Anika Therapeutics Reports Second Quarter Financial Results.Business/Health and Medical Writers WOBURN, Mass.--(BUSINESS WIRE)--Aug. 3, 2000 Anika Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. , Inc. (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 :ANIK ANIK Canadian COMSAT ) today reported that revenue for the second quarter ended June 30, 2000 increased to $3,769,000 compared with $3,533,000 for the second quarter of 1999. The company recorded a net loss for the quarter of $218,000, or $.02 per diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share, compared with a net income of $398,000, or $0.04 per diluted share, for the same period last year. For the six months ended June 30, 2000, revenue was $6,490,000 compared with $6,869,000 for the first six months of 1999. The net loss for the six months ended June 30, 2000 was $783,000, or $.08 per diluted share, compared with a net loss of $2,771,000, or $0.27 per diluted share, for the first half of 1999. Included in the first half of 1999 was a charge of $3,625,000 reflecting a previously announced change in accounting principle relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc revenue recognition for non-refundable fees. Income before the cumulative effect of the accounting change for the first six months of 1999 was $854,000, or $.08 per diluted share. J. Melville Engle, chairman, president and chief executive officer, attributed the increase to revenues associated with ORTHOVISC, primarily the recognition of certain previously deferred revenue. Gross margins for the quarter declined to 36 percent of total revenue compared with 52 percent for the same period last year. Engle said the decline was primarily due to the new supply contract terms with Bausch & Lomb Surgical announced earlier this week, which included lower prices effective retroactively ret·ro·ac·tive adj. Influencing or applying to a period prior to enactment: a retroactive pay increase. [French rétroactif, from Latin to April 1, 2000. The company closed the second quarter with cash and investments of $19.2 million. Regarding the company's future plans for ORTHOVISC following the recent announcement of disappointing clinical trial results, Engle said the results are still being evaluated by an independent research firm and the company's scientific advisory board and this evaluation must be completed before making any decision about whether to conduct additional clinical trials. About Anika Therapeutics Anika Therapeutics, Inc. (www.anikatherapeutics.com) develops, manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing of bone, cartilage cartilage (kär`təlĭj), flexible semiopaque connective tissue without blood vessels or nerve cells. It forms part of the skeletal system in humans and in other vertebrates, and is also known as gristle. and soft tissue. These products are based on hyaluronic acid hyaluronic acid: see mucopolysaccharide. Hyaluronic acid A polysaccharide which is an integral part of the gel-like substance of animal connective tissue; it supposedly serves as a lubricant and shock absorbent in the joints. (HA), a naturally occurring, biocompatible biocompatible /bio·com·pat·i·ble/ (-kom-pat´i-b'l) being harmonious with life; not having toxic or injurious effects on biological function. polymer found throughout the body. In addition to ORTHOVISC(R), a treatment for osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. of the knee (not approved for sale in the U.S.), Anika markets HYVISC(R) in the U.S. for the treatment of equine equine Any member of the ungulate family Equidae, which includes the modern horses, zebras, and asses, all in the genus Equus, as well as more than 60 species known only from fossils. Equines descended from the dawn horse (see Eohippus). osteoarthritis through Boehringer Ingelheim Vetmedica, Inc. and manufactures Amvisc(R) and Amvisc(R) Plus, HA viscoelastic Adj. 1. viscoelastic - having viscous as well as elastic properties natural philosophy, physics - the science of matter and energy and their interactions; "his favorite subject was physics" products for ophthalmic ophthalmic /oph·thal·mic/ (of-thal´mik) ocular (1). oph·thal·mic adj. Of or relating to the eye; ocular. Ophthalmic Pertaining to the eye. surgery, for Bausch & Lomb Surgical. Therapies currently under development include INCERT(R), a family of HA products designed to prevent post-surgical adhesions Adhesions Definition Adhesions are fibrous bands of scar tissue that form between internal organs and tissues, joining them together abnormally. . Anika is also collaborating with Orquest, Inc. to manufacture OSSIGEL(R), an injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation of basic fibroblast growth factor Basic fibroblast growth factor, also known as bFGF or FGF2, is a member of the fibroblast growth factor family. In normal tissue, basic fibroblast growth factor is present in basement membranes and in the subendothelial extracellular matrix of blood combined with HA designed to accelerate the healing of bone fractures Fractures Definition A fracture is a complete or incomplete break in a bone resulting from the application of excessive force. Description , which is also under development. The statements made in this press release which are not statements of historical fact 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. within the meaning of Section 27A of the Securities Exchange Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements involve known and unknown risks, uncertainties and other factors. The words "believe," "will," "would," "expects," "anticipates," "intends," "estimates," "future plans" and other expressions which are predictions of or indicate future events and trends and which do not relate to historical matters identify forward-looking statements. In particular, with respect to the new agreement with Bausch & Lomb Surgical, under certain circumstances, (i) Bausch & Lomb Surgical may have the right to terminate the agreement and/or (ii) the agreement may revert re·vert v. 1. To return to a former condition, practice, subject, or belief. 2. To undergo genetic reversion. to a non-exclusive basis; in each case, the Company cannot make any assurances such circumstances will not occur. The Company's actual results could differ materially from any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors, which include the results of its research and development efforts and timing of regulatory approval. There can be no assurances that the Company will achieve incremental Additional or increased growth, bulk, quantity, number, or value; enlarged. Incremental cost is additional or increased cost of an item or service apart from its actual cost. sales of its ophthalmic products to Bausch & Lomb Surgical and/or other companies sufficient to offset the effects of the price reduction to Bausch & Lomb Surgical. The Company can make no assurances as to its future plans, if any, regarding ORTHOVISC(R). There can be no assurances that: (i) further analysis of the clinical data or any additional clinical data will support the efficacy of ORTHOVISC(R), (ii) the Company will undertake any additional clinical trials of ORTHOVISC, (iii) it will be able to successfully complete an additional clinical trial or (iv) additional clinical trials will support a 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 application and/or 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. approval in a timely manner or at all. Moreover, there can be no assurances that the Company's investments in the clinical research and product development in OSSIGEL(R) and INCERT(R) will lead to viable products or revenue growth. Certain other factors that might cause the Company's actual results to differ materially from those in the forward-looking statements include those set forth under the headings "Business," "Risk Factors and Certain Factors Affecting Future Operating Results" and "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" 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. for the year ended December 31, 1999, as well as those described in the Company's other SEC filings.
Anika Therapeutics, Inc.
STATEMENTS OF OPERATIONS (Unaudited)
Three months ended Six months ended
June 30 June 30
2000 1999 2000 1999
(As restated) (As restated)
Product revenue $ 3,668,765 $ 3,433,346 $ 6,289,598 $ 6,668,996
Licensing payments 100,000 100,000 200,000 200,000
Total revenue 3,768,765 3,533,346 6,489,598 6,868,996
Cost of Sales 2,422,617 1,688,714 3,655,585 3,396,885
Gross Profit 1,346,148 1,844,632 2,834,013 3,472,111
Operating expenses:
Selling, general and
administrative 977,210 807,220 1,976,672 1,551,192
Total operating
expenses 1,884,437 1,732,039 4,197,637 3,183,868
Income (loss)
from operations (538,289) 112,593 (1,363,624) 288,243
Interest income, net 329,741 297,879 590,989 600,029
Income (loss)
before income
taxes (208,548) 410,472 (772,635) 888,272
Income taxes 9,941 12,584 9,941 34,563
Income (loss)
before cumulative
effect of change
in accounting
principle (218,489) 397,888 (782,576) 853,709
Cumulative effect
of change in accounting
principle -- -- -- (3,625,000)
Net (loss)
income $ (218,489)$ 397,888 $ (782,576)$(2,771,291)
Basic earnings (loss)
per share:
Income (loss) before
cumulative effect
of change in
accounting
principle $ (0.02)$ 0.04 $ (0.08)$ 0.09
Cumulative effect
of change in
accounting
principle $ -- -- $ -- (0.39)
Net (loss) income $ (0.02)$ 0.04 $ (0.08)$ (0.29)
Shares used for
computing basic EPS 9,918,842 9,558,024 9,847,476 9,395,390
Diluted earnings
(loss) per share:
Income (loss)
before cumulative
effect of change
in accounting
principle $ (0.02)$ 0.04 $ (0.08)$ 0.08
Cumulative effect
of change in
accounting
principle $ -- -- $ -- (0.36)
Net (loss) income $ (0.02)$ 0.04 $ (0.08)$ (0.27)
Shares used for
computing diluted EPS 9,918,842 10,075,826 9,847,476 10,081,235
Anika Therapeutics, Inc.
Balance Sheets as of, June 30, December 31,
2000 1999
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 5,469,430 $ 6,440,705
Short term investments 13,681,829 8,184,870
Accounts receivable 2,115,629 2,106,452
Inventories 7,234,413 5,493,701
Prepaid expenses 485,894 721,206
Total current assets 28,987,195 22,946,934
Property and equipment 8,496,529 8,116,233
Less accumulated depreciation 5,032,638 4,587,692
Net property and
equipment 3,463,891 3,528,541
Long term investments -- 5,558,029
Notes receivable from officers 353,000 353,000
Long term deposits 124,600 124,600
Total Assets $ 32,928,686 $ 32,511,104
LIABILITIES AND STOCKHOLDERS EQUITY
Current liabilities:
Accounts payable $ 1,309,382 $ 629,080
Accrued expenses 1,554,334 1,552,661
Deferred revenue 1,934,968 1,792,505
Total current
liabilities 4,798,684 3,974,246
Long term deferred revenue 2,650,000 2,825,000
Stockholders equity:
Undesignated preferred stock,
$.01 par value: authorized
1,250,000 shares; no shares
issued and outstanding -- --
Common stock, $.01 par value:
authorized 30,000,000 shares;
issued 9,991,943 shares 99,919 99,919
Additional paid in capital 31,737,212 31,959,316
Deferred compensation (384,570) (615,001)
Treasury stock (at cost),
57,663 and 200,863 shares,
respectively (279,756) (959,870)
Accumulated deficit (5,692,803) (4,772,506)
Total stockholders
equity 25,480,002 25,711,858
Total Liabilities and
Stockholders Equity $ 32,928,686 $ 32,511,104
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