Anika Therapeutics Reports 2003 Fourth Quarter and Year-End Financial Results.Business Editors/Health/Medical Writers WOBURN, Mass.--(BUSINESS WIRE)--Feb. 27, 2004 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 announced financial results for the fourth quarter and year ended December 31, 2003. Marking the company's first full year of profitable operations since 1998, net income for the year ended December 31, 2003, was $827,000, or $0.08 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 loss of $3,040,000, or $0.31 per diluted share, for 2002. Revenues grew 17% to $15,404,000 from $13,187,000 last year. For the 2003 fourth quarter, net income totaled $801,000, or $0.07 per fully diluted share, compared with net income of $829,000, or $0.08 per diluted share, in the fourth quarter of 2002. Revenues for the quarter increased 12% to $5,014,000 from $4,471,000 for the same period last year. Results for the latest quarter included recognition of $846,000 in revenue previously deferred for the first three quarters of 2003 in accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. with Anika's revenue recognition policies compared with deferred revenue of $839,000 recognized in the 2002 fourth quarter. "In the last several months we've achieved some highly significant milestones for the company," said Charles H. Sherwood, Ph.D., president and chief executive officer. "In December, we signed a multi-year U.S. licensing and supply agreement with Johnson & Johnson's Ortho Biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. Products, L.P. for OrthoVisc(R), our 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. In February, we received final marketing approval from the 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. ) for OrthoVisc. With these achievements behind us, our initial focus for 2004 is on supporting Ortho Biotech's U.S. launch for OrthoVisc and to move two potential therapies in our product pipeline -- one for cosmetic cosmetic /cos·met·ic/ (koz-met´ik) 1. pertaining to cosmesis. 2. a beautifying substance or preparation. cos·met·ic n. tissue augmentation AUGMENTATION, old English law. The name of a court erected by Henry VIII., which was invested with the power of determining suits and controversies relating to monasteries and abbey lands. and another for preventing post-surgical adhesions Adhesions Definition Adhesions are fibrous bands of scar tissue that form between internal organs and tissues, joining them together abnormally. -- into human clinical trials," he added. Anika received an initial payment of $2 million from Ortho Biotech in the fourth quarter of 2003 and has also received a milestone payment of $20 million in the first quarter of 2004 as a result of the FDA approval. Commencing in the first quarter of 2004, these cash payments are to be recognized as revenue ratably over the remaining initial ten-year term of the agreement. Gross margins were 48% and 55% for the full year and fourth quarter of 2003, respectively. This compares with 39% and 59% for the corresponding periods in 2002. The full-year improvement stemmed stemmed adj. 1. Having the stems removed. 2. Provided with a stem or a specific type of stem. Often used in combination: stemmed goblets; long-stemmed roses. from a combination of manufacturing efficiency gains and higher margin product mix, while fourth quarter of 2003 margins reflected lower production levels compared to the same quarter last year. Research and development expenses decreased 17% for the fourth quarter and 34% for the full year of 2003. The decrease was primarily due to lower costs associated with the clinical trial for OrthoVisc in 2003 compared to 2002. Selling, general and administrative (SG&A) expenses for the fourth quarter increased 20% compared with the fourth quarter of 2002 mainly due to personnel-related costs and outside and professional service fees. SG&A expenses decreased 5% on a year-over-year basis mainly due to lower overall outside and professional service fees. Cash and restricted cash at December 31, 2003, totaled $15.4 million compared with cash and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has of $13.5 million at December 31, 2002. Conference Call Information The company will hold a conference call to review its financial results on Friday, February 27, 2004, at 11:00 a.m. EST EST electroshock therapy. EST abbr. electroshock therapy . To listen to the conference call, dial 706-634-1550 approximately 10 minutes before the starting time Noun 1. starting time - the time at which something is supposed to begin; "they got an early start"; "she knew from the get-go that he was the man for her" commencement, get-go, offset, outset, showtime, start, kickoff, beginning, first and reference Anika Therapeutics. In addition, the conference call will be available to interested parties through a live audio Internet broadcast at http://www.anikatherapeutics.com/newset.htm. The call will be archived and accessible on the same Web site for one year beginning at 2:00 p.m. EST P.M. also p.m. or p.m. abbr. post meridiem Usage Note: By definition, 12 a.m. Friday, February 27. About Anika Therapeutics, Inc. Headquartered in Woburn, 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. Anika products include OrthoVisc(R), a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by Ortho Biotech Products, L.P., and Hyvisc(R), a treatment for 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 marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc. Anika manufactures Amvisc(TM) and Amvisc Plus(TM), 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. It also produces CoEase(TM), which is marketed by Advanced Medical Optics Advanced Medical Optics, Inc., (NYSE: EYE) (known as AMO) is a global medical device leader focused on the discovery and delivery of innovative vision technologies that optimize the quality of life for people of all ages. , Inc.; STAARVISC(TM)-II, distributed by STAAR STAAR Second Time Around Aussie Rescue, Inc. (Bryan, TX) STAAR Space Technology Applications Astronomy & Rocket Research (Scottish Rocket Programme) Surgical Company; and Shellgel(TM) for Cytosol cytosol /cy·to·sol/ (sit´ah-sol) the liquid medium of the cytoplasm, i.e., cytoplasm minus organelles and nonmembranous insoluble components.cytosol´ic cy·to·sol n. Ophthalmics, Inc. 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 Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements that may be identified by words such as "expectations," "remains," "focus," "expected," "prospective," "expanding," "building," "continue," "progress," "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek" and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements. These statements also include statements regarding: (i) the Company's efforts and expectations in entering into long-term arrangements to market and distribute ophthalmic and osteoarthritis products; (ii) the level of the Company's revenue or sales in particular geographic areas and/or for particular products; (iii) the market share of any of the Company's products; (iv) expectations regarding future results of operations, including the Company's expectations regarding cash utilization; (v) the Company's intention to strengthen, expand and grow its ophthalmic franchise and the growth of the Company's ophthalmic business; (vi) the Company's expectations of the size of the U.S. and European markets, including Germany and France, for osteoarthritis of the knee; (vii) the Company's intention to increase market share for ORTHOVISC(R) in international and domestic markets or otherwise penetrate growing markets for osteoarthritis of the knee; (viii) the Company's corporate objectives and research and development and collaboration opportunities, including, without limitation, intended preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. development of potential cosmetic tissue augmentation products and commencement of INCERT(R) clinical trials; and (ix) the timing and results of the U.S. launch for ORTHOVISC(R). These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties and other factors. 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, including: (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all, obtain clinical data to support a pre-market approval application and/or FDA approval, and/or receive FDA or other regulatory approvals of its products, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (ii) the success of the Company's efforts to improve the financial performance of its core business; (iii) the Company's research and product development efforts and their relative success, including whether the Company has any meaningful sales of any new products resulting from such efforts; (iv) the cost effectiveness and efficiency of our manufacturing operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations. and production planning Production planning The function of a manufacturing enterprise responsible for the efficient planning, scheduling, and coordination of all production activities. ; (v) the strength of the Turkish, German, Canadian and French economies, in general, and other economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; or (vi) future determinations by the Company to allocate To reserve a resource such as memory or disk. See memory allocation. resources to products and in directions not presently contemplated. Any delay in receiving any regulatory approvals may adversely affect the Company's competitive position. Even if regulatory approvals are obtained, there is a risk that meaningful sales of the products may not be achieved. There is also a risk that (i) the Company's existing distributors or customers will not continue to place orders at historical levels or that any of them will seek to modify or terminate existing arrangements; (ii) the Company's efforts to enter into long-term marketing and distribution arrangements will not be successful; (iii) new distribution arrangements, including the agreement with Ortho Biotech Products, L.P. pertaining per·tain intr.v. per·tained, per·tain·ing, per·tains 1. To have reference; relate: evidence that pertains to the accident. 2. to ORTHOVISC(R), will not result in meaningful sales of the Company's products; (iv) the Company will be unable to achieve performance and sales threshold milestones in its distribution agreements; (v) competitive products will adversely impact the Company's product sales; (vi) the estimated size of the markets to which the Company has targeted its products will fail to be achieved; or (vii) increased sales of the Company's products, including HYVISC(R), ORTHOVISC(R) or its ophthalmic products, will not continue or sales will decrease or not reach historical sales levels, or even if such increases occur that such increases will improve gross margins, any of which may have a material adverse effect on the Company's business and operations. 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 each of 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, 2002, its Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended September 30, 2003, and Current Reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. , as well as those described in the Company's other press releases and SEC filings.
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations
Quarter Ended Year Ended
December 31, December 31,
2003 2002 2003 2002
----------- ----------- ------------ ------------
Product revenue $4,992,000 $4,439,000 $15,330,000 $13,129,000
License revenue 22,000 32,000 74,000 58,000
----------- ----------- ------------ ------------
Total revenue 5,014,000 4,471,000 15,404,000 13,187,000
Cost of product
revenue 2,260,000 1,845,000 8,005,000 8,109,000
----------- ----------- ------------ ------------
Gross profit 2,754,000 2,626,000 7,399,000 5,078,000
Operating expenses:
Research and
development 656,000 789,000 2,595,000 3,928,000
Selling, general
and
administrative 1,264,000 1,057,000 4,209,000 4,425,000
----------- ----------- ------------ ------------
Total operating
expenses 1,920,000 1,846,000 6,804,000 8,353,000
----------- ----------- ------------ ------------
Income (loss) from
operations 834,000 780,000 595,000 (3,275,000)
Interest
(income)
expense, net (33,000) (54,000) (144,000) (240,000)
----------- ----------- ------------ ------------
Income (loss) before
provision for
income taxes 867,000 834,000 739,000 (3,035,000)
Provision for income
taxes 66,000 5,000 (88,000) 5,000
----------- ----------- ------------ ------------
Net income (loss) $801,000 $829,000 $827,000 $(3,040,000)
=========== =========== ============ ============
Basic net earnings
(loss) per share $0.08 $0.08 $0.08 $(0.31)
=========== =========== ============ ============
Basic shares
outstanding 9,979,068 9,934,280 9,953,733 9,934,280
=========== =========== ============ ============
Diluted net earnings
(loss) per share $0.07 $0.08 $0.08 $(0.31)
=========== =========== ============ ============
Diluted shares
outstanding 11,188,042 9,968,860 10,849,610 9,934,280
=========== =========== ============ ============
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
December 31, December 31,
2003 2002
------------ ------------
ASSETS
Current assets:
Cash and cash equivalents $14,592,000 $11,002,000
Restricted cash 818,000 -
Marketable securities - 2,500,000
Accounts receivable, net 1,421,000 1,198,000
Inventories 3,627,000 2,924,000
Prepaid expenses and other current assets 81,000 320,000
------------ ------------
Total current assets 20,539,000 17,944,000
Property and equipment 9,875,000 9,619,000
Less accumulated depreciation (8,684,000) (7,679,000)
------------ ------------
Net property and equipment 1,191,000 1,940,000
Long-term deposits 143,000 143,000
Loan receivable officer - 59,000
------------ ------------
Total assets $21,873,000 $20,086,000
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $349,000 $845,000
Other accrued expenses 1,297,000 1,703,000
Customer deposit -- 326,000
Deferred revenue 378,000 148,000
Income taxes payable 65,000 -
------------ ------------
Total current liabilities 2,089,000 3,022,000
Long-Term Deferred Revenue 1,800,000 --
Stockholders' equity:
Common stock 100,000 100,000
Additional paid-in capital 31,480,000 31,640,000
Treasury stock (27,000) (280,000)
Accumulated deficit (13,569,000) (14,396,000)
------------ ------------
Total stockholders' equity 17,984,000 17,064,000
------------ ------------
Total liabilities and stockholders' equity $21,873,000 $20,086,000
============ ============
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