Anika Therapeutics Reports Second Quarter Results.WOBURN, Mass.--(BUSINESS WIRE)--July 22, 1999-- 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: ANIK ANIK Canadian COMSAT ) today reported net income for the second quarter ended June 30, 1999 of $407,000, or $.04 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 $2,201,000, or $.20 per diluted share, for the same period last year. Revenues for the second quarter were $3,750,000 versus $4,596,000 for the corresponding quarter in 1998. Included in revenues for the second quarter of 1998 was a $1,500,000 licensing payment from Zimmer, Inc. for expanded marketing and distribution rights to ORTHOVISC(R), Anika's 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. Product revenue for the second quarter rose 21 percent to $3,750,000 from $3,096,000 for the second quarter of 1998. For the six-months ended June 30, 1999 net income was $752,000, or $.07 per diluted share, compared with $2,838,000, or $.26 per diluted share, for the same period in 1998. Year-to-date revenues were $6,975,000 versus $7,350,000 for the first half of last year. Product revenue for the first six months of 1999 rose 19 percent to $6,975,000 from the prior year level of $5,850,000. J. Melville Engle, chairman, president and chief executive officer, said the 21 percent increase in product revenue for the quarter was due to higher international sales of ORTHOVISC, which rose 76 percent from the previous year's quarter. "We saw a strong increase in ORTHOVISC sales for the quarter and are continuing to work closely with Zimmer on the rollout of ORTHOVISC in Europe," he said. Last month Anika announced it had further expanded its distribution agreement with Zimmer to encompass much of Eastern Europe Eastern Europe The countries of eastern Europe, especially those that were allied with the USSR in the Warsaw Pact, which was established in 1955 and dissolved in 1991. , the Middle East and Africa. "Our primary focus for the quarter has been on expediting enrollment of patients into the ORTHOVISC clinical trial, which commenced in late April," Engle said, noting that the company expects to complete enrollment of its target 350 patients at 23 clinical sites by the end of August. The company incurred approximately $500,000 in ORTHOVISC clinical trial expenses during the second quarter of 1999. In other news concerning the company's product pipeline, Anika noted it has elected to suspend further development of HA oligosaccharides oligosaccharides (ol´igōsak´ n. for the treatment of cancer. "Our senior team and scientific advisory board did a thorough evaluation of the program and we came to the conclusion that the projected development costs and time to market were too great to make strategic sense for Anika," Engle said. Anika Therapeutics, Inc. (www.anikatherapeutics.com) develops manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing Healing See also Medicine. Achilles’ spear had power to heal whatever wound it made. [Gk. Lit.: Iliad] Agamede Augeas’ daughter; noted for skill in using herbs for healing. [Gk. Myth. 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 (not for sale in U.S.), Anika currently 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 and manufactures AMVISC(R) and AMVISC(R) Along with, highly viscous viscous /vis·cous/ (vis´kus) sticky or gummy; having a high degree of viscosity. vis·cous adj. 1. Having relatively high resistance to flow. 2. Viscid. HA products used as 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" supplements 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(TM), 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 . The statements made in this press release which are not 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. within the meaning of Section 27A of the Securities Exchange Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company's actual results could differ materially from those set forth in the forward-looking statements as a result of a number of factors. In particular, there can be no assurance that the expanded agreement with Zimmer will progress as planned, that the clinical trial can be completed in a timely manner or at all, or if completed, that the results of the trial will produce data supporting the efficacy of ORTHOVISC. Even if the Company is able to successfully complete the clinical trial and the results thereof support the efficacy of ORTHOVISC, there can be no assurance that the Company will receive 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. or other regulatory approval of ORTHOVISC, or that such approval will be obtained in a timely manner or without the need for additional clinical trials. In addition, there can be no assurance that any delay in receiving any such approval will not adversely effect the Company's competitive position. Certain other factors that might cause the Company's actual results to differ materially from those set forth in the forward-looking statements include those factors set forth under the heading "Risk Factors" in the Company's 10-K filed with the Securities and Exchange Commission on March 31, 1999 as well as those listed in the Company's other SEC filings. -0-
Anika Therapeutics, Inc.
INCOME STATEMENTS (Unaudited)
Three months ended Six months ended
June 30, June 30,
1999 1998 1999 1998
Product revenue $ 3,750,275 $ 3,095,966 $ 6,974,853 $ 5,850,385
Licensing payments - 1,500,000 -- 1,500,000
Total revenue 3,750,275 4,595,966 6,974,853 7,350,385
Cost of sales 1,896,633 1,564,569 3,604,804 2,908,041
Gross profit 1,853,642 3,031,397 3,370,049 4,442,344
Operating expenses:
Research and
development 924,819 388,531 1,632,676 891,510
Selling, general
and administrative 807,220 704,228 1,562,171 1,240,214
Total operating
expenses 1,732,039 1,092,759 3,194,847 2,131,724
Income from
operations 121,603 1,938,638 175,202 2,310,620
Interest income, net 297,879 318,468 600,029 610,568
Income before
income taxes 419,482 2,257,106 775,231 2,921,188
Income taxes 12,584 55,651 23,584 82,727
Net income $ 406,898 $ 2,201,455 $ 751,647 $ 2,838,461
Basic earnings
per share $ 0.04 $ 0.22 $ 0.08 $ 0.29
Shares used for
computing basic EPS 9,558,024 9,948,095 9,395,390 9,895,082
Diluted earnings
per share $ 0.04 $ 0.20 $ 0.07 $ 0.26
Shares used for
computing diluted EPS 10,075,826 11,197,949 10,081,235 11,039,747
Anika Therapeutics, Inc.
Balance Sheets as of June 30, December 31,
1999 1998
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 5,218,037 $ 10,712,520
Short-term investments 10,158,240 12,007,503
Accounts receivable 2,840,423 3,032,737
Inventories 4,018,018 3,522,019
Prepaid expenses 610,502 250,023
Total current assets 22,845,220 29,524,802
Property and equipment 7,157,431 6,376,405
Less accumulated depreciation 4,160,340 3,809,723
Net property and equipment 2,997,091 2,566,682
Long-term investments 5,632,881 --
Notes receivable from officers 252,000 193,000
Long term deposits 108,500 108,500
Total Assets $ 31,835,692 $ 32,392,984
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 815,914 $ 891,493
Accrued expenses 1,418,954 1,356,586
Deferred revenue 200,000 200,000
Total current liabilities 2,434,868 2,448,079
Advance rent payment 22,707 50,215
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,
respectively 99,919 99,919
Additional paid-in capital 31,986,825 34,439,676
Deferred compensation (801,614) (1,074,699)
Treasury stock, (at cost) 204,707
and 344,500 shares,
respectively (978,247) (1,889,794)
Accumulated deficit (928,766) (1,680,412)
Total stockholders' equity 29,378,117 29,894,690
Total Liabilities and
Stockholders' Equity $ 31,835,692 $ 32,392,984
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