Advanced Neuromodulation Systems First-Quarter Revenue Increases 22 Percent.Business Editors DALLAS--(BUSINESS WIRE)--April 27, 2000 Advanced Neuromodulation Systems Advanced Neuromodulation System is a subsidiary of St. Jude Medical, Inc based in Plano, Texas. Among the products ANS makes and sells include spinal cord stimulators for intractable pain. Inc. (ANS (ANS Communications, Inc, Purchase, NY) An ISP, Internet backbone and provider of private data network services, founded in 1990 as Advanced Network & Services, Inc., by IBM, MCI and Merit (consortium of Michigan universities). ) (Nasdaq:ANSI (American National Standards Institute, New York, www.ansi.org) A membership organization founded in 1918 that coordinates the development of U.S. voluntary national standards in both the private and public sectors. It is the U.S. member body to ISO and IEC. ) today announced that revenue for the first quarter of 2000 from sales of its advanced Renew(TM) radio frequency (RF) neuromodulation system for the treatment of chronic intractable pain intractable pain Refractory pain Pain medicine Persistent pain which does not respond to at least 3 dosease of parenteral analgesics given over a 12-24 hr period; pain that does not respond to appropriate doses of opioid analgesics. increased 22 percent to a record $5,599,000. This compares with revenue of $4,595,000 reported for the first quarter of 1999 from sales of the company's earlier-generation RF neuromodulation system, and to revenue from Renew system sales System sales is a business term used in the franchising industry. Franchisors provide supplies, marketing and administration services to franchisees in return for a part of the franchisees' revenues. Some franchisors also operate some outlets directly. of $5,325,000 reported for the fourth quarter of 1999. The Renew system was launched in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. in June 1999. Total revenue for the 1999 first quarter was $13,495,000, which included the final $8,900,000 of contract revenue associated with the former agreement with Sofamor Danek. Net earnings for the three months ended March 31, 2000, were $181,000, or 2 cents per diluted share. This compares with net earnings of $5,446,000, or 67 cents per diluted share, for the first quarter of 1999, which included net earnings associated with the contract revenue from Sofamor Danek of 67 cents per diluted share. "First-quarter sales results continue to validate the market acceptance of our advanced Renew(TM) system. Our growth also shows that the investments we made and are continuing to make in our high- performance sales and marketing, regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: A measurement of the degree to which a firm or project relies on fixed rather than variable costs. Notes: The higher the degree of operating leverage, the greater the potential danger from forecasting risk. that will benefit our company and our shareholders as sales increase in the future," said President and Chief Executive Officer Chris Chavez. The 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. continued: "Today, ANS competes in just the RF segment of the neuromodulation market. We have built a 50 percent share of this market, which is estimated to be growing at the rate of 15 percent annually. "Later this year, we expect to expand our addressable Reachable. When something is addressable, it can be identified and manipulated independently of its surroundings. For example, screen pixels and RAM memory are addressable. Each of the screen's picture elements can be individually turned on and off, and each of the memory's bytes can be markets with the launch of two additional neuromodulation products for pain management -- our fully implantable pulse generator implantable pulse generator Cardiac pacing A pacemaker used for permanent pacing, which is placed inside a pocket under the skin; the leads are positioned in or on the heart (IPG IPG Implantable pulse generator, see there ) for treating pain of the trunk and/or limbs, and our fixed-rate implantable drug pump. "The IPG market currently exceeds $125 million and is growing at a 30 percent annual rate. Based on our success in the RF segment, and recognizing that the very same pain practitioners to whom we now sell our RF product also routinely implant IPG devices, we are confident that ANS can build its share of the IPG market once regulatory approvals are achieved. "We remain hopeful that the 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. will make a timely decision to follow the recommendation of the Neurological Devices Panel of the Medical Devices Advisory Committee to reclassify Verb 1. reclassify - classify anew, change the previous classification; "The zoologists had to reclassify the mollusks after they found new species" class, classify, sort out, assort, sort, separate - arrange or order by classes or categories; "How would you Totally Implanted Spinal Cord Stimulators Spinal Cord Stimulator (SCS) or Dorsal Column Stimulator (DCS) is an implantable medical device used to treat chronic pain of neurologic origin. An electric impulse generated by the device near the dorsal surface of the spinal cord provides a paresthesia ("tingling") (IPGs) for treatment of pain of the trunk and/or limbs from a Class III device class III device Regulatory affairs A highly regulated 'high risk' medical device–eg, life-support or life-sustaining devices–eg, pacemakers and heart valves, approved by the FDA for use in humans; CIIIDs are also defined as those which pose a to a Class II device. In addition, we expect to receive European approval for our fixed-rate drug pump later this year." At March 31, 2000, ANS reported cash and short-term investments of $8,981,000, working capital of $17,181,000, a current ratio of 6.9-to-1, no debt and shareholders' equity Shareholders' Equity A firms' total assets minus its total liabilities. Equivalently, it is share capital plus retained earnings minus treasury shares. Shareholders' equity is the amount by which a company is financed through common and preferred shares. of $37,788,000. About Advanced Neuromodulation Systems Advanced Neuromodulation Systems designs, develops, manufactures and markets implantable systems used to manage chronic intractable pain and other disorders of the central nervous system. Statements contained in this document that are not based on historical facts are "forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. ." Terms such as "plan," "should," "would," "anticipate," "believe," "intend," "estimate," "expect," "predict," "scheduled," "new market," "potential market applications" and similar expressions are intended to identify forward-looking statements. Such statements are by nature subject to uncertainties and risks, including, but not limited to: completion of research and development projects in an efficient and timely manner; obtaining regulatory approvals on a timely and cost-efficient basis to permit the introduction of new products; the successful reclassification Reclassification The process of changing the class of mutual funds once certain requirements have been met. These requirements are generally placed on load mutual funds. Reclassification is not considered to be a taxable event. of the IPG by the FDA; the satisfactory completion of clinical trials and/or market tests prior to the introduction of new products; the adequacy, acceptability and timeliness of component supply; the approval of new products by reimbursement agencies like insurance companies, HMOs, Medicare and Medicaid Medicare and Medicaid U.S. government programs in effect since 1966. Medicare covers most people 65 or older and those with long-term disabilities. Part A, a hospital insurance plan, also pays for home health visits and hospice care. ; the efficacy of the company's products for new applications; and other risks detailed from time to time in the company's Securities and Exchange Commission filings. Consequently, if such management assumptions prove to be incorrect or such risks or uncertainties materialize, anticipated results could differ materially from those forecast in forward-looking statements.
ADVANCED NEUROMODULATION SYSTEMS INC.
Consolidated Statements of Operations
(Unaudited)
Three months ended
March 31,
2000 1999
Net revenue $5,598,864 $4,595,238
Net revenue -- contract research and
development -- 8,900,000
Total net revenue 5,598,864 13,495,238
Operating expenses:
Cost of product sales 1,848,596 1,360,180
Research and development 934,875 886,268
Marketing 1,629,831 1,503,182
Amortization of intangibles 306,871 295,844
General and administrative 688,811 674,609
5,408,984 4,720,083
Earnings from operations 189,880 8,775,155
Other income (expenses):
Interest expense -- (44,861)
Interest and other income 128,057 227,532
128,057 182,671
Earnings before income taxes 317,937 8,957,826
Income taxes 136,805 3,511,468
Net earnings $ 181,132 $5,446,358
Basic earnings per share:
Net earnings $ .02 $ .70
Number of basic shares 7,434,258 7,746,402
Diluted earnings per share:
Net earnings $ .02 $ .67
Number of diluted shares 8,252,579 8,109,726
ADVANCED NEUROMODULATION SYSTEMS INC.
Condensed Consolidated Balance Sheets
March 31, Dec. 31,
2000 1999
Assets:
Current assets:
Cash and short-term investments $ 8,980,812 $ 8,751,866
Accounts receivable, net 3,374,089 3,856,684
Inventories 6,154,370 5,999,217
Deferred income taxes 644,819 654,086
Prepaid expenses and other current assets 934,828 1,107,380
Total current assets 20,088,918 20,369,233
Net equipment and fixtures 5,561,553 5,688,570
Patents, trademarks, purchased technology
and other assets, net 17,337,937 17,496,971
Total assets $42,988,408 $43,554,774
Liabilities and stockholders' equity:
Current liabilities:
Accounts payable $ 1,075,623 $ 1,765,377
Accrued salary and employee benefit costs 424,509 793,275
Accrued tax abatement liability 969,204 969,204
Income taxes payable 264,330 511,848
Other accrued expenses 174,227 151,372
Total current liabilities 2,907,893 4,191,076
Deferred income taxes 2,292,111 2,325,403
Stockholders' equity:
Common stock, 5 cents par value 435,418 435,418
Additional capital 40,218,275 40,423,457
Retained earnings 5,875,554 5,694,422
Accumulated other comprehensive income
(loss), net (223,562) (241,550)
Cost of common shares in treasury (8,517,281) (9,273,452)
Total stockholders' equity 37,788,404 37,038,295
Total liabilities and stockholders' equity $42,988,408 $43,554,774
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