Anika Therapeutics Reports 2003 Third Quarter Financial Results.Business Editors WOBURN, Mass.--(BUSINESS WIRE)--Nov. 6, 2003 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 announced financial results for the third quarter and nine-months ended September 30, 2003. For the third quarter, Anika posted revenue of $3,688,000, a 27% increase, compared with $2,905,000 for the same period last year. Net income for the quarter was $420,000, or $.04 per share, compared with a net loss of $908,000, or $.09 per share, for the third quarter of 2002. For the nine-month period ended September 30, 2003, revenue increased 19% to $10,390,000 versus $8,716,000 in the comparable period in 2002. The company reported net income for the nine-month period in 2003 of $26,000, or $0.00 per share, compared with a net loss of $3,869,000, or $0.39 per share in 2002. "This quarter the company continued to benefit from strong HYVISC(R) sales, our 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 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. , and steady momentum in the ORTHOVISC(R) business, our product for the treatment of osteoarthritis of the knee, compared with the same period last year," said Charles Sherwood This article is about the pocket knife manufacturer. For other uses, see Charles D. Sherwood. Charles Sherwood of Camillus, New York was a leading manufacturer of pocket knives in the United States during the late 1890s. , Ph.D., president and chief executive officer. "Our distribution partner for ORTHOVISC in Turkey has devoted additional resources to marketing efforts that are beginning to produce tangible results in that market and we are looking to expand market share in Europe with our recently established alliances." In September the company announced it had expanded the sales territory in Europe to include Germany and France. Marketing efforts have begun in Germany but will not begin in France until reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. approval has been received. Dr. Sherwood also said the company's ophthalmics business was steady in the third quarter, with a 10% increase year-over-year and a 13% increase on a sequential quarterly basis. "We are dedicating increased attention to establishing a distribution partner to commercialize ORTHOVISC in the U.S., pending 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. marketing clearance, and to building our product pipeline," continued Dr. Sherwood. "To this end, we are focusing on preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. for a cosmetic 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. product using our patented cross-linked 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. gel to correct dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. defects and moving INCERT(R), our product for the prevention of 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 as soon as practicable practicable adj. when something can be done or performed. ." Gross margin for the third quarter rose to 47.7% compared with 32% in the same period last year and 44.4% in the preceding second quarter, primarily reflecting ongoing improvements in manufacturing efficiencies. For the nine-month period, gross margin was 44.7% versus 28.1% in the comparable period last year. As expected, research and development expenses declined 52% to $482,000 in the most recent quarter compared with the third quarter of 2002 when the company was still conducting its pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for ORTHOVISC, which was completed in late 2002. Similarly, for the nine-month period, research and development expenses declined 38% to $1,939,000 compared with $3,139,000 incurred in the first nine months of 2002. Selling, general and administrative expenses of $885,000 for the 2003 third quarter were on par with the same period last year and declined slightly from $945,000 in the preceding quarter. For the nine months ended September 30, selling, general and administrative expenses declined 13% to $2,945,000. Cash, restricted cash and short-term investments at September 30, 2003 totaled $12.9 million compared with $11.5 million at June 30, 2003. Conference Call Information The company will hold a conference call to review its financial results Friday, November 7, 2003 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, November 7, 2003. About Anika Therapeutics, Inc. Headquartered in Woburn, Mass., 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 (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 of the knee (not approved for sale in the U.S.), Anika markets HYVISC(R) in the U.S. for the treatment of equine 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. 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 goal of obtaining FDA approval for ORTHOVISC(R), (vii) the Company's expectations of the size of 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. and European markets, including Germany and France, for osteoarthritis of the knee, (viii) the Company's intention to increase market share for ORTHOVISC(R) in international (and, eventually, domestic) markets or otherwise penetrate growing markets for osteoarthritis of the knee, and (ix) 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. 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, including ORTHOVISC(R), 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 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 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, including enlisting a domestic distribution partner for ORTHOVISC(R), (iii) new distribution arrangements will not result in meaningful sales of the Company's products, or (iv) 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, 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 June 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
Three Months Ended Nine Months Ended
September 30, September 30,
2003 2002 2003 2002
----------- ----------- ------------ ------------
Product revenue $3,666,000 $2,889,000 $10,339,000 $8,690,000
License revenue 22,000 16,000 51,000 26,000
----------- ----------- ------------ ------------
Total revenue 3,688,000 2,905,000 10,390,000 8,716,000
Cost of product
revenue 1,930,000 1,975,000 5,745,000 6,264,000
----------- ----------- ------------ ------------
Gross profit 1,758,000 930,000 4,645,000 2,452,000
Operating expenses:
Research and
development 482,000 999,000 1,939,000 3,139,000
Selling, general
and administrative 885,000 900,000 2,945,000 3,368,000
----------- ----------- ------------ ------------
Total operating
expenses 1,367,000 1,899,000 4,884,000 6,507,000
----------- ----------- ------------ ------------
Income (loss) from
operations 391,000 (969,000) (239,000) (4,055,000)
Interest income,
net 29,000 61,000 111,000 186,000
----------- ----------- ------------ ------------
Income (loss) before
income tax 420,000 (908,000) (128,000) (3,869,000)
Income tax benefit -- -- 154,000 --
----------- ----------- ------------ ------------
Net income (loss) $420,000 $(908,000) $26,000 $(3,869,000)
=========== =========== ============ ============
Basic net income
(loss) per share $0.04 $(0.09) $-- $(0.39)
=========== =========== ============ ============
Shares used to
calculate basic net
income (loss) per
share 9,959,904 9,934,280 9,945,195 9,934,280
=========== =========== ============ ============
Diluted net income
(loss) per share $0.04 $(0.09) $-- $(0.39)
=========== =========== ============ ============
Shares used to
calculate diluted
net income (loss)
per share 10,422,066 9,934,280 10,271,681 9,934,280
=========== =========== ============ ============
Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets
Sept. 30, Dec. 31,
2003 2002
------------ ------------
ASSETS
Current assets:
Cash and cash equivalents $12,611,000 $11,002,000
Restricted Cash 253,000 --
Marketable securities -- 2,500,000
Accounts receivable, net 1,909,000 1,198,000
Inventories 3,342,000 2,924,000
Prepaid expenses and other current assets 141,000 320,000
------------ ------------
Total current assets 18,256,000 17,944,000
Property and equipment, at cost 9,785,000 9,619,000
Less: accumulated depreciation (8,427,000) (7,679,000)
------------ ------------
1,358,000 1,940,000
Long-term deposits 143,000 143,000
Notes receivable from officers -- 59,000
------------ ------------
Total assets $19,757,000 $20,086,000
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $428,000 $845,000
Accrued expenses and other current
liabilities 1,145,000 1,703,000
Customer deposit -- 327,000
Deferred revenue 1,030,000 147,000
------------ ------------
Total current liabilities 2,603,000 3,022,000
Stockholders' equity:
Preferred stock, $.01 par value; 1,250,000
shares authorized, no shares issued and
outstanding -- --
Common stock, $.01 par value; 30,000,000
shares authorized, 9,991,943 shares
issued 100,000 100,000
Additional paid-in capital 31,572,000 31,640,000
Treasury stock (at cost, 30,538 and 57,663
shares) (148,000) (280,000)
Accumulated deficit (14,370,000) (14,396,000)
------------ ------------
Total stockholders' equity 17,154,000 17,064,000
------------ ------------
Total liabilities and stockholders' equity $19,757,000 $20,086,000
============ ============
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