000 Granted (683,710) 683,710 19,922 34.13 24.00 Exercised (476,739) (6,550) 31.75 7.88 Canceled 235,769 (235,769) (5,085) 32.00 9.38 --------- --------- -------- BALANCE AT JULY 4, 1993 1,701,017 2,232,015 47,852 34.13 7.88 Granted (668,405) 668,405 15,674 28.50 20.00 Exercised (463,672) (6,306) 26.75 9.25 Canceled 301,050 (301,050) (7,294) 32.00 10.00 --------- --------- -------- BALANCE AT JULY 3, 1994 1,333,662 2,135,698 49,926 32.00 9.25 Increase in options available for grant 1,500,000 Granted (836,220) 836,220 25,628 46.25 27.00 Exercised (661,292) (14,012) 34.13 10.00 Canceled 203,599 (203,599) (5,110) 34.13 10.63 --------- --------- -------- BALANCE AT JULY 2, 1995 2,201,041 2,107,027 56,432 46.25 10.00 ========= ========= ========
1988 Plan In October, 1988, the Company obtained stockholder approval of the 1988 Plan which authorized the non-discretionary grant of options to non-employee Directors. Under the 1988 Plan, non-employee Directors automatically receive stock option grants upon joining the Board of Directors and annually thereafter. Until amended in May of 1994, the 1988 Plan provided for an initial grant of an option to purchase 20,000 shares of common stock upon a Director joining the Board and an annual grant of an option to purchase 10,000 shares of stock. On May 14, 1994, the Board of Directors amended the 1988 Plan to reduce the number of shares issuable to non-employee Directors in the form of options to an initial grant of 10,000 shares and annual grants of 5,000 shares. Options issued to non-employee Directors under the 1988 Plan are nonqualified stock options having a five-year term and an exercise price equal to the fair market value of the Company's common stock on the date of grant and vesting over a four year period in the case of initial option grants and over the succeeding fiscal year in the case of annual grants. In October, 1994, the Company obtained stockholder approval to amend the 1988 Plan to increase the number of shares authorized for issuance by 75,000 shares and the term of options to be issued under the plan from five to ten years. As of July 2, 1995, options representing 162,500 shares were outstanding and exercisable under the 1988 Plan at exercise prices ranging from $13.63 to $26.50 for an aggregate exercise price of $3.7million, and the Company, as of such date, had 130,000 shares available for issuance under the 1988 Plan. The Board of Directors adopted and, on August 24, 1995, the Company's stockholders approved, the 1995 Merger Stock Incentive Plan (the "1995 Plan"), which authorized the issuance of up to 779,000 shares of Company common stock in the form of stock options. The purpose of the 1995 Plan is to allow the Company to comply with its obligations in the Agreement and Plan of Merger with Puritan-Bennett Corporation whereby the Company would issue options to purchase Company common stock to holders of unexercised options to purchase Puritan-Bennett stock as of the effective date of the merger. STOCK PURCHASE PLANS. Under the ESPP, qualified employees, not including members of the Board of Directors and executive officers, may purchase semi-annually up to a specified maximum amount of shares of Nellcor common stock through payroll deductions at a price equal to 85% of the fair market value of the stock at the beginning or end of the six month plan period, whichever is less. In October, 1994, the Company obtained stockholder approval to increase the number of shares available for purchase under the ESPP by 250,000 shares. As of July 2, 1995, 726,783 shares of common stock had been purchased under the ESPP since inception and 173,217 shares remained available for purchase by employees. 13 STOCK REPURCHASE PROGRAMS. During the fourth quarter of fiscal 1993, the Board of Directors approved a Limited Stock Repurchase Program ("the Limited Program") which commenced early in fiscal 1994. The objective of the Limited Program is to utilize a portion of available cash balances to repurchase on the open market shares of the Company's common stock, to mitigate the dilutive effects of the issuance of shares under the 1994 Plan, 1991 Plan, 1988 Plan, and ESPP. Repurchases made under the Limited Program are made on a recurring basis to the extent that stock options are exercised during the year and totaled $20.9 million (625,500 shares) and $13.6 million (522,500 shares) during the fiscal years ended July 2, 1995 and July 3, 1994, respectively. In addition to the Limited Program, the Board of Directors approved a General Stock Repurchase Program (the "General Program") during the second quarter of fiscal 1994 to repurchase and retire up to 1 million shares of the Company's common stock. The object of this General Program is to more effectively utilize an additional portion of available cash balances. No repurchases under the General Program were made in fiscal 1995; 210,000 shares were repurchased and retired during fiscal 1994, totaling $5.9 million. STOCK RIGHTS--SERIES A JUNIOR PARTICIPATING PREFERRED STOCK. During fiscal 1991, the Board of Directors declared a dividend distribution of one purchase right for each outstanding share of common stock. Each right entitles the holder to purchase from the Company one one-hundredth of a share of Series A Junior participating preferred stock, par value $.001, at a price of $90 per one-hundredth of a preferred share. Each one one-hundredth of a share of new preferred stock is substantially the economic equivalent of one share of common stock. In the event that a third party acquires 15 percent or more of the Company's common stock or announces an offer which would result in such party's owning 15 percent or more of the Company's common stock, the rights will become exercisable. The rights expire on June 26, 2001, and subject to certain conditions, may be redeemed by the Board of Directors at a price of $.001 per right. COMPENSATION TO RADIANT STOCKHOLDERS. As part of the acquisition of Radiant Systems, Inc, (Radiant) in fiscal 1990, Nellcor issued to escrow on behalf of the majority stockholders of Radiant, who were also Radiant employees, approximately 115,000 shares of Nellcor's common stock. The common stock was expected to be released over a three-year period beginning in fiscal 1991. As of the end of fiscal 1992, the majority stockholders of Radiant had terminated their employment with Radiant, and the Company released all of the remaining shares held in escrow in fiscal 1993. NOTE 8 COMMITMENTS The Company leases its facilities under agreements that expire at various dates through June 2006, which include options to renew through June 2016. Rental expenses were approximately $4.7 million, $4.5 million, and $4.0 million in fiscal years 1995, 1994, and 1993, respectively. Aggregate minimum annual rental commitments under long-term operating leases are as follows (in thousands):
Fiscal years - ------------------------------------------------------------------------- 1996 $4,117 1997 4,290 1998 3,939 1999 3,856 2000 3,454 After 2000 14,433 ------- Total rental commitments $34,089 =======
14 NOTE 9 INDUSTRY SEGMENT AND GEOGRAPHIC INFORMATION The Company operates in a single-industry segment: the design, engineering, manufacture, marketing and servicing of high-performance monitoring, measurement and therapeutic instruments and related sensors and airway adapters, and detectors for the hospital, prehospital and home care markets. The principal methods of distribution are direct sales, corporate accounts and independent distributors. Geographic information with respect to the Company's operations is as follows (in thousands):
Years ended July 2, 1995 July 3, 1994 July 4, 1993 - -------------------------------------------------------------------------------------- Net revenue: United States domestic $ 221,295 $ 205,352 $ 193,524 Unites States export 16,030 11,208 9,381 Europe 43,825 31,008 28,737 Intersegment eliminations (17,110) (12,596) (13,456) --------- --------- --------- Total net revenue $ 264,040 $ 234,972 $ 218,186 ========= ========= ========= Income (loss) from operations: United States $ 50,023 $ 41,434 $ 38,795 Europe 4,647 604 (1,105) Corporate and eliminations (325) 813 147 --------- --------- --------- Total operating income $ 54,345 $ 42,851 $ 37,837 ========= ========= ========= Identifiable assets: United States $ 125,774 $ 135,336 $ 128,474 Europe 53,853 21,892 24,363 Corporate and other 154,657 119,173 110,774 Eliminations (39,815) (38,253) (38,005) --------- --------- --------- Total assets $ 294,469 $ 238,148 $ 225,606 ========= ========= =========
Transfers between geographic areas are generally recorded at amounts above cost and in accordance with the rules and regulations of the governing tax authorities. Operating income is total revenue less cost of sales and operating expenses and does not include either interest income, other income (expense), net, or income taxes. Identifiable assets of geographic areas are those assets used in Nellcor's operations in each area. Identifiable corporate assets consist primarily of cash and cash equivalents, marketable securities and other assets. NOTE 10 LITIGATION From time to time the Company has received, and in the future may receive, notice of claims against it, which in some instances have developed, or may develop, into lawsuits. The claims may involve such matters, among others, as product liability, patent infringement, and employment-related claims. In management's opinion, the ultimate resolution of claims currently pending will not have a material adverse effect on the Company's financial position or results of operations. On July 11, 1995, the U.S. Federal District Court in Delaware issued a decision in favor of the Company, ruling that four key oximeter and sensor technology patents are valid and would be infringed by Ohmeda Inc., a subsidiary of BOC Health Care Inc., if Ohmeda sold either its adult or neonatal OxyTip sensors for use with non-Ohmeda monitors. BOC Health Care has filed a notice to appeal the decision of the U.S. Federal District Court in Delaware. BOC Health Care had filed a suit against the Company in December 1992, seeking a declaratory judgment that Nellcor's patents were invalid and would not be infringed. 15 In a related matter, in the third quarter of fiscal 1994, the Company agreed to settle trade secrets and patent litigation with BOC Health Care, Inc. and its Ohmeda, Inc. subsidiary, and Square One Technology. Under the terms of the agreement, the patent in issue was assigned to the Company. The Company also received a pretax $2 million payment and will receive ongoing royalties. The $2 million payment was recorded as non-operating income. In the fourth quarter of fiscal 1994, the Company agreed to settle its patent litigation with Camino Laboratories, Inc. ("Camino") of San Diego, CA. Under the terms of the settlement, Camino agreed not to sue the Company or its current or future customers relating to the use or sale of the Company's sensors and monitors intended for use with such sensors. A cash payment of $15 million was made by the Company to Camino and was recorded as a non-operating expense. This settlement neither recognizes the validity nor acknowledges infringement of the Camino patent at issue. NOTE 11 MERGER WITH PURITAN-BENNETT. On May 22, 1995, Nellcor and Puritan-Bennett Corporation (Puritan-Bennett) announced that their Boards of Directors had approved a definitive agreement to merge the two companies. The issuance of Nellcor common stock in connection with the Agreement and Plan of Merger was approved by shareholders at special shareholder meetings held by each company on August 24, 1995. Under the terms of the agreement, shareholders of Puritan-Bennett will receive 0.88 of a share of Nellcor common stock for each Puritan-Bennett share. Puritan-Bennett, founded in 1913, operates 11 manufacturing and research plants worldwide and is a world leader in products related to respiration used in multiple health care settings and on aircraft. Puritan-Bennett develops, manufactures and markets ventilators, respiratory monitoring instruments, and certain complementary products such as medical gases, gas-related equipment, and spirometers. Puritan-Bennett reported revenue of $336.0 million and net income of $8.4 million for its most recent fiscal year ended January 31, 1995. The new company, Nellcor Puritan Bennett Incorporated (Nellcor Puritan Bennett), will be headquartered in Pleasanton, California, site of Nellcor's current headquarters. The Board of Directors of Nellcor Puritan Bennett will have nine members: six from Nellcor, two from Puritan-Bennett and one to be selected by both companies. The merger is intended to qualify as a tax-free reorganization and will be accounted for as a pooling of interests. Pro forma combined financial results for the two companies, assuming that the merger had occurred on July 6, 1992, would be as follows (in thousands, except per share amounts):
- ---------------------------------------------------------------------------------- Pro Forma Information July 2, 1995 July 3, 1994 July 4, 1993 (Unaudited) - ---------------------------------------------------------------------------------- Net revenues $600,066 $ 544,227 $518,246 Net income 49,463 (6,422) 39,715 Net earnings per share $ 1.77 $ (0.23) $ 1.46
The pro forma financial results combine Nellcor's financial data for each of the three fiscal years ended July 2, 1995, with Puritan-Bennett's financial data for each of the three fiscal years ended January 31, 1995. The only pro forma adjustment impacting net income was an adjustment to reduce Puritan-Bennett's valuation allowance provided for its deferred tax assets based on the combined income from operations before tax of Nellcor and Puritan-Bennett as required by Statement of Financial Accounting Standards Number 109, "Accounting for Income Taxes" (SFAS 109). Intercompany transactions between the two companies for the periods presented were not material. Subsequent to the merger, Nellcor expects to incur a charge in the quarter ended October 1, 1995, currently estimated to be in the range of $50 million to $70 million, to reflect the combination of the two companies, including costs relating to severance, the elimination of duplicate systems and facilities, other integration costs, and transaction fees. Charges relating to goodwill arising from the companies' prior acquisitions may also be taken in the first quarter as a result of the merger. This amount is a preliminary estimate only and is therefore subject to change. In addition, there can be no assurance that Nellcor will not incur additional charges in subsequent quarters to reflect costs associated with the merger. 16 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS RESULTS OF OPERATIONS: Nellcor's net income for fiscal 1995 was $37.2 million, or $2.20 per share, compared to $20.6 million, or $1.22 per share, for fiscal 1994. Fiscal 1994 net income includes the effect of a net $13.0 million pretax charge ($8.0 million or $0.48 per share after tax) for trade secrets and patent litigation settlements. Excluding the after-tax effect of these settlements, fiscal 1995 net income increased 30 percent over net income of $28.6 million, or $1.70 per share, for fiscal 1994. The Company's net revenue for fiscal 1995 increased 12 percent to $264.0 million from $235.0 million in fiscal 1994. The increase in net revenue principally resulted from higher sales of oximetry products across the Company's domestic and international markets, increased sales of EdenTec apnea monitoring and recording products, and the favorable effect foreign currency exchange rates had upon revenue. The Company's oximetry products include oximetry instruments, sensors, and OEM modules. The Company's principal oximetry instruments include the N-20 portable pulse oximeter, the N-180, N-185, N-200, and N-250 standalone pulse oximeters, and the N-3000 pulse oximeter, a module of the NELLCOR SYMPHONY (TM) monitoring system. Oximetry instrument revenue for fiscal 1995 increased slightly as higher unit sales of the N-3000 pulse oximeter and the N-20 portable pulse oximeter were partially offset by lower average selling prices. Oximetry sensors include adhesive, reusable, and recycled sensor product lines. Revenue from oximetry sensors increased moderately during fiscal 1995 primarily due to continued growth in the installed base of the Company's monitors and products of the Company's licensees and OEM customers that use the Company's sensors. Higher unit sales were partially offset by slightly lower average selling prices for adhesive and recycled sensors. OEM oximetry module revenue increased significantly in fiscal 1995 as higher unit shipments were partially offset by moderately lower average selling prices. At the end of fiscal 1995, the Company had OEM or licensing agreements in place with 40 medical systems and monitor manufacturers worldwide. The principal apnea monitoring and recording products sold by EdenTec Corporation into the home health care market include the ASSURANCE 2000 heart and respiration monitor, the ASSURANCE 3000 heart and respiration monitor, and the EdenTrace II and EdenTrace II Plus (TM) multi-channel recording systems, and related products. During the fourth quarter of fiscal 1995, EdenTec acquired Pierre Medical, a privately held French manufacturer of respiratory products used in the home. Pierre Medical markets the O'nyx(TM) non-invasive ventilation system, the O'mega(TM) oxygen concentrator, and the Morphee(TM) and Morphee Plus(TM) sleep apnea therapy systems in Western Europe, primarily in France. Revenue from these home health care products significantly increased during fiscal 1995 primarily due to higher sales of the EdenTrace II Plus and the ASSURANCE 3000 as well as sales from Pierre Medical included in EdenTec's results subsequent to the acquisition, which was consummated May 3, 1995. International revenue increased 42 percent to $59.9 million in fiscal 1995 from $42.1 million in fiscal 1994. International revenue increased significantly across all markets principally due to higher sales of oximetry sensors, the N-3000 pulse oximeter, and OEM oximetry modules. Favorable foreign currency exchange rates accounted for 10 percentage points of the international revenue growth during fiscal 1995. Sales of the HEALTHQUIZ (TM) system, a patient-driven automated medical history system that electronically captures patient information, have been limited since the product was introduced in the fourth quarter of fiscal 1994. The Company regularly reviews its net investment in HEALTHQUIZ system assets and the related market opportunities. 17 Nellcor's net revenue increased 8 percent to $235.0 million in fiscal 1994 from $218.2 million in fiscal 1993. The increase in net revenue principally resulted from higher sales of adhesive and reusable sensors, as well as increased sales of apnea and oximetry products by EdenTec Corporation into the home health care market. Sales of adhesive and reusable sensors increased primarily due to continued growth in the installed base of the Company's monitors and the products of the Company's licensees and OEM customers that use the Company's sensors. Oximetry instrument revenue decreased slightly in fiscal 1994 primarily due to lower average selling prices and a continued shift to lower-priced, portable pulse oximeters such as the N-20. Unit sales of oximetry instruments decreased slightly in fiscal 1994. OEM oximetry module revenue increased in fiscal 1994 principally due to significantly higher unit shipments, partially offset by lower average selling prices. Selling prices for certain OEM modules were reduced beginning in the third quarter of fiscal 1993. International revenue increased 11 percent to $42.1 million in fiscal 1994 principally due to higher sales of adhesive and reusable sensors, the ULTRA CAP and the E-300, a multi-parameter monitoring system sold exclusively in Europe. International growth occurred principally in the Asia Pacific and European regions. Fiscal 1994 international revenue would have been approximately 6 percent higher had foreign currency exchange rates remained the same as those in effect in the comparable periods in fiscal 1993. The following sets forth, for the indicated periods, the relationship that certain items bear to net revenue:
Years Ended July 2, 1995 July 3, 1994 July 4, 1993 - ------------------------------------------------------------------------------------ Net revenue 100% 100% 100% Gross Margin 61 60 59 Operating expenses: Research and development 10 10 10 Selling, general and administrative 30 32 32 Total operating expenses 40 42 42 Income from operations 21 18 17 Litigation settlements, net -- 6 -- Income before income taxes 23 14 19 Net income 14 9 12
Gross margin increased to 61 percent in fiscal 1995 from 60 percent in fiscal 1994 primarily due to improved margins at EdenTec and the favorable effect which foreign currency exchange rates had upon revenue, partially offset by a slight shift in mix to lower margin instruments. Gross margin increased to 60 percent in fiscal 1994 from 59 percent in fiscal 1993. This increase was primarily due to a slight shift in mix to higher margin sensors and lower manufacturing and service costs, partially offset by lower oximetry instrument pricing and the unfavorable impact which foreign currency exchange rates had upon revenue. Research and development expenses at 10 percent of net revenue in fiscal 1995 were comparable to the prior year. Research and development expenses increased in absolute dollars due primarily to costs incurred related to the development of additional modules of the NELLCOR SYMPHONY monitoring system, increased sleep product development work at EdenTec and higher patent filing fees and legal costs. The Company expects to continue to invest in the research and development of new products and to defend its patents. 18 Research and development expenses at 10 percent of net revenue in fiscal 1994 were comparable to the prior year. Research and development expenses increased in absolute dollars due primarily to costs incurred related to the development of the HEALTHQUIZ(TM) PRESCREEN(TM) automated preanesthetic medical history system. Selling, general, and administrative expenses in fiscal 1995 decreased to 30 percent of net revenue from 32 percent of net revenue in fiscal 1994. Selling, general and administrative expenses increased in absolute dollars due primarily to the unfavorable effect foreign currency exchange rates had upon international operating expenses, the inclusion of operating expenses from Pierre Medical subsequent to its acquisition, and increased funding of the Company's profit sharing and bonus plans, partially offset by lower patent litigation expenses. In comparison to fiscal 1993, fiscal 1994 selling, general and administrative expenses remained unchanged at 32 percent of net revenue. Selling, general and administrative expenses increased in absolute dollars due primarily to higher patent litigation expenses. During the first quarter of fiscal 1994, a $.5 million restructuring charge was recorded. Under the restructuring, two of the Company's divisions were consolidated into a single business unit. During the third quarter of fiscal 1994, the Company agreed to settle trade secrets and patent litigation with BOC Health Care, Inc., and its Ohmeda, Inc. subsidiary, and Square One Technology. Under the terms of the agreement, the patent in issue was assigned to the Company. The Company also received a $2 million payment and will receive ongoing royalties. The $2 million payment was recorded as nonoperating income in the third quarter of fiscal 1994. During the fourth quarter of fiscal 1994, the Company announced that it had agreed to settle its patent litigation with Camino Laboratories Inc. ("Camino") of San Diego, CA. Under the terms of the settlement, Camino agreed not to sue the Company or its current or future customers relating to the use or sale of the Company's sensors and monitors intended for use with such sensors. A cash payment of $15 million was subsequently made by the Company to Camino. The payment was recorded as a nonoperating expense in the fourth quarter of fiscal 1994. In July, 1995, the Company announced that the U.S. Federal District Court in Delaware had issued a decision in favor of Nellcor in the Company's patent litigation with Ohmeda and BOC Health Care, Inc. The Court ruled that Nellcor oximeter and sensor technology patents are valid and would be infringed if Ohmeda, a subsidiary of BOC Health Care, Inc., sold its adult or neonatal Oxy Tip sensors for use with non-Ohmeda monitors. BOC Health Care has filed a notice to appeal the decision of the U.S. Federal District Court in Delaware. BUSINESS FACTORS: ACQUISITIONS. During the fourth quarter of fiscal 1995, EdenTec acquired Pierre Medical, a privately-held French manufacturer of respiratory products used in the home for $21.5 million in cash. In the event that certain profitability targets are achieved or certain of Pierre Medical's products receive FDA approval subsequent to the acquisition, additional compensation totaling 30 million French Francs ($6.2 million as of July 2, 1995) would be payable to the former principal stockholders of Pierre Medical who will continue to manage the company. Pierre Medical manufactures and markets noninvasive ventilators, sleep apnea therapy systems, oxygen concentrators and related respiratory products in Western Europe, primarily France. Pierre Medical reported revenue of approximately $10.0 million for its most recent fiscal year ended September 30, 1994. The acquisition was accounted for under the purchase method and is intended to broaden the Company's product offerings and to provide opportunities to expand sales into the home health and emergency care market segments. The final allocation of the purchase price to other identifiable intangible assets, including determining or reevaluating the likelihood of the future recoverability of these intangible assets, is dependent upon the outcome of the Company's merger with Puritan-Bennett Corporation (see Note 11) and any resulting effects the merger has upon the operations of Pierre Medical. 19 MERGER WITH PURITAN-BENNETT. During the fourth quarter of fiscal 1995, Nellcor and Puritan-Bennett Corporation (Puritan-Bennett) announced that their Boards of Directors had approved a definitive agreement to merge the two companies. The issuance of Nellcor common stock in connection with the Agreement and Plan of Merger was approved by shareholders at special shareholder meetings held by both companies on August 24, 1995. Under the terms of the agreement, shareholders of Puritan-Bennett will receive 0.88 of a share of Nellcor common stock for each Puritan-Bennett share. Puritan-Bennett, founded in 1913, operates 11 manufacturing and research plants worldwide and is a world leader in products related to respiration used in multiple health care settings and on aircraft. Puritan-Bennett develops, manufactures and markets ventilators, respiratory monitoring instruments, and certain complementary products such as medical gases, gas-related equipment, and spirometers. Puritan-Bennett reported revenue of $336.0 million and net income of $8.4 million for its most recent fiscal year ended January 31, 1995. The merger will combine companies who are worldwide leaders in two complementary areas, patient safety monitoring and respiratory therapy. In addition, the merger will allow the new company to potentially realize synergies in research and development, manufacturing, and operations. Subsequent to the merger, Nellcor expects to incur a charge in the quarter ended October 1, 1995, currently estimated to be in the range of $50 million to $70 million, to reflect the combination of the two companies, including costs relating to severance, the elimination of duplicate systems and facilities, other integration costs, and transaction fees. Charges relating to goodwill arising from the companies' prior acquisitions may also be taken in the first quarter as a result of the merger. This amount is a preliminary estimate only and is therefore subject to change. In addition, there can be no assurance that Nellcor will not incur additional charges in subsequent quarters to reflect costs associated with the merger. The new company, Nellcor Puritan Bennett, will be headquartered in Pleasanton, California, site of Nellcor's current headquarters. The Board of Directors of Nellcor Puritan Bennett will have nine members: six from Nellcor, two from Puritan-Bennett and one to be selected by both companies. The merger is intended to qualify as a tax-free reorganization and will be accounted for as a pooling of interests. PRODUCTS. In the second quarter of fiscal 1995, the Company received marketing clearance from the U.S. Food and Drug Administration (FDA) for the Pedi-CAP pediatric end-tidal CO2 detector. This disposable device, in combination with the EASY CAP(R) CO2 detector, will allow customers to verify and monitor correct endotracheal tube placement in a full range of patients, from infants to adults. Both the Pedi-CAP and EASY CAP CO2 detectors were designed to be used in transport and emergency settings as well as areas where capnography is not available. In the fourth quarter of fiscal 1995, the Company received marketing clearance from the FDA for the N-3000 pulse oximeter and the N-3100 noninvasive blood pressure monitor. The N-3000, the first module of a planned monitoring system for use on the hospital general care floor and in mobile environments, was shipped to international markets beginning in the third quarter of fiscal 1994. International shipments of the N-3100 noninvasive blood pressure monitor, the second module of the NELLCOR SYMPHONY monitoring system, began in the first quarter of fiscal 1995. Commercial shipment of both products in the U.S. market commenced late in the fourth quarter of fiscal 1995. The N-3000 and the N-3100 can be used as standalone monitors or as part of the NELLCOR SYMPHONY system. Nellcor began limited shipments of the N-400 fetal pulse oximeter in Europe in the second quarter of fiscal 1995. The N-400 is used to measure fetal oxygen levels during labor and delivery, and is expected to aid obstetricians in evaluating fetal well-being. In the first quarter of fiscal 1994, the FDA notified the Company that the N-400 fetal oximeter must be submitted under the Pre-Market Approval (PMA) Application Regulations. The PMA process, as compared to the 510(k) procedures, requires more laboratory and clinical testing data, and more detailed design and manufacturing information. This process in turn takes the manufacturer longer to gather data and prepare the PMA application. Historically, the time elapsed between submission of a PMA application and receipt of premarket approval is significantly longer than for the clearance to market granted under the 510(k) process. In June 1995, the Company filed an application for an Investigational Device Exemption with the FDA. Clinical trials of the product are expected to begin by the end of the second quarter of fiscal 1996. The Company is continuing to develop new products to address existing and new markets. The introduction of new products may be prevented or delayed by engineering obstacles, regulatory procedures, clinical trials, production difficulties, and other factors. In addition, the costs of producing, promoting, and servicing new products are generally greater than in the case of mature, higher volume products. New product introductions can also temporarily reduce revenues by interfering with sales of existing products. 20 As Nellcor's existing products reach life cycle maturity, the Company's ability to develop or acquire new products and technologies increases in importance. The Company has and will continue to pursue technology, new product, and business acquisition opportunities intended to broaden the Company's product offerings. Examples of such activities include the acquisition of Pierre Medical in fiscal 1995, and the pending merger of Nellcor and Puritan-Bennett. Such activities may result in increased expenses which could have an adverse impact on the Company's net income. MARKET CONDITIONS. As health care increasingly becomes managed care, patient care is shifting to lower cost areas of the hospital and alternate care sites outside the hospital, including subacute care centers, skilled nursing facilities and the home. Additionally, in an effort to create larger, more cost-effective entities capable of competing for managed care contracts, health care providers are consolidating and vertically integrating, and hospitals are joining local or regional multiple hospital systems in greater numbers. As a result of these ongoing changes in the delivery of health care, the Company expects that a greater proportion of its future revenue will come from sales of its products to a smaller customer base, primarily comprised of larger, consolidated health care providers and buying groups, and from sales of its products into the growing alternate care markets. In the current health care business environment, hospitals, which are the Company's principal customers, face increasing pressure to control costs. These pressures may in the future lead to a decrease in the average selling price for a number of the Company's products, which could adversely affect the Company's gross margin. During fiscal 1995 and fiscal 1994, the Company offered a number of promotional programs in an effort to increase the installed base of Nellcor oximetry instruments and OEM modules. These programs also had the effect of reducing pulse oximetry pricing. Competition in fiscal 1995 caused further price reductions for oximeters and multi-function monitors. The Company is continually seeking manufacturing cost reductions; however, these reductions may not offset the impact of future price declines. INTERNATIONAL MARKETS. The Company has devoted significant resources to development of its European markets and administrative infrastructure. Over the past five years, the Company has experienced growth in European revenues and continues to expand sales, service, and distribution operations in this market. Through its acquisition of Pierre Medical, the Company has broadened its product offerings in the European home care market. During fiscal 1995, sales to the Asia/Pacific region increased significantly. Additionally, in July of fiscal 1995, Nellcor increased its ownership interest in the Company's Tokyo-based joint venture, NCI, to 50 percent. The Company's investment in the joint venture, which it accounts for under the equity method, was immaterial at July 2, 1995. With a greater level of investment in the venture, and increased management involvement and marketing resources, the Company plans to more aggressively pursue opportunities for Nellcor and EdenTec products in Japan. The Company received ISO 9001 certification for all of its facilities in March, 1995. This certification signifies that the Company has met a rigorous set of international standards for product design, installation, and service. ISO 9001 certification is the first step necessary to be able to affix the CE (Conformitee European) mark to Nellcor products and requires the implementation of a company-wide quality system. The Company believes ISO 9001 certification provides a significant competitive advantage in global markets. The Company believes that the continued growth in international revenue and market share will be a key factor in its overall long-term performance and accordingly intends to continue to invest in its international operations. TIMING OF ORDERS AND SHIPMENTS. Historically, orders in the first quarter have been lower than in the second, third and fourth quarters. Of the monitor orders received by the Company in any quarter, a disproportionately large percentage has typically been received and shipped toward the end of the quarter. Accordingly, monitor backlog has historically been modest and not an accurate predictor of future revenues, and results for a given quarter can be adversely affected if there is a substantial order shortfall in that quarter. Backlog at the end of fiscal 1995 was approximately $9.8 million compared to $10.7 million at the end of fiscal 1994. The decrease in backlog in fiscal 1995 was primarily due to increased shipments of the N-3000 at the end of the fiscal year. 21 LIQUIDITY AND CAPITAL RESOURCES During fiscal 1995, the Company generated a net increase in cash and cash equivalents and marketable securities of $19.1 million. At July 2, 1995, the Company had cash, cash equivalents and marketable securities amounting to approximately $140.7 million compared to $121.6 million at the end of fiscal 1994. The Company has met its liquidity requirements from internally generated cash. The Company's operating activities provided positive cash flows of $55.7 million during fiscal 1995. Depreciation expense and amortization expense were significant non-cash operating activities for all years presented. Purchases of marketable securities and fixed assets, principally manufacturing equipment, and the acquisition of Pierre Medical were the principal uses of cash from investing activities. Shares of Nellcor common stock issued due to the exercise of stock options under one of the Company's stock option plans were significant sources of cash from financing activities in fiscal 1994. Shares of common stock repurchased in fiscal 1995 under the Company's Limited Stock Repurchase Program were significant uses of cash from financing activities. Shares repurchased under the Limited Stock Repurchase Program are repurchased to offset the dilutive effects of the Company's stock plans. No repurchases of shares under the General Stock Repurchase Program, which authorizes the repurchase and retirement of up to one million shares of common stock from time to time in the open market, were made in fiscal 1995. During the second quarter of fiscal 1995, the Company secured a $50 million credit facility with a syndicate of 4 banks led by ABN AMRO Bank N.V. The credit facility was obtained to provide Nellcor with additional financial resources and flexibility to take advantage of strategic business opportunities. Under the terms of the credit facility, a commitment fee of 0.25% is paid quarterly and at the end of November, 1996, outstanding borrowings are convertible into four year term loans. As of July 2, 1995, the Company had not drawn against this credit facility. The Company anticipates that current capital resources combined with cash generated from operating activities will be sufficient to meet its liquidity and capital expenditure requirements at least through the end of fiscal 1996. When the Company's merger with Puritan-Bennett is consummated, it is expected that costs associated with the merger as well as other merger-related cash outlays, will lead to a net reduction in the Company's cash and cash equivalents during fiscal 1996. The Company may consider using debt to fund certain capital and other strategic opportunities when deemed necessary and financially advantageous. 22 REPORT OF INDEPENDENT ACCOUNTANTS TO THE BOARD OF DIRECTORS AND STOCKHOLDERS OF NELLCOR INCORPORATED In our opinion, the accompanying consolidated balance sheet and the related consolidated statements of income, of stockholders' equity and of cash flows present fairly, in all material respects, the financial position of Nellcor Incorporated and its subsidiaries at July 2, 1995 and July 3, 1994, and the results of their operations and their cash flows for each of the three years in the period ended July 2, 1995, in conformity with generally accepted accounting principles. These financial statements are the responsibility of the Company's management; our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with generally accepted auditing standards which require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for the opinion expressed above. San Francisco, California July 26, 1995, except as to Note 11, which is as of August 24, 1995 23 SELECTED QUARTERLY DATA Unaudited (in thousands, except per share amounts)
Year ended July 2, 1995 1st quarter 2nd quarter 3rd quarter 4th quarter - -------------------------------------------------------------------------------------------------------------- Net revenue $55,714 $64,017 $71,035 $73,274 Gross profit 32,878 38,690 43,119 46,172 Income from operations 8,380 12,390 15,967 17,608 Net Income 5,859 8,483 11,058 11,765 Net income per share 0.35 0.50 0.65 0.69 - -------------------------------------------------------------------------------------------------------------- Year ended July 3, 1994 1st quarter 2nd quarter 3rd quarter 4th quarter - -------------------------------------------------------------------------------------------------------------- Net revenue $50,148 $58,113 $61,646 $65,065 Gross profit 29,222 34,695 37,648 39,701 Income from operations 6,638 10,543 12,373 13,297 Litigation settlements --- --- 2,000 (15,000) Net Income 4,859 6,856 9,352 (510) Net income per share 0.29 0.41 0.55 (0.03)
EX-27 4 FINANCIAL DATA SCHEDULE`
5 1,000 YEAR JUL-2-1995 JUL-4-1994 JUL-2-1995 75,642 65,039 44,304 1,274 31,446 223,367 81,896 46,083 294,469 52,880 0 18 0 0 240,703 294,469 264,040 264,040 103,181 103,181 106,514 0 0 59,947 22,782 37,165 0 0 0 37,165 2.20 2.20
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