Autonomous Reports Second Quarter Results; Announces Closing of Financing.ORLANDO, Fla.--(BW HealthWire)--August 11, 1998--Autonomous Technologies Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on NM: ATCI ATCI Albany Transcomm International ) today reported results for the second quarter ended June 30, 1998. The Company reported a net loss of $4,168,618, or $0.39 per basic share, based on 10,684,254 average shares outstanding in the quarter, versus a loss of $3,091,332 or $0.45 per basic share, based on 6,888,689 average shares outstanding, for the same quarter last year. The 1997 earnings per share figure has been restated in accordance with FASB FASB See: Financial Accounting Standards Board FASB See Financial Accounting Standards Board (FASB). 128. Since diluted per share figures are "anti-dilutive" to the company, only basic net loss figures are presented. The quarterly loss of $4.2 million was in line with the Company's expectations. The Company has been preparing for the launch of its LADARVision(r) product in the U.S. once the anticipated pre-market approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) is received. On August 7, 1998, the Company closed on its previously announced equity financing Equity Financing The act of raising money for company activities by selling common or preferred stock to individual or institutional investors. In return for the money paid, shareholders receive ownership interests in the corporation. with OZ Master Fund, Ltd. The Company sold 500 shares of a newly designated convertible preferred stock Convertible Preferred Stock Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares". for $5 million. OZ Master Fund, Ltd. has an option to purchase an additional $4 million of this convertible preferred stock from the Company no later than November 10, 1998. If the option is exercised, OZ Master Fund, Ltd. will receive a stock purchase warrant for 300,000 shares of common stock. In May, the Company announced that it expected a three-month delay in completing its U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) quality system regulation (QSR QSR Quick Service Restaurant QSR QoS (Quality of Service) Satisfaction Rate QSR Quality System Regulations QSR Quality Status Report QSR Quality System Review QSR Quarterly Status Report QSR Quality System Requirement ) audit while the Company completed further process validation procedures. At this point in time, the Company believes that it has taken the necessary steps to prepare for the upcoming QSR audit. These steps have included the addition of key personnel to the quality and engineering staffs. In June, the Company announced its receipt of ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001/EN 4600 1 Certification from a notified body. Certification was awarded following rigorous inspections and audits of Autonomous' processes for design, manufacturing, installation and servicing of its laser vision correction systems. ISO certification is an internationally recognized standard for high quality management systems. In addition to preparing for the QSR audit, the Company recently announced that the FDA has completed its review of its LADARVision(r) System pre-market approval application. In the letter received July 28, 1998, the Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. (CDRH CDRH Center for Devices and Radiological Health (US FDA) ) stated it has concurred with the February 13, 1998 FDA Ophthalmic Devices Panel recommendation and informed the Company that its PMA is approvable. The correction range stated in the approvable letter is for up to -10 diopters of myopia myopia: see nearsightedness. (sphere ) and -4 diopters of astigmatism astigmatism (əstĭg`mətĭz'əm), type of faulty vision caused by a nonuniform curvature in the refractive surfaces—usually the cornea, less frequently the lens—of the eye. (cylinder). The range for myopia is broader than the -8 diopters recommended by the Panel this past February and is based on additional data provided by Autonomous. The increase in range will make the procedure available to a larger portion of the myopic my·o·pi·a n. 1. A visual defect in which distant objects appear blurred because their images are focused in front of the retina rather than on it; nearsightedness. Also called short sight. 2. , or nearsighted near·sight·ed adj. Unable to see distant objects clearly; myopic. population. Final PMA approval cannot occur until the FDA determines that Autonomous manufacturing facilities, methods and controls comply with the FDA Quality System Regulation (QSR). Commenting on the quarter, Randy Frey, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Autonomous, stated, "An enormous effort has been spent this quarter preparing for the upcoming QSR audit. We have added key personnel and made significant progress in the areas that we believe are necessary to ultimately obtain the pre-market approval from the FDA. We are very excited about the Autonomous technology and we are pleased that we may soon be able to bring the benefits of our clinical outcomes to U.S. physicians and their patients." Autonomous is engaged in the design and development of next-generation excimer laser A gas laser in which a very short electrical pulse excites a mixture containing a halogen such as fluorine and a rare gas such as argon or krypton. It produces a brief, intense pulse of ultraviolet light. instruments for laser refractive surgery Refractive surgery A surgical procedure that corrects visual defects. Mentioned in: Photorefractive Keratectomy and Laser-Assisted In-Situ Keratomileusis refractive surgery . The Company's LADARVision System combines laser radar laser radar n. See lidar. eye tracking with narrow beam shaping technology. This press release contains forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements containing terms such as "believes," "does not believe," "no reason to believe," "expects," "plans," "intends," "estimates," or "anticipates" are considered to contain uncertainty and are forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of important factors, including the Company's ability to successfully achieve a Pre-Market Approval from the FDA within a reasonable time and the Company's future competitiveness in the laser vision correction marketplace. Receipt of an "approvable letter" does not constitute an FDA approval of the Company's product. Final PMA cannot be granted until the FDA determines that the Autonomous manufacturing facilities, methods and controls comply with the FDA Quality System Regulation (QSR). For a discussion of the important factors that could affect the Company's results, please refer to the Overview section, the Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations, and the Risk Factors section in the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. as amended. -0-
AUTONOMOUS TECHNOLOGIES CORPORATION
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
(UNAUDITED)
Three Months Ended
June 30, June 30,
1998 1997
REVENUES FROM LADARVision $45,125 $ -
Systems
REVENUES FROM RESEARCH - -
GRANTS
OPERATING EXPENSES:
Costs of revenues -
LADARVision
Systems 86,021 -
Costs of revenue - - -
research grants
Clinical trials 741,199 853,820
Unabsorbed production costs 828,648 -
Research and development 1,038,426 895,249
Selling and marketing 538,373 318,554
General and administrative 573,092 618,863
Other expenses 440,490 509,982
OPERATING LOSS (4,201,124) (3,196,468)
OTHER INCOME (EXPENSE):
Interest income 43,201 114,417
Interest expense (10,695) (9,281)
LOSS BEFORE INCOME TAXES (4,168,618) (3,091,332)
INCOME TAXES - -
NET LOSS $(4,168,618)$(3,091,332)
LOSS PER SHARE:
Basic net loss per share $(0.39) $(0.45)
Weighted average common
and common
equivalent shares used in
computing
basic net loss per share 10,684,254 6,888,689
Six Months Ended
--------------------
Cumulative
from
Inception
June 30, June 30, (July 23,
1998 1997 1985) to
June 30,
1998
REVENUES FROM LADARVision $ 104,395 $ - $141,460
Systems
REVENUES FROM RESEARCH - - 3,450,517
GRANTS
OPERATING EXPENSES:
Costs of revenues -
LADARVision 253,069 - 358,961
Systems
Costs of revenue - - - 3,465,596
research grants
Clinical trials 1,395,228 1,443,102 7,265,422
Unabsorbed production costs 1,316,123 - 2,074,924
Research and development 2,064,049 1,669,298 12,372,364
Selling and marketing 1,290,620 614,595 4,745,622
General and administrative 1,188,135 1,128,685 7,543,006
Other expenses 674,465 1,086,866 3,930,010
OPERATING LOSS (8,077,294) (5,942,546) (38,163,928)
OTHER INCOME (EXPENSE):
Interest income 126,595 271,226 1,414,317
Interest expense (22,308) (17,852) (126,671)
LOSS BEFORE INCOME TAXES (7,973,007) (5,689,172) (36,876,282)
INCOME TAXES - - 4,772
NET LOSS $(7,973,007)$(5,689,172)$(36,881,054)
LOSS PER SHARE:
Basic net loss per share $(0.79) $(0.83)
Weighted average common
and common
equivalent shares used in
computing
basic net loss per share 10,150,557 6,860,152
CONTACT: COMPANY CONTACT: Autonomous Technologies Corporation Randy Frey Chairman & CEO randyfrey@autonomous.com Jonathan Kennedy Manager of Investor Relations Investor relations The process by which the corporation communicates with its investors. jonathan@autonomous.com (407) 384-1600 or INVESTOR RELATIONS CONTACTS: Lippert/Heilshorn & Associates, Inc. Bruce Voss (Bruce@lhai.com) (310) 575-4848 Ruth Markowitz (Ruth@lhai.com) (212) 838-3777 |
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