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 June 30, 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 No. 000-16723 RESPIRONICS, INC. (Exact name of registrant as specified in its charter) Delaware 25-1304989 (State or other jurisdiction of (I.R.S. Employer Identification Number) incorporation or organization) 1001 Murry Ridge Drive Murrysville, Pennsylvania 15668 (Address of principal executive offices) (Zip Code) (Registrant's Telephone Number, including area code) 412-733-0200 Securities registered pursuant to Section 12(b) of the Act: Name of each exchange Title of each class on which registered ------------------- --------------------- None -- Securities registered pursuant to Section 12(g) of the Act: Common Stock, par value $.01 per share (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 and (2) has been subject to such filing requirements for at least the past 90 days. Yes X No . --- --- As of August 31, 1995, the aggregate market value of the shares of the registrant's Common Stock held by non-affiliates was approximately $235,000,000. As of August 31, 1995, there were 16,805,085 shares of Common Stock of the registrant outstanding. Documents Incorporated by reference: Portions of the Proxy Statement for the registrant's Annual Meeting of Shareholders to be held on November 8, 1995 are incorporated by reference into Part III of this Annual Report on Form 10-K. 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 the 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 --- INDEX Page ---- PART I Item 1 Business.................................... 1 Item 2. Description of Property..................... 15 Item 3. Legal....................................... 15 Item 4. Submission of Matters to a Vote of Security Holders............................ 16 PART II Item 5. Market for Registrant's Common Equity and Related Shareholder Matters............. 17 Item 6. Selected Financial Data..................... 18 Item 7. Management's Discussion and Analysis of Results of Operations and Financial Condition......................... 19 Item 8. Consolidated Financial Statements........... 24 Item 9. Disagreements on Accounting and Financial Disclosure........................ 41 PART III Item 10. Directors and Executive Officers of the Registrant.................................. 42 Item 11. Executive Compensation...................... 42 Item 12. Security Ownership of Certain Beneficial Owners and Management....................... 42 Item 13. Certain Relationships and Related Transactions................................ 42 PART IV Item 14. Exhibits, Financial Statement Schedules and Reports on Form 8-K........... 43 Signatures ............................................... 49 PART I Item 1. Business -------- General Respironics, Inc. designs, manufactures and markets medical products which address a wide range of respiratory and pulmonary problems by assisting patient breathing. These products are used in the home, in hospitals and in emergency medical situations. The Company is a Delaware corporation which was originally incorporated in Pennsylvania in 1976 as the successor company for certain products of Lanz Medical Products Corporation. As part of a corporate reorganization completed in 1984, the Company became a Delaware corporation. The Company has two principal operating subsidiaries, Respironics (HK) Limited, which is wholly-owned and based in Hong Kong, and Respironics Medical Products (Shenzhen) Ltd., which is wholly-owned by Respironics (HK) Limited and is based in the Peoples Republic of China. The Company has another wholly-owned subsidiary, RIC Investments, Inc., a Delaware corporation which conducts its operations in Delaware. The Company's executive offices are located at 1001 Murry Ridge Drive, Murrysville, PA 15668. Unless the context indicates otherwise, reference in this Annual Report to the "Company" or "Respironics" refers to Respironics, Inc. and its subsidiaries. In 1981, the Company developed and introduced the first commercially available single-use air-filled cushion anesthesia mask. The Company was the sole manufacturer of such masks for approximately four years and the Company believes that it continues to be one of the leading manufacturers of single-use anesthesia masks which are marketed in the United States. In 1985, the Company developed and introduced the first commercially available product designed to treat the sleeping disorder known as obstructive sleep apnea. After a two year period during which the Company was the primary provider of non-invasive sleep apnea therapy products, other and larger companies entered the market for products designed to treat obstructive sleep apnea. Currently, the Company believes that its REMstar Choice product (the fifth generation device in the sleep apnea product line) and certain of its BiPAP products (see below) continue to be the leading products in the obstructive sleep apnea therapy market in the United States. In 1989, the Company introduced the BiPAP Airway Management and Ventilatory Support Systems which are unique products that deliver non- invasive pressure support therapy to patients who require ventilatory assistance but are not dependent on a ventilator for life support and to those suffering from severe cases of obstructive sleep apnea. 1 The Company's other products are generally single-patient use products designed to provide an effective and comfortable means of patient ventilation which reduce the risk of cross contamination among patients and medical personnel. This product group includes the Company's redesigned BagEasy manual resuscitator, which was introduced in March 1995. A predecessor version of BagEasy was manufactured and sold by the Company from 1988 through 1993. Unless the context indicates otherwise, reference in this Annual Report to "fiscal year" refers to the twelve month period ending on June 30 of the year indicated. In February 1995, the Company's Board of Directors declared a two-for- one stock split of the Company's common stock, distributing on March 17, 1995 one additional share of common stock for each share held of record on March 3, 1995. All agreements concerning stock options were amended to provide for issuance of two shares of common stock for every one share issuable prior to the split. An amount equal to the par value of the shares issued was transferred from additional capital to the common stock account. This transfer has been reflected in the Consolidated Statements of Changes in Shareholders' Equity at July 1, 1992. All references to number of shares, except shares authorized, and to per-share information in the consolidated financial statements have been adjusted to reflect the stock split on a retroactive basis. "Respironics", "REMstar", "BiPAP", and "BagEasy" are registered trademarks of the Company. "The Hayek Oscillator" is a registered trademark of Flexco Medical Instruments. Products At the present time, the Company's principal products can be divided into four categories: obstructive sleep apnea products, ventilation products, face mask products and resuscitation products. Obstructive Sleep Apnea Products -------------------------------- One of the Company's principal products is its REMstar Choice Nasal CPAP system, which is designed to treat a sleeping disorder known as obstructive sleep apnea. The Company believes that this product leads the market in the United States for the treatment of obstructive sleep apnea. Obstructive sleep apnea is the repeated cessation of breathing during sleep caused by anatomical disorders. It is characterized by very loud, irregular snoring or other labored breathing sounds during sleep of which the patient may not be fully aware. The disorder is commonly found in obese individuals, and the consumption of alcohol, sleeping pills and tranquilizers by obstructive sleep apnea sufferers can make the problem worse. The most common symptom associated with obstructive sleep apnea is daytime sleepiness or fatigue. 2 The Company estimates that in the United States approximately 1,500 sleep clinics currently exist at hospitals and other medical centers where pulmonologists, technicians and other medical professionals diagnose obstructive sleep apnea (as well as other sleep disorders) and then prescribe the appropriate treatment. Such laboratories provide the most frequent source of patient introductions to the REMstar Choice product. REMstar Choice consists of a small, portable air pressurization device and a patient's breathing circuit. A nasal or full face mask is purchased separately based upon the patient's clinical needs and personal preference. All of these are prescribed by a medical professional as explained above. The mask is connected to the breathing circuit and is worn by the patient at home during sleep, and utilizes a pulmonary procedure known as Continuous Positive Airway Pressure ("CPAP"). CPAP involves the delivery of air under continuous positive pressure, generally through the patient's nose, and acts like a mechanical or pneumatic "splint" to prevent upper airway collapse or obstruction. The Company markets nasal and full face masks for use with each REMstar Choice unit and also markets nasal and full face masks, tubing, filters, and headgears for the replacement market. The REMstar Choice unit, the fifth generation device in the sleep apnea product line, was introduced in November 1991. REMstar Choice offers improved functional features compared to its predecessor devices, including improved pressure stability, reduced operating noise, and a "ramp" feature which gradually increases the pressure delivered to the patient as he or she falls asleep. The REMstar Choice unit also includes a cordless remote controller which can be used to turn the unit on and off and can also be used to activate the ramp feature. Severe cases of obstructive sleep apnea can also be treated with two models of the BiPAP Airway Management System (see "Products-Ventilation Products"). The use of a BiPAP unit in these cases is generally more comfortable to the patient because of the higher pressure levels required to treat severe obstructive sleep apnea. When accompanied by a physician's authorized prescription, the obstructive sleep apnea patient can purchase REMstar Choice or the BiPAP Airway Management System from home health care products dealer locations worldwide. Personnel at each of these locations are equipped to train the patient in the product's use and to maintain and service the product (See "Marketing, Sales, and Distribution"). The retail price for a REMstar Choice unit generally ranges from $700 to $1,300, depending on geographical market and whether certain accessories are purchased. The retail price for a BiPAP unit generally ranges from $2,800 to $8,000, depending on which model is purchased. In April 1995, the Company completed the acquisition of Vitalog Monitoring, Inc., a developer, manufacturer, and marketer of monitoring and diagnostic devices for sleep and other respiratory disorders. These diagnostic devices record and retain a variety of physiological data that is collected from a patient via sensor interfaces. Both of Vitalog's primary products, the VX4 Recording Oximeter and the HMS 5000 Monitor, interface with a personal computer to download and display the collected data. The retail price for the VX4 ranges from $1,600 to $1,800 and for the HMS 5000 ranges from $20,000 to $25,000 depending on which product configuration is ordered. 3 The acquisition of Vitalog will allow the Company to enter the market for devices related to the diagnosis and monitoring of sleep and other respiratory- related disorders and will also give the Company access to technology and development efforts led by Vitalog personnel. The Company believes that the acquisition will enhance its marketing efforts in the obstructive sleep apnea area by expanding the Company's presence in sleep labs and permitting the Company to sell diagnostic equipment that is complementary to its therapeutic devices (REMstar Choice and BiPAP). Sales of obstructive sleep apnea products and all related accessories and replacement parts accounted for 67%, 64%, and 57% of the Company's net sales for its fiscal years 1995, 1994, and 1993, respectively. Ventilation Products -------------------- The Company's principal ventilation product is the BiPAP Ventilatory Support System. Introduced in December 1989, this product is a unique, non- invasive pressure support ventilator which provides ventilatory assistance to those individuals who experience difficulty in breathing but are not dependent on a ventilator for life support. The BiPAP Ventilatory Support System is a low-pressure, electrically-driven flow generator with an electronic pressure control which is designed to augment patient ventilation by supplying pressurized air to the patient. BiPAP takes its name from "bi-level positive airway pressure" because it senses the patient's breathing and adjusts its output to assist in inhalation or exhalation. The BiPAP Ventilatory Support System minimizes the work of breathing in the presence of most mask leaks which can sometimes occur in the delivery of ventilation to the patient, thereby providing what the Company believes is a more consistent therapy than most competing ventilators. In May 1992, the Company introduced the Hospital BiPAP Ventilatory Support System which includes accessories such as an airway pressure monitor, a detachable control panel, a disposable circuit, and a mounting stand, all of which are designed to allow the system to be used more easily in the hospital environment. The Company believes that the BiPAP Ventilatory Support System offers a number of benefits compared to other volume ventilators and that it has the potential for greater patient comfort, because it adapts to the patient's breathing cycles rather than requiring the patient to adapt his or her breathing to the ventilator cycles and because it can be effectively used with a face mask. The BiPAP Ventilatory Support System is being used in hospitals and in home care applications. Pulmonary physicians and respiratory therapists are the primary caregivers and referral sources for patients currently being treated with BiPAP. The retail price for a BiPAP Ventilatory Support System generally ranges from $4,000 to $8,000, depending on which model is purchased. The Company is monitoring and sponsoring clinical trials which are investigating the benefits of BiPAP therapy for different types of patient populations. 4 The marketing of BiPAP Ventilatory Support Systems for use in these patient populations will most likely require additional 510(k) clearances from the United States Food and Drug Administration ("FDA") (see "Regulatory Matters"). The published results of recent studies have continued to be favorable with respect to the BiPAP Ventilatory Support System's use with patients with both acute and chronic respiratory insufficiency and patients with nocturnal breathing disorders who benefit from assisted ventilation. Sales of ventilatory products and all related accessories and replacement parts accounted for 26%, 27%, and 23% of the Company's net sales for its fiscal years 1995, 1994, and 1993, respectively. Face Mask Products ------------------ The Company currently provides three primary types of face masks: (1) reusable and disposable Nasal Sealing Flap Masks for use with REMstar and BiPAP devices; (2) disposable air-filled cushion anesthesia masks primarily for use during surgery; and (3) disposable resuscitation masks for use in emergency medical situations. The Company's face masks are designed, in part, to respond to the increasing demand for single patient use ventilation products which reduce the potential for cross-contamination among patients and supporting medical personnel from contagious diseases. The Company believes that its Nasal Sealing Flap Mask was the first mask to adequately seal on a patient's face for CPAP and BiPAP therapy. The Nasal Sealing Flap Mask is used with the Company's obstructive sleep apnea and ventilation products. The Company's line of disposable anesthesia masks utilizes a very thin and pliable soft plastic air-filled cushion around the nose and mouth which provides a uniform seal to prevent leakage of the anesthetic gases. The Company believes that Vital Signs, Inc., the exclusive marketer of the anesthesia masks produced by the Company, is the market share leader in the United States in single patient use anesthesia masks. Sales of all face masks (including some masks which are components of obstructive sleep apnea products, ventilation products, and resuscitation products and which are also included in the net sales figures for those product groups) accounted for 15%, 16%, and 18% of the Company's net sales for its fiscal years 1995, 1994, and 1993, respectively. 5 Resuscitation Products ---------------------- The Company's primary resuscitation product is a manual disposable resuscitator called BagEasy, which is used in emergency and critical care medicine. Manual resuscitators are used to ventilate the lungs of a patient by squeezing a self-inflating bag connected to a face mask or endotracheal tube. The device can be used to resuscitate patients who have stopped breathing and to sustain proper breathing function for a short period of time in critically ill patients. The BagEasy manual resuscitator is designed, among other things, to respond to the increasing demand for single patient use resuscitation products which reduce the potential for cross-contamination among patients and supporting medical personnel from contagious diseases. The current version of BagEasy was introduced in March 1995. In November 1993, the Company discontinued a predecessor version of the BagEasy and voluntarily recalled all remaining products in distribution channels and customer inventories. See Note J to the Consolidated Financial Statements for additional information regarding this discontinuance. The Company's other resuscitation products include several disposable resuscitation masks and non-rebreathing valves that are used primarily in the emergency medical market and in hospitals. Sales of resuscitation products accounted for 2%, 4%, and 11% of the Company's net sales for its fiscal years 1995, 1994, 1993, respectively. BagEasy sales were 0.33%, 2%, and 8% of the Company's net sales for fiscal years 1995, 1994, and 1993 respectively. Manufacturing and Properties The Company's corporate headquarters and domestic manufacturing operations are located in Murrysville, Pennsylvania (approximately 20 miles east of Pittsburgh) in a 116,000 square foot facility that was first occupied by the Company in July 1990. The facility includes a 46,000 square foot addition that was completed in November 1993. The entire facility is subject to mortgages used to secure financing related to the construction and expansion of the facility. See Note D to the Consolidated Financial Statements for additional information regarding the mortgages and the financing. The facility is a one and one-half story building of steel and concrete construction in which manufacturing, related support departments, and research and development activities comprise approximately 106,000 square feet, with the remaining 10,000 square feet devoted to corporate headquarters functions. The total cost of the facility, including the addition, was approximately $7,800,000. The Company also leases, on a month to month basis, a 22,000 square foot office facility in Plum Borough, Pennsylvania approximately two miles 6 from the existing corporate headquarters facility. This leased facility currently houses the Company's customer satisfaction and technical service groups. The operations of Vitalog, which was acquired by the Company in April 1995, are conducted in a 2,500 square foot leased facility in Redwood City, California. The Company began manufacturing operations in Hong Kong in 1981 where it currently manufactures a portion of its patient mask products. The Company's warehousing, manufacturing and administrative activities in Hong Kong are conducted in a 28,000 square foot light manufacturing complex in Kwun Tong, Kowloon, Hong Kong. The premises are leased under a renewable agreement expiring on April 30, 1997. The landlord of this space, Micro Electronics, Ltd., is a shareholder of the Company. Bernard Shou-Chung Zau, a shareholder and Director of the Company, is also a shareholder and a Director of Micro Electronics, Ltd.. The Company conducts the remainder of its patient mask manufacturing in a facility in Shenzhen City in the Peoples Republic of China, bordering Hong Kong. The Shenzhen facility is leased and operated by the Company. The present manufacturing space totals approximately 66,000 square feet. The facility is located in a special economic zone (where the Company has been operating since 1987) that was established by the Peoples Republic of China in 1980 to induce foreign investment. During fiscal year 1992, this facility, which had been operated under a "sub-contract" agreement pursuant to which the subcontractor provided employees on a monthly fee basis, began operating under a new arrangement under which the workers at the facility are employees of the Company. The Company believes that this arrangement results in improved control over the facility's operations. In addition, the Company believes that the establishment of corporate presence in the Peoples Republic of China well in advance of the 1997 transfer of control of Hong Kong to the Peoples Republic of China will reduce the likelihood that this transfer of control will affect the Company's operations. The Company believes that its present facilities in the United States, Hong Kong, and the Peoples Republic of China are suitable and adequate for its current and presently anticipated future needs. While each facility is extensively utilized, additional productive capacity is available through a variety of means including, at the Murrysville site, augmenting the current partial second shift work schedule. Rental space, which the Company believes is readily available and reasonably priced near each current location, could be utilized as well. The Company also owns approximately 20 acres of land adjacent to the 10 acre site on which the Murrysville facility is located. Future expansion in Murrysville, if needed, would likely take place on this 20 acre site. The Company generally performs all major assembly work on all of its products. It manufactures the plastic components for its face mask products and uses subcontractors to supply certain other components. The Company 7 believes that the raw materials for all of its products are readily available from a number of suppliers. Marketing, Sales and Distribution The Company sells its products to approximately 2,500 homecare and hospital dealers worldwide, and to Vital Signs, Inc. ("Vital Signs"), the exclusive customer for the Company's disposable anesthesia masks. These customers in turn resell and rent the Company's products to end users. The Company manages this dealer network through its sales management team, its own 23 person direct sales force, and approximately 60 independent manufacturers' representatives. The Company's sales management team consists of a Vice President of Sales and Marketing, a Director of Sales, and ten Regional Sales Managers. Two of the Regional Sales Managers and two of the direct sales representatives concentrate exclusively on international sales. The Company serves the home health care market with products such as REMstar Choice and the BiPAP Airway Management and Ventilatory Support systems; the hospital market with products such as the Hospital BiPAP Ventilatory Support System, the BagEasy disposable manual resuscitator, and several disposable resuscitation masks and valves; and the field emergency medical services market with products such as BagEasy and the disposable resuscitation masks and valves. The Company also sells its REMstar Choice, BiPAP and accessory products outside the United States, primarily in Europe and Canada, and to an increasing extent in South America, Latin America, Australia and the Far East (including the Peoples Republic of China). International sales accounted for approximately 20%, 20%, and 18% of the Company's net sales for its 1995, 1994, and 1993 fiscal years, respectively. The Company provides sales and promotional materials, training, and in- depth technical assistance to its dealer network. The Company also advertises in trade journals and is represented at all major trade shows for respiratory medical products. The Company's marketing organization is currently staffed with a Director of Marketing and marketing-oriented product managers who are assigned to each of the Company's principal product groups. The product managers monitor changes in the marketplace, with an emphasis on product use specifications, features, price, promotions, education and training, and distribution. 8 Vital Signs is the exclusive marketer for the Company's air-filled cushion anesthesia masks. Vital Signs is an unaffiliated corporation based in Totowa, New Jersey, which specializes in the distribution of anesthesia medical products directly to hospitals. Sales to Vital Signs, primarily of air-filled cushion anesthesia masks, accounted for 5%, 6%, and 10% of the Company's net sales for its 1995, 1994, and 1993 fiscal years, respectively. Sales of air- filled cushion anesthesia masks to Vital Signs are made under the terms of a supply agreement which will expire in June, 1997. The Company's customer base is undergoing significant consolidation. The Company's two largest customers (both of which were home care dealers) recently merged, and many smaller customers have been acquired by larger entities. This consolidation is likely to result in pricing pressure as a result of greater purchasing power and market dominance enjoyed by larger customers, however opportunities are expected to develop for increased unit sales volumes under partnering arrangements. Competition The Company believes that the principal competitive factor in all of its markets is differentiated product performance. Efficient and effective distribution and competitive price are also very important factors for its more mature products. In the case of a number of the Company's and its competitors' products, patent protection is becoming more prevalent and of increasing competitive importance. Because of the specialized nature of the Company's products, there is only one company, Nellcor Puritan-Bennett, which offers an array of products which compete with all of the Company's major products. In addition, the Company competes on a product-by-product basis with various other companies which develop and manufacture respiratory medical products for use in the home, in hospitals and in emergency medical situations. In many cases, these companies have significantly greater financial and marketing resources and broader product lines than the Company. The Company believes that it has the leading position in the market for home care devices for the treatment of obstructive sleep apnea in the United States. However, other manufacturers, including other larger and more experienced manufacturers of home health care products, have entered the market and the Company expects that strong competition will continue and increase. Healthdyne Technologies, Inc. is the primary competitor for the Company's REMstar Choice units. In addition, Nellcor Puritan-Bennett, DeVilbiss, Inc. (a division of Sunrise Medical) and ResMed Inc. compete with the Company in the obstructive sleep apnea market. ResMed offers a bi-level system for use in the obstructive sleep apnea market, and Nellcor Puritan Bennett offers a bi-level system for use in both the obstructive sleep apnea and ventilation markets. 9 Internationally, in addition to the U.S. companies described above, the Company competes with several European manufacturers of both obstructive sleep apnea and ventilation units. The disposable anesthesia mask and disposable manual resuscitator markets have become very competitive, with particular emphasis on price, and the Company expects that this trend will continue. Similar to the Company's customer base, the medical device manufacturing industry is also undergoing significant consolidation. Several of the Company's competitors have announced or completed mergers, most notably the recently completed merger of Nellcor and Puritan Bennett. The impact on the Company of this consolidation is likely to be greater competition from medical device manufacturers who can utilize greater financial and technical resources available from larger consolidated entities. Research and Development The Company conducts substantially all of its research and development for existing and potential new products in the United States. As of June 30, 1995, it employed a total of 84 engineers and technicians in such activities. Research and development activities cover overall conceptual design work through production start up and are conducted on a project basis. The Company spent approximately $7,100,000, $4,794,000, and $3,556,000 in research and development in fiscal years 1995, 1994, and 1993, respectively, to support active, ongoing product enhancement and new product development on all of the Company's product lines. Several new product introductions took place during fiscal year 1995 and early in fiscal year 1996 (including a redesigned BagEasy manual resuscitator, new face masks, and part of the family of new obstructive sleep apnea products), with additional new product introductions to follow later in fiscal year 1996. By the end of fiscal year 1996, the Company expects to have introduced new families of products in both the obstructive sleep apnea and ventilation areas. In some cases, initial distribution has been, and will be, conducted in international markets until regulatory clearance to market in the United States is obtained (see "Regulatory Matters"). The Company also maintains both formal and informal ethical relationships with physician practitioners and researchers (including sleep laboratories). Patent, Trademarks and Licenses The Company seeks patent protection for certain of its products through the acquisition of patents and exclusive licensing arrangements. In addition, the Company aggressively defends its patents against infringement by other companies. The Company currently has approximately 20 U.S. and foreign patents and 21 additional U.S. and foreign patent applications pending. 10 The Company owns the proprietary rights to most of its current products, including patents on the BiPAP Airway Management System (which was strengthened in July 1995 with receipt of additional protection under a Continuation In Part patent), components of Nasal Sealing Flap Mask and other valve and mask related accessories. Certain proprietary rights to the disposable anesthesia mask are owned by Vital Signs, Inc. (see "Marketing, Sales and Distribution"). A competitor, ResMed, Inc., through its subsidiary ResCare Limited, has brought suit alleging that certain of the Company's products infringe its patents. See "Legal Proceedings". The Company currently has approximately 55 registered U.S. and foreign trademarks and 10 additional U.S. and foreign trademark applications have been filed. Regulatory Matters The Company's products are subject to regulation by, among other governmental entities, the United States Food and Drug Administration ("FDA") and corresponding foreign agencies. The FDA regulates the introduction, manufacture, advertising, labeling, packaging, marketing and distribution of and recordkeeping for such products. In manufacturing and marketing its products, the Company must comply with FDA regulations and is subject to various other FDA recordkeeping requirements and to inspections by the FDA. Failure to comply with applicable FDA regulations can result in fines, civil penalties, suspensions or revocation of approvals, recalls or product seizures, operating restrictions or criminal penalties. The portion of the FDA regulations relating to manufacturing, labeling, packaging, distribution and recordkeeping is known as "Good Manufacturing Practice". The Company must also obtain, in certain cases, FDA or foreign regulatory approval for marketing the Company's new devices prior to their release. The testing for, preparation of, and subsequent FDA review of required applications for approval is expensive, lengthy and uncertain. Moreover, regulatory approval, if granted, can include significant limitations on the indicated uses for which a product may be marketed. There are two primary means by which the FDA permits a medical device to be marketed. First, a manufacturer may seek clearance for the device by filing a 510(k) premarket notification with the FDA. The manufacturer or distributor may not market the device until a "substantial equivalence" determination notice is issued by the FDA. This notice may be issued within 90 days of submission, but usually takes longer and often involves responding to questions from the FDA. If significant questions are raised, obtaining FDA clearance of a 510(k) premarket notification can take a number of years and require the expenditure of substantial resources. 11 If a manufacturer cannot establish to FDA's satisfaction that a new device is substantially equivalent to a previously marketed device, it will have to seek approval to market the device through the premarket approval application ("PMA") process. This is a far more complex and costly process. Foreign regulatory approvals vary widely depending on the country. Exports to foreign countries are also currently subject to FDA's jurisdiction. Three FDA inspections of the Company were conducted during fiscal year 1995. The first took place at various times between May 1994 and August 1994 at the Murrysville facility. In late August 1994, the FDA investigators issued an FDA Form 483 setting forth the results of this inspection. The Company responded to these findings in September 1994. On December 22, 1994, the Company received a "warning letter" from the FDA relating to the FDA's August 1994 inspection. A warning letter is a statement by the FDA that the agency believes that significant violations have occurred and is prepared to take enforcement action if corrective measures are not taken. In the warning letter, the FDA raised issues relating to: (i) alleged shortcomings in the Company's complaint processing procedures, (ii) the Company's alleged failure to file certain medical device reports ("MDR's") and (iii) the Company's alleged failure to obtain 510(k) premarket notification clearances that the FDA indicated were necessary for certain features of the Company's BiPAP systems and for certain claims regarding product use. Each of these issues is discussed below. Complaint Procedure. ------------------- The FDA stated that the Company's complaint records did not comply with Good Manufacturing Practice regulations. Prior to receipt of the warning letter, the Company had revised its procedures and complaint recordkeeping to address this issue. In addition, the Company's complaint processing system has been automated. Based on the results of a follow up investigation described below, the Company believes that this aspect of the FDA's warning letter has been resolved. Medical Device Reports. ---------------------- An MDR report is required to be filed (i) if a death or serious injury occurs and a manufacturer's products may have caused or contributed to the death or serious injury or (ii) if a manufacturer's product malfunctions and the product would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. The FDA stated in its warning letter that the Company had not filed an MDR for what the FDA believed to be a reportable malfunction. In response, the Company has filed MDRs with respect to certain malfunctions which the FDA referred to during the 1994 inspections, and the Company has also changed certain procedures with respect to the determination of when 12 an MDR will be filed. Based on the results of a follow up investigation described below, the Company believes that this aspect of the FDA's warning letter has been resolved. 510(k) BiPAP Ventilation Issues. ------------------------------- The Company believes that it has all 510(k) premarket notification clearances required for the uses for which it markets its BiPAP ventilatory products and for the BiPAP product itself and all of its features. The concerns cited in the FDA warning letter with respect to the Company's 510(k) premarket notification clearances related solely to its BiPAP systems and involved allegations that the Company had modified the approved devices so as to require additional clearances and that the Company was marketing the devices for uses that were not within the scope of their 510(k) premarket notification clearances. The FDA has expressed its concerns regarding the marketing of the BiPAP device for indications other than adult obstructive sleep apnea. As noted above, the Company believes that it has appropriate 510(k) premarket notification clearance for the uses for which it is marketing the device and for the device itself. During the course of the FDA inspections described above, and prior to the issuance of the FDA warning letter, the Company discontinued marketing its BiPAP products for invasive applications (which the FDA stated in the warning letter were not clearly covered in the 510(k) premarket notifications). Since receiving the warning letter, the Company has filed with the FDA additional 510(k) premarket notification requests with respect to the technical features that were cited in the warning letter and to certain uses beyond adult obstructive sleep apnea, in each case indicating that the application was filed without prejudice to the Company's position that no additional filing is required. The Company cannot predict whether the FDA will clear any of the 510(k) premarket notifications or that the clearances, if obtained, will be obtained in a timely manner. Respironics is continuing its past practice of cooperating with the FDA in attempting to resolve the issues which gave rise to the warning letter. Among other things, it is further improving its record keeping and complaint procedures and filing MDR's and 510(k) premarket notification requests even where the Company believes such filings are not required. The Company believes that it is in substantial compliance with FDA requirements relating to its products and also believes that its existing 510(k) clearances for BiPAP encompass ventilatory claims in addition to the treatment of obstructive sleep apnea in adults and the technical features cited in the FDA warning letter. While the Company cannot predict what action, if any, the FDA will take, the Company believes that there is not likely to be any interruption of its business as a result of the issues raised in the warning letter. The second FDA inspection took place at the Murrysville facility in January 1995. A report on Form 483 was issued by the FDA investigator setting forth the results of the inspection, which had focused on a voluntary recall conducted by the Company. The Form 483 also reiterated, as expected, 13 the FDA's position relative to the 510(k) clearances for BiPAP. The Company responded to the Form 483 findings in February 1995. The third FDA inspection took place at the Murrysville facility in May 1995. A report on Form 483 was issued by the FDA investigators setting forth the results of the inspection, which had focused on the Company's revised systems complaints and MDR's. Revisions had been made to these systems as described above. The Form 483 issued for this inspection did not refer to MDR's or complaint handling, but contained only the FDA's expected reiteration of its position relative to the 510(k) clearances for BiPAP. The Company responded to the Form 483 findings in June 1995. During the last three fiscal years, the Company has conducted five recalls of its products, all of which were voluntary and conducted with the knowledge of the FDA. Except for the voluntary BagEasy recall (and the related product line discontinuance) described above and in Note J to the Consolidated Financial Statements, none of these recalls has had a material adverse affect on the Company's results of operations or financial condition. Third Party Reimbursement The cost of a significant portion of medical care in the United States is funded by government and private insurance programs, such as Medicare, Medicaid, and corporate health insurance plans including health maintenance organizations and managed care organizations. If adverse changes are made in reimbursement policies for medical products under these insurance programs, the ability of the Company's customers (medical product dealers) to obtain adequate reimbursement for their resale or rental of the Company's products could be reduced. In recent years, limitations imposed on the levels of reimbursement by both government and private insurance programs have become more prevalent. For the Company's products used in home care, "procedure codes" have been obtained from the Health Care Financing Administration ("HCFA"). These procedure codes provide the mechanism for home care dealers to obtain reimbursement for providing products for patients covered by Medicare. In addition, many private insurance programs also utilize the HCFA procedure code system. However, the rate of reimbursement associated with each code can be reduced after a code is established (as the reimbursement level for the Company's REMstar Choice system was in January 1994). The Company has in the past, and plans in the future to take a very active role in working closely with HCFA and similar agencies as such agencies consider changes in reimbursement practices. For the Company's products that are used in hospitals, the primary determinant of the revenue that can be realized by hospital dealers who resell or 14 rent the Company's products is the amount of reimbursement that a hospital can obtain under the Medicare diagnosis related group ("DRG") payment system for utilizing such products in treating patients. Many private insurance programs also utilize the Medicare DRG system. The various uses of the Company's hospital products to treat patients are accepted in the DRG system. The levels of reimbursement under the DRG system are also subject to review and change. Employees As of June 30, 1995, the Company had 1,181 employees, including 257 hourly employees in the United States and 532 hourly employees in Hong Kong and the Peoples Republic of China. None of the Company's employees are covered by collective bargaining agreements. The Company considers its labor relations to be good and has never suffered a work stoppage as a result of a labor conflict. Financial Information About Foreign and Domestic Operations and Export Sales Financial Information concerning foreign and domestic operations and export sales is discussed in Part I "Marketing, Sales and Distribution" and set forth in Note G of the Consolidated Financial Statements included in this Annual Report. Item 2. Description of Properties Information with respect to the location and general character of the principal properties of the Company is included in Item 1. Item 3. Legal Proceedings Patent Litigation: The Company is a party to an action currently before the United States District Court for the Western District of Pennsylvania that was filed in January 1995 by ResCare Limited ("ResCare"), a competitor, in which ResCare alleges that in the manufacture and sale in the U.S. of nasal masks and CPAP systems and components, the Company infringes three U.S. patents, two of which are owned by and one of which is licensed to ResCare. In its complaint, ResCare seeks preliminary and permanent injunctive relief, an accounting for damages and an award of three times actual damages because of the Company's alleged actual knowledge of the alleged infringement. In its response to the action, the Company has denied the allegations and has separately sought a declaratory judgment that the ResCare patents in question are invalid and that the Company does not infringe upon the patents in any event. 15 Discovery in the case is currently under way and is scheduled to end in January 1996. The Company believes that none of its products infringes any of the patents in question in the event that any one or more of such patents should be held to be valid, and it intends to vigorously defend this position. Other Matters: The Company is, as a normal part of its business operations, a party to several legal proceedings in addition to the action described above. Legal counsel has been retained for each proceeding and none of these proceedings are expected to have a material adverse impact on the Company's operations or financial position. Item 4. Submission of Matters to a Vote of Security Holders. During the fourth quarter of the fiscal year 1995, no matters were submitted to a vote of security holders. 16 PART II Item 5. Market For Registrant's Common Equity and Related ------------------------------------------------- Shareholder Matters. ------------------- 16,744,785 shares of the Company's common stock were issued and outstanding as of June 30, 1995. These shares are traded in the over-the- counter market and are reported on the NASDAQ National Market System under the symbol "RESP". As of September 8, 1995, there were 1,400 holders of record of the Company's common stock. In February 1995, the Company's Board of Directors declared a two-for-one stock split of the Company's common stock, distributing on March 17, 1995 one additional share of common stock for each share held of record on March 3, 1995. See "Item 1 - Business" for a discussion of the stock split. The Company has never paid a cash dividend with respect to its common stock and does not intend to pay cash dividends in the foreseeable future. High and low closing sales price information for the Company's common stock for the applicable quarters is shown below. Fiscal year ending June 30, 1995: First Second Third Fourth ----- ------ ----- ------ High $10.63 $12.25 $16.88 $17.00 Low $ 8.00 $ 9.75 $11.63 $10.50 Fiscal year ending June 30, 1994: First Second Third Fourth ----- ------ ----- ------ High $11.25 $ 9.88 $12.00 $10.63 Low $ 9.00 $ 8.32 $ 9.25 $ 8.38 17 Item 6. Selected Financial Data ----------------------- Note: Per share data and number of shares outstanding have been adjusted retroactively to reflect the two-for-one stock split effected in fiscal year 1995. (Dollars in thousands except per share data) Income Statement Data: Year Ended June 30 1995 1994 1993 1992 1991 ------- ------- ------- ------- ------- Net sales $99,450 $78,171 $69,286 $48,976 $36,031 Cost of goods sold 43,077 34,830 32,114 23,360 17,554 ------- ------- ------- ------- ------- 56,373 43,341 37,172 25,616 18,477 General and administrative expense 14,050 10,028 10,581 6,538 5,295 Sales, marketing and commission expense 17,696 15,069 12,313 9,211 6,045 Research and development expense 7,077 4,794 3,556 2,311 1,646 Nonrecurring charges -0- 7,086 -0- -0- -0- Interest expense 194 171 176 201 300 Other income (1,179) (623) (550) (704) (362) ------- ------- ------- ------- ------- Income before income taxes 18,535 6,816 11,096 8,059 5,553 Income taxes 6,858 2,075 3,717 2,696 1,782 ------- ------- ------- ------- ------- Net income $11,677 $ 4,741 $ 7,379 $ 5,363 $ 3,771 ======= ======= ======= ======= ======= Primary earnings per share $ 0.67 $ 0.27 $ 0.43 $ 0.31 $ 0.26 ======= ======= ======= ======= ======= Weighted average shares of Common Stock outstanding and equivalents 17,532,422 17,280,680 17,318,606 17,056,704 14,630,592 Balance Sheet Data: June 30 1995 1994 1993 1992 1991 ---------- ---------- ---------- ------- ---------- Working capital $ 39,413 $ 31,032 $ 25,172 $19,979 $ 16,086 Total assets 78,039 58,917 54,331 43,462 36,140 Total long-term obligations 5,538 4,854 4,288 4,291 4,535 Shareholder's equity 58,369 44,224 39,148 31,391 25,799 - - ------------ There were no cash dividends declared during any of the periods presented in the above table. 18 Item 7. Management's Discussion and Analysis of Results of -------------------------------------------------- Operations and Financial Condition ---------------------------------- Results of Operations Net sales for fiscal year 1995 were $99,450,000, representing a 27% increase in net sales over the $78,171,000 recorded in fiscal year 1994. 1994 net sales represented a 13% increase over the $69,286,000 recorded in fiscal year 1993. The increase in net sales from fiscal year 1994 to fiscal year 1995 was primarily attributable to increases in total unit sales of the Company's obstructive sleep apnea and ventilatory support products and reflects sales growth across all of the Company's market bases for these product groups. In addition, sales of the Company's face mask products, including those used as accessories for its obstructive sleep apnea and ventilatory support products and those manufactured and sold on an OEM basis (disposable anesthesia masks), increased in both unit and dollar terms. Finally, the overall increase in net sales was accomplished in spite of a decrease in sales of the Company's resuscitation products resulting from the Company's November 1993 decision to discontinue production and shipment of its BagEasy line of disposable manual resuscitators, which accounted for 2% of net sales for fiscal year 1994. In March 1995, the Company introduced a redesigned version of the BagEasy product, however sales for this redesigned version accounted for less than one-half of one percent of fiscal year 1995 sales. The increase in net sales from fiscal year 1993 to fiscal year 1994 was also primarily attributable to increases in total unit sales for the Company's obstructive sleep apnea and ventilatory support products. Sales of resuscitation products decreased from fiscal year 1993 to fiscal year 1994 as a result of the discontinuance of the BagEasy manual resuscitator product discussed above (BagEasy accounted for 8% of net sales for fiscal year 1993). Finally, sales of the Company's disposable anesthesia masks decreased in both unit and dollar terms from fiscal year 1993 to fiscal year 1994 due primarily to reduced orders from the Company's customer for disposable anesthesia masks. The reduction in disposable anesthesia mask sales was also due to a reduction in the unit selling price of the masks under the terms of the June 1993 supply agreement with the Company's sole customer for these masks. Under the 1993 agreement, the customer may choose to pay a lower unit price for the masks in exchange for assuming responsibility for freight and duty costs related to mask shipments. The Company's gross profit was 57% of net sales for fiscal year 1995 as compared to 55% of net sales for fiscal year 1994 and 54% of net sales for fiscal year 1993. The increases in gross profit percentage were due primarily to the Company's ability to limit the growth in its manufacturing support costs to rates less than the rate of sales increases achieved and a shift in sales mix toward the Company's higher margin products. In addition, fiscal year 1994 gross margin was reduced because of a temporary diversion during that year of 19 engineering resources away from research and development activities and to manufacturing support activities in response to recommendations resulting from an FDA inspection. General and administrative expenses were $14,050,000 (14% of net sales) for fiscal year 1995 as compared to $10,028,000 (13% of net sales) for fiscal year 1994 and $10,581,000 (15% of net sales) for fiscal year 1993. The increase in these costs from fiscal year 1994 to fiscal year 1995 was due to a provision for year-end profit sharing bonuses based on financial results achieved in fiscal year 1995 and to higher administrative costs related to the growth of the Company, including staffing increases, increased legal fees, and increased provisions for uncollectible accounts receivable. The decrease in these costs, both in absolute dollars and as a percentage of net sales, from fiscal year 1993 to fiscal year 1994 was due primarily to the absence of profit sharing bonuses in fiscal year 1994 based on financial results achieved in that year. Sales, marketing and commission expenses were $17,696,000 (18% of nets sales) for fiscal year 1995 as compared to $15,069,000 (19% of net sales) for fiscal year 1994 and $12,313,000 (18% of net sales) for fiscal year 1993. These increases in absolute dollars were due to increased commission expenses paid to independent sales representatives resulting from a shift in sales mix towards products handled by these representatives, increased trade show and training expenses, increased salary expenses for new employees in sales and marketing management, and, for the fiscal 1994 to fiscal 1995 comparison, product literature and advertising expenses incurred in anticipation of new product launches. Research and development expenses were $7,077,000 (7% of net sales) for fiscal year 1995 as compared to $4,794,000 (6% of net sales) for fiscal year 1994 and $3,556,000 (5% of net sales) for fiscal year 1993. The continuing increases in research and development spending reflect the Company's commitment to investment in future product development and product enhancements in all of the Company's major product groups. Extensive new product development efforts were conducted during fiscal years 1994 and 1995 in anticipation of new product introductions in each major product group during calendar year 1995. Development work was conducted on new families of obstructive sleep apnea and ventilation devices and the redesigned BagEasy manual resuscitator. Certain new models of the obstructive sleep apnea devices were introduced in the first quarter of fiscal year 1996, the redesigned BagEasy manual resuscitator was introduced in March 1995, and a variety of patient interface devices were introduced at various times during the three year period. Additional costs were also incurred throughout the three year period to fund clinical studies. Finally, the increase from 1994 to 1995 resulted, to a lesser extent, from the temporary diversion during fiscal year 1994 of engineering resources away from research and development activities and to manufacturing support activities in response to recommendations resulting from an FDA inspection. 20 Nonrecurring charges totaled $7,086,000 (9% of net sales) for fiscal year 1994. The first component of these charges, recorded in the first quarter, totaled $1,966,000 and represented costs incurred by the Company in connection with its November 1993 decision to discontinue the production and sale of its BagEasy line of disposable manual resuscitators and recall all remaining BagEasy products in distribution channels and customer inventories and included provisions for write-offs of inventories and fixed assets, the satisfaction of purchase order and compensation commitments, and costs associated with the recall. The second component of these nonrecurring charges, recorded in the fourth quarter, totaled $5,120,000 and represented the write-off of the remaining balance on the prepayment for Hayek Oscillators and the net book value of units that had been purchased under the terms of the distribution agreement for that product. See Notes I and J to the Consolidated Financial Statements for additional information regarding these charges. The Company did not incur any nonrecurring charges in fiscal year 1995 or 1993. The Company's effective income tax rate was 37% for fiscal year 1995 as compared to 30% for fiscal year 1994 and 33% for fiscal year 1993. Changes in the Company's effective income tax rate were due primarily to changes in the relative proportions of taxable income attributable to its United States operation versus taxable income attributable to its Hong Kong and Peoples Republic of China operations because the United States operation pays income taxes at a higher rate (approximately 41% before available income tax credits) than do the Hong Kong and Peoples Republic of China operations. The proportion of taxable income attributable to the United States operation has increased, with the exception of fiscal year 1994. During that year, the non-recurring charges described above were incurred almost exclusively by the United States operation, reducing taxable income attributable to the U.S. operation and correspondingly reducing the Company's overall effective income tax rate. As a result of the factors described above, the Company's net income was $11,677,000 (12% of net sales) for fiscal year 1995 as compared to $4,741,000 (6% of net sales) for fiscal year 1994 and $7,379,000 (11% of net sales) for fiscal year 1993. Financial Condition, Liquidity and Capital Resources The Company had working capital of $39,413,000 and $31,032,000 at June 30, 1995 and 1994, respectively. Net cash provided by operating activities was $9,469,000, $4,568,000 and $10,669,000 for fiscal years 1995, 1994 and 1993, respectively. The increase in cash provided by operating activities from fiscal year 1994 to fiscal year 1995 was due to an increase in net income, a decrease in refundable income taxes, and increases in accounts payable and accrued expenses during fiscal year 1995 as compared to decreases or smaller increases in those liability accounts during fiscal year 1994. The reduction in cash provided by operating activities from fiscal year 1993 to fiscal year 1994 was due primarily to increases in accounts receivable 21 and refundable income taxes as well as decreases in accounts payable and accrued expenses. Trade accounts receivable increased from June 30, 1994 to June 30, 1995 at a rate greater than the percentage change in sales for the fiscal years ending on those dates primarily because the Company's quarterly sales were at their highest level for those two fiscal years during the last quarter of fiscal year 1995. In addition, the aging of the Company's receivables increased as a result of extended payment terms offered by the Company under several flexible financing programs. Net cash used by investing activities was $7,711,000, $8,415,000, and $6,363,000 for fiscal years 1995, 1994 and 1993, respectively. Net cash used for capital expenditures was $6,941,000, $7,735,000 and $6,363,000 for the respective years. Approximately $2,643,000 of the capital expenditures for fiscal year 1994 and $1,203,000 of the capital expenditures for fiscal year 1993 were for the purchase and development of additional land and expansion costs related to the Company's headquarters and manufacturing facility in Murrysville, Pennsylvania. The remainder of the significant capital expenditures for fiscal years 1995, 1994 and 1993 were made for the purchase of production equipment, office equipment and computers. In addition, fiscal year 1995 investing activities included an expenditure of $745,000 representing a portion of the purchase price of an acquired business plus related acquisition expenses. The remainder of the purchase price was paid with shares of the Company's common stock. See Note L to the Consolidated Financial Statements for additional information about this acquisition. In November 1993, the Company completed a 46,000 square foot addition to its headquarters and manufacturing facility in Murrysville, Pennsylvania. Financing for the addition includes a Redevelopment Authority Loan for $978,000 that was received in June 1994 and a $1,100,000 loan that received from the Pennsylvania Industrial Development Authority in February 1995. Both loans have a 2% fixed interest rate and a 15 year repayment term. See Note D to the Consolidated Financial Statements for additional information about long-term obligations. Funding for the remainder of the facility addition and the other capital expenditures has been provided by positive cash flows from operating activities and from cash and short-term investment balances. Net cash provided by financing activities also includes proceeds from the issuance of common stock under the Company's stock option plans and the receipt of a minority interest investment in a joint venture and is reduced by payments made on long-term obligations. In October 1994, the Company entered into a new line of credit facility with a commercial bank that provides for the availability of $1,250,000 at the bank's prime interest rate until the expiration date of the agreement on October 31, 1995. The Company expects that this line of credit facility will be renewed upon its expiration. See Note D to the Consolidated Financial Statements for a discussion of the line of credit. 22 As discussed above, in November 1993 the Company discontinued the production and sale of its BagEasy line of disposable manual resuscitators and recalled all remaining BagEasy products in distribution channels and customer inventories. The BagEasy product represented approximately 8% of the Company's total sales for the year ended June 30, 1993 (the last full fiscal year it was sold) and did not make significant contributions to profitability. In March 1995, the Company began shipping a redesigned version of the BagEasy manual resuscitator. The Company has not provided a valuation allowance for deferred income tax assets because it has determined that it is more likely than not that such assets can be realized, at a minimum, through carrybacks to prior years in which taxable income was generated. The Company believes that positive cash flow from operating and financing activities, its $1,250,000 line of credit facility, and its accumulated cash and short-term investments will be sufficient to meet its current and presently anticipated needs for fiscal year 1996 for operating activities, investing activities and financing activities (primarily consisting of payments on long-term debt). Inflation Inflation has not had a significant effect on the Company's business during the periods discussed. 23 Item 8. Consolidated Financial Statements Index to Consolidated Financial Statements Report of Independent Auditors............................ 25 Consolidated Balance Sheets as of June 30, 1995 and 1994.. 26 Consolidated Statements of Operations for the years ended June 30, 1995, 1994 and 1993............... 28 Consolidated Statements of Shareholders' Equity for the years ended June 30, 1995, 1994 and 1993....... 29 Consolidated Statements of Cash Flows for the years ended June 30, 1995, 1994 and 1993............... 30 Notes to Consolidated Financial Statements................ 31 24 Report of Independent Auditors Board of Directors Respironics, Inc. We have audited the accompanying consolidated balance sheets of Respironics, Inc. and subsidiaries as of June 30, 1995 and 1994, and the related consolidated statements of income, shareholders' equity, and cash flows for each of the three years in the period ended June 30, 1995. Our audits also included the financial statement schedule listed in the Index at Item 14(a). These financial statements and schedule are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements and schedule based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards 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. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Respironics, Inc. and subsidiaries at June 30, 1995 and 1994, and the consolidated results of their operations and their cash flows for each of the three years in the period ended June 30, 1995, in conformity with generally accepted accounting principles. Also, in our opinion, the related financial statement schedule, when considered in relation to the basic financial statements taken as a whole, presents fairly in all material respects the information set forth therein. As discussed in Note A to the consolidated financial statements, the Company changed its method of accounting for income taxes in 1994. Ernst & Young LLP Pittsburgh, Pennsylvania September 11, 1995 25 CONSOLIDATED BALANCE SHEETS RESPIRONICS, INC. AND SUBSIDIARIES June 30 1995 1994 ------------------------ ASSETS CURRENT ASSETS Cash and short-term investments $16,126,904 $12,384,054 Trade accounts receivable, less allowance for doubtful accounts of $700,000 and $525,000 19,448,187 15,011,285 Refundable income taxes -0- 1,787,265 Inventories 13,136,664 7,833,755 Prepaid expenses and other 1,951,358 1,168,167 Deferred income tax benefits 2,200,595 2,021,776 ----------- ---------- TOTAL CURRENT ASSETS 52,863,708 40,206,302 PROPERTY, PLANT AND EQUIPMENT Land 2,589,117 2,417,334 Buildings 8,674,675 7,713,405 Machinery and equipment 14,155,510 10,849,230 Furniture and office equipment 9,394,000 7,240,447 Leasehold improvements 577,175 519,744 ----------- ---------- 35,390,477 28,740,160 Less allowances for depreciation and amortization 15,443,041 11,929,911 ----------- ---------- 19,947,436 16,810,249 Funds held in trust for construction of new facility 710,929 680,372 OTHER ASSETS 2,668,592 1,220,297 COST IN EXCESS OF NET ASSETS OF BUSINESS ACQUIRED 1,847,905 -0- ----------- ----------- $78,038,570 $58,917,220 =========== =========== See notes to consolidated financial statements. 26 June 30 1995 1994 ------------------------- LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES Accounts payable $ 4,858,554 $ 3,086,776 Accrued compensation and related expenses 3,827,187 3,055,420 Accrued expenses 2,694,298 1,968,977 Income taxes 1,572,121 658,364 Current portion of long-term obligations 498,150 404,866 ----------- ----------- TOTAL CURRENT LIABILITIES 13,450,310 9,174,403 LONG-TERM OBLIGATIONS 5,537,996 4,854,440 MINORITY INTEREST 681,068 664,268 COMMITMENTS SHAREHOLDERS' EQUITY Common Stock, $.01 par value; authorized 40,000,000 shares; issued and outstanding 16,744,785 shares at June 30, 1995 and 16,344,690 shares at June 30, 1994 167,448 163,446 Additional capital 19,254,977 16,790,919 Retained earnings 38,946,771 27,269,744 ----------- ----------- TOTAL SHAREHOLDERS' EQUITY 58,369,196 44,224,109 ----------- ----------- $78,038,570 $58,917,220 =========== =========== See notes to consolidated financial statements. 27 CONSOLIDATED STATEMENTS OF OPERATIONS RESPIRONICS, INC. AND SUBSIDIARIES Year Ended June 30 1995 1994 1993 Net sales $99,450,333 $78,171,028 $69,285,613 Cost of goods sold 43,077,158 34,830,308 32,113,280 ----------- ----------- ----------- 56,373,175 43,340,720 37,172,333 General and administrative expenses 14,050,071 10,027,842 10,580,602 Sales, marketing and commission expenses 17,696,059 15,069,159 12,313,483 Research and development expenses 7,077,216 4,794,242 3,555,903 Nonrecurring charges -0- 7,086,085 0 Interest expense 193,550 171,223 175,843 Other income (1,178,685) (624,180) (549,635) ----------- ----------- ----------- 37,838,211 36,524,371 26,076,196 ----------- ----------- ----------- INCOME BEFORE INCOME TAXES 18,534,964 6,816,349 11,096,137 Income taxes 6,857,937 2,075,105 3,717,206 ----------- ----------- ----------- NET INCOME $11,677,027 $ 4,741,244 $ 7,378,931 =========== =========== =========== Earnings per share $ 0.67 $ 0.27 $ 0.43 =========== =========== =========== Weighted Average Number of Shares Used in Computing Earnings Per Share 17,532,422 17,280,680 17,318,606 See notes to consolidated financial statements. 28 CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY RESPIRONICS, INC. AND SUBSIDIARIES Common Stock ------------------- Additional Retained Shares Amount Capital Earnings Total --------- -------- ---------- ---------- ---------- Balance at July 1, 1992 as previously reported 8,065,907 $ 80,659 $16,160,464 $15,149,569 $31,390,692 Two-for-one stock split 8,065,907 80,659 (80,659) -0- -0- ---------- -------- ----------- ----------- ----------- BALANCE AT JULY 1, 1992 AS ADJUSTED 16,131,814 161,318 16,079,805 15,149,569 31,390,692 Net income for the year ended June 30, 1993 -0- -0- -0- 7,378,931 7,378,931 Shares sold pursuant to stock option plans 89,346 894 343,668 -0- 344,562 Shares sold pursuant to consulting agreement 8,000 80 33,320 -0- 33,400 ---------- -------- ----------- ----------- ----------- BALANCE AT JUNE 30, 1993 16,229,160 162,292 16,456,793 22,528,500 39,147,585 Net income for the year ended June 30, 1994 -0- -0- -0- 4,741,244 4,741,244 Shares sold pursuant to stock option plans 107,530 1,074 289,526 -0- 290,600 Shares sold pursuant to consulting agreement 8,000 80 44,600 -0- 44,680 ---------- -------- ----------- ----------- ----------- BALANCE AT JUNE 30, 1994 16,344,690 163,446 16,790,919 27,269,744 44,224,109 Net income for the year ended June 30, 1995 -0- -0- -0- 11,677,027 11,677,027 Shares sold pursuant to stock option plans 315,001 3,150 1,188,499 -0- 1,191,649 Acquistion of a business 85,094 852 1,275,559 -0- 1,276,411 ---------- -------- ----------- ----------- ----------- BALANCE AT JUNE 30, 1995 16,744,785 $167,448 $19,254,977 $38,946,771 $58,369,196 ========== ======== =========== =========== =========== See notes to consolidated financial statements. 29 CONSOLIDATED STATEMENTS OF CASH FLOWS RESPIRONICS, INC. AND SUBSIDIARIES Year Ended June 30 1995 1994 1993 ------------------------------------------ OPERATING ACTIVITIES Net income $11,677,027 $ 4,741,244 $ 7,378,931 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 3,831,793 3,571,500 3,858,339 Provision for deferred income taxes (178,819) 191,763 (1,390,181) Provision for losses on write-off of equipment -0- 270,791 -0- Provision for losses on accounts receivable 175,000 75,000 100,000 Loss on sale of equipment 35,719 -0- -0- Provision for nonrecurring charges -0- 5,120,000 -0- Changes in operating assets and liabilities: Increase in accounts receivable (4,515,077) (3,812,916) (2,198,685) Decrease (increase) in refundable income taxes 1,787,265 (1,787,265) -0- Increase in inventories and prepaid expenses (5,770,417) (1,057,575) (705,007) (Increase) decrease in other assets (1,448,295) (949,001) 289,908 Increase (decrease) in accounts payable 1,680,521 (738,842) 1,547,383 Increase (decrease) in accrued compensation and related expenses 764,557 (947,563) 1,642,235 Increase (decrease) in accrued expenses 516,442 528,074 (42,716) Increase (decrease) in accrued income taxes 912,999 (636,912) 188,668 ----------- ----------- ----------- NET CASH PROVIDED BY OPERATING ACTIVITIES 9,468,715 4,568,298 10,668,875 INVESTING ACTIVITIES Purchase of property, plant and equipment (6,940,667) (7,734,854) (6,362,511) Proceeds from sale of equipment 5,503 -0- -0- Increase in funds held in trust for construction of new facility (30,557) (680,372) -0- Acquisition of a business, net of cash acquired (745,433) -0- -0- ----------- ----------- ----------- NET CASH USED BY INVESTING ACTIVITIES (7,711,154) (8,415,226) (6,362,511) FINANCING ACTIVITIES Proceeds from long-term obligations 1,132,760 978,396 -0- Reduction in long-term obligations (355,920) (382,508) (263,601) Issuance of common stock 1,191,649 335,280 377,962 Increase in minority interest 16,800 664,268 -0- ----------- ----------- ----------- NET CASH PROVIDED BY FINANCING ACTIVITIES 1,985,289 1,595,436 114,361 ----------- ----------- ----------- INCREASE (DECREASE) IN CASH AND SHORT-TERM INVESTMENTS 3,742,850 (2,251,492) 4,420,725 Cash and short-term investments at beginning of year 12,384,054 14,635,546 10,214,821 ----------- ----------- ----------- CASH AND SHORT-TERM INVESTMENTS AT END OF YEAR $16,126,904 $12,384,054 $14,635,546 =========== =========== =========== See notes to consolidated financial statements 30 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS RESPIRONICS, INC. AND SUBSIDIARIES NOTE A -- SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation: - - --------------------------- The consolidated financial statements include the accounts of Respironics, Inc. (the Company), its consolidated wholly owned foreign subsidiary, Respironics (HK) Ltd., its wholly owned domestic subsidiary, RIC Investments, Inc., and a foreign joint venture in which it holds a 51% equity investment. The joint venture partner's 49% equity interest is included in the Company's financial statements as minority interest. All significant intercompany accounts and transactions have been eliminated in consolidation. Revenue Recognition: - - ------------------- Revenue is recognized from sales when a product is shipped. Inventories: - - ----------- Inventories are valued at the lower of cost (first-in, first-out) or market. Property, Plant and Equipment: - - ----------------------------- Property, plant and equipment is recorded on the basis of cost. Depreciation is computed using the straight-line method based upon the estimated useful lives of the respective assets, except for assets under capital leases which are depreciated using the straight-line method over the shorter of the lease term or the estimated useful lives of such assets. Amortization of assets under capital leases is included in depreciation expense. Income Taxes: - - ------------ Effective July 1, 1993, the Company adopted Statement of Financial Accounting Standards #109, "Accounting for Income Taxes". Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when differences are expected to reverse. The Company has elected not to restate the consolidated financial statements of any prior years. The cumulative effect of the adoption and the effect of the adoption on the results of operations for the year ended June 30, 1994 were not material. The Company does not provide for federal income taxes on the undistributed earnings of its foreign subsidiary (other than deemed dividends which are taxed currently) because such earnings are reinvested and, in the opinion of management, will continue to be reinvested indefinitely. Foreign Currency Translation: - - ---------------------------- The Company follows Statement of Financial Accounting Standards No. 52 for the translation of the accounts of its foreign subsidiary, Respironics (HK) Ltd., and its joint venture. Foreign currency assets and liabilities are translated into United States dollars at the rate of exchange existing at the statement date or historical rates depending upon the nature of the account. Income and expense amounts are translated at the average of the monthly exchange rates. Adjustments resulting from these translations are immaterial. Stock Split: - - ----------- In February 1995, the Company's Board of Directors declared a two-for-one stock split of the Company's common stock, distributing on March 17, 1995 one additional share of common stock for each share held of record on March 3, 1995. All agreements concerning stock options were amended to provide for issuance of two shares of common stock for every one share issuable prior to the split. An amount equal to the par value of the shares issued was transferred from additional capital to the common stock account. This transfer has been reflected in the consolidated statements of changes in shareholders' equity at July 1, 1992. All references to number of shares, except shares authorized, and to per- share information in the consolidated financial statements have been adjusted to reflect the stock split on a retroactive basis. Stock Options: - - ------------- Stock options are granted to certain employees and certain members of the Company's Board of Directors at fair market value on the date of the grant. Proceeds from the exercise of common stock options are credited to shareholders' equity at the date the options are exercised. There are no charges or credits to income with respect to these options. Earnings per Share: - - ------------------ Earnings per share is based on the weighted average number of shares outstanding during each year and the assumed exercise of dilutive stock options (less the number of treasury shares assumed to be purchased with the proceeds using the average market price of the Company's common 31 stock for primary earnings per share and the higher of the ending market price or average market price for fully diluted earnings per share). Cash and Short-Term Investments: - - ------------------------------- The Company considers all highly liquid investments with a maturity of 90 days or less when purchased to be cash and short-term investments. Capitalized Software Development Costs: - - -------------------------------------- In 1994, the Company commenced development of software to be included in certain of its new products. Software development costs have been capitalized and will be amortized to the cost of product revenues over the estimated economic lives of the products that will include such software. The products that include such software are expected to be introduced for sale during the year ending June 30, 1996. Total capitalized software development costs were $1,982,000 and $ 675,000 at June 30, 1995 and 1994, respectively. NOTE B -- SHORT-TERM INVESTMENTS Short-term investments consist primarily of money market accounts and certificates of deposit issued by large commercial banks located in the United States and Hong Kong. These investments are readily convertible to cash and are stated at cost which approximates market. NOTE C -- INVENTORIES Inventories consisted of the following: June 30 1995 1994 ----------------------- Raw materials $ 7,960,573 $5,268,039 Work-in-process 1,105,010 818,400 Finished goods 4,071,081 1,747,316 ----------- ---------- $13,136,664 $7,833,755 =========== ========== 32 NOTE D -- LONG TERM OBLIGATIONS Long-term obligations consisted of: June 30 1995 1994 ---------------------- 1989 Economic Development Revenue Bonds, variable interest rate (effective rate of 5.28%, including letter of credit and remarketing fees, at June 30,1995), principal payable in annual installments of $100,000 through 1996 and $200,000 thereafter through 2004 $1,900,000 $2,000,000 Industrial Development Authority Loan, payable in monthly install- ments of $13,777, including interest at 3%, through June 2005 1,407,312 1,528,469 Redevelopment Authority Loan, payable in quarterly installments of $14,533, including interest at 5%, through June 2005 481,137 514,172 Capital lease obligation, payable in quarterly installments of $19,834 including interest at a floating rate (2.25% at June 30, 1995) through June 1997 131,581 201,353 Redevelopment Authority Loan, payable in monthly installments of $6,296, including interest at 2%, through July 2009 921,894 978,395 Capital lease obligation, payable in monthly installments of $1,860, including interest at 4.60%, through January 1996 13,889 36,917 Industrial Development Authority Loan, payable in monthly install- ments of $7,289, including interest at 2%, through March 2010 1,132,240 -0- Capital lease obligation, payable in monthly installments of $2,284, including interest at 4.62%, through April 1997 48,093 -0- ---------- ---------- 6,036,146 5,259,306 Less current portion 498,150 404,866 ---------- ---------- $5,537,996 $4,854,440 ========== ========== The Economic Development Revenue Bonds, the Industrial Development Authority Loans, and the Redevelopment Authority Loans are secured by mortgages upon the Company's headquarters and manufacturing facility in Murrysville, Pennsylvania. Proceeds from the bonds and the loans were used to finance the construction and expansion of the facility. The Company is required to meet certain financial 33 covenants in connection with these obligations, including those relating to current ratio, ratio of total liabilities to tangible net worth, and minimum tangible net worth. At June 30, 1995 the Company was in compliance with these covenants. The Company is a party to capital lease agreements with commercial banks relating to certain of its fixed assets. The lease terms are two to four years with options for the Company to purchase the assets at the end of the lease. Assets under capital leases at June 30, 1995 consist of machinery and equipment and office equipment with a net book value of $149,228. Capital lease obligations incurred are considered non-cash items and, accordingly, are not considered in the consolidated statements of cash flows. Capital lease obligations incurred were $52,265 for the year ended June 30, 1995. The Company also has $1,250,000 available under a line of credit facility with a commercial bank at the bank's prime rate until the expiration date of October 31, 1995. Borrowings made on this line of credit are unsecured. The Company is required to meet certain financial covenants under this line of credit relating to current ratio, the ratio of total liabilities to tangible net worth and a minimum tangible net worth. There were no outstanding borrowings under this credit facility. Scheduled maturities of long-term obligations for the next five years are as follows: Minimum Lease Interest on Maturities of Payments Under on Capital Long-Term Debt Capital Leases Leases Total -------------- -------------- ----------- ---------- 1996 $ 384,875 $120,837 $(7,562) $ 498,150 1997 492,623 82,343 (2,055) 572,911 1998 500,847 -0- -0- 500,847 1999 509,516 -0- -0- 509,516 2000 518,370 518,370 Thereafter 3,436,352 -0- -0- 3,436,352 ---------- -------- ------- ---------- Total $5,842,583 $203,180 $(9,617) $6,036,146 ========== ======== ======= ========== Interest paid was $194,220, $167,718, and $180,421 for the years ended June 30, 1995, 1994, and 1993, respectively. NOTE E -- INCOME TAXES Year Ended June 30 1995 1994 1993 ----------------------------------- Income taxes consisted of: Current: Federal $5,379,275 $1,509,015 $ 3,988,590 Foreign 197,943 60,112 94,746 State 1,459,538 314,214 1,024,051 ---------- ---------- ----------- 7,036,756 1,883,341 5,107,387 Deferred: Federal (165,132) 151,826 (1,071,993) State (13,687) 39,938 (318,188) ---------- ---------- ----------- (178,819) 191,764 (1,390,181) ---------- ---------- ----------- TOTAL INCOME TAXES $6,857,937 $2,075,105 $ 3,717,206 ========== ========== =========== 34 The difference between the statutory U.S. federal income tax rate and the Company's effective income tax rate is explained below: Year Ended June 30 1995 1994 1993 ------------------ Statutory federal income tax rate 35% 34% 34% Increases (decreases): State taxes 5 3 4 Tax credits utilized (3) (7) (3) Tax on foreign earnings at less than the statutory rate -0- (5) (5) Other items, net, none of which individually exceeds 5% of federal income taxes at statutory rates -0- 5 3 ----- ---- ---- EFFECTIVE INCOME TAX RATE 37% 30% 33% ===== ==== ==== Deferred income tax assets consisted of the following: June 30 1995 1994 ---------- ---------- Deferred compensation $ -0- $204,546 Inventories 600,513 418,607 Allowance for bad debts 245,804 210,720 Depreciation 635,128 617,944 Accruals 673,926 555,645 Other 45,224 14,314 ---------- ---------- Total $2,200,595 $2,021,776 ========== ========== Income before income taxes consisted of the following: Year ended June 30 1995 1994 1993 ------------------------------------ United States $17,935,537 $5,578,476 $ 9,038,558 Foreign 599,427 1,237,873 2,057,579 ----------- ---------- ----------- Total $18,534,964 $6,816,349 $11,096,137 =========== ========== =========== Undistributed earnings of the foreign subsidiary on which no U.S. income tax has been provided amounted to $9,537,838 at June 30, 1995. The Company's operation in the Peoples Republic of China is affected by an income tax holiday. Net income increased by $339,851 ($0.02 per share), $345,564 ($0.02 per share), and $568,955 ($0.03 per share) for the years ended June 30, 1995,1994, and 1993 respectively, as a result of this income tax holiday. Under the terms of the income tax holiday, the Company's operation in the Peoples Republic of China paid no income tax for the years ended June 30, 1993 and 1994. The income tax rate increased to 7.5% for the year ended June 30, 1995 and will remain at 7.5% for years ending June 30, 1996 and 1997 and will then increase to 15% for years thereafter. The applicable statutory income tax rate in the Peoples Republic of China is approximately 33%. Income taxes paid were $4,335,733, $4,620,928, and $4,918,719 for the years ended June 30, 1995, 1994, and 1993, respectively. 35 NOTE F -- STOCK OPTION PLANS The Company has the 1984 Incentive Stock Option Plan (the "1984 Plan") which provided options to eligible employees to purchase common stock over five or ten years at fair market value at the time of the grant. Options become exercisable one year from the date of the grant at a rate not exceeding 25% per year (subject to possible acceleration in certain circumstances). The Company reserved shares of its common stock and authorized options to purchase 3,400,000 shares of common stock under the 1984 Plan. The 1984 Plan terminated as to new grants on December 31, 1993. Pertinent information regarding options under the 1984 Plan follows: Option Shares ------------- Year Ended June 30 1995 1994 1993 --------------------------------- Outstanding at beginning of period 1,298,466 1,277,860 1,330,562 Granted: $ 8.25 per share -0- -0- 5,000 $ 8.32 per share -0- 2,000 -0- $ 9.25 per share -0- 132,000 -0- $10.07 per share -0- -0- 104,362 $10.38 per share -0- -0- 1,000 Exercised: $ 1.00 per share (2,000) (10,100) (12,400) $ 1.38 per share (80,000) (46,600) (6,400) $ 2.82 per share (18,300) (11,800) (9,800) $ 4.50 per share (187,250) (34,610) (48,920) $ 5.41 per share (600) -0- -0- $ 6.22 per share (20,696) (4,420) (11,426) $10.07 per share (1,580) -0- -0- Canceled (58,726) (5,864) (74,118) --------- --------- --------- Outstanding at end of period 929,314 1,298,466 1,277,860 ========= ========= ========= Exercisable at end of period 749,134 802,758 911,866 ========= ========= ========= Shares available for future grant -0- -0- 191,236 ========= ========= ========= The Company also has the 1992 Stock Incentive Plan (the "1992 Plan") which was approved by the Company's shareholders in November 1992. Under the 1992 Plan, eligible employees may receive options to purchase common stock over ten years at option prices that may not be less than fair market value at the date of grant. Stock options granted under the 1992 Plan become exercisable no sooner than six months from grant date (subject to possible acceleration under certain circumstances) and such options may include cash payment rights. Eligible employees may also receive awards of restricted shares of the Company's common stock under the 1992 Plan. The aggregate number of options and restricted shares which may be issued under the 1992 Plan is 1,000,000. Options to purchase 106,960 shares at $9.88 per share were granted during the year ended June 30, 1994 and options to purchase 52,752 shares at $16.25 per share were granted during the year ended June 30, 1995. Options to purchase 2,575 shares at $9.88 per share were exercised during the year ended June 30, 1995. Options to purchase 5,050 shares were canceled during the year ended June 30, 1995. At June 30, 1995, total options to purchase 152,087 shares were outstanding under the 1992 Plan, of which 23,628 were exercisable. In connection with an initial public offering that was completed in June 1988, an officer of the Company exchanged his rights in certain non-patented products for an option to purchase 400,000 shares of common stock at a price of $1.88 per share. The option to purchase 80,000 of the shares was exercisable immediately, and options to purchase 80,000 shares became exercisable on each of June 30, 1989, 1990, 1991, and 1992. The option will be exercisable for a maximum period of ten years after grant. No options have been exercised under this plan. 36 In November 1991, the Company's shareholders approved the adoption of the 1991 Non-Employee Directors' Stock Option Plan (the "Directors' Plan"). The aggregate number of shares which may be issued and as to which grants of options may be made under the Directors' Plan is 200,000. All options under the Directors' Plan are granted to members of the Company's Board of Directors who are not employees of the Company. Such options are granted at fair market value on the date of grant. Under the provisions of the Directors' Plan, in November 1991 each of the four non-employee directors who had been non-employee directors for at least two years prior to the approval of the Directors' Plan received a one-time option to purchase 10,000 shares at an option price of $6.13 per share. In addition, each of the five non-employee directors (regardless of years of service) received an option to purchase 5,100 shares at an option price of $6.13 per share. In November 1992, each non-employee director received an option to purchase 5,100 shares at an option price of $10.63 per share. In November 1993, each non- employee director received an option to purchase 5,100 shares at an option price of $9.50 per share. In November 1994, each non-employee director received an option to purchase 5,100 shares at an option price of $11.25 per share. In the future, each non-employee director will receive an option to purchase an additional 5,100 shares on the third business day following the Company's annual meeting of shareholders. These grants will continue until options for all the share available under the Directors' Plan have been granted. The one time option granted to non-employee directors with more than two years of service was exercisable in full three months after the date of grant. For all other options granted under the Directors' Plan, 25% of the shares are exercisable one year after the date of the grant, 25% are exercisable two years after the date of grant, and the remaining 50% are exercisable three years after the date of grant. All options granted under the Directors' Plan expire ten years after the date of grant. Options to purchase 2,000 shares at $6.13 per share were exercised during the yearEended June 30, 1995. NOTE G -- FINANCIAL INFORMATION BY GEOGRAPHIC AREAS AND MAJOR CUSTOMERS Year Ended June 30 1995 1994 1993 ---------------------------------------- NET SALES Hong Kong: Unaffiliated Customers $ 1,720,248 $ 1,462,292 $ 1,157,402 Interarea transfers 8,430,823 7,312,399 9,281,661 ----------- ----------- ------------ 10,151,071 8,774,691 10,439,063 United States: Unaffiliated Customers 97,730,086 76,708,736 68,128,211 Interarea transfers 750,744 543,883 794,124 ----------- ----------- ------------ 98,480,830 77,252,619 68,922,335 Eliminations--transfers (9,181,567) (7,856,282) (10,075,785) ----------- ----------- ------------ NET SALES $99,450,333 $78,171,028 $ 69,285,613 =========== =========== ============ OPERATING PROFIT Hong Kong $ 877,325 $ 1,538,966 $ 2,359,200 United States 22,239,437 9,315,357 12,411,549 ----------- ----------- ------------ OPERATING PROFIT 23,116,762 10,854,323 14,770,749 Corporate expense 4,388,248 3,866,751 3,498,769 Interest expense 193,550 171,223 175,843 ----------- ----------- ------------ INCOME BEFORE INCOME TAXES $18,534,964 $ 6,816,349 $ 11,096,137 =========== =========== ============ 37 Interarea transfers are accounted for at prices comparable to unaffiliated customer sales reduced by an approximation of costs not incurred on internal sales. The Company sells to distributors in the health care industry and closely monitors the extension of credit to both domestic and foreign customers, including obtaining and analyzing credit applications for all new accounts and maintaining an active program to contact customers promptly when invoices become past due. Sales to one customer accounting for 10% or more of net sales were $10,955,000 for the year ended June 30, 1995 and $8,569,000 for the year ended June 30, 1994. Sales to another customer (accounting for 10% or more of net sales) were $6,711,000 for the year ended June 30, 1993. Additional information regarding assets and liabilities by geographic area follows: June 30 1995 1994 ------------------------ IDENTIFIABLE ASSETS Hong Kong $ 5,597,154 $ 3,773,038 United States 54,113,917 40,738,352 ----------- ----------- 59,711,071 44,511,390 Corporate assets (primarily cash and short-term investments) 18,327,499 14,405,830 ----------- ----------- TOTAL ASSETS $78,038,570 $58,917,220 =========== =========== TOTAL ASSETS Hong Kong $11,140,130 $ 9,328,819 United States 66,898,440 49,588,401 ----------- ----------- $78,038,570 $58,917,220 =========== =========== TOTAL LIABILITIES Hong Kong $ 2,712,833 $ 1,548,270 United States 16,956,541 13,144,841 ----------- ----------- $19,669,374 $14,693,111 =========== =========== NOTE H-- RETIREMENT PLAN The Company has a Retirement Savings Plan which is available to all United States employees. Employees may contribute up to 15% (to a defined maximum) of their compensation. The Company matches employee contributions (up to 3% of each employee's compensation) at a 100 % rate and may make discretionary contributions. The Company contributed $420,000, $357,000 and $169,000 to the plan for the years ended June 30, 1995, 1994, and 1993, respectively. The Company's current benefit program does not provide postretirement benefits to employees. NOTE I-- DISTRIBUTION AGREEMENT In June 1991, the Company entered into a distribution agreement with the owner of non-invasive ventilator product. Under the terms of the agreement, the Company had the exclusive United States distribution rights for a product (The Hayek Oscillator) that is produced by the manufacturer. The initial term of the agreement was three years with provisions to extend the term for additional periods. A six-month extension of the initial term expired December 31, 1994. As part of the agreement, the Company paid $5,000,000 to the manufacturer, representing a partial prepayment for the product to be sold by the Company during the initial term of the agreement. Because of the manufacturer's repeated failures to meet stipulated requirements, particularly in assuring compliance with Good Manufacturing Practice as required by FDA law and regulations, and the Company's resulting inability to introduce the product for sale, in June 1994 the Company concluded that the ultimate 38 realizability of the prepayment was no longer probable. Accordingly, during the quarter ended June 30, 1994, the Company recorded nonrecurring charges totaling $5,120,000 to write off the remaining balance on the prepayment and the net book value of units that had been purchased. NOTE J-- DISCONTINUANCE OF PRODUCT LINE In November 1993, the Company discontinued the production and sale of its BagEasy line of disposable manual resuscitators and recalled all remaining BagEasy products in distribution channels and customer inventories. Accordingly, during the quarter ended September 30, 1993, the Company recorded non-recurring charges of $1,966,000 which included provisions for write-offs of inventories and fixed assets, the satisfaction of purchase order and compensation commitments, and costs associated with the recall. NOTE K-- JOINT VENTURE During the quarter ended December 31, 1993, the Company completed a 51% equity investment, totaling approximately $600,000, in a joint venture with a company located in the Peoples Republic of China. This joint venture will facilitate the wider distribution of the Company's products in the Peoples Republic of China and will also manufacture and distribute medical products and over-the- counter medicines in that country. The joint venture is not expected to be fully operational until the second half of fiscal year 1996. NOTE L-- ACQUISITION On April 6, 1995, the Company acquired Vitalog Monitoring, Inc., a California company that designs, manufactures and markets sleep monitoring and diagnostic equipment. This combination was treated for financial reporting purposes as a purchase. Vitalog's results of operations have been included in the Company's consolidated financial statements beginning April 7, 1995. Vitalog's operations were not material in relation to the Company's consolidated financial statements and pro forma financial information has therefore not been presented. Consideration paid was $745,000 in cash (including transactions costs) and 85,094 shares of the Company's common stock valued at $1,276,000 in exchange for the outstanding stock of Vitalog, related patents, and non-competition agreements. The cost in excess of net assets acquired was $1,887,000 and is being amortized on a straight line basis over 12 years. NOTE M -- CONTINGENCY The Company is a party to an action filed in a federal District Court in January 1995 in which a competitor alleges that the Company's sale in the United States of certain products infringes three of the competitor's patents. In its response to the action, the Company has denied the allegations and has separately sought a declaratory judgment that the claims under the patents are invalid and that the Company does not infringe upon the patents. Discovery in the case is currently underway and is scheduled to end in January 1996. The Company believes that none of its products infringe any of the patents in question in the event that any one or more of such patents should be held to be valid and it intends to vigorously defend this position. 39 NOTE N -- QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) Following are the unaudited quarterly results of operations for the fiscal years ended June 30, 1995 and 1994: 1995 ---- Three Months Ended September 30 December 31 March 31 June 30 ------------ ----------- ----------- ----------- Net Sales $21,669,809 $23,867,803 $25,599,736 $28,312,985 Gross Profit 12,199,078 13,679,172 14,485,883 16,009,042 Net Income 2,420,016 2,696,380 3,071,740 3,488,891 Earnings Per Share 0.14 0.15 0.17 0.20 1994 ---- Three Months Ended September 30 December 31 March 31 June 30 ------------ ----------- ----------- ----------- Net Sales $18,224,518 $18,600,037 $19,307,611 $22,038,862 Gross Profit 9,989,061 10,099,895 10,704,488 12,547,276 Non-recurring charges 1,966,085 -0- -0- 5,120,000 Net Income (Loss) 873,481 2,063,884 2,244,295 (440,416) Earnings (Loss) Per Share 0.05 0.12 0.13 (0.03) 40 Item 9. Changes in and Disagreements with Accountants on Accounting and --------------------------------------------------------------- Financial Disclosure. -------------------- None. 41 PART III Items 10 through 13. - - -------------------- In accordance with the provisions of General Instruction G to Form 10-K, the information required by Item 10 (Directors and Executive Officers of the Registrant), Item 11 (Executive Compensation), Item 12 (Security Ownership of Certain Beneficial Owners and Management) and Item 13 (Certain Relationships and Related Transactions) is not set forth herein because prior to October 28, 1995 the Company will file with the Commission a definitive Proxy Statement which involves the election of Directors at its Annual Meeting of Shareholders to be held on November 8, 1995, which Proxy Statement will contain such information. The information required by Items 10, 11, 12 and 13 is incorporated herein by reference to such Proxy Statement. 42 PART IV Item 14. Exhibits, Financial Statement Schedules and Reports on ------------------------------------------------------ Form 8-K. --------- The financial statements, financial statement schedules and exhibits listed below are filed as part of this annual report. (a) (1) Financial Statements: --------------------- The Consolidated Financial Statements of the Company and its subsidiaries, together with the report of Ernst & Young LLP, dated September 11, 1995, filed as part of this annual report are listed in the index to Consolidated Financial Statements in Item 8. (a) (2) Financial Statement Schedules: ------------------------------ Page ---- Financial Statement Schedules: Schedule II-Valuation and Qualifying Accounts................ 44 Schedule I, III, IV and V are omitted since the subject matter thereof is not present. (a) (3) Exhibits:.................................................... 45 43 SCHEDULE II VALUATION AND QUALIFYING ACCOUNTS RESPIRONICS, INC. COL. A COL. B COL. C COL. D COL. E - - --------------------------------------------------------------------------------------------------------------------------- ADDITIONS Balance at ------------------------------------ Balance at Beginning of Charged to Costs Charged to Other End of DESCRIPTION Period and Expenses Accounts-Describe Deductions-Describe Period ----------- ------------ ---------------- ----------------- ------------------- ----------- Year ended June 30, 1995: Deducted from asset accounts: Allowance for doubtful accounts $525,000 $175,000 $0 $700,000 ======== ======== == ======== Year ended June 30, 1994: Deducted from asset accounts: Allowance for doubtful accounts $450,000 $ 75,000 $0 $525,000 ======== ======= == ======== Year ended June 30, 1993: Deducted from asset accounts: Allowance for doubtful accounts $350,000 $100,000 $0 $450,000 ======== ======== == ======== 44 EXHIBITS Exhibit No. Description and Method of Filing - - ----------- -------------------------------- 3.1 Restated Certificate of Incorporation of the Company, Filed as Exhibit 3.2 to Amendment No. 1 to Form S-1, Registration No. 33- 20899. 3.2 Amendment to Restated Certificate of Incorporation of the Company, filed as Exhibit 3.2 to Form S-1, Registration No. 33- 39938. 3.3 By-Laws of the Company, filed as Exhibit 3.4 to Amendment No. 2 to Form S-1,Registration No. 33-20899. 3.4 Amendment to Restated Certificate of Incorporation of the Company, filed as Exhibit 4.2 to Form S-8, Registration No. 33-89308. 4.1 Loan Agreement dated November 1, 1989 between the Company and the Pennsylvania Economic Development Financing Authority, filed as Exhibit 4.1 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1990. 4.2 Consent, Subordination, and Assumption Agreement dated April 20, 1990 between the Company and the Greater Murrysville Industrial Corporation, filed as Exhibit 4.2 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1990. 4.3 Loan Agreement dated June 5, 1990 between the Company and the Redevelopment Authority of the County of Westmoreland, to be filed with the Commission upon request. 4.4 Consent, Subordination, and Assumption Agreement dated June 21, 1994 between the Company and the Redevelopment Authority of the County of Westmoreland, filed as Exhibit 4.4 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1994 4.5 Consent, Subordination, and Assumption Agreement dated February 22, 1995 between the Company and the Central Westmoreland Development Corporation, filed as Exhibit 4.5 this Annual Report. 10.1 Amended and Restated Incentive Stock Option Plan of Respironics, Inc. and form of Stock Option Agreement used for Stock Options granted after December 31, 1987, filed as Exhibit 10.2 to Form S- 1, Registration No. 33-20899. 10.2 Agreements between the Company and Gerald E. McGinnis, filed as Exhibit 10.4 to Amendment No. 2 to Form S-1, Registration No. 33- 20899. 45 10.3 Employment Agreement, dated September 2, 1982, and effective October 1, 1982, between the Company and Kam-Kwen Ng, filed as Exhibit 10.5 to Form S-1, Registration No. 33-20899. 10.4 Employment Agreement dated September 1983 between the Company and Eugene N. Scarberry, filed as Exhibit 10.6 to Form S-1, Registration No. 33-20899. 10.5 Letter Agreements between the Company and Vital Signs, Inc., filed as Exhibit 10.11 to Form S-1, Registration No. 33-20899. 10.7 Respironics, Inc. Retirement Savings Plan, filed as Exhibit 10.11 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1989. 10.8 Incentive Bonus Plan dated January 26, 1985, filed as Exhibit 10.16 to Form S-1, Registration No. 33-20899. 10.10 Consulting Agreement dated July 1, 1988 between the Company and Dr. Mark Sanders, filed as Exhibit 10.15 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1989. 10.11 Employment and Royalty Agreement dated September 21, 1982 and March 1, 1989 and effective October 1, 1982 and March 1, 1989 between the Company and Ronald J. Zdrojkowski, filed as Exhibit 1 to the Company's Form 10-Q for the quarter ended September 30, 1989. 10.12 Supply Agreement with Vital Signs, Inc. effective July 1, 1993 and expiring June 30, 1997, filed as Exhibit 10.12 to Annual Report on Form 10-K for fiscal year ending June 30, 1993. 46 10.18 Line of Credit Agreement dated November 14, 1994 with PNC Bank, filed as Exhibit 10.18 to this Annual Report. 10.19 Employment Agreement dated and effective as of April 1, 1995 between the Company and Gerald E. McGinnis, filed as Exhibit 10.19 to this Annual Report. 10.20 Employment Agreement dated and effective as of December 1, 1994 between the Company and Robert D. Crouch, filed as Exhibit 1 to Quarterly Report on Form 10-Q for the quarter ended December 31, 1994. 10.21 Employment Agreement dated and effective as of December 1, 1994 between the Company and Dennis S. Meteny, filed as Exhibit 2 to Quarterly Report on Form 10-Q for the quarter ended December 31, 1994. 10.22 1991 Non-Employee Directors' Stock Option Plan, filed as Exhibit A to 1991 Proxy Statement incorporated by reference into Annual Report on Form 10-K for Fiscal Year ending June 30, 1991. 10.23 1992 Stock Incentive Plan, filed as Exhibit A to 1992 Proxy Statement incorporated by reference into Annual Report on Form 10-K for Fiscal Year ending June 30, 1992. 11.1 Statement re: Earnings per share, filed as Exhibit 11.1 to this Annual Report. 21.1 List of Subsidiaries, amending Exhibit 22.1 to Form S-1, Registration No. 33-20899, filed as Exhibit 22.1 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1992. 23.1 Consent of Ernst & Young, filed as Exhibit 23.1 to this Annual Report 47 (b) Reports on Form 8-K: -------------------- No events which resulted in the filing of a current report on Form 8-K occurred during the fourth quarter of fiscal year 1995. 48 SIGNATURES ---------- Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. RESPIRONICS, INC. /s/ Dennis S. Meteny ------------------------------- By: Dennis S. Meteny, President and Chief Executive Officer Date: September 27, 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 Company in the capacities indicated on September 27, 1995: /s/ Dennis S. Meteny /s/ James H. Hardie - - -------------------------------- --------------------------------- Dennis S. Meteny James H. Hardie (President and (Director) Chief Executive Officer and Director) /s/ Daniel J. Bevevino - - -------------------------------- --------------------------------- Daniel J. Bevevino Joseph C. Lawyer (Controller and Chief Financial (Director) and Accounting Officer) /s/ Gerald E. McGinnis /s/ George J. Magovern - - -------------------------------- --------------------------------- Gerald E. McGinnis George J. Magovern, M.D. (Chairman of the (Director) Board of Directors) - - -------------------------------- --------------------------------- Daniel P. Barry Bernard Shou-Chung Zau (Director) (Director) /s/ Douglas A. Cotter - - -------------------------------- Douglas A. Cotter (Director) 49 EXHIBITS INDEX Exhibit No. Description and Method of Filing - - ----------- -------------------------------- 3.1 Restated Certificate of Incorporation of the Company, Filed as Exhibit 3.2 to Amendment No. 1 to Form S-1, Registration No. 33-20899. 3.2 Amendment to Restated Certificate of Incorporation of the Company, filed as Exhibit 3.2 to Form S-1, Registration No. 33-39938. 3.3 By-Laws of the Company, filed as Exhibit 3.4 to Amendment No. 2 to Form S-1, Registration No. 33-20899 3.4 Amendment to Restated Certificate of Incorporation of the Company, filed as Exhibit 4.2 to Form S-8, Registration No. 33-89308. 4.1 Loan Agreement dated November 1, 1989 between the Company and the Pennsylvania Economic Development Financing Authority, filed as Exhibit 4.1 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1990. 4.2 Consent, Subordination, and Assumption Agreement dated April 20, 1990 between the Company and the Greater Murrysville Industrial Corporation, filed as Exhibit 4.2 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1990. 4.3 Loan Agreement dated June 5, 1990 between the Company and the Redevelopment Authority of the County of Westmoreland, to be filed with the Commission upon request. 4.4 Consent, Subordination, and Assumption Agreement dated June 21, 1994 between the Company and the Redevelopment Authority of the County of Westmoreland, filed as Exhibit 4.4 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1994 4.5 Consent, Subordination, and Assumption Agreement dated February 22, 1995 between the Company and the Central Westmoreland Development Corporation, filed herewith at page --------- 10.1 Amended and Restated Incentive Stock Option Plan of Respironics, Inc. and form of Stock Option Agreement used for Stock Options granted after December 31, 1987, filed as Exhibit 10.2 to Form S-1, Registration No. 33-20899. 10.2 Agreements between the Company and Gerald E. McGinnis, filed as Exhibit 10.4 to Amendment No. 2 to Form S-1, Registration No. 33-20899. 10.3 Employment Agreement, dated September 2, 1982, and effective October 1, 1982, between the Company and Kam-Kwen Ng, filed as Exhibit 10.5 to Form S-1, Registration No. 33-20899. 10.4 Employment Agreement dated September 1983 between the Company and Eugene N. Scarberry, filed as Exhibit 10.6 to Form S-1, Registration No. 33-20899. 10.5 Letter Agreements between the Company and Vital Signs, Inc., filed as Exhibit 10.11 to Form S-1, Registration No. 33-20899. 10.7 Respironics, Inc. Retirement Savings Plan, filed as Exhibit 10.11 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1989. 10.8 Incentive Bonus Plan dated January 26, 1985, filed as Exhibit 10.16 to Form S-1, Registration No. 33-20899. 10.10 Consulting Agreement dated July 1, 1988 between the Company and Dr. Mark Sanders, filed as Exhibit 10.15 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1989. 10.11 Employment and Royalty Agreement dated September 21, 1982 and March 1, 1989 and effective October 1, 1982 and March 1, 1989 between the Company and Ronald J. Zdrojkowski, filed as Exhibit 1 to the Company's Form 10-Q for the quarter ended September 30, 1989. 10.12 Supply Agreement with Vital Signs, Inc. effective July 1, 1993 and expiring June 30, 1997, filed as Exhibit 10.12 to Annual Report on Form 10-K for fiscal year ending June 30, 1993. 10.18 Line of Credit Agreement dated November 14, 1994 with PNC Bank, filed herewith at page . ------- 10.19 Employment Agreement dated and effective as of April 1, 1995 between the Company and Gerald E. McGinnis, filed herewith at page . ------ 10.20 Employment Agreement dated and effective as of December 1, 1994 between the Company and Robert D. Crouch, filed as Exhibit 1 to Quarterly Report on Form 10-Q for the quarter ended December 31, 1994. 10.21 Employment Agreement dated and effective as of December 1, 1994 between the Company and Dennis S. Meteny, filed as Exhibit 2 to Quarterly Report on Form 10-Q for the quarter ended December 31, 1994. 10.22 1991 Non-Employee Directors' Stock Option Plan, filed as Exhibit A to 1991 Proxy Statement incorporated by reference into Annual Report on Form 10-K for Fiscal Year ending June 30, 1991. 10.23 1992 Stock Incentive Plan, filed as Exhibit A to 1992 Proxy Statement incorporated by reference into Annual Report on Form 10-K for Fiscal Year ending June 30, 1992. 11.1 Statement re: Earnings per share, filed herewith at page . ------- 21.1 List of Subsidiaries, amending Exhibit 22.1 to Form S-1, Registration No. 33-20899, filed as Exhibit 22.1 to Annual Report on Form 10-K for Fiscal Year ending June 30, 1992. 23.1 Consent of Ernst & Young, filed herewith at page . -----------