-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VJzQsb7dquggl1H92roeEb0Cv6L1LxzYtu11lwNYB/sw439WdxYCWFwyl+MBl4KY y5zmOLAfrIr91CSdyU+2Ig== 0001017062-99-001394.txt : 19990810 0001017062-99-001394.hdr.sgml : 19990810 ACCESSION NUMBER: 0001017062-99-001394 CONFORMED SUBMISSION TYPE: 10-Q/A PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19990331 FILED AS OF DATE: 19990809 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOLASE TECHNOLOGY INC CENTRAL INDEX KEY: 0000811240 STANDARD INDUSTRIAL CLASSIFICATION: DENTAL EQUIPMENT & SUPPLIES [3843] IRS NUMBER: 870442441 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q/A SEC ACT: SEC FILE NUMBER: 000-19627 FILM NUMBER: 99681604 BUSINESS ADDRESS: STREET 1: 981 CALLE AMANECER CITY: SAN CLEMENTE STATE: CA ZIP: 92673 BUSINESS PHONE: 7143611200 MAIL ADDRESS: STREET 1: 981 CALLE AMANECER CITY: SAN CLEMENTE STATE: CA ZIP: 92673 10-Q/A 1 QUARTERLY REPORT FOR PERIOD ENDED 03-31-1999 U.S. SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q/A Amendment No. 1 (Mark One) [X] Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended March 31, 1999 -------------- [_] Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from _______ to _______ Commission File Number 0-19627 ------- BIOLASE TECHNOLOGY, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 87-0442441 (State or other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification No.) 981 Calle Amanecer, San Clemente, CA 92673 (Address of Principal Executive Offices) (949) 361-1200 (Registrant's Telephone Number, Including Area Code) Indicate by check whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No --- --- Indicate the number of shares outstanding of each of the issuer's classes of Common Stock, as of the latest practicable date. Common Stock, $.001 par value 17,657,387 - ----------------------------- ---------------------------- Title Class Number of Shares Outstanding at May 21, 1999 ITEM 2. Management's Discussion and Analysis of Financial Condition and Results - -------------------------------------------------------------------------------- of Operations. - -------------- Qualifying Statement With Respect To Forward-Looking Information The United States Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for certain forward-looking statements. Such forward-looking statements are based upon the current expectations of the Company and speak only as of the date made. These forward-looking statements involve risks, uncertainties and other factors. The factors discussed below under "Forward- Looking Statements" and elsewhere in this Quarterly Report on Form 10-Q are among those factors that in some cases have affected the Company's historic results and could cause actual results in the future to differ significantly from the results anticipated in forward-looking statements made in this Quarterly Report on Form 10-Q, future filings by the Company with the Securities and Exchange Commission, in the Company's press releases and in oral statements made by authorized officers of the Company. When used in this Quarterly Report on Form 10-Q, the words "estimate," "project," "anticipate," "expect," "intend," "believe," "hope," "may" and similar expressions, as well as "will," "shall" and other indications of future tense, are intended to identify forward-looking statements. The following discussion should be read in conjunction with the consolidated condensed financial statements and notes thereto. Results of Operations - Three-month period ended March 31, 1999 as compared to three-month period ended March 31, 1998: Sales during the first three months of 1999 were $1,786,000, an increase of $1,523,000, or 580%, over the $263,000 reported for the comparable period in 1998. The sales reported during the first quarter of 1999 represent the highest quarterly sales in the Company's history and is attributed principally to the Company's increased marketing efforts of its Millennium(TM) YSGG HydroKinetic(TM) system. Increased marketing efforts, establishment of new domestic and foreign distributor relationships, increases in the Company's domestic sales force and recent Food and Drug Administration clearance for all classes of carries removal have contributed to the significant increase in sales. The Company intends to continue its market awareness of the Millennium through advertising in professional journals, design and distribution of creative marketing brochures, sponsorship of "Laser Lunch and Learn" sessions at professional dental practices and continued participation at significant dental trade shows, both domestically and abroad. 1 Sales of the Company's LazerSmile(TM) tooth-whitening system continue to improve, though at a nominal rate. The Company continues to employ its strategy of utilizing experienced consumer marketing groups that specialize in the distribution of home consumer health products through such channels as television shopping networks, specialty catalogs and traditional consumer distribution channels. To date, sales of the LazerSmile(TM) tooth-whitening system have been achieved predominately through advertising on the Internet, professional trade journals and cosmetic journals and magazines. Cost of sales as a percentage of sales decreased significantly from 91% reported for the three months ended March 31, 1998 to 55% reported for the three months ended March 31, 1999. The improvement was due principally to the Company's increased manufacturing efficiency coupled with an improved absorption of fixed manufacturing costs due to higher manufacturing volumes. Operating expenses increased $609,000 or 73% during the first quarter of 1999 to $1,442,000 from the $833,000 reported during the comparable period in 1998. Sales and marketing expense increased $229,000 or 75% for the first quarter of 1999 from the $305,000 reported for the comparable period in 1998. The increase was due principally to a significant growth in the Company's domestic sales force and international sales management team, increased selling commissions as a result of higher sales, increased costs related to marketing and advertising of the Company's Millennium(TM) system and, to a lesser degree, costs related to advertising and marketing of the LazerSmile(TM) tooth-whitening system that was absent during the first quarter of 1998. General and administrative expense for the first quarter of 1999 was $436,000, an increase of $182,000, or 72%, above the $254,000 reported for the first quarter of 1998. The increase is due principally to increases in the Company's executive management and regulatory staffing and related personnel expenses, insurance costs and professional expenses associated with the Company's growth, and patent/trademark expenses related to the Company's continued efforts to protect its proprietary technologies. Engineering and development expense increased $198,000, or 72% during the first quarter of 1999, from $274,000 reported during the comparable period in 1998. The increase was attributed principally to increases in engineering staffing requirements necessitated by the continued refining and enhancement of existing products, and continued design and development of new products requiring research and development. On July 2, 1998, the Company acquired substantially all of the assets of Laser Skin Toner, Inc., a development stage company ("LSTI"). The assets acquired related primarily to the proprietary in-process laser-based technology being developed by LSTI for non invasive laser treatment in the field of aesthetic skin rejuvenation, including all intellectual property rights consisting of patents, patent applications, a trademark application and certain know-how. The in-process laser system technology acquired by the Company from LSTI consists of six critical components: (1) a coupling system; (2) a pneumatic control system; (3) a distal end; (4) packaging/cabinetry; (5) a pharmaceutical membrane; and (6) FDA clearance. Each of these components were estimated to require additional research and development efforts, as set forth below: Coupling System. The coupling system involves integration of the --------------- laser receptacle, proximal end of the fiber, the fiber and jacket, the hand piece and the wand of the laser system, and allows the transfer of power through each phase of the laser. The transfer of power from the laser to the fiber delivery system and ultimately to the device that touches the patient's face (the distal end) involves linking different technologies; it also requires further development of the LSTI "SmartConnect" technology, which is intended to assure the appropriate therapeutic dose of laser energy and to monitor skin contraction during the procedure. Management had estimated at the time of acquisition that this component was less than 50% complete and would require the efforts of two mechanical engineers and one electrical engineer for three months, estimated at a cost of $70,000, to bring it to the production phase. In addition, the Company estimated at the time of acquisition that it would be required to incur $350,000 of non- recurring engineering fees for an original equipment manufacturer to provide the customized power source for the laser. Pneumatic Control System. The pneumatic control system is intended to ------------------------ ensure that the laser does not burn the patient. It is a cooling mechanism using a pressure system to maintain the correct temperature through a pump and fiber interface, and requires interaction with the laser, fiber and distal end. Steps remaining at the time of acquisition to complete this component included the selection of a suitable compressed air system, estimated at $30,000, and design and test of the pump and fiber interface. The Company estimated at the time of acquisition that approximately two engineers would be required to work on this project for three months at an estimated cost of $81,000. Distal End. The distal end of the laser system will provide the ---------- surgeon with control while housing all of the electronics needed to deliver the correct amount of power and pulse duration. At the time of acquisition, it was contemplated that the laser system would initially include three distal ends, each tailored for different sized wrinkles located on different parts of the body. At that time, it was also anticipated that three additional distal ends would be made available in the second half of 1999. Management of the Company had estimated at the time of acquisition that development of the distal end was then less than 40% complete. Completion of the initial three distal ends was estimated at the time of acquisition to require the efforts of two optical engineers for approximately three months, with an additional four months required for the remaining three distal ends. Estimated costs to complete this portion of the project were estimated at the time of acquisition to be $138,000. Packaging/Cabinetry. The packaging/cabinetry of the laser will ------------------- provide the housing or outer surface for the entire system. This housing can be quite elaborate and may be comprised of different types of metal or plastic. Management believes that this component of the system is the only one that will not require the development of technology in order to complete; however, the design of the packaging/cabinetry is required to ensure an efficient, aesthetically pleasing medical devise for the practitioner. The Company estimated at the time of acquisition that completion of this portion of the project would require the efforts of two engineers for approximately ten and one-half months at an estimated cost of $259,000. Pharmaceutical Membrane. LSTI contemplated that pharmaceutical ----------------------- membranes would be applied to the patient for a 90-day period after the resurfacing procedure. The membranes would carry an active pharmaceutical agent employing a specific concentration, mix and delivery of an anti- inflammatory agent, various anti-oxidants and a neo-collagen-promoting agent. At the time of the acquisition, the pharmaceutical membrane was in the initial phase of development. Significant tasks remaining at the time of acquisition included integration of the chemicals and membrane material, which had never before been accomplished, and design, development and integration of a time release system to be incorporated with the membrane system. Non-recurring engineering related the membranes was estimated at the time of acquisition to cost approximately $350,000 to $450,000, with an additional $50,000 to $75,000 for each of four clinical trials then expected. Management estimated at the time of acquisition that completion of this portion of the project would require approximately seven and one- half months of full-time effort by one engineer at an estimated cost of $40,000. FDA Clearance. The completed laser system must go through two FDA -------------- approval processes, one of which was subsequently received following the acquisition of the LSTI technology. The remaining process was estimated at the date of acquisition to require approximately four to six months of data gathering prior to submission to the FDA for approval. The costs estimated for the approval process remaining at the date of acquisition were $312,000. At the time of the acquisition, the intellectual property embodying this developmental effort represented substantially all of LSTI's assets, and the developmental efforts did not appear applicable to any alternative use. At the time of acquisition, the Company intended to proceed with those additional research and development efforts needed to bring the product to market and to fund the costs from working capital. In anticipation of and then in response to the clearance it received in October 1998 from the FDA to market its Millennium(TM) tissue cutting system for dental hard tissue applications, the Company shortly after acquiring the LSTI technology decided to focus its limited resources on the marketing of its Millennium(TM) system, including a build-up of inventory and expansion of sales staff. The Company has since determined that it is in the best interests of its stockholders to continue its focus on the marketing and further enhancement of products embodying its HydroKinetic (TM) technology, including its Millennium (TM) system, and not to further develop the LSTI technology. The Company's efforts devoted to the LSTI technology since the date of acquisition have not provided a basis for the Company either to revise or to validate its estimates made at the time of acquisition regarding the time and resources required to complete the development of the LSTI technology. The loss from operations decreased to $644,000, or 36% of reported sales during the first quarter of 1999 compared to an operating loss of $809,000, or 308% of reported sales for the comparable period in 1998. The reduction in the operating loss is a result of increased sales and improved product margins offset to a lesser degree by increases in operating expenses associated principally with the Company's growth. Interest income and interest expense were comparable between the first quarters of 1999 and 1999. Financial Condition Cash, cash equivalents and marketable securities in the aggregate increased from $676,000 at December 31, 1998 to $3,582,000 at March 31, 1999, primarily as a result of a 2 SIGNATURE PAGE Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this amended report to be signed on its behalf by the undersigned thereunto duly authorized. BIOLASE TECHNOLOGY, INC. a Delaware Corporation Date: August 9, 1999 /s/ Jeffrey W. Jones -------------- ---------------------------------------- Jeffrey W. Jones President & Chief Executive Officer 3 -----END PRIVACY-ENHANCED MESSAGE-----